STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX

K093636 · Boston Scientific Corp · LIT · Dec 23, 2009 · Cardiovascular

Device Facts

• Record ID: K093636
• Device Name: STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX
• 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 ES Monorail and Over-the-Wire 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

Sterling ES PTA Balloon Dilatation Catheters are medical devices used for peripheral vascular interventions. The device features a coaxial shaft design with a semi-compliant balloon at the distal tip. It is available in Monorail (MR) and Over-the-Wire (OTW) configurations, compatible with 0.014" guidewires. Two radiopaque marker bands facilitate accurate positioning under fluoroscopy. The device is operated by a physician in a clinical setting (e.g., interventional suite). The physician advances the catheter to the stenosis, inflates the balloon to a known diameter and length at recommended pressures to dilate the vessel or post-dilate a stent, and then deflates the balloon for removal. This process restores blood flow in obstructed peripheral arteries or dialysis fistulae, providing therapeutic benefit to the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Coaxial shaft design; semi-compliant balloon; two radiopaque marker bands; compatible with 0.014" guidewires; working length approx. 143 cm. Mechanical device; no energy source or software.

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 also 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 ES Monorail (MR) and Over-the-Wire (OTW) PTA Balloon Dilatation Catheters (K080982)

Submission Summary (Full Text)

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# 510(k) Summary

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 | DEC 2 3 2009 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Shannon Pettit | |
| Phone Number: | 763-494-2833 | |
| Fax Number: | 763-494-2981 | |
| Prepared: | November 23, 2009 | |
| Trade Name: | Sterling™ ES MR and OTW PTA Balloon Dilatation Catheters | |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter | |
| Classification: | II | |
| Product Code: | LIT<br>21 CFR 870.1250 | |
| Predicate Devices: | Sterling ES Monorail (MR) and Over-the-Wire (OTW) PTA Balloon Dilatation<br>Catheters (K080982; clearance date July 14, 2008) | |

### Device Description

The Sterling ES PTA Balloon Dilatation Catheters consist of a Monorail and an Over-The-Wire catheter designs with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the wire lumen permits the use of 0.014" guidewires 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.

Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheters are approximately 143 cm.

#### Indications for 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, illo-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.

#### Substantial Equivalence

The Sterling ES MR and OTW PTA Balloon Dilatation Catheter 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 Sterling ES MR and OTW PTA Balloon Dilatation Catheter 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures or faces, resembling a bird in flight.

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

Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

DEC 2 3 2009

Re: K093636

Trade/Device Name: Sterling ES Monorail & Over-the-Wire PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: November 23, 2009 Received: November 24, 2009

Dear Ms. Pettit:

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.

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 (reporting of medical

and the country of the county of and the country of the county of the county of and the state of the same . . .

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Page 2 - Ms. Shannon Pettit

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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

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 (if known)

K093636

Device Name Sterling™ ES Monorail® and Over-the-Wire PTA Balloon Dilatation Catheters

Indications for The Sterling ES Monorail and Over-the-Wire PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in Use 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 postdilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter
Use

:

. *

W. W

ardiovascular Devices

510(k) Number L013636