Solitaire X Revascularization Device

K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · POL · Mar 1, 2021 · Neurology

Device Facts

• Record ID: K203358
• Device Name: Solitaire X Revascularization Device
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: POL · Neurology
• Decision Date: Mar 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. 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. 2. 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. 3. 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.

Device Story

Solitaire X Revascularization Device is a mechanical thrombectomy tool for acute ischemic stroke. Device consists of a distal nitinol stent retriever with Platinum/Iridium radiopaque markers; delivered via microcatheter to intracranial vessels (ICA, MCA, basilar, vertebral arteries). Operated by neurointerventionalists in clinical settings. Device deployed to engage and remove thrombus, restoring blood flow. Output is visual confirmation of clot retrieval and revascularization via fluoroscopy. Benefits include reduced disability through rapid vessel recanalization. Device is single-use and sterile.

Clinical Evidence

No new clinical trials were conducted. Substantial equivalence supported by non-clinical bench testing (delivery force, resheathing, durability, tensile strength, torque, radial outward force, particulate testing) and a GLP-compliant porcine animal study (sub-acute and 30-day). Clinical support provided via retrospective analysis of vessel sizes using existing STRATIS registry data (K193576).

Technological Characteristics

Stent/pushwire: Nitinol. Markers: 90% Platinum/10% Iridium. Push-wire shrink tubing: PTFE. Introducer sheath: Marlex 5502/Orevac 18300/Grilamid L25. Sterilization: Ethylene Oxide. Form factor: 3 mm diameter stent retriever. Connectivity: None (mechanical).

Indications for Use

Indicated for patients with acute ischemic stroke, including those with persistent proximal anterior circulation large vessel occlusion (ICA or MCA-M1) and smaller core infarcts. Applicable to patients eligible for IV t-PA (within 6 hours) or those ineligible/failed IV t-PA (within 8-16 hours).

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment is subject to the following special controls:

*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.

Predicate Devices

• Solitaire™ 4 Revascularization Device (K183022)
• Solitaire™ 2 Revascularization Device (K181807)
• Solitaire™ Platinum Revascularization Device (K181807)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

1. 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.

2. 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.

3. 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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary - K203358

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin Kong, M.Sc., RAC<br>Principal Regulatory Affairs Specialist<br>Telephone: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | February 25, 2021 |
| Trade Name of Device: | Solitaire™ X Revascularization Device |
| Common Name of Device: | POL: Neurovascular Mechanical Thrombectomy Device for<br>Acute Ischemic Stroke Treatment<br>NRY: Catheter, Thrombus Retriever |
| Classification of<br>Device: | Class II, 21 CFR 882.5600; 21 CFR 870.1250 |
| Product Code: | POL; NRY |
| Predicate Device: | Primary Predicate Device:<br>Solitaire™ 4 Revascularization Device (K183022)<br><br>Additional Predicate Device:<br>Solitaire™ 2 Revascularization Device, Solitaire™ Platinum<br>Revascularization Device (Solitaire™ Revascularization<br>Device) (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:

- 1. 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.
- 2. 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.
- 3. 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™ X<br>Revascularization |
| | (K183022) | (K181807) | Device |
| Indications<br>for Use | 1. The Solitaire™ Revascularization Device<br>is indicated for use to restore blood flow in<br>the neurovasculature by removing<br>thrombus for the treatment of acute<br>ischemic stroke to reduce disability in<br>patients with a persistent, proximal<br>anterior circulation, large vessel occlusion,<br>and smaller core infarcts who have first<br>received intravenous tissue plasminogen<br>activator (IV t-PA). Endovascular therapy<br>with the device should be started within 6<br>hours of symptom onset.<br><br>2. The Solitaire™ Revascularization Device<br>is indicated to restore blood flow by<br>removing thrombus from a large<br>intracranial vessel in patients experiencing<br>ischemic stroke within 8 hours of symptom<br>onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are<br>candidates for treatment. | 1. The Solitaire™ Revascularization Device is indicated for<br>use to restore blood flow in the neurovasculature by<br>removing thrombus for the treatment of acute ischemic<br>stroke to reduce disability in patients with a persistent,<br>proximal anterior circulation, large vessel occlusion, and<br>smaller core infarcts who have first received intravenous<br>tissue plasminogen activator (IV t-PA). Endovascular<br>therapy with the device should be started within 6 hours of<br>symptom onset.<br><br>2. The Solitaire™ Revascularization Device is indicated to<br>restore blood flow by removing thrombus from a large<br>intracranial vessel in patients experiencing ischemic stroke<br>within 8 hours of symptom onset. Patients who are<br>ineligible for IV t-PA or who fail IV t-PA therapy are<br>candidates for treatment.<br><br>3. The Solitaire™ Revascularization Device is indicated for<br>use to restore blood flow in the neurovasculature by<br>removing thrombus for the treatment of acute ischemic<br>stroke to reduce disability in patients with a persistent,<br>proximal anterior circulation, large vessel occlusion of the<br>internal carotid artery (ICA) or middle cerebral artery<br>(MCA)-M1 segments with smaller core infarcts (< 70 cc<br>by CTA or MRA, < 25 cc by MR-DWI). Endovascular<br>therapy with the device should start within 6-16 hours<br>of time last seen well in patients who are ineligible<br>for intravenous tissue plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy. | Same as the<br>Additional Predicate<br>- Solitaire™ Platinum, Solitaire™<br>2 Revascularization<br>Devices (K181807) |
| Principles of<br>Operation | The device is used in the neurovasculature to<br>restore blood flow for treatment of<br>acute ischemic stroke. | Same | Same |
| Device<br>Size(s) | 4-20-05 mm | Solitaire™ 2:<br>4-15 mm | 3-20-10 mm<br>3-40-10 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 | |
| Device<br>Materials | Stent: Nitinol<br>Pushwire: Nitinol<br>Markers:90%Platinum/10%Iridium<br>Push-wire shrink Tubing: PTFE<br>Introducer Sheath: PTFE/Grilamid L25 | Same | Stent: Same<br>Pushwire: Same<br>Markers: Same<br>Push-wire shrink<br>Tubing: Same<br>Introducer Sheath:<br>Marlex 5502/ Orevac<br>18300/ Grilamid L25 |
| Packaging<br>Materials | Stored within dispenser coil, Tyvek/Nylon<br>pouch, and shipping carton. | Stored within dispenser coil, Tyvek pouch, and shipping<br>carton. | Same as the primary<br>predicate |
| Sterilization<br>Method | Ethylene Oxide…