Coda LP Balloon Catheter

K150970 · Cook Incorporated · DQY · May 12, 2015 · Cardiovascular

Device Facts

• Record ID: K150970
• Device Name: Coda LP Balloon Catheter
• Applicant: Cook Incorporated
• Product Code: DQY · Cardiovascular
• Decision Date: May 12, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.

Device Story

Over-the-wire catheter; 9.0 French; 100 or 120 cm length; 32 mm inflated balloon diameter; 30 cc balloon volume. Dual-lumen shaft: one lumen for 0.035-inch wire guide, one for balloon inflation/deflation. Used by physicians in clinical settings for temporary vessel occlusion or endovascular graft expansion. Device inserted via introducer sheath; balloon inflated to expand prostheses or occlude flow. Benefits include precise vessel management and graft deployment. Sterile, single-use device.

Clinical Evidence

Bench testing only. Testing included balloon burst, inflation/deflation time (within 30 seconds), simulated use (insertion/retraction/graft expansion), fatigue (40 cycles), occlusion/migration, and tensile strength. All acceptance criteria met.

Technological Characteristics

Over-the-wire catheter; dual-lumen extrusion; 9.0 French; 32 mm balloon diameter; 30 cc volume. Sterile, single-use. No specific material standards or software/AI components described.

Indications for Use

Indicated for temporary occlusion of large vessels or expansion of vascular prostheses in patients requiring such procedures.

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

• K032869
• K122917

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Public Health Service

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

May 12, 2015

Cook Incorporated Chad Schulenburg Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47404

Re: K150970

Trade/Device Name: Coda LP Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 10, 2015 Received: April 13, 2015

Dear Chad Schulenburg:

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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

510(k) Number (if known) K150970

Device Name Coda® LP Balloon Catheter

Indications for Use (Describe)

The Coda® LP Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.

## 510(k) SUMMARY

Submitted By: Chad Schulenburg, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: [phone] x104073 Fax: [phone] Date Prepared: May 12, 2015

#### Device:

| Trade Name: | Coda® LP Balloon Catheter |
|----------------------|--------------------------------------------------|
| Common Name: | Occlusion Balloon Catheter |
| Classification Name: | Catheter, Percutaneous<br>DOY (21 CFR §870.1250) |

### Indications for Use:

The Coda® Low Profile Balloon Catheter is intended for the temporary occlusion of large vessels, or to expand vascular prostheses.

## Predicate Devices:

The device subject of this submission is substantially equivalent to the predicate devices, cleared for market under 510(k) numbers K032869 on November 19, 2003 and K122917 on June 28, 2013.

#### Comparison to Predicate Devices:

It has been demonstrated that the Coda LP Balloon Catheters are comparable to the predicate devices. The Coda LP Balloon Catheters are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate devices. The device changes consist of a balloon with a smaller diameter and volume, and a smaller catheter French size. The Coda LP Balloon Catheters are also used through a smaller introducer sheath. The safety and effectiveness of the modifications are supported by testing.

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The logo is simple and clean, and the red and white color scheme is eye-catching.

# Device Description:

The Coda LP Balloon Catheters are over-the-wire catheters that are available with an inflated balloon diameter of 32 millimeters and a balloon volume of 30 cc. The catheters are 9.0 French and are available in lengths of 100 or 120 centimeters. The Coda LP Balloon Catheter shaft contains two independent lumens within a single extrusion. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the two inflation media exit ports within the balloon. The catheters are supplied sterile and are intended for one-time use.

### Test Data:

The following tests were performed to demonstrate that the Coda LP Balloon Catheters met applicable design and performance requirements and support a determination of substantial equivalence.

- . Balloon Burst Testing - Testing showed that the balloons burst above the maximum rated volume, with all failures being non-fragmentary. The acceptance criteria were met.
- . Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 30 seconds and fully deflated within 30 seconds. The acceptance criteria were met.
- . Simulated Use Testing - Testing showed that the catheters were capable of being inserted into and retracted from an appropriately sized sheath without experiencing excessive resistance. Testing showed that this device was able to expand an endovascular graft by inflating the balloon. The acceptance criteria were met.
- Fatigue Testing – Testing showed that the balloons were free from leakage and damage on inflation, withstanding 40 cycles of inflation/deflation. The acceptance criterion was met.
- . Occlusion and Migration Testing – Testing showed that this device was able to occlude fluid flow without migrating. The acceptance criteria were met.
- . Tensile Strength Testing – Testing showed that under proper clinical use of the device, the peak load values were in accordance with the acceptance criteria.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The logo is simple and clean, and the red and white colors are eye-catching.

cook incorporated 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: [phone] TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

# Conclusion:

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices.