(75 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 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery. M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries.
The provided text describes the Solitaire™ Platinum Revascularization Device and its performance data to establish substantial equivalence with a predicate device. The information primarily focuses on bench testing and biocompatibility rather than clinical studies involving human or animal subjects for the new devices (4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The table below combines information from multiple sections of the document to present the acceptance criteria and the conclusion for each test. The "Reported Device Performance" column reflects the conclusion stated in the document, which consistently indicates that the device met the acceptance criteria and is substantially equivalent to the predicate.
| Test Category / Description | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-5 and are substantially equivalent to the predicate device. |
| Sensitization | ISO 10993-10 | Test article does not elicit a sensitization response. | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device. |
| Irritation | 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).