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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K043067 B. Purpose for Submission: New Device C. Measured: Ancient antibodies (SSA, SSB, Sm, Sm/RNA, Scl70, and Jo1)

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination:

1. Gather necessary information: Start by collecting all relevant data and documentation related to your medical device. This may include product specifications, labeling information, clinical data, and any other supporting materials.
2. Identify predicate device(s): Determine the appropriate predicate device(s) that are already legally marketed and similar to your device. Predicate devices serve as a benchmark for comparing the safety and effectiveness of your device.
3. Prepare a summary of device comparison: Compare your device to the selected predicate(s) and document the similarities and differences. This summary should cover all aspects, such as design, materials, intended use, and technological characteristics.
4. Conduct a risk analysis: Evaluate the potential risks associated with your device and compare them to the risks of the predicate device(s). This analysis should consider factors like device malfunctions, adverse events, and patient safety.
5. Assess the technological differences: Determine if any technological differences between your device and the predicate(s) could impact safety, effectiveness, or performance. This assessment should provide a detailed explanation of how the differences are addressed and managed.
6. Provide clinical data (if applicable): If your device does not rely solely on substantial equivalence but requires additional clinical data to support its safety and effectiveness, include this data in the submission. Ensure that the clinical studies comply with applicable regulatory requirements.
7. Compile the submission package: Organize all the gathered information and create a comprehensive submission package for the 510k substantial equivalence determination. This package should include a cover letter, a completed FDA Form 3514, a summary of the comparison, labeling information, and any supporting documentation.

Who needs 510k substantial equivalence determination?

1. Manufacturers of medical devices: Companies or individuals who intend to market a new medical device in the United States are required to submit a 510k application to the U.S. Food and Drug Administration (FDA). This includes both domestic and foreign manufacturers.
2. Existing device modifications: When making significant modifications to an already marketed medical device, manufacturers must assess the substantial equivalence of the modified device to determine if it requires a new 510k submission.
3. Importers or distributors: If you are importing or distributing medical devices in the U.S., you may also need to comply with the 510k requirements. This ensures that the devices you handle are determined to be substantially equivalent to those already on the market.

Please note that the information provided here is a general guideline. It is crucial to consult the FDA's official guidance documents and seek professional advice specific to your device and regulatory needs.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who intend to market a new device in the US are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, manufacturers need to provide information about the device, its intended use, performance data, and comparison to a predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510(k) substantial equivalence determination is to demonstrate that the new medical device is as safe and effective as a legally marketed device.

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

The information reported on a 510(k) substantial equivalence determination includes device description, intended use, indications for use, design, materials, performance data, and biocompatibility.