(23 days)
The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery 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 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal distal/proximal) 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 polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 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 lumen. 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 document is a 510(k) summary for a medical device (PVS 1700 Steerable Delivery System®-10 Microcatheter), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.
Therefore, many of the requested details about specific acceptance criteria from a clinical study, sample size, expert ground truth establishment, and MRMC studies are not applicable or available in this type of regulatory submission. The device is primarily evaluated through bench testing and comparison to existing, cleared devices.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it provide detailed performance numbers in a table. Instead, it generally states that tests "yielded acceptable results" or "confirmed biocompatibility."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards for 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).