PTA BALLOON DILATATION CATHETER

K141150 · Boston Scientific Corp · LIT · Sep 25, 2014 · Cardiovascular

Device Facts

• Record ID: K141150
• Device Name: PTA BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sterling™ Monorail™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, 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

High-performance, rapid-exchange (Monorail) balloon dilatation catheter; used for peripheral angioplasty and stent post-dilatation. Features coaxial shaft, semi-compliant balloon, and tapered tip. Input: 0.014 or 0.018 inch guidewires. Operation: Physician advances catheter over guidewire to stenosis; balloon inflated to specific diameter/pressure to dilate vessel. Radiopaque marker bands enable fluoroscopic positioning. Output: Mechanical dilation of stenotic lesions. Used in clinical settings (e.g., cath lab) by physicians. Benefits: Restores blood flow in peripheral vasculature and dialysis fistulae.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1: cytotoxicity, hemocompatibility, chemical characterization) and extensive in-vitro performance testing (bond integrity, deflation time, rated burst pressure, multiple inflation, crossing profile, tensile strength, particulate evaluation, and torque). Results met all acceptance criteria and were similar to predicate devices.

Technological Characteristics

Coaxial shaft, rapid-exchange (Monorail) design. Semi-compliant balloon. Materials: manifold, corewire, shafts, balloon, marker bands, and bumper tip are identical to predicates. Dimensions: 0.014/0.018 inch guidewire compatibility; effective lengths 80, 90, 135, 150 cm. Sterilization: same method as predicates. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty in peripheral arteries (iliac, femoral, popliteal, infrapopliteal, renal, carotid) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also 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™ Monorail™ PTA Balloon Dilatation Catheter (K053118)
• Sterling™ OTW PTA Balloon Dilatation Catheter (K132430)
• Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheters (K093720)

Submission Summary (Full Text)

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

September 25, 2014

Boston Scientific Corp. Ms. Diane Nelson Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K141150

Trade/Device Name: Sterling MR PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 21, 2014 Received: August 25, 2014

Dear Ms. Nelson.

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. 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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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 Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

for

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

K141150 510(k) Number (if known):

#### Device Name: Sterling™ Monorail™ Balloon Dilatation Catheter

Indications for Use:

Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, 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.

Prescription Use × (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)

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## 510(k) Summary

### per 21 CFR §807.92

| 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 | Diane Nelson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | 02 May 2014 |
| Proprietary<br>Name | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| Predicate<br>Device(s) | Sterling™ Monorail™ PTA Balloon Dilatation Catheter, K053118, cleared<br>16 December 2005 |
| | Sterling™ OTW PTA Balloon Dilatation Catheter, K132430, cleared 17<br>October 2013 |
| | Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheters,<br>K093720, cleared 23 December 2009 |
| Device<br>Description | The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA)<br>Balloon Dilatation Catheter is a high performance balloon catheter for<br>peripheral indications. The device features an ultra low profile, semi-<br>compliant balloon combined with a low profile tip. The catheter is<br>compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires. |
| | The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand<br>rapid exchange catheter with a semi-compliant balloon fixed at the distal tip.<br>The balloon catheter has a coaxial shaft design. The outer lumen is used<br>for inflation of the balloon, and the wire lumen permits the use of guidewires<br>0.014 in / 0.018 in (.36 mm / .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 advancement of the catheter<br>to and through the stenosis. Two radiopaque marker bands (one proximal<br>and one distal), in conjunction with fluoroscopy, enable accurate positioning<br>of the balloon. Markers on the 80 cm and 90 cm effective length catheters<br>indicate the exit of the dilatation catheter tip out of the guiding catheter (one<br>at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective<br>length catheters indicate the exit of the dilatation catheter tip out of the<br>guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of<br>the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with<br>a luer port is included for flushing the distal inner lumen prior to the |
| Intended Use/<br>Indications for<br>Use of Device | The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for<br>Percutaneous Transluminal Angioplasty in the peripheral vasculature,<br>including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries,<br>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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insertion of appropriate guidewires.

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#### Comparison of Technological Characteristics

The Sterling Monorail 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 Monorail and OTW Balloon Dilatation Catheters.

Comparison to Predicate Device in Materials and Manufacturing

| Characteristic | Comparison to Predicates |
|------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manifold | Same material and design serving the same function. |
| Manifold Bond<br>Adhesive | Same material and design serving the same function. |
| Corewire | Same material and design serving the same function. |
| Outer Shaft | Same material and design serving the same function. |
| Inner Shaft | Same material, colorant and design serving the same<br>function. |
| Balloon | Same material and design serving the same function<br>and fundamental technology. |
| Markerbands | Same component serving the same function. |
| Proximal Marks | Same material and design serving the same function. |
| Coating | Same coating serving the same function. |
| Bumper Tip | Same material, colorant and design serving the same<br>function. |
| Sterilization<br>Method | Same method. |
| SAL | Same level of assurance. |
| Balloon<br>Diameters | Additional balloon diameters: 1.5, 2.0, and 2.5mm. |
| Balloon<br>Lengths | Additional balloon lengths: 100, 150, 200, and<br>220mm. |
| Usable<br>Catheter<br>Lengths | Additional catheter lengths: 90 and 150cm. |
| Rated Burst<br>Pressure<br>(RBP) | Same Rated Burst Pressure. |
| Recommended<br>Introducer<br>Sheath<br>Compatibility | Sheath compatibility within the predicate compatibility<br>range, same function. |
| Recommended<br>Guidewire | Same compatibility. |
| 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 Monorail PTA Balloon Dilatation Catheter met all acceptance<br>criteria 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 Monorail PTA Balloon Dilatation Catheter: | | |
| | 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.<br>The following leveraged in-vitro performance tests were completed on the<br>Sterling Monorail PTA Balloon Dilatation Catheter: | | |
| | Bench<br>Bond Integrity<br>Working Length<br>Deflation Time<br>Balloon Rated Burst Pressure (RBP)<br>Balloon Multiple Inflation<br>Crossing Profile<br>Full Catheter Tensile Extension and<br>Deflation | Balloon Burst Mode<br>Balloon Compliance<br>Balloon Nominal Diameter<br>Burst in a Stent<br>Balloon Body Length<br>Guidewire Movement<br>Sheath Withdrawal | |
| | Balloon Multiple Inflation in a Stent<br>Particulate Evaluation<br>Proximal Balloon Bond and Shaft<br>Tensile Strength | Marker Band to Balloon Alignment<br>Torque After Conditioning | |
| Conclusion | Based on the Indications for Use, technological characteristics, safety and<br>performance testing, the Sterling™ Monorail™ PTA Balloon Dilatation<br>Catheter has been shown to be appropriate for its intended use and is<br>considered to be substantially equivalent to the Sterling™ Monorail™ PTA<br>Balloon Dilatation Catheter (K021721 cleared 16 December 2005) and the<br>Sterling™ OTW Balloon Dilatation Catheter (K132430 cleared 17 October<br>2013) and the Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation<br>Catheters (K093720 cleared 23 December 2009). | | |