CONCENTRIC BALLOON GUIDE CATHETER

K102657 · Concentric Medical, Inc. · DQY · Nov 17, 2010 · Cardiovascular

Device Facts

• Record ID: K102657
• Device Name: CONCENTRIC BALLOON GUIDE CATHETER
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.

Device Story

Coaxial-lumen, braid-reinforced, variable stiffness catheter; distal radiopaque marker for angiographic visualization; distal compliant balloon for temporary vascular occlusion; proximal bifurcated luer hub for flushing, inflation, and aspiration. Used by physicians in clinical settings during angiographic procedures to facilitate catheter guidance and provide vascular occlusion. Acts as a conduit for the Merci Retriever. Device design, materials, and function are identical to predicate devices.

Clinical Evidence

No new clinical data provided. Safety and effectiveness were demonstrated by referencing bench testing, biocompatibility, and sterility information from predicates K010954 and K021899, and clinical trial data from K070521 and K082034.

Technological Characteristics

Coaxial-lumen, braid-reinforced, variable stiffness catheter; radiopaque distal marker; compliant distal balloon; bifurcated proximal luer hub. No changes in materials or design from predicate devices.

Indications for Use

Indicated for patients requiring intravascular catheter insertion and guidance in peripheral and neurovascular systems, temporary vascular occlusion during angiographic procedures, and as a conduit for the Merci Retriever.

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 Balloon Guide Catheters (K010954)
• Concentric Balloon Guide Catheters (K021899)

Reference Devices

• MERCI (K070521)
• Multi MERCI (K082034)

Submission Summary (Full Text)

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K102657

## 510(K) Summary

#### General Information

| Trade Name | Concentric Balloon Guide Catheter |
|----------------|-----------------------------------------------------------------------------------------------------------------------|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 - Class II |
| Submitter | Concentric ® Medical, Inc.<br>301 E. Evelyn Avenue<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone] |
| Contact | Kirsten Valley<br>Senior Vice President, Technology and Regulatory Affairs |

## Predicate Device

Concentric Balloon Guide Catheters (K010954 and K021899).

### Device Description

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker on the distal end facilitates angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. The Balloon Guide Catheter is identical to K010954 and K021899.

#### Indications for Use

The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.

#### Technological Characteristics

The Concentric Balloon Guide Catheter has the same technological characteristics as the predicate device. The device design, materials used, function, physical properties and composition have not been changed. Specifically, the device is coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end. A soft, compliant balloon is mounted on the distal end. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration.

## Testing Summary

The Balloon Guide Catheter is identical to K010954 and K021899 and there were no design changes. For this 510k, Concentric Medical referenced the bench testing, biocompatibility and sterility information in K010954 and K021899. The safety and effectiveness of the Balloon Guide Catheter was also demonstrated by referencing the MERCI and Multi MERCI clinical trials in (K070521 and K082034).

NOV 1 7 2010

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#### Summary of Substantial Equivalence

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The Concentric Balloon Guide Catheters are substantially equivalent to the predicate device with regard to device design, intended use, and patient population. As a result, the Concentric Balloon Guide Catheter is as safe and effective as the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Concentric Medical, Inc. c/o Ms. Kristen Valley Senior Vice President, Technology and Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041

### Re: K102657

Trade/Device Name: Concentric Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 14, 2010 Received: September 15, 2010

NOV 1 7 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Kristen Valley

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Esa A. Rhmbr
Melvin R. Robinson

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

## INDICATIONS FOR USE

| 510(k) Number (if known): | This application K102657 | NOV 17 2010 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Concentric Balloon Guide Catheter | |
| Indications for Use: | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever. | |

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k102657