• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Guidance On The Content Of Premarket Notification [510(K)] Submissions For Protective Restraints (Text Only)

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR PROTECTIVE RESTRAINTS

 
                  
                             GUIDANCE
                        ON THE CONTENT OF
           PREMARKET NOTIFICATION [510(K)] SUBMISSIONS 
                    FOR PROTECTIVE RESTRAINTS


                 GENERAL HOSPITAL DEVICES BRANCH
  DIVISION OF DENTAL, INFECTION CONTROL AND GENERAL HOSPITAL DEVICES
                   OFFICE OF DEVICE EVALUATION

                          DECEMBER 1995

This guidance does not create or confer any rights, privileges, or benefits
for or on any person, nor does it operate to bind FDA or any other person. 
The agency will consider individual circumstances on a case-by-case basis.

                        TABLE OF CONTENTS

I.   INTRODUCTORY INFORMATION

     A.   Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
     B.   Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
     C.   Definitions . . . . . . . . . . . . . . . . . . . . . . . . . .2
     D.   Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . .2
     E.   General Principles Regarding Presentation of Data . . . . . . .3
     F.   Supplementary Guidance. . . . . . . . . . . . . . . . . . . . .4
     G.   The Review Process. . . . . . . . . . . . . . . . . . . . . . .5
     H.   Standards . . . . . . . . . . . . . . . . . . . . . . . . . . .7

II.  CONTENT AND ORGANIZATION OF 510(K)S FOR PROTECTIVE RESTRAINT DEVICES

     A.   Cover Letter. . . . . . . . . . . . . . . . . . . . . . . . . .8
     B.   Labels and Labeling . . . . . . . . . . . . . . . . . . . . . .8
          1.   General Information 
          2.   Labeling Requirements and Recommendations
     C.   Device Description. . . . . . . . . . . . . . . . . . . . . . .11
          1.   General Description
          2.   Drawing/Picture
          3.   Intended Use 
          4.   Specifications
               a.   Physical
               b.   Mechanical
          5.   Materials 
          6.   Biocompatibility
     D.   Descriptive Comparison to a Legally Marketed Device . . . . . .13
     E.   Performance Data. . . . . . . . . . . . . . . . . . . . . . . .14
          1.   Introduction
          2.   Types of Performance Tests
          3.   Performance Data Considerations
          4.   Elements of a Simulated Use Study
          5.   Summary
          6.   Additional Data Requirements
     F.   Features of Safe and Effective 
          Protective Restraint Devices. . . . . . . . . . . . . . . . . .19
     G.   Future Revisions. . . . . . . . . . . . . . . . . . . . . . . .19

     Appendices:

          1.   Example of Comparison Table . . . . . . . . . . . . . . . 20
          2.   Example of Vest Pictorial . . . . . . . . . . . . . . . . 21
          3.   Examples of Bed Pictorials. . . . . . . . . . . . . . . . 22    
          4.   Examples of Wheelchair Pictorials . . . . . . . . . . . . 23
          5.   Examples of Sizing Guides . . . . . . . . . . . . . . . . 24 
                                  
I.   INTRODUCTORY INFORMATION
                                                 
A.   Background and Scope

     Protective restraints, as defined in Section I.C., Page 2,
     have been implicated in numerous injuries and deaths from
     asphyxiation.  Vests and jackets have been involved most
     frequently, although body holders also have been reported on
     occasion.  Human factors issues such as inadequate warning
     labels, difficult-to-read user instructions, and design
     deficiencies may contribute to accidents.

     In order to help address the problems, on [DATE] FDA revised
     the protective restraint and wheelchair accessory
     classification regulations to require premarket notification
     510(k) submissions for protective restraints not already
     regulated under another classification [FR REFERENCE]. 
     Under the revised rules, a 510(k) is required (1) for any
     protective restraint intended to be introduced into
     commercial distribution on or after [DATE], and (2) for any
     protective restraint already in commercial distribution or
     that is marketed prior to [DATE].

     This document provides guidance on the form and content of
     510(k)s for protective restraints.  The document is also a
     voluntary guide for persons marketing devices which may have
     protective restraints as components, such as operating
     tables and chairs that are regulated under other devices
     that are exempt from 510(k) requirements.  Devices
     pertaining to this guidance include wristlets, anklets,
     vests, straight jackets, body/limb holders, and other types
     of protective restraints that are intended for medical
     purposes.  

