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SICAV GmbH & Co. KG Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 53177 Bonn, NRW GERMANYDecember 4, 2019Re: K192348 Trade/Device Name: SICAV Implant V2.0 Regulation

How to fill out 510k summary 2 0

How to fill out 510k summary 2 0

1. To fill out a 510k summary 2.0, follow these steps:
2. Start by providing the relevant details about the medical device you are submitting the 510k summary for.
3. Include a clear description of the device, its intended use, and any technological features.
4. Provide information about the indications for use, contraindications, and any warnings or precautions.
5. Describe the device's design, including its materials, components, and performance specifications.
6. Include any performance testing, clinical test results, and other supporting data to demonstrate the device's safety and effectiveness.
7. Clearly state any modifications made to previous versions of the device, if applicable.
8. Include any relevant labeling or instructions for use.
9. Provide a summary of the scientific and clinical evidence supporting the device's substantial equivalence to a legally marketed predicate device.
10. Review the completed 510k summary 2.0 for accuracy and completeness before submission.
11. Submit the filled-out 510k summary 2.0 along with any required supporting documents to the appropriate regulatory authorities.

Who needs 510k summary 2 0?

1. The 510k summary 2.0 is needed by medical device manufacturers who intend to market a new device in the United States.
2. It is required as part of the premarket notification process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
3. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA), review the 510k summary 2.0 to assess the safety and effectiveness of the new device and determine if it can be cleared for marketing.

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What is 510k summary 2.0?

510k summary 2.0 is an updated version of the premarket notification submission that provides a summary of the safety and effectiveness of a medical device.

Who is required to file 510k summary 2.0?

Manufacturers seeking to market a new medical device in the U.S. are required to file 510k summary 2.0.

How to fill out 510k summary 2.0?

To fill out 510k summary 2.0, manufacturers need to provide detailed information about the device, its intended use, similarities to other devices on the market, and data supporting its safety and effectiveness.

What is the purpose of 510k summary 2.0?

The purpose of 510k summary 2.0 is to demonstrate that a new medical device is substantially equivalent to a legally marketed device and does not raise any new safety or effectiveness concerns.

What information must be reported on 510k summary 2.0?

Information that must be reported on 510k summary 2.0 includes device description, intended use, materials, design, performance data, and labeling information.