MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM

K092455 · Boston Scientific Corporation · LIT · Sep 4, 2009 · Cardiovascular

Device Facts

• Record ID: K092455
• Device Name: MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Device Story

System comprises catheter, inflation unit, connecting cable, rechargeable battery pack, and liquid nitrous oxide inflation medium (14g cartridge). Used for peripheral artery stenosis dilatation, treatment of obstructive lesions in PTFE grafts/AV fistulae, and post-stent expansion. Operated by clinicians in clinical settings. Device utilizes cryotherapy (nitrous oxide) to dilate vessels/lesions. Output is physical dilatation of target vasculature. Benefits include improved blood flow and stent apposition.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes catheter, inflation unit, connecting cable, rechargeable battery, and liquid nitrous oxide inflation medium. Operates via cryotherapy dilatation principle. No specific materials or software algorithm class specified.

Indications for Use

Indicated for patients requiring dilatation of stenoses in peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, subclavian arteries), treatment of obstructive lesions in PTFE access grafts or native arteriovenous dialysis fistulae, and post-deployed expansion of self-expanding peripheral vascular stents.

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.

Submission Summary (Full Text)

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| Sponsor: | Boston Scientific Corporation<br>150 Baytech Drive<br>San Jose, CA |
|-----------------|--------------------------------------------------------------------|
| Contact Person: | Shannon Pettit |
| Phone Number: | 763-494-2833 |
| Fax Number: | 763-494-2981 |
| Prepared: | |
| Trade Name: | PolarCath™ Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT<br>21 CFR 870.1250 |

#### PolarCath Peripheral Dilatation System Predicate Devices:

### Device Description

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

#### Indications for Use

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

## Substantial Equivalence

The PolarCath Peripheral Dilatation System design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.

## Performance Data

The substantial equivalence of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific.

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Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an abstract bird.

SEP 0 4 2009

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

Ms. Shannon Pettit Senior Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311

Re: K092455

> PolarCath Peripheral Dilatation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: August 6, 2009 Received: August 10, 2009

Dear Ms. Pettit:

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. Drue, 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.

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 mav publish further announcements concerning your device in the Federal Register.

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# Page 2 - Ms. Shannon Pettit

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/McdicalDevices/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.

Duna R. Valuner

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 Statement

510(k) Number (if known)

K092 455

Device Name

PolarCath Peripheral Dilatation System

Indications for Use

The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109
✓

OR

Over-The-Counter Use

Dune R. Achmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number k092455