POLARCATH PERIPHERAL DILATATION SYSTEM

K071042 · Boston Scientific Corp · LIT · Jun 13, 2007 · Cardiovascular

Device Facts

• Record ID: K071042
• Device Name: POLARCATH PERIPHERAL DILATATION SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 13, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The PolarCath™ Peripheral Dilatation System is a percutaneous transluminal angioplasty catheter system. It utilizes liquid nitrous oxide as an inflation medium to dilate peripheral vascular stenoses, treat obstructive lesions in dialysis access grafts/fistulae, and expand self-expanding stents. The system comprises a catheter, an inflation unit, a connecting cable, and a rechargeable battery pack. The inflation unit controls the delivery of the nitrous oxide from a disposable 14-gram cartridge. The device is operated by a physician in a clinical setting. The system provides controlled balloon inflation to achieve therapeutic vessel dilation or stent expansion, potentially improving blood flow and vessel patency.

Clinical Evidence

Bench testing only. Verification testing assessed the function of the inflation unit and circuitry through 12 sequential inflations of the balloon to ensure the circuit board modifications did not impact performance.

Technological Characteristics

System includes a catheter, inflation unit, connecting cable, and rechargeable battery pack. Inflation medium is liquid nitrous oxide (14g disposable cartridge). Modification involves circuit board components (resistors, fuses, capacitors, voltage suppressor). No changes to materials or design elements compared to predicate.

Indications for Use

Indicated for patients requiring dilation of stenoses in peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, subclavian arteries), treatment of obstructive lesions in PTFE access grafts or 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.

Predicate Devices

• PolarCath™ Peripheral Dilatation System (K062594)

Submission Summary (Full Text)

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K071042

## ATTACHMENT 4

JUN 1 3 2007

## 510(k) Summary

per 21 CFR §807.92

| Submitter's Name and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Monica Morrison<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | April 11, 2007 |
| Proprietary Name(s) | PolarCath™ Peripheral Dilatation System |
| Common Name | Percutaneous Transluminal Angioplasty Catheter |
| Product Code | LIT/DQY |
| Classification of Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | PolarCath™ Peripheral Dilatation System K062594 September 28, 2006 |
| 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. |
| Intended Use of Device | 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. |

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CONFIDENTIAL

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| Comparison of<br>Technological<br>Characteristics | The proposed changes to the PolarCath™ Peripheral Dilatation<br>System apply only to the circuit board within the Inflation Unit.<br>These changes include the addition of resistors, fuses, capacitors,<br>a voltage suppressor and an update to the circuit board layout.<br>There are no changes to the other materials or design elements of<br>this product as compared to the currently cleared PolarCath™<br>Peripheral Dilatation System. |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Support of<br>Substantial<br>Equivalence | Boston Scientific Corporation considers the proposed PolarCath™<br>Peripheral Dilatation System to be substantially equivalent to the<br>existing PolarCath™ Peripheral Dilatation System (K062594,<br>Cleared September 28, 2006). This assessment is based upon the<br>successful completion of verification testing (refer to Section 5.2<br>and Attachment 3) which assessed the function of inflation units<br>and their circuitry through 12 sequential runs, or inflations, of the<br>balloon. In addition, there have been no changes to the overall<br>design, function, material, intended use, labeling, or directions for<br>use of the PolarCath™ Peripheral Dilatation System. The changes<br>only affect the Inflation Unit circuit board and have been proven<br>not to adversely affect the function of the device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2007

Boston Scientific Corp. c/o Ms. Monica Morrison Regulatory Affiars One Scimed Place Maple Grove, MN 55311

Re: K071042

PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Peripheral Dilation Catheter Regulatory Class: Class II Product Code: LIT/DQY Dated: April 16, 2007 Received: May 29, 2007

Dear Ms. Morrison:

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.

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 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. Monica Morrison

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Sincerety Jours,

R

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 2

## Indications for Use Statement

K071042 510(k) Number:

PolarCath™ Peripheral Dilatation System Device Name:

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.

Prescription Use X (part 21 CFR 801 Subpart D)

AND/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)

Divisio S/C

Division S/m-On)
Division of Cardiovascular Devices
510(k) Number K071042

Boston Scientific Corporation

CONFIDENTIAL

PolarCath™ Peripheral Dilatation System Page 11 of 14