(105 days)
-
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.
-
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.
-
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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
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.
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March 1, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Kevin Kong, M.Sc., RAC Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K203358
Trade/Device Name: Solitaire X Revascularization Device Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: January 28, 2021 Received: January 29, 2021
Dear Kevin Kong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203358
Device Name Solitaire™ X Revascularization Device
Indications for Use (Describe)
-
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 plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
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.
-
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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K203358
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214 |
|---|---|
| Contact Person: | Kevin Kong, M.Sc., RACPrincipal Regulatory Affairs SpecialistTelephone: (949) 837-3700E-mail: kevin.kong2@medtronic.com |
| Date Summary Prepared: | February 25, 2021 |
| Trade Name of Device: | Solitaire™ X Revascularization Device |
| Common Name of Device: | POL: Neurovascular Mechanical Thrombectomy Device forAcute Ischemic Stroke TreatmentNRY: Catheter, Thrombus Retriever |
| Classification ofDevice: | Class II, 21 CFR 882.5600; 21 CFR 870.1250 |
| Product Code: | POL; NRY |
| Predicate Device: | Primary Predicate Device:Solitaire™ 4 Revascularization Device (K183022)Additional Predicate Device:Solitaire™ 2 Revascularization Device, Solitaire™ PlatinumRevascularization Device (Solitaire™ RevascularizationDevice) (K181807) |
Device Description
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
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sterile and are intended for single- use only.
Indications for Use:
-
- 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 plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
- 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.
-
- The Solitaire™M 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 (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Device Comparison
A comparison of the technological characteristics of the subject device, Solitaire™ X Revascularization Device - 3 mm devices and the predicate Solitaire™ 4 Revascularization Device - 4 mm and 6 mm devices (K183022) is provided in Table 1. The subject 3 mm Solitaire™ X Revascularization Device is a line extension of the existing Solitaire™ 4 Revascularization Device (cleared under K183022).
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| Table 1: Device Comparison | |||
|---|---|---|---|
| Primary Predicate | Additional Predicate | Subject Device | |
| Solitaire™ 4 Revascularization Device | Solitaire™ Platinum, Solitaire™ 2 Revascularization Devices | Solitaire™ XRevascularization | |
| (K183022) | (K181807) | Device | |
| Indicationsfor Use | 1. The Solitaire™ Revascularization Deviceis indicated for use to restore blood flow inthe neurovasculature by removingthrombus for the treatment of acuteischemic stroke to reduce disability inpatients with a persistent, proximalanterior circulation, large vessel occlusion,and smaller core infarcts who have firstreceived intravenous tissue plasminogenactivator (IV t-PA). Endovascular therapywith the device should be started within 6hours of symptom onset.2. The Solitaire™ Revascularization Deviceis indicated to restore blood flow byremoving thrombus from a largeintracranial vessel in patients experiencingischemic stroke within 8 hours of symptomonset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy arecandidates for treatment. | 1. The Solitaire™ Revascularization Device is indicated foruse to restore blood flow in the neurovasculature byremoving thrombus for the treatment of acute ischemicstroke to reduce disability in patients with a persistent,proximal anterior circulation, large vessel occlusion, andsmaller core infarcts who have first received intravenoustissue plasminogen activator (IV t-PA). Endovasculartherapy with the device should be started within 6 hours ofsymptom onset.2. The Solitaire™ Revascularization Device is indicated torestore blood flow by removing thrombus from a largeintracranial vessel in patients experiencing ischemic strokewithin 8 hours of symptom onset. Patients who areineligible for IV t-PA or who fail IV t-PA therapy arecandidates for treatment.3. The Solitaire™ Revascularization Device is indicated foruse to restore blood flow in the neurovasculature byremoving thrombus for the treatment of acute ischemicstroke to reduce disability in patients with a persistent,proximal anterior circulation, large vessel occlusion of theinternal carotid artery (ICA) or middle cerebral artery(MCA)-M1 segments with smaller core infarcts (< 70 ccby CTA or MRA, < 25 cc by MR-DWI). Endovasculartherapy with the device should start within 6-16 hoursof time last seen well in patients who are ineligiblefor intravenous tissue plasminogen activator (IV t-PA) orwho fail IV t-PA therapy. | Same as theAdditional Predicate- Solitaire™ Platinum, Solitaire™2 RevascularizationDevices (K181807) |
| Principles ofOperation | The device is used in the neurovasculature torestore blood flow for treatment ofacute ischemic stroke. | Same | Same |
| DeviceSize(s) | 4-20-05 mm | Solitaire™ 2:4-15 mm | 3-20-10 mm3-40-10 mm |
