Most 510k clearances will include some type of performance testing 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
Importance
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.
Objectives
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.
Performance testing- Bench
The objective of the testing is to find the performance of the device and to verify the device’s design. It is also tested to find how safe and effective the device is when conducted with different requirements or loads. The performance bench test includes both mechanical and biological engineering testing (such as fatigue, wear, tensile strength, compression, and burst pressure).
Bench testing will contain the majority of design verification and validation testing. It should be included in the final submission if bench-test results are used to support substantial equivalence.
Performance testing- Animal
Animal testing is not obligatory but can be used to support substantial equivalence. the FDA also relies on animal data to determine whether medical products pose an increased risk of cancer or reproductive and developmental toxicity.
Performance testing- Clinical
Clinical testing is also not obligatory, and FDA will consider alternatives to clinical studies given that those proposed alternatives are supported by an adequate scientific rationale. As for clinical testing, the FDA will always consider alternatives to clinical studies when the proposed alternatives are supported by an adequate scientific rationale.
The first step will be to determine if the study is a significant or non-significant risk. If the study is determined to be a significant risk, you’ll need to conduct the study under the IDE regulations (21 CFR Part 812). If not, there are abbreviated requirements in 21 CFR Part 812.2(b). Regardless of the risk level, if you are sponsoring a clinical trial, you must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
Requirements
To identify the correct testing requirements and carry 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.
The I3CGLOBAL 510k Consultants specializes in assisting medical device manufacturers and specification developers in efficiently preparing and submitting their 510(k) files to the FDA, reducing the likelihood of receiving an initial “Refuse to Accept” (RTA) decision.
