Most 510(k) submissions will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate significant equivalence of your device to one or more legally marketed devices (predicate devices). The data may include test results from the bench, animal, and clinical tests.
Performance tests are conducted to determine the safety and efficacy of the device and also to establish substantial equivalence with the predicate device. They are Important in the 510(k) submission as the FDA reviews the 510k submission for the medical device based on its safety, efficacy, and substantial equivalence with the predicate device.
The objectives of these tests are to establish that the device functions efficiently as per the claims of the manufacturer and is safe to use. These tests also help compare the performance characteristics of the proposed device with that of the predicate device thereby establishing substantial equivalence.
To identify the correct testing requirements and for carrying out the performance tests, the first step is to classify your device and find the product code. With the help of the product code, you can find the standard test methods associated with it in the guidance documents or performance standards linked with it.
Many product codes have no guidance documents or performance standards linked to them. It’s important to remember that the FDA has not issued guidance documents for many product codes.
In situations where the FDA’s product classification, guidance document, and recognized consensus standards databases do not reveal the testing requirements for a particular device, you can use the FDA’s 510(k) Premarket Notification database. This database contains information about testing completed for previously cleared devices under the same product code. The FDA will most likely require similar testing for the subject device. If the device sponsor has already selected a predicate device for their 510(k) submission, reviewing the 510(k) summary in the FDA database can give you details of the necessary performance tests that have to be done for your device.
Difference between Performance test: bench, animal, and clinical in 510(k) submissions
This type of testing is designed to rule out performance-related mechanical or design flaws in the medical device and is performed by either the device manufacturer or a third-party testing facility Performance bench testing of medical devices also evaluates their endurance and capability to perform with the same efficiency under different forms of load. Non-clinical bench performance testing includes but is not limited to mechanical and biological engineering performance (such as fatigue, wear, tensile strength, compression, and burst pressure); bench tests using ex vivo, in vitro, and in situ animal or human tissue; and animal carcass or human cadaveric testing.
The submission must include a complete test report would include information such as:
Description of methods (including protocols, test parameters, equipment used, and conditions);
- Assessment criteria.
- Test sample size/selection.
- Pass/Fail criteria.
- Data analysis plan; and
- Protocol deviations, if any.
The animal study is for the applicant to provide evidence of safety, including performance and handling. In many cases, the performance of a particular device is intricately linked to its safety, such as for products that provide circulatory support. The in vivo setting generally provides an initial assessment of how the device interacts with biological systems and also how the biological system may affect the device, such as via device corrosion and structural deformities.
Animal testing is not obligatory in a 510(k) submission but can be used to support substantial equivalence. If animal tests are done the submission should include:
- Specific animal tests
- Description of test protocol: objective of the test, test articles used, test methods and procedures, study endpoint, the specific parameter measured, pre-defined acceptance or pass/fail criteria
- Summary of results
- Analysis and conclusions
Clinical testing is mostly done for high-risk medical devices which include all class III and some class II devices. Clinical tests are not obligatory for a 510(k) submission, and FDA will consider alternatives to clinical studies given that those proposed alternatives are supported by an adequate scientific rationale. If clinical tests are done, the submission should include:
- Objective of the test
- Test methods and procedures (including any specific test conditions)
- Study endpoints (safety and effectiveness)
- Statistical methodology used.
In conclusion, Performance tests are an integral part of the 510k submission as it helps in proving to the reviewer that your device is safe to use and does what it claims to do, and also is substantially equivalent to an already marketed device.
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff General Considerations for Animal Studies for Cardiovascular Devices https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k#link_12 https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k#link_12 https://www.meddevicecorp.com/fda-510k-submission/ https://www.reghelps.com/us-fda/510k-premarket-notification/ https://www.i3cglobal.uk/fda-510k-submission-consultant/ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket