Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

K193576 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · POL · Nov 20, 2020 · Neurology

Device Facts

• Record ID: K193576
• Device Name: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: POL · Neurology
• Decision Date: Nov 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solitaire™ 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™ 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™ 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

Neurovascular mechanical thrombectomy device; used to restore blood flow in patients with acute ischemic stroke by removing thrombi from large intracranial vessels (ICA, MCA, basilar, vertebral arteries). Device consists of distal nitinol stent retriever with radiopaque markers; delivered via catheter to occlusion site. Physician operates device under imaging guidance; stent expands to engage clot; clot retrieved through withdrawal. Benefits include restored perfusion and reduced disability. Used in clinical/interventional settings. Labeling modification expands use to smaller vessel diameters (1.5 mm).

Clinical Evidence

Retrospective analysis of STRATIS registry data. Subgroup analysis compared clinical performance and safety of 4 mm device in vessels 1.5-2.0 mm against predicate performance. Results demonstrated similar safety and performance profiles.

Technological Characteristics

Stent and pushwire: Nitinol. Markers: 90% Platinum/10% Iridium. Push-wire shrink tubing: PTFE. Introducer sheath: PTFE/Grilamid. Principle: Mechanical clot retrieval via stent expansion. Sterilization: Ethylene Oxide. Single-use.

Indications for Use

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

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™ Platinum Revascularization Device (K181186)
• Solitaire™ 4 Revascularization Device (K183022)
• Solitaire™ Platinum Revascularization Device (K181807)
• Solitaire™ 2 Revascularization Device (K181807)

Submission Summary (Full Text)

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November 20, 2020

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Jennifer Correa, MS, RAC Program Manager, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

### Re: K193576

Trade/Device Name: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire 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: October 26, 2020 Received: October 27, 2020

Dear Jennifer Correa:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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,

for 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) K193576

#### Device Name

Solitaire™ Platinum Revascularization Device, Solitaire™ X Revascularization Device (Solitaire™ Revascularization Device)

#### Indications for Use (Describe)

1. The Solitaire™ 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™ 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™ Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ische 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) |
|-------------------------------------------------|
|-------------------------------------------------|

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

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| 510(K) Summary | K193576 | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 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: | Jennifer Correa<br>Program Manager, Regulatory Affairs<br>Telephone: [phone]<br>E-mail: [e-mail] | |
| Date Summary<br>Prepared: | November 18, 2020 | |
| Trade Name of<br>Device: | Solitaire™ Platinum Revascularization Device,<br>Solitaire™ X Revascularization Device<br>(Solitaire™ Revascularization Device) | |
| Common Name of<br>Device: | Neurovascular Mechanical<br>Thrombectomy Device for Acute<br>Ischemic Stroke Treatment | Catheter, Thrombus Retriever |
| Classification: | Class II, 21 CFR 882.5600 | Class II, 21 CFR 870.1250 |
| Product Code: | POL | NRY |
| Primary Predicate<br>Devices: | Solitaire™ Platinum Revascularization Device (K181186);<br>Solitaire™ 4 Revascularization Device (K183022) | |
| Additional<br>Predicate Devices: | Solitaire™ Platinum Revascularization Device and Solitaire™ 2<br>Revascularization Device (K181807) | |

## Device Description:

The Solitaire™ Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Revascularization Device is intended 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 Solitaire™ Revascularization Device facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends and also features radiopaque markers along the circumference of the working length of the devices are supplied sterile and are intended for single-use only.

## Indications for Use:

- The Solitaire™ Revascularization Device is indicated for use to restore blood flow in the 1. 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.

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- 2. The Solitaire™ 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 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 Solitaire™ Revascularization Device and the predicate Solitaire™ 2 Revascularization Device (Solitaire™ Platinum Revascularization Device K181807, K181186; Solitaire™ 4 Revascularization Device K183022) is provided in Table 1. This 510(k) is for a labeling modification to reduce the recommended minimum vessel diameter for the subject Solitaire™ Revascularization Device, 4 mm device models. The Indications for Use (IFU) of the subject Solitaire™ Revascularization Device remain unchanged and are identical to the legally marketed additional predicate device. The subject Solitaire™ Revascularization device is identical to the primary predicate Solitaire™ Revascularization Devices, apart from these labeling modifications.

