(366 days)
The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Solitaire™ Platinum Revascularization Device (6x40 mm)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes both biocompatibility testing and non-clinical bench testing. There is also clinical data leveraged from a registry.
Biocompatibility Acceptance Criteria & Performance:
| Test Category | Test Description | Method | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|---|---|
| Cytotoxicity | L929 MTT Cytotoxicity | ISO 10993-5 | Viability is $\geq$ 70%. | Acceptance criteria met |
| Sensitization | Guinea Pig Maximization Sensitization | ISO 10993-10 | Test article does not elicit a sensitization response. | Acceptance criteria met |
| Irritation | Intracutaneous Irritation Test | ISO 10993-10 | Differences in the mean test and control scores of the extract dermal observations are $ |
§ 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).