STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS

K080982 · Boston Scientific Corp · LIT · Jul 14, 2008 · Cardiovascular

Device Facts

• Record ID: K080982
• Device Name: STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterling ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.00 mm - 4.00 mm balloon devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Story

PTA balloon dilatation catheter; Monorail and Over-The-Wire (OTW) configurations; coaxial shaft design. Input: 0.014 inch guide wire for catheter advancement to stenosis. Operation: semi-compliant balloon at distal tip inflated to known diameter/length at recommended pressures to dilate peripheral vasculature or arteriovenous fistulae. Positioning: two radiopaque marker bands visualized via fluoroscopy. Output: mechanical dilation of stenotic lesions or stent post-dilatation. Used in clinical settings by physicians. Benefits: restores vessel patency; improves blood flow in peripheral arteries and dialysis access sites.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing conducted to demonstrate substantial equivalence to the predicate device. No clinical data provided.

Technological Characteristics

Coaxial shaft design; semi-compliant balloon; two radiopaque marker bands for fluoroscopic positioning; 143 cm working length; compatible with 0.014 inch guide wires. Sterilization method not specified.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. 2.00 mm - 4.00 mm models indicated for post-dilatation of peripheral 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

• Sterling OTW PTA Balloon Dilatation Catheter (K053116)

Submission Summary (Full Text)

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## 510(k) Summary
per 21 CFR §807.92

JUL 1 4 2008

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|
| Contact Name<br>and Information | Mark Murphy<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | April 4, 2008 | | |
| Proprietary<br>Name(s) | Sterling TM ES MR and OTW PTA Balloon Dilatation<br>Catheters | | |
| Common Name | PTA Balloon Dilatation Catheter | | |
| Product Code | LIT | | |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 | | |
| Predicate Device | Sterling OTW PTA<br>Balloon Dilatation<br>Catheter | K053116 | December 16, 2005 |
| Device<br>Description | The Sterling ES PTA Balloon Dilatation Catheters consist of<br>a Monorail and an Over-The-Wire catheter with a semi-<br>compliant balloon fixed at the distal tip. The balloon catheter<br>has a coaxial shaft design. The outer lumen is used for<br>inflation of the balloon, and the wire lumen permits the use<br>of 0.014 in (0.39 mm) guide wires to facilitate advancement<br>of the catheter to and through the stenosis to be dilated.<br>The balloon is designed to provide an inflatable segment of<br>known diameter and length at recommended pressures.<br><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 catheters are 143 cm. | | |

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| Intended Use of<br>Device | The Sterling ES MR and OTW PTA Balloon Dilatation<br>Catheters are indicated for Percutaneous<br>Transluminal Angioplasty (PTA) in the peripheral<br>vasculature, including iliac, femoral, ilio-femoral, popliteal,<br>infra-popliteal and renal arteries, and for the treatment<br>of obstructive lesions of native or synthetic arteriovenous<br>dialysis fistulae. The 2.00 mm - 4.00 mm balloon<br>devices are also indicated for post-dilatation of balloon<br>expandable and self-expanding stents in the peripheral<br>vasculature. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The Sterling ES MR and OTW catheters incorporate a<br>substantially equivalent design, packaging, fundamental<br>technology, manufacturing, sterilization and intended use as<br>those featured in the predicate BSC Sterling OTW PTA<br>Balloon 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 identified during<br>device testing. |
| Conclusion | Based on the Indications for Use, technological<br>characteristics, safety and performance testing, the Sterling<br>ES MR and OTW PTA Balloon Dilatation Catheters have<br>been shown to be appropriate for its intended use and is<br>considered to be substantially equivalent to the Sterling<br>OTW PTA Balloon Dilatation Catheter (K053116; cleared<br>December 16, 2005). |

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and the comments of the comments of

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like design with three curved lines representing the bird's wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2008

Boston Scientific Corp. c/o Mr. Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K080982

Trade Name: Sterling ES Monorail and Over-The-Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 25, 2008 Received: June 26, 2008

Dear Mr. Murphy:

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 -- Mr. Mark Murphy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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,

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<br>(if known) | K080982 | |
| Device Name | Sterling™ ES Monorail™ and Over-the-Wire PTA Balloon<br>Dilatation Catheters | |
| Indications For Use | The Sterling ES MR and OTW PTA Balloon Dilatation<br>Catheters are indicated for Percutaneous Transluminal<br>Angioplasty (PTA) in the peripheral vasculature, including<br>iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal<br>arteries, and for the treatment of obstructive lesions of native<br>or synthetic arteriovenous dialysis fistulae.<br><br>The 2.00 mm - 4.00 mm balloon devices are also indicated<br>for post-dilatation of balloon expandable and self-expanding<br>stents in the peripheral vasculature. | |
| Prescription Use: X<br>(Per 21 CFR §801 Subpart D) | OR | Over-The-Counter Use:<br>(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) | | |

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(Division Sign-Off)
Division of Cardiovascular Devices

K080982 510(k) Number_