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The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device's central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.

SINGLE CHANNEL BALLOON CANNULA

I apologize, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a "Single Channel Balloon Cannula," indicating that the device is substantially equivalent to legally marketed predicate devices.

The text focuses on regulatory approval, specifically:

• Device Name: Single Channel Balloon Cannula
• Manufacturer: Conkin Surgical Instruments Ltd.
• FDA Decision: Substantial Equivalence (K974801)
• Indications For Use: Mobilization of the uterus and injection of dye during procedures requiring uterine manipulation (e.g., minilap, laparoscopic tubal occlusion, diagnostic and operative laparoscopy), and as an intrauterine injector for laparoscopic tubal patency studies and hysterosalpingography.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information is typically found in a summary of safety and effectiveness data submitted to the FDA, which is not provided here.

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