     Other relevant guidance documents that contain additional
     information are referenced in Section I.F., Supplementary
     Guidance, on Page 4.  

B.   Purpose

     As noted, manufacturers of protective restraints, including
     those devices already in commercial distribution and
     previously exempted from premarket notification, are
     required to submit a premarket notification to FDA. 
     Therefore, this guidance is intended:

     1.   to guide FDA review staff in conducting and documenting
          the review of premarket notifications for protective
          restraint devices;
     2.   to assist persons (i.e., manufacturers, distributors,
          or importers) in assembling and organizing premarket
          notifications for protective restraints; and
     3.   to achieve consistency in content of the 510(k)s in
           order to facilitate document review. 

C.   Definitions

     1.   Accessory Device: a device that aids or contributes in
          a secondary manner to the effectiveness of another
          device (e.g., wheelchair accessories ref. 21 CFR
           890.3910).
     2.   Intended Use: the objective intent of the persons
          legally responsible for the labeling of the device. 
          The intent is determined by such persons' expressions
          or may be shown by the circumstances surrounding the
          distribution of the device.  The objective intent may,
          for example, be shown by labeling claims, advertising
          matter, oral or written statements by such persons or
          their representatives.  It may be shown by the
          circumstances that the device is, with the knowledge of
          such persons or their representatives, offered and used
          for a purpose for which it is neither labeled nor
          advertised (ref. 21 CFR  801.4, FDA Labeling).     
     3.   Labeling: all labels and other written, printed, or
          graphic matter (1) on any device or any of its
          containers or wrappers, or (2) accompanying such device
          (ref. Sec. 201, F,D,& C Act) 
     4.   Protective Restraint: a device, including but not
          limited to, a wristlet, anklet, vest, mitt, straight
          jacket, body/limb holder, or other type of strap that
          is intended for medical purposes and that limits the
          patient's movements to the extent necessary for
          treatment, examination, or protection of the patient or
          others
          (ref. 21 CFR  880.6760).
     5.   Vehicle: for purposes of this guidance, the object to
          which a restraint is attached (e.g., a bed, wheelchair
          or stretcher).

D.   Abbreviations  
          
     AAMI  Association for the Advancement of Medical
           Instrumentation        
     ANSI  American National Standards Institute
     ASTM  American Society for Testing and Materials
     CDRH  Center for Devices and Radiological Health
     CFR   Code of Federal Regulations
     DSMA  Division of Small Manufacturers' Assistance
     FDA   Food and Drug Administration
     FR    Federal Register
     HCFA  Health Care Financing Administration
     ISO   International Organization for Standardization
     MDR   Medical Device Report
     NSE   Not Substantially Equivalent
     OBRA  Omnibus Budget Reconciliation Act
     ODE   Office of Device Evaluation
     PMA   Premarket Approval Application
     PRP   Product Reporting Program
     SMDA  Safe Medical Devices Act of 1990


E.   General Principles Regarding Presentation of Data

     1.   Editorial Considerations:  The 510(k) should be
          carefully edited, as well as scientifically reviewed,
          before it is submitted to FDA.  It should be proofread
          to assure that all pages/sections are included and are
          properly indicated, consecutive, distinctly copied and
          legible.
     2.   Abbreviations:  Standard abbreviations acceptable to a
          significant peer reviewed journal should be used
          wherever possible.  All other abbreviations should be
          identified at the beginning of each section in which
          they are used or in footnotes to tables and graphs.
     3.   Data Availability:  This document outlines typical
          circumstances of data review.  It is not possible to
          anticipate all situations that may require FDA review. 
          Thus, those submitting applications should be aware
          that they may be asked to submit additional data, to
          present data in another format or to provide more
          detailed explanations of the information submitted if
          required to establish equivalence.

          Applicants should keep data used for the 510(k)
          submission on file in a controlled and well-organized
          format.  This will allow the applicant to expeditiously
          supply FDA with additional information or analysis, if
          required.  Errors in data that are identified by the
          applicant after submission to FDA should be brought
          immediately to FDA's attention.
     4.   Tables and Graphs:  Well-constructed tables are
          fundamental to the reporting and evaluation of data. 
          All tables should be clearly identified and captioned
          with symbols keyed to a footnote or accessible
          reference page that adequately indicates the nature of
          the data.

