(90 days)
The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Savvy PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.
This document, K971010, is a Premarket Notification 510(k) for the Cordis Corporation's Savvy PTA (Percutaneous Transluminal Angioplasty) Catheters. It asserts substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria and a study proving device conformance cannot be provided as this 510(k) submission does not contain such a study.
Instead, the submission focuses on:
- Intended Use and Device Description: Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and to treat obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
- Biocompatibility: All appropriate biocompatibility tests were successfully performed.
- Substantial Equivalence: The Savvy PTA Catheters are claimed to be substantially equivalent to predicate devices (Cordis Corporation's Savyy PTA Catheters, Cordis Corporation's Opta 5 PTA Catheters, and Meditech's Ultra Thin PTA Catheter) based on similar design, construction, indications for use, and performance characteristics.
Without a performance study against predefined acceptance criteria, it's impossible to fill in the requested table and details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics. The 510(k) process often relies on demonstrating equivalence to existing, legally marketed devices rather than extensive new clinical performance data if the new device does not raise new questions of safety and effectiveness.
§ 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).