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Valve Nasal Mask Series Section 6: 510(k) Summary Section 6: 510(k) SUMMARY As required by 21 CFR 807.92 Date Prepared: June 12, 2013,3 Official Contact: DC2321 Alex Lucia Vice President 3B Medical,

How to fill out section 6 510k summary

How to fill out section 6 510k summary?

1. Begin by carefully reviewing the instructions provided by the regulatory authority or agency responsible for reviewing the 510k submission.
2. Start filling out section 6 510k summary by providing a concise and accurate description of the device and its intended use. Include specific details such as the device's name, model number, and any relevant accessories or components.
3. Clearly state the intended use of the device and describe its basic principles of operation. This should include information on how the device is intended to be used, who will use it, and what benefits it provides.
4. Include a brief summary of the device's technological characteristics. This should cover aspects such as the device's design, materials used, and any unique features or innovations it incorporates.
5. Outline any significant performance data or results obtained during relevant testing or clinical studies. Include information on how the device performed compared to established benchmarks or standards, and highlight any positive outcomes or benefits observed.
6. Provide a summary of any potential risks or hazards associated with the device's use. This should include information on any known adverse events, safety concerns, or limitations that users should be aware of.
7. It is important to include a comparison with any similar devices already on the market, highlighting the device's similarities and differences in terms of design, performance, intended use, and risks.
8. Conclude the section by summarizing the benefits and advantages of the device over existing alternatives, emphasizing how it addresses unmet needs or improves patient outcomes.
9. Proofread and review the completed section to ensure clarity, accuracy, and compliance with regulatory requirements.

Who needs section 6 510k summary?

1. Manufacturers or sponsors of medical devices seeking clearance or approval from regulatory authorities generally need to include a section 6 510k summary in their submission.
2. Regulatory authorities or agencies responsible for reviewing 510k submissions require the section 6 510k summary to evaluate the safety and effectiveness of the medical device.
3. Healthcare professionals and clinicians who may be involved in the evaluation or use of the device may also benefit from reviewing the section 6 510k summary to understand its intended use, performance, and potential risks.

For pdfFiller’s FAQs

What is section 6 510k summary?

Section 6 of a 510k submission is a summary of the information provided in sections 1-5, which includes details about the device, its intended use, and the comparison to the predicate device.

Who is required to file section 6 510k summary?

Manufacturers or sponsors of medical devices are required to file section 6 510k summary as part of the overall 510k submission to the FDA.

How to fill out section 6 510k summary?

Section 6 of the 510k submission should be filled out by providing a concise summary of the information presented in the previous sections, highlighting key points and differences from the predicate device.

What is the purpose of section 6 510k summary?

The purpose of section 6 510k summary is to provide a brief overview of the information contained in the submission and to help the FDA reviewers quickly grasp the key points of the submission.

What information must be reported on section 6 510k summary?

The section 6 510k summary should include a summary of the device description, intended use, substantial equivalence to the predicate device, and any additional testing or data provided in the submission.

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