MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

K060572 · Boston Scientific Corporation · DQY · Mar 15, 2006 · Cardiovascular

Device Facts

• Record ID: K060572
• Device Name: MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 15, 2006
• 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

PolarCath Peripheral Dilatation System is a percutaneous transluminal angioplasty (PTA) catheter system. It utilizes liquid nitrous oxide as an inflation medium, supplied via a disposable 14g cartridge, to achieve dilatation. System components include a catheter, inflation unit, connecting cable, and rechargeable battery pack with receptacle. Used in clinical settings for peripheral vascular interventions; operated by physicians. Device functions by delivering controlled inflation to stenotic lesions or stents; output is mechanical dilatation of the target vessel or graft. Benefits include restoration of blood flow in peripheral arteries and maintenance of dialysis access patency.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System comprises a catheter, inflation unit, connecting cable, and rechargeable battery pack. Inflation medium is liquid nitrous oxide (14g disposable cartridge). Operates as a PTA catheter for peripheral vasculature. No consensus standards identified by the sponsor.

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.

Predicate Devices

• PolarCath Peripheral Dilatation System (K051916)

Submission Summary (Full Text)

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MAH 1 6 2006

040572
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#### 4. 510(k) Summary

| Sponsor: | Boston Scientific Corporation<br>160 Knowles Drive<br>Los Gatos, CA 95032 |
|-----------------|---------------------------------------------------------------------------|
| Contact Person: | Elaine Aplaon |
| Phone Number: | 408 866 3204 |
| Fax Number: | 408 376 3677 |
| Prepared: | March 1, 2006 |
| Trade Name: | PolarCathTM Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT/DQY |
| | 21 CRF 870.1250 |

Predicate Devices: PolarCath Peripheral Dilatation System

### 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 safety and effectiveness 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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K060572
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#### Modified Device Information II.

- 1. General
- Device Name a.

PolarCath™ Peripheral Dilatation System

- b. Sponsor/Contract Sterilizer Registration Numbers
Boston Scientific's establishment registration number is 3003882783. The company's Owner/Operator number is 9912058.

The contract sterilizer is IBA Medical Sterilization and Analytical Labs (Sterigenics) located in Los Angeles, CA. The Establishment registration number is 2011171.

- Device Class ে.
Class II

- d. Predicate Device Information The predicate device is the PolarCath Peripheral Dilatation System cleared in K051916, SE 8.5.2005.
- ে. Labeling A draft copy of the Instructions for Use (IFU) and labels can be found in Appendices A and B. All changes to the labeling are highlighted.
- f. 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. This is the same intended use as previously cleared for the PolarCath Peripheral Dilatation System (K051916, SE 8.5.2005).

The Indications for Use statement can be found on page 11 of this submission.

- Consensus Standards ಸ್ಸಿ A search was conducted of the consensus standards database found at www.CDRH.gov. No applicable standards were found.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

Boston Scientific, Inc. c/o Ms. Elaine Aplaon 160 Knowles Drive Los Gatos, CA 95032

Re: K060572

> Trade Name: PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Angioplasty Catheter Regulatory Class: II (two) Product Code: DQY, LIT Dated: March 3, 2006 Received: March 6, 2006

Dear Ms. Aplaon:

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. Elaine Aplaon

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 (OS) 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.

Sincerely yours,

Bfzimmerman 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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#### 3. 510(k) Indications for Use

510(k) Number (if known):

Device Name:

KC60572

PolarCath™ Peripheral Dilatation System

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 native 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.Rammana
(Division Sign-Off)

n Sign-Off) Division of Cardiovascular Devices

510(k) Number K060572