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.
July 26, 1995 (reformatted 12/18/97)
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 (729) to identify the guidance you are requesting.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD 20850
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.
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 890.5100 (Immersion Hydrobath) should follow the format below and must contain all specified information that is applicable to the device.
- 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.
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 physical medicine devices panel)].
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.
DEVICE DESCRIPTIVE INFORMATION
Identify the specific intended use(s), including the specific therapeutic and/or diagnostic 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.
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.
- Provide a written description of the device, including all device components, instruments, and any new features of the device.
- Identify the relevant dimensions of the device and all possible configurations.
- Describe how the device works and interconnects with other components.
- Provide engineering drawings 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 drawings must include the dimensions of the device and its major component parts. Photographs or other illustrations, such as dimensioned drawings, must provide views of all sides of the device. The submission must also include illustrations of all internal and external features of the device including plumbing and fittings.
- Circuit diagrams for all novel or complex electrical components or systems in the new device, and, if available, in the predicate device. It is not necessary to provide these for standard equipment, such as simple motors, power packs, switches and gauges.
Identify the materials for each component (i.e., the specific kind and grade of metal used), the voluntary standards with which the device materials will conform or will be compared, and describe any additional processing that may affect the material properties.
List all patient contacting materials in the new device. The materials and design of the device should enable proper cleaning to prevent infection.
- Provide draft or sample package labeling, package inserts, including complete instructions for use for the new device.
Provide instructions for disinfection of the hydrobath. These instructions should include:
- the names of all recommended disinfectants;
- a cleaning step for removal of visible tissue residue or fluids before disinfection;
- recommended contact times and concentrations of the disinfectants to be used based on the disinfectant's label;
- a rinse step to reduce the residues of the disinfectant remaining on the bath to a nontoxic level; and
- an examination step after disinfection to check the hydrobath for damage and the extent of disinfection.
- Provide information concerning compatibility of the hydrobath materials with the recommended disinfectants.
If your device uses controlling software, you should refer to the FDA document entitled "Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review", dated August 29, 1991. As described in this document, you should determine and justify the level of concern you believe to be associated with your device's software. Further, in accordance with this guidance, provide documentation, commensurate with the level of concern, including: 1) System and Software Requirements & Design, 2) Software Development, 3) Verification & Validation (V&V), 4) Test Results and Analysis, and 5) Certification. You must also provide a hazards analysis for the software, identifying safety requirements for the software and system.
Please be advised that if you provide only the minimum information highlighted in the "510(k) Review Software Documentation Matrix", this may not assure adequate information to make a determination about the software. In documenting V&V procedures (all levels of concern), you should provide pass/fail and test completion criteria, and a system level functional test plan. You should refer to the sample questions provided in this guidance and to other sources, as necessary. You are encouraged to submit a summary of the development life cycle in terms of how it assures traceability of the safety concerns throughout development, and how the testing and analyses adequately demonstrate that the software meets its functional and safety requirements. Overall, the software documentation provided should allow for an adequate assessment of the quality of the software design and development, and of the level of software quality control.
Copies of this guidance document can be obtained from the Division of Small Manufacturers Assistance (DSMA), at 800-638-2041.
- Describe the power source, i.e. whether AC or battery powered. If battery powered, the hydrobath should be inoperable when in the charge mode.
- Provide a specification for the ground leakage current.
- Provide the device's electrical specifications, stating whether the device meets any applicable electrical or mechanical safety standards.
- Provide information on the ground fault circuit interrupter.
- Specify the range of hydrobath water temperatures.
- Include a description of the means of mixing hot and cold water for the desired temperature, e.g. the thermostatic control valve. Also, describe the means of maintaining the water temperature, e.g. the thermostat. The means of introducing water should include a vacuum breaker on the faucets to prevent suctioning of water from the hydrobath into the water system.
- Describe the water agitator or pump and the specifications for the motor which drives the pump, indicating the maximum power draw of the motor.
- If the hydrobath includes a disinfection system, provide a description of it and any disassembly instructions.
Electromagnetic compatibility (EMC):
You should be aware that the issue of EMC may need to be addressed in future applications for this type of device. Such a requirement will be announced in advance.
SUBSTANTIAL EQUIVALENCE INFORMATION
The legally marketed predicate device with which the subject device is to be compared for the determination of substantial equivalence must be identified. Evidence must be provided that the device was placed into interstate commerce for other than research uses or as part of a plant-to-plant transfer and was actually labeled and promoted for the intended use to which the submitter of the premarket notification is claiming substantial equivalence. This may be accomplished by providing copies of the firm's advertisements, catalog pages, or other promotional material dated prior to May 28, 1976 and shipping documents such as invoices, bills of lading, receipts showing the interstate transit of the device (for other information which can be used to prove Pre-Amendment status contact DSMA).
Alternatively, the 510(k) number(s) of the predicate device(s) may be identified. The 510(k) number may be obtained from the Electronic Docket (ED), an automated retrieval system of the Division of Small Manufacturers Assistance (DSMA), which provides medical device regulations, FDA talk papers and press releases, device evaluation guidance, and the listing of all approved 510(k)s sorted by applicant name. This 510(k) information is located under the Product Clearance Main Menu Item # 12. Dial (301) 594-4802 or (800) 252-1366. For more guidance on how to assess this information contact DSMA. Call toll free (800) 638-2041, (301) 443-6597, or fax (301) 443-8818.
- The submission should include a description of all significant similarities and differences between the new and predicate devices. To facilitate review, the submission should contain a summary table which compares the two devices in terms of the intended medical uses, functions and physical characteristics, including safety characteristics. In addition, the submission should provide a written summary as to the substantial equivalence of the new device compared to the predicate in terms of safety and effectiveness considerations.
510(K) SUMMARY OR STATEMENT
- Provide a 510(k) summary of safety and effectiveness information in the premarket notification submission upon which an equivalence determination could be based, written in accordance with the content and format requirements that are specified in 21 CFR 807.92, or
- Provide a 510(k) statement that safety and effectiveness information will be made available to interested persons upon request. This statement must follow the format and contain the wording as specified in 21 CFR 807.93.
TRUTHFUL AND ACCURATE STATEMENT
Provide a statement that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted, as required by 21 CFR 807.87(j).