(15 days)
The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic Or interventional procedures.
The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and neurovasculature for selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.
The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polyment material and has an inside diameter of 0.021". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 31 mm apart at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the 1500 SDS. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.
The provided text describes a medical device, the PVS 1500 SDS (an infusion catheter), and its testing to demonstrate substantial equivalence to predicate devices, rather than a study evaluating an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for PVS 1500 SDS
The study primarily focused on demonstrating the PVS 1500 SDS's substantial equivalence to existing predicate devices by meeting established performance standards for infusion catheters.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices - Part 1 | Confirmed biocompatibility as an external communicating, blood contact, short duration ( |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).