(105 days)
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The Solitaire™ X 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 plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
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The Solitaire™ X 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.
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The Solitaire™ X 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (
The subject 3 mm Solitaire™ X Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The subject 3 mm Solitaire™ X 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 subject 3 mm Solitaire™ X Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends. The subject 3 mm Solitaire™ X Revascularization Device also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single- use only.
The Solitaire X Revascularization Device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke. The device, specifically the 3mm variant, underwent several tests to demonstrate its performance and safety, leading to its substantial equivalence determination.
Here's a breakdown of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Delivery Force | Verified maximum delivery force through microcatheters to the M2 section of a representative tortuous anatomical model. | Acceptance criteria met |
| Resheathing Test | Verified that the device is able to be resheathed into microcatheters in the M2 section of a representative tortuous anatomical model. | Acceptance criteria met |
| System Lengths | Device system length measured from the proximal end of the pushwire to the proximal end of the keyhole marker band and total system length in sheath. | Acceptance criteria met |
| Durability and Reusability Test | Verified that the device is able to be reliably deployed and resheathed into a microcatheter for four times for four passes in a clinically relevant tortuosity model. | Acceptance criteria met |
| System Tensile Strength Test | Performed following simulated use via delivery through a microcatheter in a clinically relevant tortuosity model. | Acceptance criteria met |
| Distal and Body Marker Tensile Test | Performed following simulated use via delivery through a microcatheter in a clinically relevant tortuosity model. | Acceptance criteria met |
| Torque Test | Verified if the stent joint can withstand a minimum of one rotation in a clinically relevant tortuosity model. | Acceptance criteria met |
| Radial Outward Force (ROF) | Measured to specification. | Acceptance criteria met |
| Stent Outer Diameter | Average device diameter measured post-simulated use testing. | Acceptance criteria met |
| Particulate Test | Particulates generated during simulated use (including multiple deployment cycling). | Acceptance criteria met |
| Fluorosafe Marker Distance | Distance from the distal tip of the device subassembly to the distal end of the fluorosafe marker in-sheath is measured. | Acceptance criteria met |
| Biocompatibility | A risk-based approach assessing the materials and manufacturing of the introducer sheath indicated no change in biocompatibility profile. | Minor material differences in introducer sheath concluded not to change biocompatibility profile. |
| Animal Study Safety and Usability | Demonstrated safety and usability in a porcine model at sub-acute and 30-day (chronic) time points. | Safety and usability results suggest substantial equivalence to the predicate device. |
| Clinical Study (Retrospective Analysis) | Evaluation of vessel sizes using existing registry data to support substantial equivalence. | Retrospective analysis of STRATIS registry data performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a retrospective analysis of vessel sizes using the STRATIS registry data as a "clinical" study to support substantial equivalence. While it explicitly states this, it does not provide the sample size of this retrospective analysis.
- Data Provenance: The STRATIS registry data was "previously submitted in K193576," suggesting it's existing, likely multi-center, clinical trial or registry data. The country of origin is not specified but is likely international, given the nature of major stroke registries. It is retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the retrospective analysis of vessel sizes. Given it's a "retrospective analysis of vessel sizes," the ground truth would likely be based on imaging reports and clinical assessments already documented in the STRATIS registry by the original clinicians and radiologists involved in the patient care and data collection.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the retrospective analysis. As it relies on existing registry data, the "ground truth" would implicitly be the clinical diagnoses and measurements recorded at the time of the original study or patient care within the STRATIS registry.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
The document does not describe an MRMC comparative effectiveness study involving human readers with or without AI assistance. The described "clinical" study is a retrospective analysis of vessel sizes, not an evaluation of AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
The document does not describe a standalone performance study of an algorithm. The Solitaire™ X Revascularization Device is a physical mechanical thrombectomy device, not an AI or software algorithm. The "clinical" study mentioned is a retrospective analysis of vessel sizes, likely performed to understand the distribution of vessel sizes relevant to the device's application, rather than to evaluate an algorithm's performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the retrospective analysis, the ground truth would inherently be
- Imaging measurements and clinical diagnoses documented within the STRATIS registry data. This would include measurements of vessel sizes and characterization of occlusions based on imaging (e.g., CTA, MRA) and patient outcomes. It's a form of outcomes data and expert-reported imaging findings from the original clinical context.
8. The Sample Size for the Training Set:
The document does not mention a training set for an algorithm. The Solitaire™ X Revascularization Device is a physical medical device, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for an algorithm, this question is not applicable.
§ 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.