          Graphs should supplement, not replace, data tables. 
          They should be of a high quality.
     5.   Published Literature:  Published methods or data
          referenced in study reports should be made available to
          FDA upon request.  Reprints of other referenced
          published or unpublished reports or data should also be
          made available to FDA upon request.  All referenced
          reports and data should be summarized including an
          explanation regarding how it relates to the current
          submission.  Reference citations should be complete
          (e.g., title, author, volume and year).
     6.   Protocols and Data Analysis:  Test reports must include
          the protocol (objectives, precise description of
          materials, experimental methods and controls),
          observations, statistical methods and analyses,
          conclusions and comments.  Do not submit raw data
          unless requested to do so by FDA.  Additional specific
          directions on protocols are included in sections that
          follow.
     7.   Reference to Submitted Data:  In support of the 510(k),
          the applicant may reference any information previously
          submitted to FDA.  If the applicant did not submit the
          referenced data, he must provide a letter of
          authorization.  Often, if the data are not extensive,
          resubmitting data in the 510(k) will facilitate the
          review of the document.

F.   Supplementary Guidance

     The following relevant guidance documents are available from
     DSMA [(800)638-2041 or (301)443-6597], unless otherwise
     indicated:

     1.   Biological evaluation of medical devices - Part 1: 
          Evaluation and Testing ISO 10993.
     2.   ODE Blue Book Memorandum #K86-3, Premarket Notification
          Review Program.
     3.   Write It Right: Recommendations for Developing User
          Instruction Manuals for Medical Devices Used in Home
          Health Care (HHS Publication FDA 93-4258).
     4.   Human Factors Principles for Medical Device Labeling.
     5.   ANSI/AAMI HE48-1993:  Human factors engineering
          guidelines and preferred practices for the design of
          medical devices (available from the Association for the
          Advancement of Medical Instrumentation: (703) 525-4890,
          or (800) 332-2264).
     6.   "Medical Devices: protective restraints; revocation of
          exemptions from 510(k) premarket notification
          procedures and current good manufacturing practice
          regulations," Proposed Rule, June 19, 1992 (57 FR:
          27397-27400).
     7.   ANSI Z535, Committee on safety signs and colors, New
          York, 1991.
     8.   ODE Blue Book Memorandum #G91-1, Device Labeling
          Guidance.
     9.   Omnibus Budget Reconciliation Act of 1989 (OBRA '87).
     10.  21 CFR Part 801, Device Labeling
     11.  Proposed and Final Rules (Federal Register) pertaining
          to 21 CFR Part 880, General Hospital and Personal Use
          Devices and Part 890, Physical Medicine Devices.
     12.  Labeling Regulatory Requirements for Medical Devices
          (FDA 89-4203).

     DSMA also has additional guidance documents that are
     generally relevant to the marketing of medical devices, such
     as guidance on good manufacturing practices. 

G.   The FDA Review Process

     Questions often arise regarding the FDA review process for
     510(k) submissions.  The following is a brief outline of
     that process.

     Administrative Review

     1.   The applicant submits a 510(k) to the FDA Document Mail
          Center.
     2.   The Document Mail Center assigns the 510(k) number and
          determines if the 510(k) states the classification for
          the device.    

          If it does not include the FDA device class, then
          the applicant is notified by phone that they
          should amend the 510(k) to note the class, and the
          submission is placed on hold.  

          If it includes the class, then an acknowledgement
          of receipt letter is sent to the applicant.

     3.   The 510(k) with the class information is directed to
          the reviewing division.
     4.   Division personnel conduct an initial administrative
          review of the 510(k) to determine if it includes the
          basic information required by regulation.  The document
          is also administratively triaged into one of three
          levels or Tiers which determines the type of scientific
          review that will be afforded the device.  Tier 1
          devices have a limited review while Tier 3 devices have
          a comprehensive and rigorous review.  Protective
          restraint devices are considered Tier 2 devices at this
          time requiring focussed scientific review.

          If the 510(k) is not administratively complete,
          then the submission is placed on hold by a letter
          that is sent to the applicant explaining the
          administrative deficiencies.

