CONCENTRIC BALLOON GUIDE CATHETER

K112404 · Concentric Medical, Inc. · DQY · Mar 15, 2012 · Cardiovascular

Device Facts

• Record ID: K112404
• Device Name: CONCENTRIC BALLOON GUIDE CATHETER
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 Retrieval devices.

Device Story

Coaxial-lumen, braid-reinforced, variable stiffness catheter; radiopaque distal marker for angiographic visualization; compliant distal balloon for temporary vascular occlusion; bifurcated proximal luer hub for flushing, inflation, and aspiration. Used by clinicians in peripheral and neurovascular procedures to facilitate catheter guidance and act as a conduit for retrieval devices. Device design and function remain consistent with predicate; minor addition of colorant to optional dilator.

Clinical Evidence

Bench testing only. No clinical data. Verification testing included tensile, leak, dimensional, torque, kink resistance, simulated use, balloon fatigue, and inflation/deflation testing. Biocompatibility testing for the new colorant included hemolysis (direct contact and extract methods) and ISO MEM elution cytotoxicity.

Technological Characteristics

Coaxial-lumen, braid-reinforced catheter; variable stiffness; radiopaque distal marker; compliant balloon; bifurcated luer hub. Materials and design identical to predicate, except for colorant added to dilator. Biocompatibility verified per ISO standards.

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 retrieval devices.

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 (K102657)

Submission Summary (Full Text)

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KJ2404

# 510(K) Summary

#### General Information

| Trade Name<br>Common Name<br>Classification | Concentric Balloon Guide Catheter<br>Percutaneous Catheter<br>Percutaneous Catheter, 21CFR 870.1250 - Class II |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Owner | 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 |
| Date Prepared | August 4, 2011 |

# Predicate Device

Concentric Balloon Guide Catheters (K102657)

# Device Description

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for 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.

### Indications for Use

The modified Indications for Use are as follows:

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 Retrieval devices.

The modification to the indications does not impact the intended therapeutic use of the device. As a result, the safety and effectiveness of the device are not impacted when used as indicated.

### Technological Characteristics

The Concentric Balloon Guide Catheter has the same technological characteristics as the predicate device. A colorant has been added to the dilator. Apart from this minor modification, the device design, materials used, function, physical properties and composition have not been changed.

# Testing Summary

The same performance standards and specifications as those previously submitted in the predicate device 510(k) submission are applicable. No additional verification testing was required for

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the change to the indications statement requested in this submission. The results of verification and validation conducted on the predicate device remain applicable. Specifically, the device meets the predetermined specifications for the following tests:

- Tensile Testing .
- . Leak Testing
- . Dimensional Testing
- . Torque Testing
- Kink Resistance
- . Simulated Use
- . Biocompatibility Testing
- . Balloon Fatique
- . Inflation/Deflation Testing

To confirm the biocompatibility of the new colorant, the following testing was successfully performed:

- Hemolysis, Direct Contact Method ●
- Hemolysis, Extract Method ●
- . Cytotoxicity - ISO MEM Elution

Based on conformance with these test requirements, the Concentric Balloon Guide Catheter is as safe and effective as the legally marketed predicate device.

# Summary of Substantial Equivalence

The Concentric Balloon Guide Catheters are substantially equivalent to the predicate device with regard to device design, intended use, and patient population.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Concentric Medical, Inc. c/o Regulatory Technology Services, LLC Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313

Re: K112404

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: February 28, 2012 Received: February 29, 2012

Dear Mr. Job:

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.

MAR 1 5 2012

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Page 2 - Mr. Mark Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportaProblem/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 yours,

Malvina B. Eydelman, M.D. 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):

Device Name:

Indications for Use:

K112404

Concentric Balloon Guide Catheter

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 Retrieval devices.

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)

Quyñ Hoang

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112404