MUSTANG BALLOON DILATAION CATHETERS

K110122 · Boston Scientific · FGE · May 12, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110122
• Device Name: MUSTANG BALLOON DILATAION CATHETERS
• Applicant: Boston Scientific
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Mustang™ Balloon Dilatation Catheters are intended for dilatation of strictures in the biliary system.

Device Story

Mustang Balloon Dilatation Catheter is an over-the-wire balloon catheter featuring a dual lumen shaft design. One lumen accommodates 0.035" guidewires; the second lumen facilitates balloon inflation and deflation. The proximal end includes a Y-connector manifold with luer lock fittings. Radiopaque marker bands under the balloon assist in positioning; a silicone coating on the balloon improves insertion and withdrawal. Available in balloon diameters 3.0 mm to 12.0 mm, lengths 2 cm to 12 cm, and shaft lengths of 40 cm, 75 cm, and 135 cm. Used by clinicians in a medical setting to dilate biliary strictures, potentially improving bile flow and relieving obstruction.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility testing. Bench tests included effective length, shaft outer diameter, balloon crossing profile, sheath insertion/withdrawal force, rated burst pressure, fatigue, compliance, coating integrity, inflation/deflation time, tensile strength, kink resistance, torque strength, radiopacity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, USP physicochemical, latex, hemolysis, complement activation, PTT, hemocompatibility, Ames mutagenicity, and mouse lymphoma assays.

Technological Characteristics

Over-the-wire dual lumen catheter; silicone-coated balloon; radiopaque marker bands. Materials and design are equivalent to predicate. Sterilization method not specified. Standalone device; no software or electronic components.

Indications for Use

Indicated for the treatment of biliary strictures using catheters with balloons up to 120 mm in length.

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

• SC 35 Balloon Dilatation Catheter (K993303)

Submission Summary (Full Text)

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K 110122
pg 1 of 2

MAY 1 2 2011

## 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 Information | Anne V. Rossi<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Prepared | 14 January 2011 | |
| Proprietary<br>Name | Mustang™ Balloon Dilatation Catheter | |
| Common Name | Balloon Dilatation Catheter | |
| Product Code | FGE | |
| Classification | Class II, 21 CFR Part 876.5010 | |
| Predicate<br>Device | SC 35 Balloon Dilatation Catheter<br>K993303 23 March 2000 | |
| Device<br>Description | The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-<br>wire balloon catheter with a dual lumen shaft design. One lumen is used to<br>pass the catheter over 0.035" guidewires. The second lumen communicates<br>with the balloon and is used to inflate and deflate the balloon during the<br>procedure. The guidewire lumen and the balloon lumen terminate at the<br>proximal end of the catheter in a Y-connector manifold with luer lock fittings.<br>There are radiopaque marker bands located under the balloon to aid in<br>positioning the system during the procedure. A silicone coating is applied to<br>the balloon to enhance insertion and withdrawal performance.<br>The Mustang™ Balloon Dilatation Catheter will be available with balloon<br>diameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaft<br>lengths of 40 cm, 75 cm, and 135 cm. | |
| Intended Use of<br>Device | The Mustang™ Balloon Dilatation Catheters are intended for dilatation of<br>strictures in the biliary system. | |
| Indications for<br>Use | The Mustang Balloon Dilatation Catheters with balloons up to 120 mm in<br>length are indicated for the treatment of biliary strictures. | |
| Comparison of<br>Technological<br>Characteristics | The Mustang™ Balloon Dilatation Catheter incorporates substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process and<br>intended use as those featured in the Boston Scientific predicate device, SC<br>35 Balloon Dilatation Catheter (K993303). | |
| 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. No<br>new safety or performance issues were raised during the testing. | |
| | The following biocompatibility tests were completed on the Mustang™ Balloon<br>Dilatation Catheter: | |
| | Cytotoxicity | Direct Contact Hemolysis |
| | Sensitization | Complement Activation |
| | Intracutaneous Reactivity | Partial Thromboplastin Time |
| | Acute Systemic Toxicity | In Vitro Hemocompatibility |
| | Materials Mediated Pyrogenicity | Ames Mutagenicity |
| | USP Physicochemical | Mouse Lymphoma Assays |
| | Latex | |
| | The following in-vitro performance tests were completed of the Mustang™<br>Balloon Dilatation Catheter: | |
| | Effective Length | Balloon Inflation/ Deflation Time |
| | Shaft Outer Diameter | Device Tensile |
| | Balloon Crossing Profile | Shaft Kink Resistance |
| | Sheath Insertion and Withdrawal<br>Force | Balloon Rated Burst Pressure in<br>Stent |
| | Balloon Rated Burst Pressure | Torque Strength |
| | Balloon Fatigue | Balloon Fatigue in Stent |
| | Balloon Compliance & Distension | Radiopacity |
| | Coating Integrity | Particulate Evaluation |
| Conclusion | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the Mustang™ Balloon Dilatation Catheter has been<br>shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the Boston Scientific SC 35 Balloon Dilatation<br>Catheter (K993303) | |

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K110/22
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-Gt Silver Spring, MD 20993-0002

## MAY 1 2 2011

Mr. James M. Taufen Regulatory Affairs Manager Boston Scientific Corporation One Scimed Place MAPLE GROVE MN 55311-1566

Re: K110122

Trade/Device Name: Mustang™ Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: May 5, 2011 Received: May 6, 2011

Dear Mr. Taufen:

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 indivitions 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, its inc. Act. devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liablity warranties. We remind you, however, that device labeling must be truthful and 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 theart 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

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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.html 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 Production 807.97). For questions regarding the reporting of adverse events under the MDR regulting (1 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 nomber [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours.

Stuker Lemur, MD

Herbert P. Lerner, M.D., Director (Acting) 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 (if known): KII0122

Device Name Mustang™ Balloon Dilatation Catheter

Indications for Use

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

Prescription Use (Per 21 CFR 801 Subpart D)

OR

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

oductive, Gastro-Renal, and

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