          If it is complete, then the submission is placed
          in a queue for the scientific review, appropriate
          for the assigned Tier.
Scientific Review
     
     Substantial equivalence is determined as detailed in the
     Blue Book 510(k) Memorandum #86-3 available from DSMA. 
     Basically, there are four main questions the FDA reviewer
     considers: 

     1.   Does the new device have the same intended use as the
          legally marketed device that is identified by the
          applicant?
     2.   Does the new device have the same technological
          characteristics (i.e., design, materials, energy
          source, etc.) as the legally marketed device?
     3.   Does evaluation of the new device and its technology
          raise new types of safety or effectiveness questions
          when compared to the legally marketed device?            
     4.   Are performance data needed to determine if the new
          device is as safe and effective as the legally marketed
          device?

     There are basically one of three outcomes from the
     scientific review:

     1.   The device is determined to be substantially equivalent
          to a legally marketed device and for which premarket
          approval is not required, and a letter is sent to the
          applicant which allows the device to be legally
          marketed.  
     2.   The reviewer needs more information to complete the
          review.  The reviewer either calls the applicant or FDA
          sends a letter, depending on the complexity of the
          deficiencies or questions.  If the reviewer calls, the
          510(k) may be placed on an administrative hold status. 
          If FDA sends a letter then either:  (1) a 30 day limit
          is placed on the response time, or (2) FDA considers
          the 510(k) withdrawn due to the complexity of the
          deficiencies.

          If more information is requested, and the submission is
          not considered withdrawn, the review stops until the
          information is received.  When the applicant submits a
          response the reviewer places the amended 510(k) in a
          separate amendment queue for review.   

           If the information is not received in the time
           frame noted in the deficiency letter, or as
           requested over the telephone, then the submission
           is considered withdrawn.

           If received, but not complete, FDA may find the
           device not substantially equivalent or may ask for
           more information, and another supplement is
           required.

     3.   The device is found not substantially equivalent (NSE). 
          An NSE device requires an approved PMA or it must be
          reclassified into Class I or II before it may be
          legally marketed.
          
H.   Standards 

     The applicant may list relevant standards and certify that
     the device meets the standards (e.g., AAMI, ASTM, ISO,
     etc.).  The applicant then is obliged to meet the standard
     and maintain documentation of testing showing that the
     device meets the standard.  Certification of meeting a
     specific standard and reference to standards in the 510(k)
     may reduce the documentation needed in the 510(k)
     submission, as noted in the sections on specifications and
      testing.     

II.  CONTENT AND ORGANIZATION OF 510(K)S FOR PROTECTIVE RESTRAINT
     DEVICES

A.   Cover Letter

     The 510(k) should begin with a cover letter that clearly
     identifies the submission as a 510(k).  Title 21 CFR  807.87
     specifies information that is required in the 510(k).  The
     information required under  807.87(a),(b),(c), and (d) can
     be included in the cover letter.  Table 1 notes the required
     class, panel number, product code and the common names that
     are used for protective restraints (ref. FDA Publication 91-4246, 
     Classification Names for Medical Devices and In Vitro
     Diagnostic Products).

				Table 1
ClassPanelProcodeCommon Name
I80PMQProtective
Restraint
I89KIDWheelchair
Accessory
B. Labeling

     1.   General Information for the Applicant
          a.   The submission must contain proposed draft or
               final labeling (ref.  807.87(e)).  Labeling
               includes LABELS affixed to the device, container,
               and/or packaging.  Labeling also includes
               professional and patient package INSERTS, POSTERS
               and any other information accompanying the device
               (e.g, video training).
          b.   Labeling is the primary emphasis of this guidance. 
               Special attention is given to information related
               to human factors issues such as restraint
               application and fastening, positioning and
               orientation, size selection, and patient
               monitoring.  
          c.   Some of the guidance related to human factors
               issues are not uniformly applicable to all
               restraint types.  Applicants should tailor the
               labeling to the specific protective restraint. 
               Consider both the design and the hazards
               associated with the specific use of the device. 
          d.   The labeling must comply with 21  CFR 801, the
               general labeling regulations.  This guidance
               provides additional labeling recommendations.  The
               recommendations provide latitude because of
               differences in device design, size, and available
               labeling space.

