Medical Devices
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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
| Class | Panel | Procode | Common Name |
| I | 80 | PMQ | Protective Restraint |
| I | 89 | KID | Wheelchair 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
| FACTORS | NEW DEVICE | LEGALLY 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.
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