MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044

K072796 · Concentric Medical, Inc. · DQO · Dec 18, 2007 · Cardiovascular

Device Facts

• Record ID: K072796
• Device Name: MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
• Applicant: Concentric Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• 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. The Concentric Microcatheter is indicated for use in the selected placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Device Story

Merci Retriever: flexible Nitinol core wire with distal shaped loops; radiopaque coil tip for fluoroscopic visualization. Microcatheter: delivery conduit. Procedure: Microcatheter placed distal to thrombus/foreign body; Retriever deployed through Microcatheter; loops engage target; system withdrawn to remove thrombus/foreign body. Used in interventional radiology/neuro-interventional settings by physicians. Benefits: restoration of blood flow in ischemic stroke; removal of misplaced foreign bodies.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Nitinol core wire; radiopaque coil tip; flexible loop design. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients experiencing ischemic stroke ineligible for or failing IV t-PA therapy for thrombus removal; also indicated for retrieval of misplaced foreign bodies in neuro, peripheral, and coronary vasculature. Microcatheter indicated for delivery of fluids/devices into neuro, peripheral, and coronary vasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Merci Retriever (K072796)
• Merci Microcatheter (K072796)

Submission Summary (Full Text)

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# DEC 1 & 2007

K072796

12

# 510(k) Summary

#### General Information

| Trade Name | Modified Merci® Retriever |
|----------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name | Endovascular Retriever |
| Classification | Class II, Catheter, thrombus Retriever per 21 CFR § 870.1250 |
| | and |
| Trade Name | Merci® Microcatheter |
| Common Name | Intravascular Diagnostic Catheter |
| Classification | Class II, Catheter, thrombus Retriever per 21 CFR § 870.1200 |
| Submitter | Concentric® Medical, Inc.<br>301 E. Evelyn Ave.<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone] |
| Contact | Kirsten Valley<br>Senior Vice President, Operations and Regulatory Affairs |

#### Intended Use

#### 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.

# Concentric Microcatheter

The Concentric Microcatheter is indicated for use in the selected placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

#### Predicate Device

Merci Retriever Merci Microcatheter

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# Device Description

Like the predicate device, the 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 shaped loops of the Retriever are deployed distal to the thrombus or foreign body through the 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.

# Materials

All materials used in the manufacture of the various Retrievers and Microcatheters are suitable for the intended use of the device.

# Testing Summary

All devices met the required specifications for the completed tests.

# Summary of Substantial Equivalence

The Merci® Retrievers and the Concentric Microcatheters are substantially equivalent to their respective predicate devices. In each case the indications for use, function, and materials used are equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a modern interpretation of the Rod of Asclepius, a traditional symbol of medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2007

Concentric Medical, Inc. % Ms. Kirsten Valley Sr. VP, Operations & Regulatory Affairs 301 East Evelyn Avenue Mountain View, California 94041

Re: K072796

Trade/Device Name: Merci Retriever and Merci Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY, DQO Dated: November 19, 2007 Received: November 20, 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 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

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Page 2 -- Ms. Kirsten Valley

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.

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 Prosmarket 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. Millerson

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. | | |
| Device Name: | Merci Microcatheter | | |
| Indications for Use: | The Merci Microcatheter is indicated for use in the selected<br>placement of fluids and/or other devices or agents into the<br>peripheral, coronary and neuro vasculature during diagnostic<br>and/or therapeutic procedures. | | |
| Prescription Use <b>X</b><br>(Per 21 CFR 801.109) | AND/OR | Over-The-Counter Use<br>(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 (OØG)

ice Evaluation (ODI)

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

**510(k) Number** 11072796