               The applicant should also include a summary
               analysis of the literature, if any, relevant to
               the specific design of the restraint submitted for
               review.
          e.   FDA recommends that applicants consider label
               positions and configuration carefully, that is,
               where labels are placedand how they are arranged. 
               For example, a warning attached to the outside of
               a restraint should advise a user not to tie the
               restraint to an inappropriate part of the bed.  It
               is recommended that labels be oriented so that
               they can be read without turning the device
               upside-down.  In addition to providing written
               information, a prominent label on the outside of
               the device also may serve as a marker immediately
               alerting the staff to improper positioning on the
               patient (e.g., label appears at bottom, instead of
               top, after upside-down placement). 
          f.   Labels and labeling should be legible and designed
               for readability and comprehension (see Write It
               Right).  Thus, type size, wording, readability,
               graphics, step-by-step procedures, highlighting,
               blank space, legibility, use of color, formatting,
               reading level, sentence length, writing style,
               etc. are all important.  For example, large type
               sizes are best for reading under poor lighting
               conditions by a wide range of device users.  Also,
               user reading levels should be considered with
               respect to vocabulary and sentence structure.  
          g.   Applicants should consider providing instructions
               in both English and other common languages.
          h.   Recommended formats for pictorials and a sizing
               guide for use in labeling are included in the
               Appendix.

     2.   Labeling Requirements and Recommendations          
          a.   Package Labels  
               Labeling on the packaging should include the
               following information:
                    name of product, type of restraint,
                    manufacturer or distributor (with address),
                    number of components, and net quantity;
                    size; and
                    a prescription labeling statement which reads
                    as follows:  "Caution:  Federal law restricts
                    this device to sale by or on the order of a
                    physician or licensed healthcare
                    practitioner."

          b.   Device Labels
               The protective restraint itself should display the
               following information:
                    the manufacturer and product identification;
                    on vests, jackets and other upper torso
                    restraints (e.g., bodyholders) a position
                    label noting the orientation of the device on
                    the patient (e.g., top/bottom, front/back,
                    inside/outside). 

                    NOTE: The applicant may consider combining
                    different position markers into a single
                    label on one side of the vest (e.g.,
                    "outside/top/back"). 

                    the common size (e.g., small, medium, large)
                    plus body measurements and weight ranges (see
                    Appendix);               
                    a cleaning instruction label, if appropriate;
                    specific warnings related to incorrect
                    placement, wrong size, improper application
                    to the "vehicle", knots preventing quick
                    release and the use of restraints in
                    damaged/poor condition;  
                    pictorials illustrating hazards (e.g.,
                    proper/improper placement) to the patient,
                    when appropriate (see Appendix);
                    cautionary information about the need for
                    frequent patient monitoring and device
                    flammability; and
                    the most important application steps,
                    whenever possible. 

          c.   Instructions For Use
                    The instructions for use (e.g., package
                    insert, poster, etc.) should include the
                    following:  manufacturer's name and address;
                    description of restraint; sizing table;
                    indications for use; contraindications;
                    warnings and precautions; application and
                    fitting instructions; and the FDA required
                    prescription statement from Section 801.

                    NOTE:  Ample use of pictorials is highly
                    recommended.    

                    Labeling should advise restraint users to
                    consult their hospital policy or the
                    individual(s) prescribing the use of the
                    device for further directions on (1) wearing
                    time/release intervals, and (2) frequency of,
                    and reasons for, patient monitoring and
                    supervisory requirements.  Labeling should
                    also recommend periodic refresher training.

                    Each piece of labeling should pertain to only
                    a specific model unless all the instructions
                    in the piece of labeling applies to all the
                    models listed. 

C.   Device Description
     The applicant must include in the 510(k) a complete
     description of the protective restraint, including ALL
     variations of the device.  The description should include:
     1.   General Description
          Provide a detailed description of the protective
          restraint design including any straps, buckles, other
          attachments or accessories.  
     2.   Drawing/Picture
          Provide clear pictorial and labeled representation of
          the device.  Poor quality pictures will delay
          processing of the 510(k).  The labeling may have
          sufficient representations (e.g., graphic
          illustrations) for review purposes.  If this is the
          case, then the applicant should refer FDA to the
          labeling.
     3.   Intended Use
          Provide clear statements of all intended uses for the
          subject  protective restraint.  The intended use should
          address the intended patient condition(s), (e.g.,
          postural support, severe agitation, etc.) and
          vehicle(s) to which the protective restraint may be
          attached (e.g., wheelchair or bed).  Provide clear
          statements of all claims pertaining to the subject
          protective restraint.  The intended use and claims must
          be consistent with the labeling.

