MODIFIED CONCENTRIC RETRIEVER, MODEL 90037

K030476 · Concentric Medical, Inc. · DQY · Mar 11, 2003 · Cardiovascular

Device Facts

• Record ID: K030476
• Device Name: MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Device Story

Modified Concentric Retriever consists of Nitinol tapered wire with helical distal tip and platinum coil; used for retrieval of misplaced foreign bodies in neuro, peripheral, and coronary vascular systems. Device operated by clinicians during interventional radiological procedures; fluoroscopic visualization enabled by radiopaque distal coil. Device functions as mechanical retrieval tool; no electronic or software components. Benefits patient by allowing removal of misplaced foreign bodies during vascular interventions.

Clinical Evidence

Bench testing only. Device tested in same manner as predicate; all components and subassemblies met required specifications.

Technological Characteristics

Nitinol tapered wire with helical distal tip; platinum coil for radiopaque fluoroscopic visualization. Percutaneous catheter (21 CFR 870.1250).

Indications for Use

Indicated for retrieval of misplaced foreign bodies in neuro, peripheral, and coronary vascular systems during interventional radiological procedures.

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 (K003410)

Submission Summary (Full Text)

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Concentric Medical, Inc.

11030476

#### 510(k) Summary

MAR 1 1 2003

General Information

| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|----------------|---------------------------------------------------------------------------|
| Trade Name | Modified Concentric Retriever |
| Submitter | Concentric Medical, Inc.<br>1380 Shorebird Way<br>Mountain View, CA 94043 |
| | 650-938-2100 |
| Contact | Kevin F. MacDonald<br>Vice President, Clinical and Regulatory Affairs |

### Intended Use

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Predicate Devices Concentric Retriever K003410 Manufactured by Concentric Medical, Inc.

#### Device Description

The Concentric 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 modified Concentric Retriever are suitable for this use and have been used in numerous previously cleared products.

#### Testing Summary

The modified Concentric Retriever was tested in the same manner as the predicate Concentric Retriever (K003410). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The modified Concentric Retriever was designed under the Concentric Quality System which is in compliance with 21CFR 8820.30.

## Summary of Substantial Equivalence

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

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MAR 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030476

> Trade/Device Name: Modified Concentric Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 12, 2003 Received: February 13, 2003

Dear Mr. MacDonald:

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 - Mr. Kevin F. MacDonald

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsmamain.html

Sincerely yours.

V.R. Delatorre, M.D.

Bram D. Žuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

'

Indications for Use:

This application

Modified Concentric Retriever

The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

X. C. M.

Number KD30474

(Optional Format 1-2-96)