Search Results

The sterile singe-use catheter is intended for introducing washed spermatozoa into the uterine cavity.

The Intrauterine Insemination Catheter is a singe-use, sterile, disposable device for use in intrauterine insemination. The catheter has two opposing smooth side eyes and a rounded, smooth, closed distal tip. The device has an overall length of 18cm and consists of a flexible end inner catheter and a detachable outer sheath, which is attached to the inner catheter by a Luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath Luer is attached to the catheter, the inner catheter protrades from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end. The device is identified as AR-IUI.

This 510(k) summary describes a medical device, the CooperSurgical Intrauterine Insemination Catheter, and its substantial equivalence to a predicate device. It does not contain the kind of performance data that would typically be described with acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.

The information provided focuses on material composition, intended use, and general safety/effectiveness of a physical medical device compared to an existing one. There is no mention of an algorithm, AI, or any performance metrics like sensitivity, specificity, or accuracy that would be associated with such a system.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• "The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements." This indicates testing related to material safety and mechanical fit, not an algorithm's performance.
• "CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and has the same working dimensions." This is the core argument for its approval, not a performance study as you've described.

In summary, this document is for a physical medical device (catheter), not an AI/algorithm-based diagnostic or assistive device that would have the type of performance criteria and studies you are asking about.

Ask a specific question about this device