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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k100341 B. Purpose for Submission: New Device C. Measured: Sperm concentration D. Type of Test: A one step, immunochromatographic

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination?

1. Start by gathering all the required information and documentation. This includes detailed descriptions of both the new medical device and the predicate device (the device that the new one is claiming substantial equivalence to).
2. Identify the intended use of the new device and compare it to the intended use of the predicate device. This analysis will help determine if there are any differences in their indications for use.
3. Evaluate the technological characteristics of the new device and compare them to the predicate device. This involves assessing the design, materials, and performance of both devices to determine if there are any significant differences.
4. Conduct a thorough risk analysis of the new device and compare it to the risk profile of the predicate device. This includes identifying potential hazards, assessing the severity of possible harm, and analyzing the adequacy of mitigations.
5. Determine if there are any differences in the principles of operation between the new device and the predicate device. This involves understanding how each device functions and whether there are any notable distinctions that could impact safety or effectiveness.
6. Review any non-clinical testing and performance data for the new device, comparing it to the data available for the predicate device. This step helps to determine if any additional testing or evaluation is necessary to demonstrate substantial equivalence.
7. Compile all the findings and supporting documentation into a comprehensive submission package. This package will typically include a cover letter, summary of the substantial equivalence determination, and any relevant testing or performance data.

Who needs 510k substantial equivalence determination?

1. Medical device manufacturers who are introducing a new device to the market that is not exempt from the 510k requirements need to go through the substantial equivalence determination process.
2. In order to legally market a medical device in the United States, manufacturers must demonstrate that the device is substantially equivalent to a legally marketed predicate device, unless the device is exempt from premarket notification requirements.
3. This process is required by the U.S. Food and Drug Administration (FDA) to ensure that new medical devices are safe and effective for their intended use, and that they do not pose unreasonable risks to patients.
4. The substantial equivalence determination allows the FDA to assess the similarities and differences between the new device and the predicate device, helping to determine the appropriate regulatory pathway for the new device.
5. The substantial equivalence determination is necessary for obtaining clearance to market the new device through the 510k premarket notification program, which is a regulatory pathway for moderate-risk medical devices.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process by which the FDA compares a new medical device to a legally marketed device (predicate) to determine if they are substantially equivalent in terms of safety and effectiveness.

Who is required to file 510k substantial equivalence determination?

Any manufacturer intending to market a new medical device in the US that is not exempt from 510k requirements.

How to fill out 510k substantial equivalence determination?

To fill out a 510k submission, manufacturers must provide information on the new device, the predicate device, comparison of similarities and differences, and technical data to support substantial equivalence.

What is the purpose of 510k substantial equivalence determination?

The purpose is to demonstrate that the new device is as safe and effective as the predicate device and therefore can be marketed in the US under the 510k regulatory pathway.

What information must be reported on 510k substantial equivalence determination?

Information on device description, intended use, technical specifications, performance data, biocompatibility, sterilization, software, labeling, and any applicable standards.