Guidance on the Content of Premarket Notification [510(K)] Submissions for Protective Restraints
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
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|
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