(51 days)
The Penumbra System / Penumbra System MAX are intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
The subject Penumbra System 110 Aspiration Tubing Assembly connects the Pump Canister to the Reperfusion Catheters, providing a means for introducing vacuum during procedures, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. Furthermore, the 110 Aspiration Tubing has a flow valve that allows the physician to start and stop the flow of aspiration, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing has a slightly larger inner diameter of 0.110in compared to the predicate to accommodate larger clot burdens, this is the only difference to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing is compatible with all Penumbra System Reperfusion Catheters and Separators included in K133317 and K142458. The device is provided sterile, non-pyrogenic, and intended for single use only, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458].
This document is a 510(k) premarket notification for the Penumbra System 110 Aspiration Tubing, a medical device used for revascularization in acute ischemic stroke patients. The provided text describes the acceptance criteria and study results for this device, which focuses on non-clinical testing for biocompatibility and bench-top performance.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test / Attribute | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|
| Biocompatibility Testing | |||
| Cytotoxicity (MEM Elution) / EN ISO 10993-5 | Sample extracts must yield a cell lysis grade of 2 or lower. | Grade 0: None | Pass |
| Sensitization / EN ISO 10993-10 | Test Group shall yield Grade |
§ 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).