STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER

K141112 · Boston Scientific · LIT · Jul 16, 2014 · Cardiovascular

Device Facts

• Record ID: K141112
• Device Name: STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
• Applicant: Boston Scientific
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Story

Sterling OTW PTA Balloon Dilatation Catheter is a high-performance, over-the-wire catheter for peripheral vascular interventions. Device features coaxial shaft, semi-compliant balloon, and tapered tip. Input: 0.014-inch or 0.018-inch guidewires. Operation: Physician advances catheter over guidewire to stenosis; balloon inflated to specific diameter/pressure to dilate vessel or stent. Radiopaque marker bands facilitate positioning under fluoroscopy. Output: Mechanical dilation of obstructive lesions. Used in clinical settings (e.g., cath lab) by physicians. Benefits: Restores blood flow in peripheral arteries and arteriovenous fistulae; optimizes stent apposition.

Clinical Evidence

Bench testing only. Testing included balloon compliance, rated burst pressure, multiple inflation, crossing profile, tensile strength, guidewire movement, sheath withdrawal, and marker band alignment. Results confirm conformance to requirements and substantial equivalence to predicate.

Technological Characteristics

Coaxial shaft design; semi-compliant balloon; tapered tip; radiopaque marker bands. Compatible with 0.014" or 0.018" guidewires. Available in lengths 90cm/150cm and balloon sizes 1.5-4.0mm diameter. Sterilization via established method with same SAL as predicate. Materials and manifold design identical to predicate.

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 (K132430)

Submission Summary (Full Text)

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JUL 1 6 2014

## 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 | Carol Tiffany<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | | |
| Date Prepared | 29 April 2014 | | | |
| Proprietary<br>Name | Sterling™ Over-the-Wire 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 K132430 October 17, 2013 | | | |
| 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 balloon<br>combined with a low profile tip. The catheter is compatible with either 0.014<br>in (0.36 mm) or 0.018 in (0.46 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<br>wires0.014 in or 0.018 in to facilitate advancement of the catheter to and<br>through the stenosis to be dilated. The balloon is designed to provide an<br>inflatable segment of known diameter and length at recommended<br>pressures. The catheter includes a tapered tip to facilitate advancement of<br>the catheter to and through the stenosis. Two radiopaque marker bands<br>(one proximal and one distal), in conjunction with fluoroscopy, enable<br>accurate positioning of the balloon.<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.<br><br>The balloon lengths are available in 20, 30, 40, 60, 200 and 220 mm sizes<br>with diameters of 1.5, 2.0, 2.5, 3.0, 3.5 and 4.0 mm. The combinations of<br>balloon sizes are displayed below. | | | |

.

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| Balloon<br>(mm) | Balloon Length (mm) | | | | | |
|-----------------|---------------------|---------------|---------------|---------------|---------------|---------------|
| | 20 | 30 | 40 | 60 | 200 | 220 |
| 1.5 | 90cm<br>150cm | | 90cm<br>150cm | | | |
| 2.0 | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | | 90cm<br>150cm |
| 2.5 | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | | 90cm<br>150cm |
| 3.0 | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | | 90cm<br>150cm |
| 3.5 | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | 90cm<br>150cm | | 90cm<br>150cm |
| 4.0 | | | | | 90cm<br>150cm | 90cm<br>150cm |

Intended Use/ Indications for Use of Device

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 fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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#### Special 510(k) Submission Sterling™ OTW Balloon Dilatation Catheter

#### Comparison of Technological Characteristics

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

| Characteristic | Comparison to Sterling OTW Predicate |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Manifold | Same material. Same design serving the same<br>function. |
| Strain Relief | Same material. Same design serving the same<br>function. |
| Inner Shaft/Outer Shaft | Same material. Same design serving the same<br>function. |
| Balloon | Same material. Same design serving the same<br>function. |
| Marker Bands | Same component. Same design serving the same<br>function. |
| Proximal Marks | Same material. Same design serving the same<br>function. |
| Coating | Same material. Same design serving the same<br>function. |
| Bumper Tip | Same material. Same design serving the same<br>function. |
| Sterilization Method/SAL | Same method and same level of assurance. |
| Balloon Diameters | Smaller diameters than the predicate range. |
| Balloon Lengths | 200 and 220 mm are the same as predicate range.<br>Adding balloon lengths of 20, 30, 40, and 60 mm. |
| Usable Catheter Lengths | Same lengths. |
| Rated Burst Pressure<br>(RBP) | Same Rated Burst Pressure. |
| Sheath/Guide<br>Compatibility | Compatibility the same for larger sizes, slightly<br>different compatibility depending on balloon<br>diameters. |
| Packaging | Same function and design. |
| Guidewire | Same Compatibility. |
| Manufacturing | Manufactured on the same manufacturing lines. |

#### Performance Data

Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.

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The following bench testing was completed on the Sterling™ OTW PTA Balloon Dilatation Catheter:

| Bench | |
|-----------------------------------------------------|-------------------------------------|
| Balloon Compliance | 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 |
| Proximal Balloon Bond and<br>Shaft Tensile Strength | Deflation Time |

#### Conclusion

Based on the Indications for Use, technological characteristics, safety and performance testing, the Sterling OTW PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Sterling OTW PTA Balloon Dilatation Catheter (K0132430 cleared October 17, 2013).

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles three wavy lines or abstract human figures.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 16, 2014

Boston Scientific Ms. Carol Tiffany Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K141112

. Trade/Device Name: Sterling Over-The Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Tiffany:

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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Page 2 - Ms. Carol Tiffany

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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely vour

**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

510(k) Number (if known):

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 illac, 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 postdilatation 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/11 description: The image shows the name "Kenneth J. Cavanaugh -S" in black font. The letters are clearly visible and evenly spaced. In the middle of the name, there is a logo that appears to be the FDA logo.