MUSTANG BALLOON DIALATION CATHETER

K141597 · Boston Scientific Corporation · FGE · Aug 22, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141597
• Device Name: MUSTANG BALLOON DIALATION CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm in length are indicated for the treatment of biliary strictures.

Device Story

Mustang Balloon Dilatation Catheter is an over-the-wire, dual-lumen catheter used for biliary stricture treatment. One lumen facilitates tracking over 0.035" guidewires; the second lumen enables balloon inflation/deflation. Proximal end features Y-connector manifold with luer lock fittings. Radiopaque marker bands under the balloon assist in fluoroscopic positioning. Silicone coating on the balloon improves insertion/withdrawal performance. Operated by physicians in clinical settings. Device is inflated to dilate strictures, potentially improving biliary flow. Substantial equivalence established via bench testing comparing design, materials, and performance to predicate catheters.

Clinical Evidence

Bench testing only. In-vitro performance testing included balloon compliance, nominal diameter, crossing profile, sheath insertion/withdrawal force, rated burst pressure, burst mode, protector removal force, multiple inflation, proximal bond tensile, and burst in a stent.

Technological Characteristics

Dual-lumen over-the-wire catheter; 0.035" guidewire compatibility; silicone-coated balloon; radiopaque marker bands; Y-connector manifold with luer lock fittings. Materials are substantially equivalent to predicates. Sterilization method and SAL are unchanged.

Indications for Use

Indicated for the treatment of biliary strictures in patients requiring balloon dilatation.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• MustangTM Balloon Dilatation Catheter (K110122)
• Gladiator Elite TM Balloon Dilatation Catheter (K132810)

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

August 22, 2014

Boston Scientific Corporation Melanie Raska Director, Regulatory Affairs One Scimed Place Maple Grove, MN 55311-1566

Re: K141597

> Trade/Device Name: Mustang™ Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 5, 2014 Received: August 6, 2014

Dear Melanie Raska,

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.

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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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number K141597 (if known) Device Name Mustang ™ PTA Balloon Dilatation Catheters Indications for The Mustang ™ Balloon Dilatation Catheters with balloons up to 120mm in Use length are indicated for the treatment of biliary strictures.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 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)

Boston Scientific Corporation

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## 510k 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 Information | Elaine Ruddle<br>Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail]<br>Or<br>Melanie Raska<br>Director, Regulatory Affairs<br>Phone :[phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared | June 12, 2014 | | |
| Proprietary<br>Name | MustangTM Balloon Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Angioplasty Dilatation Catheter | | |
| Product Code | FGE - Catheter, Biliary, Diagnostic | | |
| Classification | Class II, 21 CFR Part 876.5010 | | |
| Predicate<br>Device(s) | MustangTM Balloon Dilatation<br>Catheter<br>K110122<br>Gladiator Elite TM Balloon Dilatation<br>Catheter<br>K132810 | 12 May 2011<br><br>28 February 2014 | |
| Device<br>Description | Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters with<br>a dual lumen shaft design. One lumen is used to pass the catheter over<br>0.035" guidewires. The second lumen communicates with the balloon and is<br>used to inflate and deflate the balloon during the procedure. The guidewire<br>lumen and the balloon lumen terminate at the proximal end of the catheter in a<br>Y-connector manifold with luer lock fittings. There are radiopaque marker<br>bands located under the balloon to aid in positioning the system during the<br>procedure. A silicone coating is applied to the balloon to enhance insertion<br>and withdrawal performance. | | |
| Intended Use of<br>Device | The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm in<br>length are indicated for the treatment of biliary strictures. | | |
| Indications for<br>Use | The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm in<br>length are indicated for the treatment of biliary strictures. | | |

Boston Scientific Corporation

Premarket Notification – Special 510(k) Mustang Balloon Dilatation Catheter Attachment 2: 510k Summary

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### Comparison of Technological Characteristics

The Mustang Balloon Dilatation Catheter incorporates substantially equivalent device materials , design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific predicate devices.

| | Characteristic | Proposed compared to Predicates | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Components | Same components, configuration, design and<br>function | |
| | Materials | Same materials. Balloon contains an additional<br>material not new to the device | |
| | Packaging | Same packaging materials and configuration | |
| | Sterilization Method /SAL | Same method and level of assurance | |
| | Guidewire compatibility | Same compatibility | |
| | Balloon Diameters and<br>Lengths | Same sizes | |
| | Effective length | Same length catheters | |
| | Rated Burst Pressure (RBP) | Same RBP | |
| Performance<br>Data | Bench testing was performed to support a determination of substantial<br>equivalence. The results of these tests provide reasonable assurance that the<br>proposed device has been designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or performance issues were<br>raised during the testing and therefore, these devices may be considered<br>substantially equivalent to the predicate devices. | | |
| | The following in-vitro performance tests were completed on the Mustang<br>Balloon Dilatation Catheter: | | |
| | Balloon Compliance | Balloon Multiple Inflation | |
| | Balloon Nominal Diameter | Proximal Bond Tensile | |
| | Balloon Crossing Profile | Balloon Multiple Inflation in a Stent | |
| | Sheath Insertion and Withdrawal<br>Force | Initial Sheath insertion Force | |
| | Balloon Rated Burst Pressure | Sheath Withdrawal | |
| | Balloon Burst Mode | Crossing Profile | |
| | Balloon Protector (Wingtool removal<br>Force ) | Burst in a stent | |
| Conclusion | Gladiator Elite Balloon Dilatation Catheter. | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the Mustang Balloon Dilatation Catheter has been shown<br>to be appropriate for its intended use and is considered to be substantially<br>equivalent to the Boston Scientific Mustang Balloon Dilatation Catheter and | |

#### Comparison to predicate Devices :

Boston Scientific Corporation