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Section VIII. A 510(k) Summary MAY 022013 510(k) Number K130174 Date: Mar 11 2013 Submitter: Issue Americas Inc. 27051 Town Center Drive Foothill Ranch, CA 92610 Phone: 9492683185 Establishment Registration

How to fill out a 510k summary

How to fill out a 510k summary:

1. Firstly, gather all the necessary information and data related to the medical device that the summary will be prepared for. This includes product information, design specifications, performance data, risk assessment reports, labeling information, and any other relevant documentation.
2. Begin by providing a clear and concise description of the medical device, including its intended use, indications for use, and technological characteristics. This section should also mention any similarities or differences to other devices already on the market.
3. Next, outline the proposed technological characteristics and design specifications of the device. This should include details such as materials used, dimensions, construction methods, and any unique features or innovations.
4. Conduct a comprehensive risk assessment for the device, identifying potential hazards and associated risks. Describe the measures taken to mitigate these risks, such as design modifications, warning labels, or user instructions.
5. Include a review of any clinical data or studies conducted to demonstrate the device's safety and effectiveness. This may involve providing details of preclinical testing, animal studies, or human clinical trials. Make sure to include the study design, sample size, endpoints, and results.
6. Provide a summary of any nonclinical performance testing performed to validate the device's functional performance, mechanical characteristics, and biocompatibility. This should also cover any software validation or testing if relevant.
7. Include a detailed description of the device's labeling, including instructions for use, warnings, contraindications, and precautions. Ensure that the labeling meets the regulatory requirements and is consistent with the device's intended use and specifications.
8. Finally, compile all the relevant data, documentation, and supporting information into a well-organized and comprehensive 510k summary. Review the summary for accuracy, completeness, and clarity before submitting it to the appropriate regulatory authorities.

Who needs a 510k summary:

1. Medical device manufacturers who intend to market a new medical device in the United States usually need to submit a 510k summary as part of the US Food and Drug Administration (FDA) regulatory process.
2. The purpose of the 510k summary is to demonstrate the device's substantial equivalence to a legally marketed predicate device, thereby establishing its safety and effectiveness.
3. Additionally, companies seeking to make modifications or upgrades to an existing device may also need to submit a 510k summary to obtain FDA clearance before marketing the modified device.

Overall, the 510k summary is a crucial document for medical device manufacturers seeking regulatory approval to market their products in the United States. It serves as a comprehensive overview of the device, including its design, performance, and safety features, and helps demonstrate its compliance with FDA regulations and requirements.

For pdfFiller’s FAQs

What is a 510k summary?

A 510k summary is a concise overview of the information submitted in a 510k premarket notification.

Who is required to file a 510k summary?

Any company seeking to market a medical device in the United States must file a 510k summary.

How to fill out a 510k summary?

To fill out a 510k summary, companies must provide detailed information about the safety and effectiveness of their medical device.

What is the purpose of a 510k summary?

The purpose of a 510k summary is to demonstrate to the FDA that a medical device is substantially equivalent to a legally marketed device.

What information must be reported on a 510k summary?

A 510k summary must include information on the device, its intended use, a comparison to a similar device, and any supporting data.

When is the deadline to file a 510k summary in 2023?

The deadline to file a 510k summary in 2023 is typically within 90 days of receiving a request for additional information from the FDA.

What is the penalty for the late filing of a 510k summary?

The penalty for the late filing of a 510k summary can include fines, delays in market approval, and possible recall of the device.

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