          The intended use statements and claims must be
          supported by comparison to a legally marketed
          protective restraint.  The scope of use and claims are
          very important in defining the type and amount of data
          that is needed in the 510(k) submission, and defined in
          Section E of this document.     
     4.   Specifications
          The applicant should provide the applicable
          specifications noted below.  State the specification
          and tolerances, and provide a summary of all supporting
          test data which validate that the device meets the
          stated specifications.
          
          The applicant may refer to an accepted, relevant
          industry standard and certify that they will meet the
          standard as supporting evidence.  Section  II.E.,
          Performance Data, provides further directions on test
          data.

          The applicant should provide the rationale for each
          specification.  For example, the applicant should cite
          data relevant to size specifications.  If possible,
          applicable anthropometric data, standards, research and
          guidelines should be referenced.  Comparison of
          specifications to other legally marketed protective
          restraints may also suffice.   

          a.   Physical Specifications
               (1)  Sizing:  Provide a chart of the specified
                    sizes and dimensions (see Appendix). The
                    sizing should be based upon available
                    anthropometric data reflecting dimensions
                    (weight, extremity circumference, chest size,
                    trunk length, etc.) for typical patient
                    populations.  Address, the following factors
                    in the rationale for the sizing
                    specifications:

                         Male/Female
                         Adult/Pediatric
                         Older Adult compensations
               (2)  Color (e.g., size coding, see Appendix): 
                    Different colors should be used to
                    differentiate sizes.  There is no standard
                    color coding, however, FDA strongly
                    recommends that the color codes in the
                    Appendix be used.  FDA will acknowledge a
                    request in the 510(k) to allow for a
                    transition to the recommended color code in
                    order to permit depletion of current stock
                    and to make manufacturing changes, as needed. 
                    The transition period should not exceed 180
                    days.  State the original color scheme for
                    the record.  FDA will consider alternatives
                    but the applicant should provide ample
                    justification.
               (3)  Special features:  Any other unique physical
                    features and specifications of the protective
                    restraint should be noted.               
               (4)  Overall:  Describe keyed locks or design  locks 
                    and any pressure relief accessories
                    (e.g., gel foam, lambs wool).

          b.   Mechanical Specifications
               (1)  Include all mechanical specifications in the  
                    premarket notification including those of the
                    following components:
                      buckles
                      belts
                      hooks 
                      snaps
                      straps
                      ties    
                      locks and accessories
               (2)  Mechanical specifications should include, but
                    not be limited to the following:
                      Basis for the criteria
                      Strength of connection mechanism to device 
                      including failure strength of components  
                      Tensile strength of materials including          
                      pass/fail criteria
                      Reuse durability of device and attached
                      labels
     5.   Materials
          Provide a complete listing of all materials used in the
          construction of the protective restraint.  This should
          include the materials used for all attachments such as
          buckles, ties, etc.  Identify all colors (e.g., ink,
          dyes) used in manufacturing the device.  Flame
          retardant materials should be described if utilized.     
     6.   Biocompatibility
          The materials, including colors, should meet
          biocompatibility requirements in accordance with the
          ISO 10993. 

D.   Descriptive Comparison to a Legally Marketed Device
     According to 21 CFR  807.87(f), a premarket notification
     must include a comparison of the new device to a legally
     marketed device.  The purpose of this comparison is to help
     FDA establish that the new device is as safe and effective
     as the claimed legally marketed device.  Therefore, FDA has
     called for 510(k)s for ALL protective restraints, new ones
     as well as those previously marketed due to safety concerns.
     1.   If a protective restraint was on the market prior to
          May 28, 1976 (preamendment) and has not since that date
          been modified in a manner that would significantly
          affect the safety or effectiveness of the device or
          undergone a major change or modification in the intended use of the
          device, a 510(k) is not required.  See 21 CFR  807.81.
     2.   All other protective restraints modified as described
          above or marketed on or after May 28, 1976 must be the
          subject of a 510(k) to be legally marketed.

          The applicant should include the following comparisons
          of the new device and a legally marketed device (i.e. a
          preamendment device or device that has been found
          substantially equivalent to a legally marketed device
          by FDA) in the 510(k) submission:
          a.   Compare and contrast the intended use and all
               claims of the new device to the claimed legally
               marketed predicate device(s).  Compare and
               contrast other aspects of labeling (labels,
               instructions for use, promotional material).  To
               facilitate comparison, also include clear
               representations of the legally marketed device(s).              
          b.   Compare and contrast all materials used to
               fabricate the device. 
          c.   Compare and contrast the technological aspects.
          d.   Compare and contrast the specifications, test, and
               performance data.

