MERCI RETRIEVER, MODELS 90065, 90066

K033736 · Concentric Medical, Inc. · NRY · Aug 11, 2004 · Cardiovascular

Device Facts

• Record ID: K033736
• Device Name: MERCI RETRIEVER, MODELS 90065, 90066
• Applicant: Concentric Medical, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 11, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Merci Retriever is a mechanical thrombus removal device used in neurovascular procedures. It consists of a Nitinol tapered wire featuring a helical distal tip and a platinum coil for radiopaque fluoroscopic visualization. The device is operated by a physician in an interventional radiology or neuro-interventional setting. The physician navigates the retriever to the site of the thrombus under fluoroscopic guidance; the helical tip engages the clot, allowing for mechanical retrieval and restoration of blood flow. This provides a treatment option for ischemic stroke patients who cannot receive or have failed IV t-PA therapy. The device also functions as a tool for retrieving misplaced foreign bodies during vascular interventions.

Clinical Evidence

The MERCI Clinical Study was conducted to evaluate the safety and effectiveness of the Merci Retriever for thrombus removal compared to foreign body removal in the neurovasculature. The study established that no new issues of safety or effectiveness exist for the intended use.

Technological Characteristics

Nitinol tapered wire with helical distal tip; platinum coil for radiopaque visualization. Mechanical device; no energy source. Dimensions/form factor: Models X5 and X6. Sterilization method not specified. No software or algorithm components.

Indications for Use

Indicated for patients experiencing ischemic stroke who are ineligible for or failed IV t-PA therapy, for the purpose of thrombus removal in the neurovasculature. 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

• Concentric Retriever (K030476)

Submission Summary (Full Text)

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Concentric Medical, Inc.

K033736 1/2

# AUG 1 1 2004

510(k) Summary

#### General Information

| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|----------------|---------------------------------------------------------------------------|
| Trade Name | Concentric Merci® Retriever<br>Models X5 and X6 |
| Submitter | Concentric Medical, Inc.<br>1380 Shorebird Way<br>Mountain View, CA 94043 |
| | Tel: [phone]<br>Fax: [phone] |
| Contact | Kevin F. MacDonald<br>Vice President, Clinical 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 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 Devices K030476 Concentric Retriever Manufactured by Concentric Medical, Inc.

#### Device Description

The Merci Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A platinum coil is attached over the helical distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.

#### Materials

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

#### Testing Summary

The Merci Retriever was tested in the same manner as the predicate Concentric Retriever (K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The Merci Retriever was designed under the Concentric Quality System that is in compliance with 21CFR§820.30.

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KC 3373C

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## Summary of Clinical Testing

The MERCI Clinical Study established that no new issues of safety and effectiveness exist when the Merci Retriever is used for thrombus removal versus foreign body removal from the neurovasculature.

## Summary of Substantial Equivalence

The Merci Retriever is equivalent to the predicate device, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Concentric Medical, Inc. believes the Merci Retriever is substantially equivalent to existing legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2004

Mr. Kevin 1 . MacDonald Vice President, Clinical and Regulatory Affairs Concentric Medical, Inc. 1380 Shorebird Way Mountain View, California 94043

Re: K033736

Trade/Device Name: Concentric Merci® Retriever Models X5 and X6 Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, thrombus retriever Regulatory Class: II Product Code: NR Y Dated: May 28, 2004 Received: June 2, 2004

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 roxy premier is substantially equivalent (for the indications felcrenced above und nave actoring ally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, de necs that have been receive approval of a premarket approval application (PMA). and Costicule Tec (110) that to neview subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of use ice, 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 If your device is classified (600 abovetrols. Existing major regulations affecting your device can may oc subject to such additions. 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 I lease of advised that I Drivision that your device complies with other requirements of the Act that I DT has made a wond regulations administered by other Federal agencies. You must or any it cactares and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kevin F. MacDonald

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting of substantial equivalence of your device to a legally premaired 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 If you desire specific davice 101 Jour 2011) 594-4659. Also, please note the regulation entitled, Connact the Office of Company of Company (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Celia M. Witt, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. 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): | K033736 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Concentric Merci® Retriever<br>Models X5 and X6 |
| Indications for Use: | The Merci Retriever is intended to restore blood flow in the<br>neurovasculature by removing thrombus in patients experiencing<br>ischemic stroke. Patients who are ineligible for treatment with<br>intravenous tissue plasminogen activator (IV t-PA) or who fail IV<br>t-PA therapy are candidates for treatment. The Merci Retriever is<br>also indicated for use in the retrieval of foreign bodies misplaced<br>during interventional radiological procedures in the neuro,<br>peripheral and coronary vasculature. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the co


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