| Table 1: Device Comparison | |||
| Primary Predicate | Additional Predicate | Subject Device | |
| Solitaire™ X | |||
| Solitaire™ 4 Revascularization Device | Solitaire™ Platinum, Solitaire™ 2 Revascularization Devices | Revascularization Device | |
| (K183022) | (K181807) | ||
| 4-40-10 mm | 4-20 mm | ||
| 6-20-10 mm | 4-40 mm | ||
| 6-24-06 mm | 6-20 mm | ||
| 6-40-10 mm | 6-30 mm | ||
| Solitaire™ Platinum: | |||
| 4-20-05 mm | |||
| 4-20-10 mm | |||
| 4-40-10 mm | |||
| 6-20-10 mm | |||
| 6-24-06 mm | |||
| 6-40-10 mm | |||
| DeviceMaterials | Stent: NitinolPushwire: NitinolMarkers:90%Platinum/10%IridiumPush-wire shrink Tubing: PTFEIntroducer Sheath: PTFE/Grilamid L25 | Same | Stent: SamePushwire: SameMarkers: SamePush-wire shrinkTubing: SameIntroducer Sheath:Marlex 5502/ Orevac18300/ Grilamid L25 |
| PackagingMaterials | Stored within dispenser coil, Tyvek/Nylonpouch, and shipping carton. | Stored within dispenser coil, Tyvek pouch, and shippingcarton. | Same as the primarypredicate |
| SterilizationMethod | Ethylene Oxide | Same | Same |
| Distal fingermarkers | Platinum/Iridium Coils or Bands | Same | Platinum/Iridium Bands |
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Performance Data
Biocompatibility:
There are minor material differences in the introducer sheath for the subject 3 mm Solitaire™ X Revascularization Device from the previously cleared Solitaire™ 4 Revascularization Device – 4 mm and 6mm devices (K183022). A risk-based approach assessing the materials and manufacturing of the introducer sheath was used to evaluate biocompatibility. The minor differences were concluded to not change the biocompatibility profile for the introducer sheath.
The following non-clinical bench tests were performed to support the subject 3 mm Solitaire™ X Revascularization Device:
| Table 2: Performance Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Delivery Force | The delivery force is performed to verify the Maximumdelivery force through microcatheters to the M2section of a representative tortuous anatomical model. | Acceptance criteria met |
| Resheathing Test | The resheathing test is performed to verify that thedevice is able to be resheathed into microcatheters inthe M2 section of a representative tortuous anatomicalmodel. | Acceptance criteria met |
| System Lengths | The device system length from the proximal end of thepushwire to the proximal end of the keyhole markerband and total system length in sheath. | Acceptance criteria met |
| Durability and Reusability Test | The reusability and durability test is performed toverify that the device is able to be reliably deployedand resheathed into a microcatheter for four times forfour passes in a clinically relevant tortuosity model. | Acceptance criteria met |
| System Tensile Strength Test | System tensile strength test is performed followingsimulated use via delivery through a microcatheter in aclinically relevant tortuosity model. | Acceptance criteria met |
| Distal Marker Tensile Test and BodyMarkerTensile Test | Marker band tensile strength test is performedfollowing simulated use via delivery through amicrocatheter in a clinically relevant tortuosity model. | Acceptance criteria met |
| Torque Test | Torque testing is performed to verify if the stent jointcan withstand a minimum of one rotation in a clinicallyrelevant tortuosity model. | Acceptance criteria met |
| Radial Outward Force | The maximum radial outward force (ROF) is measuredto specification. | Acceptance criteria met |
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| Table 2: Performance Testing | |||
|---|---|---|---|
| Test | Test Method Summary | Conclusions | |
| Stent Outer Diameter | The average device diameter is measured postsimulated use testing. | Acceptance criteria met | |
| Particulate Test | Particulates generated during simulated use(including multiple deployment cycling). | Acceptance criteria met | |
| Fluorosafe MarkerDistance | The distance from the distal tip of the devicesubassembly to the distal end of the fluorosafe markerin-sheath is measured. | Acceptance criteria met |
Performance Data- Animal:
Non-clinical animal testing was performed to evaluate the safety of the 3mm Solitaire™ X Revascularization Device in a porcine model at sub-acute and 30-day (chronic) time points. The study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). The safety and usability results from the sub-acute and chronic animal study suggest that the subject 3mm Solitaire™ X Revascularization Device is substantially equivalent to the predicate Solitaire™ 4 Revascularization Device (K183022).
Clinical:
To support substantial equivalence of the subject 3mm Solitaire™ X Revascularization Device, a retrospective analysis of vessel sizes was performed using the STRATIS registry data, previously submitted in K193576.
Conclusion:
Testing confirmed that the subject 3 mm Solitaire™ X Revascularization Device met product specifications and the differences in design did not raise new questions of safety and effectiveness. Additionally, there are no changes to the fundamental scientific technology of the device.
Therefore, the information provided in this submission supports a determination of substantial equivalence for the subject 3 mm Solitaire™ X Revascularization Device to the primary predicate Solitaire™ 4 Revascularization Device (K183022) and additional predicate devices -Solitaire™ Platinum Revascularization Device, Solitaire™ 2 Revascularization Device (K181807).
§ 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.