STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX

K053118 · Boston Scientific Corp · DQY · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K053118
• Device Name: STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-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™ Monorail™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid 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

Monorail rapid exchange PTA balloon dilatation catheter; coaxial shaft design; semi-compliant balloon at distal tip. Input: guidewires (0.014 in / 0.018 in) for catheter advancement. Operation: physician advances catheter to stenosis; balloon inflated to known diameter/length at recommended pressures to dilate vessel/lesion. Positioning: two radiopaque marker bands visualized via fluoroscopy. Output: mechanical dilatation of peripheral vasculature or stents. Used in clinical settings by physicians. Benefits: restores vessel patency; facilitates stent expansion.

Clinical Evidence

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

Technological Characteristics

Monorail rapid exchange catheter; coaxial shaft; semi-compliant balloon; two radiopaque marker bands; 80 cm and 135 cm working lengths; compatible with 0.014 in / 0.018 in guidewires. Sterilization method not specified.

Indications for Use

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

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

Submission Summary (Full Text)

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DEC 16 2005

BSC Sterling™ Monorail™ PTA Balloon Dilatation ✆. ↓↓↓↓

## 510(k) Summary per 21 CFR §807.92

| Submitter's Name and Address | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name 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 Name(s) | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | DQY |
| Classification of Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Ultra-soft™ SV Balloon Dilatation Catheter<br>K050389<br>May 25, 2005 |
| Device Description | The Sterling™ Monorail™ PTA Balloon Dilatation Catheter<br>is a Monorail brand rapid exchange catheter with a semi-<br>compliant balloon fixed at the distal tip. The balloon<br>catheter has a coaxial shaft design. The outer lumen is<br>used for inflation of the balloon, and the wire lumen permits<br>the use of guidewires 0.014 in / 0.018 in (0.36 mm/ 0.46<br>mm) to facilitate advancement of the catheter to and<br>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 to<br>and through the stenosis. Two radiopaque marker bands,<br>in conjunction with fluoroscopy, enable accurate positioning<br>of the balloon.<br>The working lengths of the balloon catheter are 80 cm and<br>135 cm. A needle with a luer port is included for flushing<br>the distal inner lumen prior to the insertion of appropriate<br>guidewires. |

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| Intended Use of<br>Device | The SterlingTM MonorailTM PTA Balloon Dilatation Catheter<br>is indicated for Percutaneous Transluminal Angioplasty<br>(PTA) in the peripheral vasculature, including iliac, femoral,<br>ilio-femoral, popliteal, renal, and carotid arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This device is also indicated<br>for post-dilatation of balloon expandable and self-expanding<br>stents in the peripheral vasculature. |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The SterlingTM MonorailTM catheter will incorporate a<br>substantially equivalent design, packaging, fundamental<br>technology, manufacturing, sterilization and intended use as<br>those 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, and safety and performance testing, the<br>SterlingTM MonorailTM PTA Balloon Dilatation Catheter has<br>been shown to be appropriate for its intended use and is<br>considered to be substantially equivalent to the Ultra-soft<br>SV Balloon Dilatation Catheter (K050389; cleared May 25,<br>2005). |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human figures.

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: K053118

KUS3118
Sterling™ Monorail™ PTA Balloon Dilatation Catheter
Sterling™ Monorail™ PTA 1959 Sterling - Homber: 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
ty the indication we can in the device is substantially equivalent (for the indicat We have reviewed your Section > IQK ) premiums.illy equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments, for use stated in the enclosure) to the enatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enaculient with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while he views of the Art (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or a potherns of the Act. The Act. The
You may, therefore, market the device, subject to the general controls of listing You may, therefore, market the device, subject to the general or annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act theilude requirements in the many of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire) and may be subjections affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Existing mays to 898. In addition, I'DA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. I be found in the Code of Federal Regulations, Frid 20, in the Federal Register.

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Page 2 - Ms. Maureen Montbriand

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmanon that your ac-roo be roo someph .
or any Federal statutes and regulations administered by other Federal and listing or any Federal statutes and regulations administers of registration and listing (21)
comply with all the Act's requirements, including, but not researches requirements as set comply with an the Act 3 requirements; me; good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 807); good and 10 pplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1400, 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decions 991 - 12 decribed in your Section 510(k)
This letter will allow you to begin marketing your device of way davice to legs) This letter will anow you to begin markemig your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. The PDA Inding of substantal equive 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 If you desire specific advice for your do not of the of any please note the regulation entitled, whitely contact the Office of Comphalled at (210) 276 of 807.97). You may obtain "Misbranding by reference to premance noutheation" (= " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = other general information on your responsion.com its toll-free number [phone] or 191 Manufacturers, International and Consultion in the Marcel of Constitutions try/support/index.html.

Sincerely yours,

Dunna R. Vochner

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 |
|--|-------------------------------|
| | K053118 |

| 510(k) Number<br>(if known) | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Indications For Use | The Sterling™ Monorail™ PTA Balloon Dilatation Catheter is<br>indicated for Percutaneous Transluminal Angioplasty (PTA)<br>in the peripheral vasculature, including iliac, femoral, ilio-<br>femoral, popliteal, renal, and carotid arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This device is also indicated<br>for post-dilatation of balloon expandable and self-expanding<br>stents in the peripheral vasculature. |

Prescription Use:_____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801 Subpart D) Over-The-Counter Use: __ (21 CFR 807 Subpart C)

(Please do not write below this line - continue on another Page if needed)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

une R. de huer

(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(k) Number kor 311 8