STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER

K132430 · Boston Scientific Corp · LIT · Oct 17, 2013 · Cardiovascular

Device Facts

• Record ID: K132430
• Device Name: STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-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

Over-the-wire (OTW) balloon dilatation catheter; coaxial shaft design; semi-compliant balloon at distal tip; compatible with 0.014 in or 0.018 in guidewires. Used by physicians in clinical settings for peripheral angioplasty and stent post-dilatation. Input: guidewire advancement through stenosis. Operation: inflation of balloon via outer lumen to specific diameter/pressure to dilate lesions. Radiopaque marker bands allow fluoroscopic visualization for accurate positioning. Output: mechanical dilation of vascular stenosis. Benefits: restoration of vessel patency; improved blood flow.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1: MEM Elution Cytotoxicity, Hemocompatibility, USP Physicochemical) and in-vitro performance (bond integrity, burst pressure, deflation time, crossing profile, tensile strength, particulate evaluation, and balloon compliance). All results met acceptance criteria and were similar to the predicate.

Technological Characteristics

Coaxial shaft catheter; semi-compliant balloon; radiopaque marker bands. Materials: same as predicate. Energy: pneumatic (inflation). Connectivity: none. Sterilization: same as predicate. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal 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

• Sterling OTW PTA Balloon Dilatation Catheter (K053116)

Submission Summary (Full Text)

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K132430 .p. 1 of 4

## 510(k) Summary

### per 21 CFR §807.92

OCT 1 7 2013

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and<br>Information | Christopher Dachel<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | 17 October 2013 |
| Proprietary<br>Name | Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| Predicate<br>Device(s) | Sterling OTW PTA Balloon Dilatation Catheter, K053116, December 16, 2005 |
| Device<br>Description | The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon<br>Dilatation Catheter is a high performance balloon catheter for peripheral<br>indications. The device features an ultra low profile, semi-compliant<br>balloon combined with a low profile tip. The catheter is compatible with<br>either 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.<br><br>The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire<br>(OTW) catheter with a semi-compliant balloon fixed at the distal tip. The<br>balloon catheter has a coaxial shaft design. The outer lumen is used for<br>inflation of the balloon, and the wire lumen permits the use of guide wires<br>0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of the<br>catheter to and through the stenosis to be dilated. The balloon is designed<br>to provide an inflatable segment of known diameter and length at<br>recommended pressures. The catheter includes a tapered tip to facilitate<br>advancement of the catheter to and through the stenosis. Two radiopaque<br>marker bands (one proximal and one distal), in conjunction with<br>fluoroscopy, enable accurate positioning of the balloon.<br><br>The balloon lengths are available in 120, 150, 200 and 220 mm sizes with<br>diameters of 5.0, 6.0 and 7.0 mm for each balloon length.<br><br>The effective lengths of the balloon catheter are 90 cm and 150 cm.<br>Markers on the 90 cm effective length catheter indicate the exit of the<br>dilatation catheter tip out of the guiding catheter (one at 50 cm and two at<br>60 cm). Markers on the 150 cm effective length catheter indicate the exit of<br>the dilatation catheter tip out of the guiding catheter (one at 90 cm and two<br>at 100 cm). The proximal portion of the catheter includes one female Luer-<br>lock port connected to the inflation lumen, and one female Luer-lock port<br>for guidewire lumen. |

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| Intended Use/<br>Indications for<br>Use of Device | The Sterling OTW PTA Balloon Dilatation Catheter is indicated for<br>Percutaneous Transluminal Angioplasty (PTA) in the peripheral<br>vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal<br>arteries, and for the treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This device is also indicated for post-<br>dilatation of balloon expandable and self-expanding stents in the peripheral<br>vasculature. |
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#### Comparison of Technological Characteristics

The Sterling OTW PTA Balloon Dilatation Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, materials, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling OTW Balloon Dilatation Catheter.