E.   Performance Data
     1.   Introduction
          Performance data should be submitted for protective
          restraints.  The applicant must establish with test
          data that the new restraint is as safe and effective as
          a legally marketed restraint for the same intended use. 
          
          The applicant should provide the test protocol, all
          data or summary data and a full presentation of the
          results.  The test protocol should include the
          objective, sampling plan, response variables, pass/fail
          criteria, basis for criteria, a summary of the data,
          analysis (statistical when possible), and conclusions. 

          This guidance does not prescribe any specific test
          protocols.  Rather, the guidance provides overview
          information and several considerations that FDA
          believes will assist applicants.  There are standard
          methods that may be used for engineering bench tests. 
          If used, the standard should be referenced.  If there
          is no standard method for a test, then the applicant
          should devise a scientifically sound test method that
          meets the stated test objective.
     2.   Types of Performance Tests
          The applicant should submit at a minimum bench,
          biocompatibility, and simulated use test data.  In the
          case of significant new designs, FDA may require
          prospective clinical trials, as well.  In lieu of test
          data, FDA will consider scientifically sound
          alternative information which addresses concerns
          related to the performance and biocompatibility of the
          restraint.  Prospective clinical or animal data will be
          requested on a case-by-case basis.
          a.   Bench Tests
               Device specifications and related labeling
               statements should be validated by bench and other
               engineering tests.  For instance, the specified
               strength of a belt or material should be verified
               and the basis for the strength specification must
               be explained.
          b.   Biocompatibility Tests
               In order to validate material biocompatibility,
               the applicant should either (1) certify that the
               identical materials for each component, including
               fabrics, dyes or colors, have been used in other
               legally marketed devices with the same or similar
               intended use or (2) provide test results in
               accordance with the ISO 10993.
          c.   Simulated Use Tests
               As explained in Section II.E.4., the 510(k) should 
                 include data from tests using health care
               workers who   typically use the type of device
               (nurses, aides, technicians, etc).  The following
               sections provide more detail on the applicable
               tests including important factors to consider.  

     3.   Performance Data Considerations          
          a.   The applicant should submit ALL valid scientific
               evidence (either prospective or retrospective)
               which they believe may help demonstrate that their
               protective restraint is safe and effective.    
          b.   Performance data should support the claims and
               intended use for the device.    
          c.   FDA will consider arguments for foregoing
               simulated use tests for new restraints with
               identical design and labeling to a legally
               marketed restraint.         
          d.   There are several types of protective restraint
               devices, and studies must be adapted to the
               variables associated with the particular devices. 

               For instance, vests and jackets represent different use and
               safety factors than do wrist restraints.  Thus
               studies of the latter will include some factors
               not represented in the study of vests and jackets
               and vice versa.

          e.   The applicant must consider the nature of the
               population of patients and users associated with a
               device study.  The prevalence and incidence of
               protective restraint injuries may vary between
               institutions, within different services in the
               same institutions, and within services over time. 
               Training, experience, native language, and the
               learning curve of users will also vary. 
               Therefore, the people selected to test the devices
               should be representative of the population of
               users. 

     4.   Elements of a Simulated Use Study
          a.   Introduction
               To validate device labeling and design, the
               applicant should conduct simulated use tests.  The
               simulation should mimic clinical use with respect
               to the user and subject population, the
               fitting/attachment procedures used, the labeling,
               and the conditions of use.  

               The "users" are the individuals fitting and
               applying the devices, while the "subjects" are the
               individuals to whom the restraints will be fitted
               and attached.

               Data based on the use of instructional models is
               not sufficient to establish substantial
               equivalence.  If not conducted under actual
               institutional conditions, the protocol should
               replicate to the extent possible as many
               conditions as is feasible (e.g., lighting, real-world 
	       requirements for speed of attachment, etc.). 
               The data should demonstrate that the device
               function will be reliable and reproducible as
               intended under controlled conditions when used as
               indicated in labeling.

               The simulated, controlled use tests should be
               designed to (1) isolate problems with the device
               and optimize the design, (2) identify deficiencies
               in labeling, and (3) evaluate the type of training
               needed.

