CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037

K040700 · Concentric Medical, Inc. · DQY · Jun 21, 2004 · Cardiovascular

Device Facts

• Record ID: K040700
• Device Name: CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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

The Concentric Retriever is a mechanical device designed for the retrieval of foreign bodies misplaced during interventional radiological procedures. It consists of a Nitinol tapered wire featuring a helical-shaped distal tip and a radiopaque distal coil to facilitate fluoroscopic visualization. The device is operated by a physician in a clinical setting, such as an interventional radiology suite. By navigating the helical tip to the site of the foreign body, the physician can capture and remove the object from the neuro, peripheral, or coronary vascular systems. This retrieval process helps mitigate complications associated with misplaced foreign bodies, potentially improving patient outcomes by avoiding the need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. The device underwent testing of components and subassemblies to ensure compliance with specifications. No clinical data was provided.

Technological Characteristics

Nitinol tapered wire with helical distal tip; radiopaque distal coil for fluoroscopic visualization. Materials are biocompatible and previously cleared. Device is a mechanical percutaneous catheter (21 CFR 870.1250).

Indications for Use

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

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)
• Concentric Retriever (K030476)

Submission Summary (Full Text)

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JUN 2 1 2004

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## 510(k) Summary

General Information

| Classification | Class II, Percutaneous Catheter per 21 CFR § 870.1250 |
|----------------|---------------------------------------------------------------------------|
| Trade Name | 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 K003410, K030476 Concentric Retriever Manufactured by Concentric Medical, Inc.

## Device Description

The Concentric Retriever consists of a Nitinol tapered wire with a helical shaped 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 a similar manner as the predicate Concentric Retriever (K003410, K030476). 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§820.30.

## 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 1 2004

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

- K040700 Re:
Trade/Device Name: Percutaneous Introducer Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: June 11, 2004 Received: June 14, 2004

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 10(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosure) to regally the Medical Device Amendments, or to commerce prof to May 20, 1910, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent of the general controls provisions of the Act. The I ou may, merelore, manel of the Act include requirements for annual registration, listing of general controls provisions wastice, 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 (\$60 a00 ro) als. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ovavents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dri 3 issualles complies with other requirements of the Act that I DA has made a develations administered by other Federal agencies. You must or any I catal statues and registements, 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 forth in the quality systems (QS) regulation (DF OF S42 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 901 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin markstuig your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equiralend thus, premarket notification. The PDA inding of substantial equive 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
r the If you desire specific advice for your active at [phone]. Additionally, for questions of Compliance at 3 contact the Office of Compliance at (301) 591 - 1612 - 12 - 1 Compliance at (301) 594promotion and advertising of your device, please contact the Office of Company of promotion and advertising of your ac-roo, pear ".
4639. Also, please note the regulation entitled, "Misbranding by reference to premation on van 4639. Also, please note the regulation entreal. Other general information on your notification" (21CFK Part 807.77) your hajred from the Division of Small Manufacturers,
responsibilities under the Act may be obtained from the Division of Small Ma responsibilities under the Act may be out its toll-free number [phone] or [phone]
International and Consumer Assistance at its toll-free number (800) tour l niternational and Consultip://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dumer 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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## Indications for Use

K040700

510(k) Number (if known):

Device Name:

Indications for Use:

This application

Concentric Retriever

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

Prescription Use

(Per 21 CFR 801 Subpart D)

**X**

OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

D

Dunner (Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K040700