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The Hysteroscopic GIFT Catheter Sets are used to transfer gametes directly into the fallopian tube via hysteroscopic guidance. These catheters and sets are intended for one time use and will be marketed sterile.

The Hysteroscopic GIFT Catheter Sets are used to transfer gametes directly into the fallopian ube. The materials used in these devices are TFE and Stainless Steel. Materials used in these sets are widely used in the medical field and biocompatibility is assured.

The provided document for the "Hysteroscopic GIFT Catheter Sets" (K983587) is a 510(k) summary focusing on substantial equivalence to predicate devices, rather than a study demonstrating a device's performance against specific acceptance criteria.

Therefore, the document does not contain the information requested in points 1-9 of your prompt. It doesn't detail acceptance criteria or a study proving that the device meets them. Instead, it asserts equivalence based on "indications for use, design, construction and materials equivalence" and states that "materials used in these sets are widely used in the medical field and biocompatibility is assured."

The key takeaway from the document is related to the regulatory process:

• Substantial Equivalence: The FDA's decision is based on the determination that the "Hysteroscopic GIFT Catheter Sets" are substantially equivalent to legally marketed predicate devices, specifically similar to the "Lee Hysteroscopic Intrafallopian Transfer Catheter manufactured by Cook Australia."
• Lack of Performance Data: The 510(k) summary explicitly states, "Cook OB/GYN understands due to the recent reclassification there are not predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness." This indicates that the safety and effectiveness are being inferred through comparison to existing, already approved devices, not through new performance studies outlined in this submission.

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