STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO

K093720 · Boston Scientific Corp · LIT · Dec 23, 2009 · Cardiovascular

Device Facts

• Record ID: K093720
• Device Name: STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Sterling SL PTA Balloon Dilatation Catheter is a peripheral vascular intervention device; features coaxial shaft design with outer inflation lumen and wire lumen for 0.014 in or 0.018 in guidewires. Device includes tapered tip to facilitate advancement to and through stenosis. Available in 90 cm and 150 cm working lengths. Used by physicians in clinical settings to dilate obstructive lesions via balloon inflation at recommended pressures. Provides mechanical dilation of peripheral arteries and dialysis fistulae to improve blood flow.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Coaxial shaft design; balloon catheter with tapered tip; compatible with 0.014 in or 0.018 in guidewires; 90 cm and 150 cm working lengths. Mechanical inflation mechanism.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, ilio-femoral, infrapopliteal, popliteal, renal arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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 ES PTA Balloon Dilatation Catheters (K080982)
• Sterling Monorail PTA Balloon Dilatation Catheters (K053118)
• Sterling OTW PTA Balloon Dilatation Catheters (K053116)

Reference Devices

• Polarcath Peripheral Dilatation System

Submission Summary (Full Text)

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K093720

## 510(k) Summarv

| Submitter: | Boston Scientific Corporation<br>One Scimed Place Maple Grove, MN 55311 | DEC 23 2009 |
|------------------------|-------------------------------------------------------------------------|-------------|
| Contact Person: | Mark Murphy | |
| Phone Number: | 763-494-2377 | |
| Fax Number: | 763-494-2981 | |
| Date Prepared: | November 25, 2009 | |
| Device Trade Name: | Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters | |
| Common Name: | Percutaneous Transluminal Angioplasty Dilatation Catheter | |
| Device Classification: | Class II 21 CFR 870.1250 Product Code: LIT | |

### Predicate Devices

Sterling ES PTA Balloon Dilatation Catheters, Sterling Monorail and OTW PTA Balloon Dilatation Catheters and Polarcath Peripheral Dillatation System.

### Device Description

The Sterling SL PTA Balloon Dilatation Catheters has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) or 0.018 in (0.46 mm) to facilitate advancement of the . catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.

#### Indications for Use

The Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Substantial Equivalence

The Sterling SL PTA Balloon Dilatation Catheters line extension design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982), Sterling Monorail (K053118), Sterling OTW (K053116)

#### Performance Data

The substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters is demonstrated with design control activities and bench testing on file at Boston Scientific.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to represent its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Boston Scientific Corporation c/o Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

DEC 2 3 2009

Re: K093720

> Trade/Device Name: Sterling SL Monorail and Over-the-Wire Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: December 1, 2009 Received: December 2, 2009

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 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. 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 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 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/MedicalDevices/Safety/ReportalProblem/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,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Premarket Notification - Special 510(k) 1 Tomanton Notinodaon - Openal OTW PTA Balloon Dilatation Catheters

# Indications for Use Statement

12093720 510(k) Number (if known) Sterling SL MR & OTW PTA Balloon Dilatation Catheters Device Name Sterling SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Indications for Transluminal Angioplasty (PTA) in the peripheral vasculature, including Use iliac, femoral, ilio-femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

## 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

W.M.

Division of Cardiovascular Devices

510(k) Number K093726