MODIFIED MERCI RETRIEVER, MODEL 90092

K061059 · Concentric Medical, Inc. · NRY · May 25, 2006 · Cardiovascular

Device Facts

• Record ID: K061059
• Device Name: MODIFIED MERCI RETRIEVER, MODEL 90092
• Applicant: Concentric Medical, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified 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 Modified 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 Nitinol core wire with distal shaped loops; radiopaque coil tip for fluoroscopic visualization. Device placed distal to thrombus/foreign body via microcatheter; microcatheter retracted to deploy loops; retriever and microcatheter pulled back to engage thrombus/foreign body in loops; system removed from body. Used in interventional radiological procedures; operated by physicians. Output is physical removal of obstruction; restores blood flow; benefits ischemic stroke patients by mechanical recanalization.

Clinical Evidence

Bench testing only; no clinical data presented. Device met all required specifications.

Technological Characteristics

Nitinol core wire; radiopaque coil tip; flexible catheter-based form factor; fluoroscopic visualization; manual operation.

Indications for Use

Indicated for patients experiencing ischemic stroke ineligible for or failing IV t-PA therapy to restore neurovascular blood flow; 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 X6

Submission Summary (Full Text)

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Concentric Medical, Inc. Modified Merci Retriever

# MAY 2 5 2006

## Attachment D

#### 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 |
| Date | April 14, 2006 |

#### Intended Use

The Modified 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 Modified 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 X6

### Device Description

Like the predicate device, 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.

Both the predicate Retriever and the Modified Merci Retriever are placed distal to the thrombus or foreign body using a microcatheter which is retracted to deploy the loops of the Retriever. The Retriever and microcatheter are pulled back into the thrombus or foreign body, engaging it in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcather are then removed from the body.

#### 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.

Confidential

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## Testing Summary

The Modified Merci Retriever was tested in the same manner as the predicate Merci Retriever X6. All devices met the required specifications for the completed tests. The Modified Merci Retriever was designed under the Concentric Quality System in compliance with 21CFR 8820.30.

## Summary of Substantial Equivalence

The Modified Merci Retriever is equivalent to the predicate device, Merci® Retriever X6. The indications for use, function, and materials used are substantially equivalent.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures intertwined. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

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

Re: K061059

Trade/Device Name: Modified Merci® Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: April 26, 2006 Received: April 28, 2006

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 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 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, 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. Kirsten Valley

This letter will allow you to begin marketing your device as described in your Section 510(k) Fins letter with and my Jorne 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/dsma/dsmamain.html

Sincerely yours,

emelli.

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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Concentric Medical, Inc. Modified Merci Retriever

K06 1059

## PREMARKET NOTIFICATION

## INDICATIONS FOR USE

| 510(k) Number (if known): | This application |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified Merci® Retriever |
| Indications for Use: | The Modified Merci® Retriever is intended to restore blood flow<br>in the neurovasculature by removing thrombus in patients<br>experiencing ischemic stroke. Patients who are ineligible for<br>intravenous tissue plasminogen activator (IV t-PA) or who fail<br>IV t-PA therapy are candidates for treatment. The Modified<br>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)

ellmelli

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

KOS 1059 510(k) Number_

Confidential