ADVANCE 18LP PTA DILATATION CATHETER

K073378 · Cook, Inc. · DQY · Dec 28, 2007 · Cardiovascular

Device Facts

• Record ID: K073378
• Device Name: ADVANCE 18LP PTA DILATATION CATHETER
• Applicant: Cook, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Advance™ 18LP PTA Dilatation Catheter is an over-the-wire balloon catheter used for percutaneous transluminal angioplasty (PTA). The device is operated by a physician in a clinical setting to treat narrowed or obstructed peripheral arteries and arteriovenous dialysis fistulae. The catheter is compatible with a 0.018-inch guidewire. During the procedure, the physician advances the catheter to the lesion site and inflates the balloon to dilate the vessel lumen. The device is supplied sterile for single-use. Clinical benefit is derived from the restoration of blood flow in obstructed vessels.

Clinical Evidence

Bench testing only. Testing included tensile, balloon inflation/deflation, balloon burst, balloon compliance, balloon fatigue, balloon profile, bond strengths, shelf life, sterility, sheath compatibility, and biocompatibility testing.

Technological Characteristics

Over-the-wire balloon catheter; 4.0 French nylon tubing; compatible with 0.018-inch guidewire; sterile; single-use.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) for lesions in peripheral arteries (iliac, renal, popliteal, infrapopliteal, femoral, iliofemoral) or obstructive lesions in native/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

• PTA Balloon Catheter (K073378 - Note: Document refers to a generic 'PTA Balloon Catheter' marketed by Cook as the predicate)

Submission Summary (Full Text)

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K073378 9. 1 of 2 25

Special 510(K) Premarket Notification PTA Balloon Catheter Cook Incorporated

## 510(k) Summary

### Submitted By:

Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 November 30, 2007

DEC 3 8 2007

#### Device:

| Trade Name: | Advance™ 18LP PTA Dilatation Catheter |
|--------------------------|------------------------------------------------------------|
| Proposed Classification: | Catheter, Angioplasty, Peripheral, Translumina<br>(74 DQY) |

#### Indications for Use:

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 Devices:

The Advance™ 18LP PTA Dilatation Catheter is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous angioplasty of vessel lumens which are narrowed or obstructed.

#### Device Description:

The Advance™ 18LP PTA Dilatation Catheter is an over-the wire balloon catheter 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. The device will be made with 4.0 French nylon tubing compatible with a 0.018-inch guidewire. It will be supplied sterile, intended for one-time use.

## Substantial Equivalence:

Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance™ 18LP PTA Dilatation Catheter. The similar indications for use and technological characteristics of the Advance™ 18LP PTA Dilatation Catheter as compared to the predicate device support a determination of substantial equivalency.

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Special 510(K) Premarket Notification PTA Balloon Catheter Cook Incorporated

# Test Data:

The Advance™ 18LP PTA Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Tensile test 1.
- Balloon inflation/deflation test 2.
- Balloon burst test 3.
- Balloon compliance test 4.
- 5. Balloon fatigue test
- Balloon profile test 6.
- 7. Bond strengths test
- 8. Shelf life test
- 9. Sterility test
- Sheath compatibility test 10.
- Biocompatibility test 11.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter.

K073379

. 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Nathan Simon Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402-0489

Re: K073378

Trade/Device Name: Advance™ 18LP PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 30, 2007 Received: December 3, 2007

Dear Mr. Simon:

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 includine 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 In microadic
in the 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, n3 and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations aftecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Nathan Simon

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Blymmerman fr

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) Premarket Notification PTA Balloon Catheter Cook Incorporated

| 510(k) Number (if known): | K073378<br>CONCULTION |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Device Name: Advance™ 18LP PTA Balloon Catheter

Indications for Use:

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.

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

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Hummer
District Clerk, Rio

Division Simn Off Division of Cardiovascular Devices 510(k) Number