Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A silicone coating is applied to the balloon to enhance insertion and withdrawal performance.

AI/ML Overview

This document describes Boston Scientific Corporation's Mustang™ Balloon Dilatation Catheter (K141597) for the treatment of biliary strictures. The device is being compared to its predicate devices, the Mustang™ Balloon Dilatation Catheter (K110122) and the Gladiator Elite™ Balloon Dilatation Catheter (K132810).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds. Instead, it states that "No new safety or performance issues were raised during the testing and therefore, these devices may be considered substantially equivalent to the predicate devices." This implies that the acceptance criteria were met if the performance of the new device was comparable to or better than the predicate devices and did not introduce new safety concerns.

The performance data listed consists of a series of in-vitro performance tests. The implicit "reported device performance" is that the device successfully passed these tests without raising new safety or performance issues, demonstrating substantial equivalence to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
No new safety or performance issues compared to predicate devices.	"No new safety or performance issues were raised during the testing."
Conformance to requirements for intended use.	"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."
Performance in listed in-vitro tests comparable to predicate.	All listed in-vitro tests were "completed" with implicit satisfactory results. These tests include: Balloon Compliance, Balloon Nominal Diameter, Balloon Crossing Profile, Sheath Insertion and Withdrawal Force, Balloon Rated Burst Pressure, Balloon Burst Mode, Balloon Protector (Wingtool removal Force ), Balloon Multiple Inflation, Proximal Bond Tensile, Balloon Multiple Inflation in a Stent, Initial Sheath insertion Force, Sheath Withdrawal, Crossing Profile, Burst in a stent.
Substantial equivalence to predicate device.	"The Mustang Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific Mustang Balloon Dilatation Catheter and Gladiator Elite Balloon Dilatation Catheter."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing was performed" and lists "in-vitro performance tests." This indicates that the testing was conducted on samples of the device in a laboratory setting, rather than in human subjects.

Sample Size: The specific number of devices or components used for each individual in-vitro test is not provided in this summary.
Data Provenance: The tests are in-vitro bench tests, meaning they were conducted in a controlled laboratory environment. The country of origin of the data is not explicitly stated, but given Boston Scientific Corporation's address (Maple Grove, MN) and the FDA submission, it can be inferred that the testing likely took place in the USA or within the company's global testing facilities dedicated to satisfying US regulatory requirements. The data is prospective for these specific tests as it was generated to support the 510(k) submission for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the provided document. The study described is a series of in-vitro bench tests, not a clinical study involving human patients or expert assessment of medical images/diagnoses. The "ground truth" for these tests would be established by validated test methods, calibration of equipment, and adherence to industry standards, rather than expert consensus on medical conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers or experts in clinical studies, particularly when establishing ground truth. Since the reported studies are in-vitro bench tests, such adjudication methods are not relevant. The results of the tests would be objectively measured without requiring human judgment beyond the execution of the test protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The document describes a medical device (balloon catheter) for treating biliary strictures, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a physical medical instrument (catheter), not an algorithm or software. Therefore, there is no "standalone" algorithm-only performance to assess.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For in-vitro bench testing, the "ground truth" is defined by the objective physical and material properties of the device and its performance under specified mechanical conditions. This is established through:

Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) for testing medical devices.
Measurement Equipment: Calibrated instruments providing quantitative data (e.g., pressure gauges for Rated Burst Pressure, optical systems for balloon diameter).
Material Specifications: Compliance of components with predefined material properties.
Design Specifications: The device's physical dimensions and characteristics as per its engineering design.

The "ground truth" is not derived from human expert consensus, pathology, or patient outcomes in this context, but rather from reproducible scientific and engineering measurements.

8. The sample size for the training set

This section is not applicable. The development described is for a physical medical device (catheter) and involves bench testing for performance and safety, not the training of a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable, as there is no training set for this type of device submission.

Summary

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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 (800) 638-2041 or (301) 796-7100 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'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Nameand Information	Elaine RuddleSpecialist, Regulatory AffairsPhone: +353 91 517936Fax: 763-494-2222e-mail: ruddlee@bsci.comOrMelanie RaskaDirector, Regulatory AffairsPhone :763-494 -2212Fax: 763-494-2222e-mail: raskam@bsci.com
Date Prepared	June 12, 2014
ProprietaryName	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
PredicateDevice(s)	MustangTM Balloon DilatationCatheterK110122Gladiator Elite TM Balloon DilatationCatheterK132810	12 May 201128 February 2014
DeviceDescription	Mustang Balloon Dilatation Catheters are over-the-wire balloon catheters witha dual lumen shaft design. One lumen is used to pass the catheter over0.035" guidewires. The second lumen communicates with the balloon and isused to inflate and deflate the balloon during the procedure. The guidewirelumen and the balloon lumen terminate at the proximal end of the catheter in aY-connector manifold with luer lock fittings. There are radiopaque markerbands located under the balloon to aid in positioning the system during theprocedure. A silicone coating is applied to the balloon to enhance insertionand withdrawal performance.
Intended Use ofDevice	The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm inlength are indicated for the treatment of biliary strictures.
Indications forUse	The Mustang TM Balloon Dilatation Catheter with balloons up to 120mm inlength 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 andfunction
	Materials	Same materials. Balloon contains an additionalmaterial 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 andLengths	Same sizes
	Effective length	Same length catheters
	Rated Burst Pressure (RBP)	Same RBP
PerformanceData	Bench testing was performed to support a determination of substantialequivalence. The results of these tests provide reasonable assurance that theproposed device has been designed and tested to assure conformance to therequirements for its intended use. No new safety or performance issues wereraised during the testing and therefore, these devices may be consideredsubstantially equivalent to the predicate devices.
	The following in-vitro performance tests were completed on the MustangBalloon 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 WithdrawalForce	Initial Sheath insertion Force
	Balloon Rated Burst Pressure	Sheath Withdrawal
	Balloon Burst Mode	Crossing Profile
	Balloon Protector (Wingtool removalForce )	Burst in a stent
Conclusion	Gladiator Elite Balloon Dilatation Catheter.	Based on the indications for use, technological characteristics, and safety andperformance testing, the Mustang Balloon Dilatation Catheter has been shownto be appropriate for its intended use and is considered to be substantiallyequivalent to the Boston Scientific Mustang Balloon Dilatation Catheter and

Comparison to predicate Devices :

Boston Scientific Corporation

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
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.(b)
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.