SOLITAIRE 2 REVASCULARIZATION DEVICE

K123378 · Micro Therapeutics Dba Ev3 Neurovascular · NRY · Nov 30, 2012 · Cardiovascular

Device Facts

• Record ID: K123378
• Device Name: SOLITAIRE 2 REVASCULARIZATION DEVICE
• Applicant: Micro Therapeutics Dba Ev3 Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Nov 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solitaire™ 2 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.

Device Story

The Solitaire™ 2 is a catheter-based thrombus retriever designed to restore blood flow in ischemic stroke patients. The device features a distal nitinol portion for clot retrieval, equipped with Pt-Ir radiopaque markers for visualization. Modifications from the predicate include a redesigned attachment zone for increased tensile strength, a redesigned marker band for improved crimping, a fluorosafe marker on the pushwire, and the use of single-piece PTFE tubing. The device is operated by a physician in a clinical setting to mechanically remove thrombi. By restoring intracranial blood flow, the device aims to improve patient outcomes following stroke. No clinical or animal testing was required due to the maintenance of fundamental scientific technology and indications for use.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence was supported by non-clinical bench testing, including delivery force, withdrawal force, system length, marker performance, durability, radiopacity, torque response, torque strength, and system tensile strength, as well as a 1-year accelerated aging study.

Technological Characteristics

Catheter-based thrombus retriever; distal nitinol retrieval component; Pt-Ir radiopaque markers; PTFE tubing; fluorosafe marker on pushwire. Mechanical operation; no energy source. Sterilization method not specified. No software or algorithm components.

Indications for Use

Indicated for patients experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset who are ineligible for or failed IV t-PA therapy.

Regulatory Classification

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.

Predicate Devices

• Solitaire™ FR Revascularization Device (K113455)

Submission Summary (Full Text)

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# K123378

29 October 2012

NOV 3 0 2012

-

### Solitaire™ 2 Revascularization Device

## 3. 510(k) Summary

ﺗ ,

| 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: | Larry Boucher<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone]<br>E-mail: [e-mail] |
| Date Summary<br>Prepared: | 27 November 2012 |
| Trade Name of<br>Device: | Solitaire™ 2 Revascularization Device |
| Common Name of<br>Device: | Catheter, Thrombus Retriever |
| Classification of<br>Device: | 21 CFR 870.1250 - Class II |
| Predicate Device: | Solitaire™ FR Revascularization Device (K113455) |
| Device Description: | The Solitaire™ 2 device is designed to restore blood flow in subjects<br>experiencing ischemic stroke due to large intracranial vessel occlusion<br>within 8 hours of symptom onset. It is indicated for subjects who are<br>ineligible for intravenous tissue plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy. The distal nitinol portion of the device<br>facilitates clot retrieval and has Pt-Ir radiopaque markers on the<br>proximal and distal ends.<br>The following modifications have been made to the device in support of<br>this application:<br>• The attachment zone has been redesigned for greater tensile<br>strength.<br>• The marker band has been redesigned to aid the crimping<br>process.<br>• The pushwire now contains a fluorosafe marker.<br>• The Solitaire™ 2 Device uses one piece of PTFE tubing. |
| Intended Use: | The Solitaire™ 2 Revascularization Device is intended to restore blood<br>flow by removing thrombus from a large intracranial vessel in patients<br>experiencing ischemic stroke within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous tissue plasminogen activator<br>(IV t-PA) or who fail IV t-PA therapy are candidates for treatment. |

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29 October 2012

#### Performance Data:

The following tests were performed to support the changes to the Solitaire™ 2 Revascularization Device:

#### Non-Clinical

#### Bench Testing:

- . Delivery Force
- Withdrawal Force .
- Total System Length .
- Fluoro Safe Marker Length ●
- . Distal Tip to Fluoro Marker Length
- Durability .
- . Radiopacity
- Torque Response
- Torque Strength .
- . System Tensile

1-Year Accelerated Aging Study

- Delivery Force .
- ◆ Withdrawal Force
- Durability .
- . Torque Response
- Torque Strength ●
- System Tensile Strength .

The following tests were not performed as they are not related to the changes being made to the Solitaire™ 2 Revascularization Device:

#### Bench Testing:

- . Kink Resistance
- Marker Coil Tensile Strength .
- . Radial Force

In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.

#### Conclusion:

The Solitaire™ 2 device is substantially equivalent to the Solitaire™ FR Revascularization Device based on the successful completion of non-clinical testing as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 30, 2012

Micro Therapeutics DBA ev3 Neurovascular c/o Mr. Larry Boucher Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618

Re: K123378

Trade/Device Name: Solitaire 2 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: October 29, 2012 Received: November 1, 2012

Dear Mr. Larry Boucher:

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. 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.

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Page 2 - Mr. Larry Boucher in

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Quynh T. Hoang for: .

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### 510(k) Number: K123378

Device Name: Solitaire™ 2 Revascularization Device

Indications For Use:

The Solitaire™ 2 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.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Quynh T. Hoang

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123378

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