ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER

K132020 · Cook, Inc. · LIT · Oct 25, 2013 · Cardiovascular

Device Facts

• Record ID: K132020
• Device Name: ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Applicant: Cook, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter has been designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including illiac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Over-the-wire PTA balloon dilatation catheter; used for percutaneous transluminal angioplasty of peripheral artery lesions and arteriovenous dialysis fistulae. Device consists of catheter shaft and inflatable balloon; compatible with 0.035-inch wire guide. Operated by physician in clinical setting. Balloon inflated to dilate stenotic lesions; restores vessel patency. Sterile, single-use device.

Clinical Evidence

Bench testing only. Testing included compliance, balloon profile, fatigue (10 cycles), burst pressure, inflation/deflation time (<60s), sheath compatibility, and tensile strength. All tests met predetermined acceptance criteria and conformed to ISO 10555-1 and ISO 10555-4 standards.

Technological Characteristics

Over-the-wire PTA balloon catheter; 5.2F or 5.7F; 80cm or 135cm lengths; balloon diameters 3-12mm; balloon lengths 1.5-20cm. Compatible with 0.035-inch wire guide. Sterile, single-use. Mechanical design; no software or electronics.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of peripheral artery lesions (iliac, renal, popliteal, infrapopliteal, femoral, iliofemoral) and obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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

• Advance® 35LP Low Profile PTA Balloon Dilatation Catheters (K091527)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and professional, and it is likely used on Cook Medical's products and marketing materials.

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

K132020 og. 1 of 2

### 510(k) SUMMARY

Submitted By:

Steven Lawrie, MS, MA Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: [phone] x 104518 Fax: [phone] Date Prepared: October 22, 2013

OCT 2 5 2013

Device:

Trade Name:

Common Name: Classification Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter PTA Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal LIT (21 CFR §870.1250)

### Indications for Use:

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

## Predicate Device:

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheters are identical in terms of intended use, principles of operation, materials of construction, and technological characteristics to the predicate device. Additional combinations of balloon diameter and length have been included. The device, subject of this submission, is substantially equivalent to the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters cleared under 510(k) number K091527.

#### Comparison to Predicate Device:

It has been demonstrated that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters are comparable to the predicate device. The predicate device and the device subject of this submission are indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, femoral and iliofemoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The predicate device and the proposed device are completely identical in terms of design, intended use, and materials.

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Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, sans-serif font on the top line. Below that, the word "MEDICAL" is in a smaller, sans-serif font. The background is black, and the text is white.

COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
MONE 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

K132020 pg. 2 of 2

# Device Description:

The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.

## Test Data:

The following tests were performed to demonstrate that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters met applicable design and performance requirements and support a determination of substantial equivalence.

- . Compliance Testing - Testing showed that, under simulated body temperature conditions, each balloon met its labeled diameter at the nominal pressure. The predetermined acceptance criteria were met.
- 미 Balloon Profile Testing - Testing showed that diameters for each catheter were less than the maximum outside diameter appropriate for the intended sheath size. The predetermined acceptance criteria were met.
- 0 Balloon Fatigue Testing - Testing showed that the balloons were from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation. In conformance with the applicable sections of ISO 10555-4, the predetermined acceptance criteria were met.
- . Balloon Burst Testing - Testing showed that the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
- 0 Balloon Inflation/Deflation Testing - Testing showed that the balloons inflated to rated burst pressure within 60 seconds and fully deflated within 60 seconds. The predetermined acceptance criteria were met.
- l Sheath Compatibility Testing - Testing showed that the catheters were capable of being inserted and retracted from an appropriately sized sheath without experiencing excessive resistance. The predetermined acceptance criteria were met.
- D Tensile Strength Testing - Testing showed that under proper clinical use of the device, the peak load values shall be in accordance with the applicable values of ISO 10555-1. The predetermined acceptance criteria were met.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 25, 2013 ·

Cook Inc. Mr. Steven Lawrie, MS, MA Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Re: K132020

Trade/Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: LIT Dated: September 26, 2013 Received: September 27, 2013

Dear Mr. Lawrie:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

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Page 2 - Mr. Steven Lawrie, MS, MA

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.

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

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Special 510(k): Device Modification PTA Balloon Catheter: Advance 351.P Low Profile PTA Balloon Dilatation Catheter Cook Incorporated June 28 2013

### Indications for Use

510(k) Number (if known): K132020

Device Name: Advance® 35LP Low Profile PTA Balloon Dilatation Catheter

Indications for Use for the Advance 35LP Low Profile PTA Balloon Dilatation Catheter:

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter has been designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including illiac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use XX (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)

Kenneth J. Cavanaugh -S