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V OL1O-)7 (f 0 1 3) SECTION 2 -510(k) SUMMARY APR 3 0 2004 Analog Loop Anchor Submitter's Name and Address: Deputy Mites a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062 Contact

How to fill out section 2 -510k summary

How to fill out section 2 -510k summary:

1. Begin by providing the necessary information such as the device name, manufacturer, and the intended use of the medical device.
2. Include a brief description of the technological characteristics of the device, outlining its design, materials, and specifications.
3. Next, provide a summary of the performance testing conducted on the device, including any clinical studies or laboratory testing that has been performed.
4. Include information on any predicate devices that the medical device is based on, highlighting the similarities and differences between the two.
5. Describe any proposed labeling or instructions for use that will accompany the device, ensuring that it complies with regulatory requirements.
6. Lastly, provide a demonstration of the device's compliance with the appropriate regulatory standards, certifications, or guidelines.

Who needs section 2 -510k summary:

1. Medical device manufacturers who intend to market and sell their products in the United States are required to submit a 510(k) premarket notification to the Food and Drug Administration (FDA).
2. Section 2 of the 510(k) application is specifically dedicated to the device's summary information, including the 510(k) summary.
3. The 510(k) summary section is needed by manufacturers to provide a concise overview of the device's safety, effectiveness, and similarities to predicate devices, thereby demonstrating that the new device is as safe and effective as legally marketed devices.

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