| Table 1: Device Comparison | | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------|
| Indication for Use | Primary Predicate SolitaireTM<br>Revascularization Device<br>(K181186, K183022) | Additional Predicate SolitaireTM<br>Revascularization Device<br>(K181807) | Subject SolitaireTM<br>Revascularization Device | |
| | 1. The SolitaireTM Revascularization<br>Device is indicated for use to restore<br>blood flow in the neurovasculature by<br>removing thrombus for the treatment of<br>acute ischemic stroke to reduce<br>disability in patients with a persistent,<br>proximal anterior circulation, large<br>vessel occlusion, and smaller core<br>infarcts who have first received<br>intravenous tissue plasminogen<br>activator (IV t-PA). Endovascular<br>therapy with the device should be<br>started within 6 hours of symptom<br>onset.<br>2. The SolitaireTM Revascularization<br>Device is indicated to restore blood<br>flow by removing thrombus from a<br>large intracranial vessel in patients<br>experiencing ischemic stroke within 8<br>hours of symptom onset. Patients who<br>are ineligible for IV t-PA or who fail IV | 1. The SolitaireTM Revascularization<br>Device is indicated for use to restore<br>blood flow in the neurovasculature by<br>removing thrombus for the treatment of<br>acute ischemic stroke to reduce<br>disability in patients with a persistent,<br>proximal anterior circulation, large<br>vessel occlusion, and smaller core<br>infarcts who have first received<br>intravenous tissue plasminogen<br>activator (IV t-PA). Endovascular<br>therapy with the device should be<br>started within 6 hours of symptom<br>onset.<br>2. The SolitaireTM Revascularization<br>Device is indicated to restore blood<br>flow by removing thrombus from a<br>large intracranial vessel in patients<br>experiencing ischemic stroke within 8<br>hours of symptom onset. Patients who<br>are ineligible for IV t-PA or who fail IV | Same as<br>additional<br>predicate | |
| | Table 1: Device Comparison | | | |
| | Primary Predicate Solitaire™<br>Revascularization Device<br>(K181186, K183022) | | Additional Predicate Solitaire™<br>Revascularization Device<br>(K181807) | Subject<br>Solitaire™<br>Revascularization<br>Device |
| | t-PA therapy are candidates for<br>treatment. | t-PA therapy are candidates for<br>treatment.<br>3. The Solitaire™ Revascularization<br>Device is indicated for use to restore<br>blood flow in the neurovasculature by<br>removing thrombus for the treatment of<br>acute ischemic stroke to reduce<br>disability in patients with a persistent,<br>proximal anterior circulation, large<br>vessel occlusion of the internal carotid<br>artery (ICA) or middle cerebral artery<br>(MCA)-M1 segments with smaller core<br>infarcts (< 70 cc by CTA or MRA, < 25<br>cc by MR-DWI). Endovascular therapy<br>with the device should start within 6-16<br>hours of time last seen well in patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA)<br>or who fail IV t-PA therapy. | | |
| Principles<br>of<br>Operation | The device is used in the neurovasculature<br>to restore blood flow for treatment of acute<br>ischemic stroke | Same | | Same |
| Vessel Size | 2.0 to 4.0 mm (4 mm device)<br>2.0 to 5.5 mm (6 mm device) | Same | | 1.5 to 4.0 mm (4<br>mm device)<br>2.0 to 5.5 mm (6<br>mm device) |
| | | Dimensions and Materials | | |
| Device<br>Size(s) | 4-20-05 mm<br>4-20-10 mm<br>4-40-10 mm<br>6-20-10 mm<br>6-24-06 mm<br>6-40-10 mm | 4-15 mm<br>4-20 mm<br>4-40 mm<br>6-20 mm<br>6-30 mm | 4-20-05 mm<br>4-20-10 mm<br>4-40-10 mm<br>6-20-10 mm<br>6-24-06 mm<br>6-40-10 mm | Same as Primary<br>Predicate |
| 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 | Same | Same | Same |
| | Sterilization and Packaging | | | |
| Packaging<br>Materials | Stored within dispenser coil, pouch, and<br>shipping carton. | Same | | Same |
| Sterilization<br>Method | Ethylene Oxide | Same | | Same |
| How<br>Supplied | Sterile, Single Use | Same | Same | Same |

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## Performance Testing - Bench:

The subject Solitaire™ Revascularization device is identical to the primary predicate Solitaire™ Revascularization Devices including device design, materials, manufacturing, packaging, sterilization, and shelf-life. Therefore, previously conducted biocompatibility tests, sterilization validation, and shelf-life were leveraged from the predicate devices. The following non-clinical bench test was performed to support the labeling modification:

| Test | Test Method Summary | Conclusions |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Durability | Durability was evaluated on the ability to withstand simulated use of the device, including delivery, resheathing and retrieval in a representative tortuous model with the appropriate ancillary devices | Acceptance criteria met |
| Radial Force | Radial force measured at a minimum vessel diameter. | Acceptance criteria met |

## Performance Testing - Animal:

No additional animal testing was performed or required to support the labeling modification. Previously conducted animal studies included vessels of appropriate size to support the labeling modifications for minimum recommended vessel diameter.

## Performance Testing - Clinical:

To support substantial equivalence of the subject Solitaire™ Revascularization Device, a retrospective analysis of subject vessel size was performed using the STRATIS registry data. This retrospective subgroup analysis demonstrates that the subject Solitaire™ Revascularization 4 mm device, with vessel diameters of 1.5 to 2.0 mm, has similar clinical performance and safety profile compared to the predicate Solitaire™ Revascularization 4 mm device.

# Summary of Substantial Equivalence:

There is no change to the Indication for Use Statements or design for the Solitaire™ Revascularization Device in comparison to the legally marketed predicate device. The additional bench testing, existing animal testing and the retrospective vessel diameter analysis demonstrates that the labeling modification does not raise any new or different questions of safety or effectiveness of the Solitaire™ Revascularization Device. The information provided in this submission supports a determination of substantial equivalence for the Solitaire™ Revascularization Device