(176 days)
Opportunity Inc.'s Suture Removal Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing suture removal.
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The provided documents are FDA 510(k) clearance letters for various medical kits, including the "Opportunity Suture Removal Kit." This type of document is a notification of intent to market a device based on its substantial equivalence to a legally marketed predicate device.
These documents indicate that the FDA determined substantial equivalence based on a review of the company's submission, but they do NOT contain information on specific acceptance criteria, device performance studies, or the methodologies listed in your request.
The FDA 510(k) clearance process primarily evaluates whether a new device is as safe and effective as another legally marketed device, often without requiring new clinical trials or detailed performance studies in the same way a Premarket Approval (PMA) would. The manufacturer would have provided information demonstrating substantial equivalence to a predicate device, which would include descriptions of the device's components and intended use.
Therefore, I cannot provide the requested information because it is not present in the provided FDA clearance letters. The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of Act." This indicates a regulatory review based on equivalence, not detailed performance studies against pre-defined acceptance criteria.
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