(102 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its clinical trial results, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is intended to restore blood flow by removing thrombus, which directly treats the ischemic stroke condition.
No
The device is intended to restore blood flow by removing thrombus from a large intracranial vessel, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "nitinol self-expanding, fully retrievable, stent-based design" and mentions physical components like "Pt-Ir radiopaque markers," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended to restore blood flow by removing thrombus from a blood vessel. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical device (a stent-based design) used for mechanical clot retrieval.
- Mechanism of Action: The device physically interacts with the clot within the blood vessel.
- Lack of In Vitro Testing: IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. There is no indication that this device is used for such testing.
- Clinical Trial Design: The performance study describes a clinical trial where the device is used on patients to treat a condition, not to analyze samples.
In summary, the Solitaire™ FR Revascularization Device is a therapeutic medical device used for the treatment of ischemic stroke, not an IVD used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Solitaire™ FR 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Solitaire™ FR Revascularization Device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intracranial vessel, neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries.
Indicated Patient Age Range
Age 22-85
Intended User / Care Setting
physicians trained in interventional neuroradiology and treatment of ischemic stroke.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical Performance Data:
Non-clinical bench and animal testing
Bench Testing: Overall rate of successful clot retrieval was 96.2% in an in vitro tortuous anatomical model.
Acute Animal study: Successful clot retrieval was 100% (6/6). Arterial histological response was substantially equivalent to the Merci devices.
Chronic Animal Study: Acute results: Successful clot retrieval and recanalization was 100% (6/6). Chronic results: Successful clot retrieval was 87.5% (7/8); recanalization after chronic period was 75% (6/8). Arterial histological response was substantially equivalent to the Merci devices.
Clinical Performance Data:
Study Design: The SWIFT (Solitaire™ FR with the Intention for Thrombectomy) Study is a multi-center. IDE, randomized, prospectively controlled Study comparing the performance of the Solitaire™ FR Revascularization Device with a commercially available Merci® Retriever. Randomization to the Solitaire FR arm or Merci arm occurred on a 1:1 basis. Assessments for the primary efficacy endpoint were done post procedure and subjects were followed for up to 90 days (±15days) for neurological outcomes and safety assessments.
Sample Size: A total of 144 Subjects contributed to the ITT (intention-to-treat) population of which 31 (21.5%) were Solitaire FR roll-in (non-randomized). 58 (40.3%) were randomized to Solitaire FR and 55 (38.2%) were randomized to Merci. Comparative analyses for the purpose of study endpoints were based solely upon the ITT randomized study population.
Statistical Analysis: The primary efficacy analysis (successful recanalization measured by TIMI flow without symptomatic hemorrhage) was performed using a one-sided test under Blackwelder's method of testing non-inferiority at the 0.025 level of significance. The primary safety endpoint of device- and/or procedure-related Serious Adverse Events (SAEs) was evaluated descriptively.
Key Results:
Primary efficacy endpoint: The Solitaire FR group success rate was 60.7% (34/56) compared to 24.1% (13/54) for the Merci group. The criterion for non-inferiority was met with an associated p
§ 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).
0
MAR - 2 2017
8 and 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
- . Use of warfarin anticoagulation with INR > 3.0
- Platelet count 100 cc of tissue) on presentation
- . CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
- Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis i
6
| Reason for Screen Failure | Occurrence |
|---|---|
| Angiographic | 91 |
| No occlusion on angiogram | 35 |
| Complete cervical carotid occlusion | 28 |
| Occlusion located in ineligible vessel | 16 |
| Vessel tortuosity | 7 |
| Vessel dissection | 5 |
| Clinical | 234 |
| NIHSS does not qualify for study | 81 |
| Age | 38 |
| Neurological signs improvement | 34 |
| Stroke onset time unknown | 29 |
| Time from stroke onset exceed 8 hrs | 23 |
| Exclusion criteria not documented | 11 |
| Unable to consent | 11 |
| No intervention per physician | 2 |
| INR exceed required limit | 2 |
| Uncontrolled hypertension | 1 |
| Subject presented comatose | 1 |
| Pre-existing condition, tumor | 1 |
| Imaging | 55 |
| CT/MRI showing infarct | 23 |
| Hemorrhage present at baseline | 22 |
| Imaging exclusion specific not listed | 5 |
| Infarct involving greater than 1/3 of the MCA territory | 4 |
| No mismatch on MRI | 1 |
| Other | 11 |
| Total | 391 |
Primary Safety and Efficacy Outcomes:
Analysis of the primary efficacy endpoint showed statistically significant evidence that Solitaire FR was non-inferior to the Merci device in the arterial recanalization of occluded target vessels without any presence of symptomatic intracranial hemorthage. The Solitaire FR group success rate was 60.7% (34/56) compared to 24.1% (13/54) for the Merci group. The criterior for non-inferiority was met with an associated p