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 Exercise Equipment
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, 9200 Corporate Blvd., HFZ-410, Rockville, MD 20850. • For questions regarding the use or interpretation of this guidance, contact the Restorative Devices Branch at 301-594-1296. • 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 (326) 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 ADMINISTRATIVE INFORMATION • Provide the name, address, phone and fax number 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. • Identify whether confidentiality is requested. Requests for confidentiality must contain all information specified in 21 CFR 807.95(b). 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 (trade) name of the new device; The generic (common or usual) 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, i.e., Class II (performance standards). (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)]. See HHS Publication Number FDA 91-4246 (Classification Names for Medical Devices and In Vitro Diagnostic Products) for guidance. The classification name(s) and number(s) should include one or more of the following: Classification Name Number Bars, parallel, powered 89IRR Ergometer, treadmill 89BYQ Exerciser, finger, powered 89JFA Exerciser, measuring 89ISD Exerciser, passive, measuring 89ISC Exerciser, powered 89BXB System, isokinetic testing and measuring 89IKK Treadmill, powered 89IOL The number of the regulation(s) that classifies the device into Class II and type of device specified in the regulation. This shall include one or more of the following: Regulation Number Device Type 21 CFR 890.1925 Isokinetic Testing and Evaluation System 21 CFR 890.5360 Measuring Exercise Equipment 21 CFR 890.5380 Powered Exercise Equipment 21 CFR 890.5410 Powered Finger Exerciser • The proprietary (trade) name of the new device; • The generic (common or usual) 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, i.e., Class II (performance standards). (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)]. See HHS Publication Number FDA 91-4246 (Classification Names for Medical Devices and In Vitro Diagnostic Products) for guidance. The classification name(s) and number(s) should include one or more of the following: Classification Name Number Bars, parallel, powered 89IRR Ergometer, treadmill 89BYQ Exerciser, finger, powered 89JFA Exerciser, measuring 89ISD Exerciser, passive, measuring 89ISC Exerciser, powered 89BXB System, isokinetic testing and measuring 89IKK Treadmill, powered 89IOL 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)]. See HHS Publication Number FDA 91-4246 (Classification Names for Medical Devices and In Vitro Diagnostic Products) for guidance. The classification name(s) and number(s) should include one or more of the following: • The number of the regulation(s) that classifies the device into Class II and type of device specified in the regulation. This shall include one or more of the following: Regulation Number Device Type 21 CFR 890.1925 Isokinetic Testing and Evaluation System 21 CFR 890.5360 Measuring Exercise Equipment 21 CFR 890.5380 Powered Exercise Equipment 21 CFR 890.5410 Powered Finger Exerciser The number of the regulation(s) that classifies the device into Class II and type of device specified in the regulation. This shall include one or more of the following: • Specify whether this device: Has been previously submitted to the FDA for identical or different indications; 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; • 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), including the specific diagnostic and/or therapeutic indications, 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. Identify all available and intended motions, and the muscles and/or joints to be exercised. These intended uses should be clearly identified in the labeling. Note that FDA regulates exercise equipment only if the equipment is intended to be used for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. FDA does not regulate exercise equipment intended only for general physical conditioning and/or for the development of athletic abilities in individuals who lack physical impairment. Therefore, it is not necessary to notify FDA of an intent to market a device if it will not be labeled or promoted for medical uses. However, FDA will regulate the equipment and may require premarket notification if any promotional material appears which makes medical claims after marketing begins. Device Description • Provide a written device description (e.g., mechanical, electrical, materials considerations), specifically including any measuring systems/components, describing how they interface the device, and any new features of the device. • Identify the relevant dimensions of the device and all possible configurations. • Also, identify all exercise functions, and if applicable, all measuring functions of the new device. • Provide engineering drawings and/or photographs of the device, and provide circuit diagrams for novel or complex electrical components or systems. Also provide illustrations or photographs and written descriptions of the predicate device. • Provide a hazards analysis for the new device, identifying the device’s safety features. • For each intended motion, the range of motion through which the intended muscles and/or joints are exercised and the range of forces exerted should be provided. For powered exercise equipment, the speed by which the intended muscles and or joints will be exercised should also be provided. If available, provide this information for the predicate device (for documentation of substantial equivalence as discussed in Substantial Equivalence section below). Performance data must be provided for all clinical measuring functions. The testing methodology and conclusions of the testing should be described. For each intended motion, the range of motion through which the intended muscles and/or joints are exercised and the range of forces exerted should be provided. For powered exercise equipment, the speed by which the intended muscles and or joints will be exercised should also be provided. If available, provide this information for the predicate device (for documentation of substantial equivalence as discussed in Substantial Equivalence section below). Performance data must be provided for all clinical measuring functions. The testing methodology and conclusions of the testing should be described. Materials Identify the specific materials for each component, any additional processing that may affect the material properties and the voluntary standards with which the device materials will conform. Labeling • Provide draft or sample package labeling, package inserts, including complete operator’s and maintenance instructions for the new device. • Include copies of promotional materials for the new and predicate devices. • Depending on the device’s indication, the following prescription statement may be required (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.”
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