(121 days)
The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
The proposed Arrow GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.
The provided text describes the Arrow GPSCath™ Balloon Dilatation Catheter and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of a diagnostic or AI-driven system.
The document is a traditional 510(k) notification for a physical medical device (a balloon catheter) and focuses on engineering and performance criteria for the device itself, rather than diagnostic accuracy or AI performance. The "performance data" section refers to bench testing, biocompatibility, and physical characteristics of the catheter.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria for an AI/diagnostic device, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The closest relevant section is:
I. Performance Data:
- Bench top tests: balloon compliance, catheter body burst strength, catheter torque strength, catheter balloon bond strength, catheter tip-pull strength, simulated use, balloon rated burst pressure, balloon fatigue, and balloon inflation/deflation time, contrast media flow rate, and catheter visual inspections.
- Other tests: biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, systemic toxicity, hemolysis, complement activation, thromboresistence, partial thromboplastin time, and MEM elution), package and simulated use test data.
J. Conclusions:
- "The Arrow GPSCath Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. All test results demonstrate that the Arrow GPSCath Balloon Dilatation Catheter met the established specifications necessary for consistent performance during its intended use."
This indicates that acceptance criteria were established and met for the physical device's engineering performance. However, these are not the type of acceptance criteria you would typically find for an AI diagnostic device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).