Issue Date: July 25, 1995
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles

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. This guidance document may contain references to addresses and telephone numbers that are now obsolete. The following contact information is to be used instead: • While this guidance document represents a final document, comments and suggestions may be submitted at any time for Agency consideration to the Restorative Devices Branch, 10903 New Hampshire Avenue, Silver Spring, MD 20993. • For questions regarding the use or interpretation of this guidance, contact the Restorative Devices Branch at 301-796-5650. • To contact the CDRH-Division of Industry and Consumer Education (DICE), call 1-800-638-2041 or 301-796-7100; email DICE@fda.hhs.gov ; or write to DICE, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number (346) to identify the guidance you are requesting. To contact the CDRH-Division of Industry and Consumer Education (DICE), call 1-800-638-2041 or 301-796-7100; email DICE@fda.hhs.gov ; or write to DICE, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number (346) to identify the guidance you are requesting. PREFACE The purpose of this document is to provide guidance to the sponsors of premarket notifications [510(k)’s] for restorative devices. This document is intended to assist the sponsors in organizing and providing the essential information that should be submitted to the Food and Drug Administration (FDA) for review. This guidance is based on the Restorative Devices Branch’s (REDB’s) identification of specific criteria necessary to conduct an adequate evaluation of a 510(k) for the purpose of determining substantial equivalence for physical medicine/restorative devices. The objective of this document is to delineate to the device manufacturer important administrative, descriptive, and scientific information that should be included in a 510(k) for a restorative device. Individual 510(k) submissions may require additional information pertinent to each specific device. The suggestions and recommendations included in the guidance reflect the minimal requirements that would allow an evaluation of the device as determined by REDB. While the use of this document in the preparation of a 510(k) premarket notification will not ensure FDA clearance of a device, following the guidance will ensure that sufficient basic information is available to initiate a substantive review. Note that the guidance document is a living document. It will be periodically revised as scientific knowledge and regulations change. INTRODUCTION Any 510(k) notification submitted under premarket notification procedures described in 21 Code of Federal Regulations (CFR) Part 807, Subpart E, for FDA’s determination that a new device is substantially equivalent to a predicate (existing) device in 21 CFR 890.3850 (Mechanical Wheelchair), 21 CFR 890.3860 (Powered Wheelchair), 21 CFR 890.3880 (Special Grade Wheelchair), 21 CFR 890.3890 (Stair-climbing Wheelchair), 21 CFR 890.3900 (Standup Wheelchair), and 21 CFR 890.380 (Motorized Three-wheeled Vehicle) should follow the format below and must contain all specified information that is applicable to the device. ADMINISTRATIVE INFORMATION • Provide the name and address of the manufacturer and sponsor of the 510(k) submission. • Provide the FDA registration number (if available) of the manufacturer of the new device. • Identify the official contact person for all correspondence. DEVICE IDENTIFICATION • As stated in 21 CFR 807.90(d), a 510(k) shall be submitted separately for each product the manufacturer intends to market. Therefore, a submission can describe no more than one new device. A submission can describe more than one component of, or attachment to, a single device. The submission must compare each such component or attachment with that of a predicate device, or must state that the predicate device lacks such a component or attachment. As stated in 21 CFR 807.90(d), a 510(k) shall be submitted separately for each product the manufacturer intends to market. Therefore, a submission can describe no more than one new device. A submission can describe more than one component of, or attachment to, a single device. The submission must compare each such component or attachment with that of a predicate device, or must state that the predicate device lacks such a component or attachment. • The following information must be provided: The proprietary name of the new device; The generic name of the device; The classification of the predicate device e.g., Class II. Refer to 21 CFR and section 513 of the Food, Drug, and Cosmetic Act; The proposed regulatory class for the new device, e.g., Class II. (21 CFR 862-892 contains the regulatory classifications for medical devices); and The panel code(s) for the device. [If the product is not classified under the physical medicine devices panel, identify the panel under which it is classified and provide the panel identification code (e.g., 89 is the code for the physical medicine devices panel)]. • The proprietary name of the new device; • The generic name of the device; • The classification of the predicate device e.g., Class II. Refer to 21 CFR and section 513 of the Food, Drug, and Cosmetic Act; • The proposed regulatory class for the new device, e.g., Class II. (21 CFR 862-892 contains the regulatory classifications for medical devices); and • The panel code(s) for the device. [If the product is not classified under the physical medicine devices panel, identify the panel under which it is classified and provide the panel identification code (e.g., 89 is the code for the physical medicine devices panel)]. • Specify whether this device: Has been previously submitted to the FDA for identical or different indications; or Is currently being reviewed for different indications by the same or different branch within ODE; or Has been previously cleared by the FDA for different indications. • Has been previously submitted to the FDA for identical or different indications; or • Is currently being reviewed for different indications by the same or different branch within ODE; or • Has been previously cleared by the FDA for different indications. DEVICE DESCRIPTIVE INFORMATION Intended Use Identify the specific intended use(s) for the subject device and the predicate device. The new device must have the same intended medical uses as those specified for the predicate device, to the extent that the changes do not alter the therapeutic or diagnostic effect and do not affect safety and effectiveness. These intended uses must be consistent with the descriptions of intended medical uses contained within the CFR section that is applicable to the device and must identify the specific medical conditions for which the device is indicated. If the indication differs, you must provide a justification as to how the change(s) do not affect safety and effectiveness. If special labeling claims are sought, information must be provided to support these claims. Device Description • Provide a written device description, including all device components, accessories, instruments, and any new features of the device. • Specify the relevant dimensions of the device and all possible configurations, and functions of each device component. • Describe how the device works and interconnects with other components. • Provide engineering diagrams and/or photographs of the device, and complete written descriptions of the new and predicate devices. The document must contain illustrations of all internal and external features of both devices. Engineering diagrams must provide the lengths, widths, and heights of the devices and their major component parts. • Photographs or other illustrations, such as dimensioned drawings, must provide front, rear and side views of the devices. • Specify the dimensions and weight of the device. • Indicate the kind of surface on which the device can be operated. • Specify the maximum weight bearing capacity of the device. • Report the results of “tiltover” tests performed laterally, posteriorly and anteriorly with a user of maximum allowable weight and maximum allowable seat height or when standing up (these usually apply to standup wheelchairs or wheelchairs in which the seat can be elevated). You may also report the results of the VA drop test if performed. (This is not a requirement.) Report the results of “tiltover” tests performed laterally, posteriorly and anteriorly with a user of maximum allowable weight and maximum allowable seat height or when standing up (these usually apply to standup wheelchairs or wheelchairs in which the seat can be elevated). • Specify whether the device design conformance to any other voluntary performance standards, e.g., ANSI/RESNA standards. Materials Identify the specific materials for each component any additional processing that may affect the properties of the materials, and the voluntary standards with which the device materials will conform. The information should also include a description of the material strength tests performed on the frame and wheels. The results of flame retardant tests of the upholstery materials should be reported. Labeling • Provide draft or sample package labeling, package inserts, including complete operator’s instructions, and required labeling regarding electromagnetic interference (EMI) according to FDA’s March 26, 1994 labeling letter mailed to wheelchair manufacturers ( copy attached ). • Provide the following prescription statement (both on the device itself and in the operator’s manual, and in any advertising and/or promotional materials) according to 21 CFR 801.109: Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices.” Provide the following prescription statement (both on the device itself and in the operator’s manual, and in any advertising and/or promotional materials) according to 21 CFR 801.109: • Include copies of promotional materials for the new and predicate devices. • Provide cleaning instructions.

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