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The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via ultrasound guidance. The device is sterile and intended for one time use.

The Intratubal Transfer Sets are used to inject either sperm, gametes or embryos into the uterine ostium of the fallopian tube via a transvaginal approach utilizing ultrasound guidance. The materials used in these sets are TFE, echosight polyethylene, polyethylene, and stainless steel. All materials are widely used in the medical field and biocompatibility testing has been assured.

The provided text is a 510(k) Premarket Notification for "Intratubal Transfer Sets" and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as a legally marketed device that existed prior to May 28, 1976 (or has been reclassified).

Therefore, I cannot provide the requested information based on the given text.

Here's why:

• No Acceptance Criteria or Performance Data: The document states the device will be manufactured under process controls and a Quality Assurance Program, and will undergo similar packaging. It does not define specific acceptance criteria (e.g., a certain percentage of successful transfers, a specific breakage rate, or measurable biological outcomes) or include any performance data from a specific study.
• Focus on Substantial Equivalence: The core of this 510(k) submission is to argue that the "Intratubal Transfer Sets" are "substantially equivalent to other sperm, gametes or embryo transfer sets in terms of indications for use, design, construction and materials equivalence." This is a regulatory pathway that often relies on comparison to existing devices rather than a de novo performance study with defined acceptance criteria.
• "Predicate Devices: Cook Australia products": The document explicitly states that Cook OB/GYN used Cook Australia products as predicates "to illustrate safety and effectiveness." This implies that the safety and effectiveness are established by the predicate devices, and the new device is considered equivalent.

If this were a newer type of submission, or a device that didn't have substantial equivalency to a predicate, then performance data and acceptance criteria would be essential components.

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