STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX

K053116 · Boston Scientific Corp · DQY · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K053116
• Device Name: STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Story

Sterling OTW PTA Balloon Dilatation Catheter is an over-the-wire catheter with a semi-compliant balloon at the distal tip. Coaxial shaft design; outer lumen for balloon inflation; wire lumen accommodates 0.014 in/0.018 in guidewires to navigate to and through stenotic lesions. Two radiopaque marker bands facilitate positioning under fluoroscopy. Used by physicians in clinical settings to dilate peripheral vasculature or obstructive lesions in dialysis fistulae, and to post-dilate stents. Device provides controlled diameter and length at recommended pressures to restore vessel patency.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Over-the-wire coaxial shaft catheter; semi-compliant balloon; two radiopaque marker bands; compatible with 0.014 in/0.018 in guidewires; available in 40 cm, 80 cm, and 135 cm working lengths.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, renal arteries) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also indicated for post-dilatation of balloon-expandable and self-expanding 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

• Ultra-soft™ SV Balloon Dilatation Catheter (K021735)
• Ultra-soft™ SV Balloon Dilatation Catheter (K050389)

Submission Summary (Full Text)

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## 510(k) Summary
per 21 CFR §807.92

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Maureen Montbriand<br>Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | November 4, 2005 |
| Proprietary<br>Name(s) | Sterling ™ OTW PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | DQY |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Ultra-soft™ SV<br>Balloon Dilatation<br>Catheter<br>K021735 August 8, 2002 |
| | Ultra-soft™ SV<br>Balloon Dilatation<br>Catheter<br>K050389 May 25, 2005 |
| Device<br>Description | The Sterling OTW PTA Balloon Dilatation Catheter is an<br>Over-The-Wire catheter with a semi-compliant balloon fixed<br>at the distal tip. The balloon catheter has a coaxial shaft<br>design. The outer lumen is used for inflation of the balloon,<br>and the wire lumen permits the use of 0.014 in/0.018 in<br>(0.36 mm/0.46 mm) guidewires to facilitate advancement of<br>the catheter to and through the stenosis to be dilated. The<br>balloon is designed to provide an inflatable segment of<br>known diameter and length at recommended pressures.<br>Two radiopaque marker bands (one proximal and one<br>distal), in conjunction with fluoroscopy, enable accurate<br>positioning of the balloon. The working lengths of the<br>balloon catheter are 40 cm, 80 cm and 135 cm. |
| Intended Use of<br>Device | The Sterling OTW PTA Balloon Dilatation Catheter is<br>indicated for Percutaneous Transluminal Angioplasty<br>(PTA) in the peripheral vasculature, including iliac, femoral,<br>ilio-femoral, popliteal and renal arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This device is also<br>indicated for post-dilatation of balloon expandable and self-<br>expanding stents in the peripheral vasculature. |
| Comparison of<br>Technological<br>Characteristics | The Sterling OTW catheter will incorporate a substantially<br>equivalent design, packaging, fundamental technology,<br>manufacturing, sterilization and intended use as those<br>featured in the predicate BSC Ultra-soft SV Balloon<br>Dilatation Catheter. |
| Support of<br>Substantial<br>Equivalence | Bench testing and biocompatibility testing were performed<br>to support a determination of substantial equivalence. The<br>results of these tests provide reasonable assurance that the<br>proposed device has been designed and tested to assure<br>conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the<br>testing regimen. |
| Conclusion | Based on the Indications for Use, technological<br>characteristics, safety and performance testing, the Sterling<br>OTW PTA Balloon Dilatation Catheter has been shown to<br>be appropriate for its intended use and is considered to be<br>substantially equivalent to the Ultra-soft SV Balloon<br>Dilatation Catheter (K050389; cleared May 25, 2005 and<br>K021735; cleared August, 8 2002). |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporattion c/o Ms. Maureen Montbriand Regulatory Affairs Specialist Two Scimed Place Maple Grove, MN 56311-1566

Re: K053116

Sterling™ OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: November 4, 2005 Received: November 7, 2005

Dear Ms. Montibriand:

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. Maureen Montibriand

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.

Sincerely yours,

Duna R. Vachner

A 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) | K053116 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sterling ^TM OTW PTA Balloon Dilatation Catheter |
| Indications For Use | The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. |

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (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)

Dune R. Vachner

Division Sign-Off)
Division of Cardiovascular Devices

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