(175 days)
- The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
- The Solitaire™ Platinum Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.
The Solitaire™ Platinum Revascularization Device is designed to restore blood flow by removing thrombus 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, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal, nitinol portion of the device facilitates clot retrieval and features an "overlap-design." The Solitaire™ Platinum Revascularization Device is designed with Platinum/Iridium radiopaque markers on the proximal and distal ends. In addition, the Solitaire™ Platinum Revascularization Device features radiopaque markers along the circumference of the working length. The Solitaire™ Platinum Revascularization Device is supplied sterile and intended for single-use.
The purpose of this submission is to modify the labeling for the subject Solitaire™ Platinum Revascularization Device to increase the number of flow restoration recoveries per device, align the minimum recommended vessel diameter across all models, and to update the list of optional accessories to include a guide catheter (minimum 5F).
The request asks to describe the acceptance criteria and study proving device meets these criteria, but the provided text is a 510(k) summary for a medical device which does not contain information about acceptance criteria or specific study results in the manner requested (e.g., performance metrics, sample sizes, expert ground truth establishment for an AI/imaging device).
The document is a premarket notification for a predicate device, specifically the Solitaire™ Platinum Revascularization Device, which is a mechanical thrombectomy device for acute ischemic stroke treatment. The submission aims to modify its labeling, not to introduce a new AI/imaging device or to provide detailed clinical study results with acceptance criteria tables.
Therefore, I cannot fulfill the request based on the provided text, as this information is not present within the document. The document primarily discusses device comparison to predicates, manufacturing details, and general compliance with regulations.
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.