MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6

K063774 · Concentric Medical, Inc. · NRY · Jan 24, 2007 · Cardiovascular

Device Facts

• Record ID: K063774
• Device Name: MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
• Applicant: Concentric Medical, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Jan 24, 2007
• 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA the monglos candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neurs, peripheral and coronary vasculature.

Device Story

Endovascular retriever device; consists of flexible Nitinol core wire with shaped loops at distal end; radiopaque coil at tip for fluoroscopic visualization. Used in interventional radiological procedures; physician-operated. Device placed distal to thrombus or foreign body via microcatheter; retriever and microcatheter pulled back to engage target in loops; system removed from body. Restores blood flow in ischemic stroke patients; retrieves misplaced foreign bodies. Benefits include mechanical removal of obstructions where pharmacological therapy is contraindicated or ineffective.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible Nitinol core wire; shaped loops at distal end; radiopaque coil tip for fluoroscopy. Materials are biocompatible and previously cleared. No software or electronic components.

Indications for Use

Indicated for patients experiencing ischemic stroke who are ineligible for or failed IV t-PA therapy, to restore neurovasculature blood flow via 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 (K033736)
• Modified Merci® Retriever (K061059)

Submission Summary (Full Text)

{0}------------------------------------------------

Concentric Medical, Inc. Merci Retriever Modification (PFI)

063774

## Attachment 5

JAN 2 4 2007

## 510(k) SUMMARY

### General Information

| Trade Name | Merci® Retriever |
|----------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name | Endovascular Retriever |
| Classification | Class II, Catheter, thrombus Retriever per 21 CFR § 870.1250 |
| Submitter | Concentric Medical, Inc.<br>1380 Shorebird Way<br>Mountain View, CA 94043<br>Tel [phone]<br>Fax [phone] |
| Contact | Kirsten Valley<br>Senior Vice President, Operations and Regulatory Affairs |

#### 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA the monglos candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neurs, peripheral and coronary vasculature.

#### Predicate Devices

Merci® Retriever (K033736) Modified Merci® Retriever (K061059)

### Device Description

Like the predicate devices, the modified Merci Retriever consists of a flexible, Nitinol core wire with shaped loops at the distal end. A radiopaque coil covers the tip allowing visualization under fluoroscopy.

The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.

{1}------------------------------------------------

Concentric Medical, Inc. Merci Retriever Modification (PFI)

K063774

# Materials

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

# Testing Summary

All devices met the required specifications for the completed tests.

# Summary of Substantial Equivalence

The modified Merci Retriever is equivalent to the predicate devices. The indications for use, function, and materials used are substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. % Ms. Kirsten Valley Senior VP, Operations and Regulatory Affairs 1380 Shorebird Way Mountain View, California 94043

Re: K063774

Trade/Device Name: Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: December 20, 2006 Received: December 22, 2006

IAN 2 4 2007

Dear Ms. Valley:

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 coaxi. 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 subject 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, RDA 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 not 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.

{3}------------------------------------------------

Page 2 - Ms. Kirsten Valley

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Concentric Medical, Inc. Merci Retriever Modification (PFI)

### Attachment 3

## 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 neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for 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.

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)

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

510(k) Num

Confidential

Page 29 of 33