MODIFICATION TO MERCI RETRIEVER

K082034 · Concentric Medical, Inc. · NRY · Aug 15, 2008 · Cardiovascular

Device Facts

• Record ID: K082034
• Device Name: MODIFICATION TO MERCI RETRIEVER
• Applicant: Concentric Medical, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Device Story

Endovascular retriever; flexible, tapered Nitinol core wire with distal helix shape; platinum coil and polymer filaments attached to distal end; hydrophilic coating on proximal core wire. Used in interventional radiological procedures; operated by physicians. Device introduced into microcatheter via provided insertion tool; torque device facilitates manipulation. Helix engages and removes thrombus or foreign bodies from vasculature to restore blood flow. Benefits include mechanical recanalization in stroke patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flexible, tapered Nitinol core wire; distal helix shape; platinum coil; polymer filaments; hydrophilic coating. Torque device and insertion tool included. Sterilization process used.

Indications for Use

Indicated for patients experiencing ischemic stroke who are ineligible for or failed IV t-PA therapy, to restore neurovasculature blood flow by thrombus removal. Also indicated for retrieval of misplaced foreign bodies in neuro, peripheral, and coronary vasculature.

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

• Merci® Retriever (K081305)

Submission Summary (Full Text)

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AUG 1 5 2008

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## General Information

| Trade Name | Merci® Retriever |
|----------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name | Endovascular Retriever |
| Classification | Thrombus Retriever, 21CFR 870.1250 – Class II |
| Submitter | Concentric® Medical, Inc.<br>301 E. Evelyn Avenue<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone] |
| Contact | Laraine Pangelina<br>Director, Regulatory Affairs |

#### Intended Use

The intended use for the modified Merci Retriever is the same as the intended use of the predicate Merci Retriever:

The Merci® Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

#### Predicate Device

Merci® Retriever, K081305

#### Device Description

Like the predicate device, the design of the modified Merci Retriever consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcatheter during the procedure.

#### Materials

All materials used in the manufacture of the modified Merci Retriever are suitable for the intended use of the device and have been used in numerous previously cleared products.

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## Testing Summary

Results of design verification and validation testing performed on the modified Merci Retriever confirm that the device conforms to the required specifications and establish substantial equivalence to the predicate device.

#### Summary of Substantial Equivalence

The modified Merci Retriever is substantially equivalent to the predicate device with regard to intended use, operating principal, design concept, materials, shelf life, packaging and sterilization processes.

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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. % Ms. Laraine Pangelina Director, Regulatory Affairs 301 East Evelyne Avenue Mountain View, California 94041

AUG 1 5 2008

Re: K082034

Trade/Device Name: Merci Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regula ory Class: II Product Code: NRY Dated: July 16, 2008 Received: July 17, 2008

Dear Ms. Pangelina:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subj .ct to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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## Page 2 -- Ms. Laraine Pangelina

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Walken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

| 510(k) Number (if known): | This application |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Merci Retriever |
| Indications for Use: | The Merci® Retriever is intended to restore blood flow in the<br>neurovasculature by removing thrombus in patients<br>experiencing ischemic stroke. Patients who are ineligible for<br>treatment with intravenous tissue plasminogen activator (IV t-<br>PA) or who fail IV t-PA therapy are candidates for treatment.<br>The Merci Retriever is also indicated for use in the retrieval of<br>foreign bodies misplaced during interventional radiological<br>procedures in the neuro, peripheral and coronary vasculature. |

Prescription Use _X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhiser

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082034