(168 days)
These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
The Medtronic ClearView® Intravascular Arteriotomy Shunt is a temporary arterial shunt for use during coronary artery bypass grafting procedures (CABG). The device features two teardrop shaped bulbs over-molded onto the ends of a flexible tubular shaft. The device is provided in nine sizes. A tag attached to each device identifies size. The device is radiopaque.
The provided document does not describe the acceptance criteria or a study proving the device meets them in the context of an AI-powered medical device. This document is a 510(k) Summary for a Medtronic ClearView® Intravascular Arteriotomy Shunt, which is a physical medical device (a temporary arterial shunt for use during coronary artery bypass grafting procedures).
Therefore, I cannot provide answers to the requested information (1-9) as they pertain to the evaluation of AI/ML-based medical devices.
The document focuses on non-clinical performance data for a physical device, including:
- Biocompatibility testing: Performed according to ISO 10993-1, testing for cytotoxicity, hemolysis, sensitization, systemic toxicity, and intracutaneous toxicity. All tests were negative.
- Flow Curve testing: Compared the shunt's flow characteristics to a predicate device, showing equivalent or better flow.
- Radiopacity testing: Confirmed that the shunt's radiopaque components were visible via radiographic imaging on a phantom chest device.
- Tensile Strength testing: Demonstrated the device could withstand physical forces exceeding normal usage without failure.
The conclusion states that these non-clinical tests indicate the device is safe and effective for its indicated use and substantially equivalent to the predicate device.
To reiterate, the questions asked (1-9) are specific to the evaluation of AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, use of expert-annotated test sets, MRMC studies), which are not applicable to the physical medical device described in this 510(k) summary.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).