MODIFIED CONCENTRIC RETRIEVER, MODEL 90039

K051838 · Concentric Medical, Inc. · DQY · Sep 1, 2005 · Cardiovascular

Device Facts

• Record ID: K051838
• Device Name: MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Device Story

Modified Concentric Retriever is a percutaneous catheter-based device designed for foreign body retrieval in vascular systems. Device consists of flexible tapered core wire with five helical loops at distal end; polymer filaments attached to helix facilitate entrapment; radiopaque coil allows fluoroscopic visualization; hydrophilic coating reduces friction. Physician operates device under fluoroscopic guidance, delivering it to treatment site via compatible microcatheter. Insertion tool and torque device assist manipulation. Marker on proximal end indicates tip position relative to microcatheter. By capturing misplaced foreign bodies, device enables removal, potentially preventing complications from retained objects in neuro, peripheral, or coronary vasculature.

Clinical Evidence

Bench testing only. The device successfully passed all performance and functional testing to demonstrate compliance with product specifications.

Technological Characteristics

Flexible tapered core wire with helical loops; polymer filaments for entrapment; radiopaque coil for fluoroscopy; hydrophilic coating. Delivered via microcatheter. Materials are biocompatible and previously cleared in other products. No software or electronic components.

Indications for Use

Indicated for removal of misplaced foreign bodies during interventional radiological procedures in neuro, peripheral, and coronary vascular systems. No specific age or gender restrictions provided.

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 LX (K040745)

Submission Summary (Full Text)

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Concentric Medical, Inc. Modified Concentric Retriever

SEP - 1 2005

## 510(k) Summary

| General Information<br>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<br>tel: [phone] |
| Contact | Jean M. Caillouette, RAC<br>Manager, Regulatory Affairs |

### Intended Use

The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Predicate Device K040745 Concentric Retriever LX Manufactured by Concentric Medical, Inc.

### Device Description

The Modified Concentric Retriever consists of a flexible, tapered core wire with five The Nically-shaped helical loops at the distal end. Polymer filaments are fastened to the helix to aid in the entrapment and retrieval of foreign bodies. A radiopaque coil is attached over the distal end to facilitate fluoroscopic visualization. The device is covered with a hydrophilic coating to reduce friction during use. A visible marker on the Retriever wroximal end aids the physician in determining when the Retriever tip is about to exit the Microcatheter tip. The device is provided with an insertion tool to facilitate introduction into a Microcatheter and a torque device to facilitate manipulation. The Modified Coocentric Retriever is delivered to the treatment site using a compatible Microcatheter as specified in the Instructions for Use.

#### Materials

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

#### Testing Summary

The Modified Concentric Retriever has successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification. The Modified Concentric Retriever has

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Concentric Medical, Inc. Modified Concentric Retriever

been designed, developed and manufactured in accordance with the Concentric Quality System which complies with the requirements of Title 21, CFR\$820.30.

# Summary of Substantial Equivalence

Dulminal y of Bubbannal the Modified Concentric Retriever are either identical or substantially equivalent to the existing, legally marketed predicate device identified in this application. As such, Concentric Medical, Inc. believes the Modified Concentric Retriever is substantially equivalent to the legally marketed predicate device.

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Public Health Service

SEP - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical, Inc. c/o Ms. Jean M. Caillouette Manager, Regulatory Affairs 1380 Shorebird Way Mountain View, CA 94043

Re: K051838

Modified Concentric Retriever, Model 90039 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY · Dated: August 11, 2005 Received: August 12, 2005

Dear Ms. Caillouette:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave uctchined the acrese to actives marketed in interstate for use stated in the encrosule, to regary manological Device Amendments, or to commerce prior to May 28, 1970, the characterial as a securitions of the Federal Food, Drug, devices that nave been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. and Cosmetic Act (Act) that do not require upprovite of the general controls provisions of the Act. The Y ou may, merelore, market the device, saloject to the gentration, listing of
general controls provisions of the Act include requirements for annual registration, includes a general controls provisions of the free here.................................................................................................................................. adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) this effective major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller. Entrological on 898. In addition, FDA may be found in the Code of Peastal Registering your device in the Federal Register.

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Page 2 - Ms. Jean M. Caillouette

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. 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,

Durna R. Vochner

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

Enclosure

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Concentric Medical, Inc. Modified Concentric Retriever

## Indications for Use

| 510(k) Number (if known): | This application K051838 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified Concentric Retriever |
| Indications for Use: | The Modified Concentric Retriever is intended to<br>remove foreign bodies misplaced during interventional<br>radiological procedures in the neuro, peripheral and<br>coronary vascular systems. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(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)

suma R. Jochner

Division Sign-Off) Tivision of Cardiovascular Devices

: 10(k) Number_k 051838

Confidential

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