               There are no standardized, validated methods to
               simulate clinical use of protective restraints,
               and thus the applicant must devise a
               scientifically valid protocol.  The protocol
               should be comprehensive (e.g., must include the
               objective, manner of subject selection,
               independent variables, measures, etc.).  Some
               considerations for the test are discussed below.

          b.   Study Considerations
               The users should be actual nurses, nurses aides,
               and lay care givers. 

               Volunteer subjects may be individuals selected
               from either institutional or non-institutional
               settings (company subject pools, etc.).

               Bias should be minimized by the selection of a
               justified sample size of participants to provide
               balanced subjective and objective performance
               measures.

               The test evaluators and subjects should have no
               conflicting interest in the device, although they
               may be compensated for their participation.

               Test protocols should yield both subjective data
               (e.g., labeling preferences; opinions about device
               fitting and attachment; etc.) and behavioral data
               (time to read instructions and attach/release
               device; snugness of attachments; neck clearance
               and overall fit; errors; false starts; etc.). 

               The behavioral and study variables should include
               the following: selection of restraint by size
               (e.g., from bin or shelf in which collectively
               stored); vehicle to which attached (e.g., bed,
               wheelchair, gerichair, etc.); experience level of
               user; behavior of "subject" (e.g., slumping over,
               etc.); label design (format, font size, wording,
               etc.); label configuration and positioning; and
               lighting conditions during restraint attachment.

               Should the applicant be testing a new design, it
               should be tested against a legally marketed device
               having the same intended use, whenever possible.

          c.   Test Preparation and Report
               Commencement of the study should be preceded by a
               program to instruct the participants on the study
               protocol to ensure
               (1) uniformity of test procedures, (2) consistent
               observations, scoring, and evaluations, and (3)
               complete data collection.

               The evaluators should enter the test results on
               report forms.  Separate forms may be used to
               report adverse effects and performance.

          d.   Report Forms
               The report form should include various types of
               queries, quantitative data, observations, and
               narrative comments.  The applicant should consider
               the following data elements (not necessarily an
               exhaustive list):

               (1)  general tracking information, such as date,
                    time periods, name of institution,
                    evaluator's name, etc;
               (2)  numbers and types of tested devices;
               (3)  graded ability to attach/fit the devices,
                    select correct size, read and understand the
                    labeling, etc;
               (4)  discrete errors and safety impacts;               
               (5)  observational descriptions (e.g.,
                    unanticipated behaviors, ease of
                    attachment/release, etc.);
               (6)  labeling preferences, problems, design flaws,
                    and recommended changes;
               (7)  additional training requirements; and
               (8)  impact of the time to install the device upon
                    user acceptance.

     5.   Summary
          The critical points of the performance section are as
          follows:   
               Performance data should always include bench,
               biocompatibility, and simulated use data or
               scientifically valid alternatives which address
               concerns related to the labeling, device
               performance and the biocompatibility of the
               protective restraint.

               All important response variables should be
               considered when devising the study.

               Simulated tests usually will be sufficient in
               cases in which the device design does not differ
               significantly from existing devices.  In selected
               cases, FDA may require prospective clinical
               testing.

     6.   Additional Data Requirements
          FDA cannot anticipate all situations that may exist for
          a particular restraint design in a 510(k).  Therefore,
          FDA maintains its prerogative to request additional
          information not specified in this guidance.

F.   Features of Safe and Effective Protective Restraint Devices

     Effective, safe protective restraint use will not be
     achieved as a result of this guidance alone.  Many other
     actions will help, such as adequate education and training
     of personnel.  With respect to restraint characteristics,
     the following features are especially desirable:

          Position (e.g., "top") and size are clearly marked on
          the device.

          Pictorial and written warnings about misapplication,
          incorrect sizes, and the hazards of attaching to the
          wrong fixture are labeled so that they are obvious to
          the person attending the patient.

          The device should be designed such that it is
          reasonably easy to apply and does not in any way
          present a danger to the patient.

G. Future Revisions

     This guidance will be amended based on public and potential
     FDA advisory committee comment.  Until, and unless, it is
     amended, this document serves as the FDA current
     recommendations for a 510k.  More specifics may be provided
     in future revisions.   

Appendix  1         

				Example of Comparison Table
FACTORSNEW DEVICELEGALLY MARKETED DEVICE
intended use
and claims
  
technological
features
  
materials  

specifications:

physical

mechanical

 

  
other  

 

Appendices 2, 3, 4 and 5 can be viewed in pdf format.