Search Results

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparossopic surgical procedures of the lower abdomen or pelvic areas. As a general surgery transillumination device, the Stryker Ureteral Illuminator System III replaces and is substantially equivalent to existing predicate fiberoptic light ureteral catheter transillumination devices.

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. The Stryker Ureteral Illuminator System III illumination source will comply with UL 544 Standard for Medical and Dental Equipment and 21 CFR 1040.10 Performance Standards for Lasers. The Stryker Ureteral Illuminator System III fiberoptic light ureteral catheter kit will be constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The Stryker Ureteral Illuminator System III EtO sterilization processes are validated per AAMI/ANSI/ISO 11135, to a SAL of 10-6.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI integration for the Stryker Ureteral Illuminator System III. The submission is a 510(k) for a medical device that predates the widespread use of sophisticated AI in medical devices, and focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide answers to the requested points, as the information is not present in the given document. The document primarily discusses:

• Device Name and Classification: Stryker Ureteral Illuminator System III, classified under 21 CFR 876.4020 for fiberoptic light ureteral catheters.
• Intended Use: To transilluminate the ureter during laparoscopic and open surgical procedures to help locate the ureters.
• Safety and Effectiveness: Stated to be equivalent to existing marketed devices (specifically Gabriel Ureteral Illuminator System II - K945088).
• Compliance: Mentions compliance with UL 544, 21 CFR 1040.10, ISO 10993 for biocompatibility, and AAMI/ANSI/ISO 11135 for sterilization validation.
• FDA Determination: A letter from the FDA stating the device is substantially equivalent to predicate devices marketed before May 28, 1976.

The traditional 510(k) process for a device like this relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a detailed performance study against specific acceptance criteria in the manner you've described for AI/algorithm-driven devices. Performance is often inferred from the predicate device's established safety and effectiveness.

Ask a specific question about this device