OCCLUSION BALLOON CATHETER MODEL OBC

K101877 · Cook, Inc. · DQY · Aug 6, 2010 · Cardiovascular

Device Facts

• Record ID: K101877
• Device Name: OCCLUSION BALLOON CATHETER MODEL OBC
• Applicant: Cook, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

Device Story

Triple lumen balloon catheter designed for temporary occlusion of large vessels; used in clinical settings by physicians. Features infusion lumen for contrast material, distal .035 lumen for wire guide placement, and balloon lumen for inflation/deflation. Includes two radiopaque marker bands for fluoroscopic visualization. Balloon reaches maximum 40 mm diameter; catheter length 75 cm. Device provides temporary vessel occlusion to assist in clinical procedures; benefits include controlled vessel management during interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included burst pressure, bond strength, tensile, fatigue, sheath compatibility, inflation/deflation time, occlusion, and accelerated aging to ensure design performance.

Technological Characteristics

Triple lumen catheter; radiopaque marker bands for fluoroscopy; variable balloon diameter up to 40 mm; 75 cm length. Mechanical device; no energy source or software. Biocompatibility testing performed.

Indications for Use

Indicated for temporary occlusion of large vessels in patients requiring vessel blockage.

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

• CODA Balloon Catheter (K032869)

Submission Summary (Full Text)

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K101877 page 1 of 2

AUG 0 6 2010

Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

510(k) SUMMARY

Submitted By:

Lisa Webb, MBA, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Device:

Trade Name: Proposed Classification:

Occlusion Balloon Catheter Catheter, Percutaneous DQY (21 CFR §870.1250)

#### Indications for Use:

The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

## Predicate Device:

The Occlusion Balloon Catheter is similar in terms of intended use, method of operation, materials of construction, and technological characteristics to the predicate device which was cleared as the CODA Balloon Catheter (K032869).

#### Device Description:

_ '

The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon.

The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.

### Substantial Equivalence:

Cook Incorporated currently markets the predicate CODA Balloon Catheter, which was Cook moorporated Carrences 19, 2003 (K032869). The similar indications for use, enethod of operation, and technological characteristics of the Occlusion Balloon Catheter as compared to the predicate device support a determination of substantial equivalence.

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K101877 page. 2 of 2

Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

# Test Data:

The proposed Occlusion Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

- Burst Pressure Testing
- 트 Bond Strength Testing
- 트 Tensile Testing
- Fatigue Testing 트
- 트 Sheath Compatibility Testing
- Inflation/Deflation Time
- 트 Occlusion Testing
- 프 Accelerated Aged Testing
- 트 Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

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

Cook, Inc. c/o Ms. Lisa Webb Regulatory Affairs Manager 750 Daniels Way Bloomington, IN 47402

Re: K101877

Trade/Device Name: Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: July 2, 2010 Received: July 6, 2010

Dear Ms. Webb:

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. Lisa Webb

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

R. Valner

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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Special 510(k): Device Modification Occlusion Balloon Catheter Cook Incorporated 2 July 2010

## Indications for Use

510(k) Number (if known):

1/10/877

Device Name: Occlusion Balloon Catheter

Indications for Use for the Occlusion Balloon Catheter:

The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.

AUG 0 6 2010

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

hummer R.S. humel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K101872