| Comparison to Predicate Device in Materials and Manufacturing | |
|---------------------------------------------------------------|--|
|---------------------------------------------------------------|--|

| Characteristic | Comparison to Sterling OTW Predicate |
|---------------------------------------------------|----------------------------------------------------------------------------------|
| Manifold | Same material. Same design serving the same function. |
| Manifold Bond Adhesive | Same material. Same design serving the same function. |
| Strain Relief | Same material. Same design serving the same function. |
| Corewire | Same material. Same design serving the same function. |
| Outer Shaft | Same material. Same design serving the same function. |
| Inner Shaft | Same material. Same colorants. Same design serving the same function. |
| Balloon | Same material. Same design serving the same function and fundamental technology. |
| Markerbands | Same component serving the same function. |
| Proximal Marks | Same material. Same design serving the same function. |
| Coating | Same coating serving same function. |
| Bumper Tip | Same material. Same colorant. Same design serving the same function. |
| Sterilization Method | Same method |
| SAL | Same level of assurance |
| Balloon Diameters | Diameters within the predicate diameter range, service the same function. |
| Balloon Lengths | Additional balloon lengths; 120, 150, 200, and 220 mm |
| Usable Catheter Lengths | Additional catheter lengths; 90 and 150 cm |
| Rated Burst Pressure<br>(RBP) | Same Rated Burst Pressure |
| Recommended<br>Introducer Sheath<br>Compatibility | Sheath compatibility within the predicate compatibility range, same function |
| Recommended<br>Guidewire | Same compatability |
| Packaging | Same function and design |

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| Performance<br>Data | Bench testing and biocompatibility testing were performed to support a<br>determination of substantial equivalence. The results of these tests provide<br>reasonable assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. The<br>Sterling OTW PTA Balloon Dilatation Catheter met all acceptance criteria<br>for the bench and biocompatibility testing with results similar to the<br>predicate. No new safety or performance issues were raised during the<br>testing and, therefore, these devices may be considered substantially<br>equivalent to the predicate devices. | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|
| | The following biocompatibility and bench testing were completed on the<br>Sterling OTW PTA Balloon Dilatation Catheter:<br>Biocompatibility<br>The device was tested for biocompatibility per ISO 10993-1 for short<br>duration contact with blood (<24 hours). The testing included MEM Elution<br>Cytotoxicity, Hemocompatibility (Direct Contact), Chemical<br>Characterization-USP Physicochemical, and Natural Rubber Latex | | | | |
| | | | | | |
| | The following in-vitro performance tests were completed on the Sterling<br>OTW PTA Balloon Dilatation Catheter: | | | | |
| | Bench | | | | |
| | Bond Integrity | Balloon Burst Mode | | | |
| | Working Length | Balloon Compliance | | | |
| | Deflation Time | Balloon Nominal Diameter | | | |
| | Balloon Rated Burst Pressure (RBP) | Burst in a Stent | | | |
| | Balloon Multiple Inflation | Balloon Body Length | | | |
| | Crossing Profile | Guidewire Movement | | | |
| | Full Catheter Tensile Extension<br>and Deflation | Sheath Withdrawal | | | |
| | Balloon Multiple Inflation<br>in a Stent | Marker Band to Balloon<br>Alignment | | | |
| | Particulate Evaluation | Torque after Conditioning | | | |
| | Proximal Balloon Bond and<br>Shaft Tensile Strength | | | | |
| Conclusion | Based on the Indications for Use, technological characteristics, safety and<br>performance testing, the Sterling OTW PTA Balloon Dilatation Catheter has<br>been shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the Sterling OTW PTA Balloon Dilatation<br>Catheter (K053116 cleared December 16, 2005). | | | | |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human form. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2013

Boston Scientific Corporation Mr. Christopher Dachel Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K132430

> Trade/Device Name: Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 22, 2013 Received: August 23, 2013

Dear Mr. Dachel:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Christopher Dachel

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 DZuckerman -S

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

510(k) Number (if known): _ K132430

Device Name: Sterling™ Over-the-Wire™ (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, 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 X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Bram 2013.1

Boston Scientific Corporation

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