(49 days)
The PVS "Pivot™" Steerable Delivery System® 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 "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PVS "Pivot™" Steerable Delivery System® Microcatheter:
Acceptance Criteria and Device Performance
The submission does not explicitly list quantitative "acceptance criteria" in the format of a requirement and a corresponding measured value for the individual performance tests. Instead, it states that the tests "yielded acceptable results" or were "verified in accordance with" standards. The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting established industry standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ISO 10993-1 for Biocompatibility | "Biocompatibility of the PVS 'Pivot™' Steerable Delivery System® Microcatheter has been verified in accordance with ISO 10993-1... Test results confirmed biocompatibility of the subject device when tested 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).