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

The Boston Scientific Mustang™ Balloon Dilatation Catheter is an over-the-wire balloon catheter 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. The Mustang™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 2 cm to 12 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.

This document is a 510(k) summary for the Boston Scientific Mustang™ Balloon Dilatation Catheter, a medical device intended for the dilatation of strictures in the biliary system. It is a premarket notification for a Class II device, seeking to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance values for the Mustang™ Balloon Dilatation Catheter. Instead, it describes various tests performed and states that "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."

However, we can infer the types of acceptance criteria indirectly from the tests conducted. The underlying acceptance criterion for all these tests is that the device performs equivalently or better than the predicate device without raising new safety concerns, and meets relevant standards for medical devices of its type.

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes "bench testing" and "biocompatibility testing." These are laboratory-based studies, not clinical studies involving human patients. Therefore, the concept of a "test set" in the context of clinical data (like patient cases) is not directly applicable here.

• Sample Size: The specific number of devices or material samples used for each bench test or biocompatibility test is not disclosed in this summary.
• Data Provenance: The data provenance is laboratory testing ("bench testing and biocompatibility testing"). Given that Boston Scientific Corporation is based in Maple Grove, MN, USA, it's highly probable that these tests were conducted in the USA, likely at internal Boston Scientific labs or by contracted testing facilities. These are prospective tests performed specifically to support this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Since this submission relies on bench and biocompatibility testing, there is no "test set" of clinical cases that would require expert adjudication for ground truth. The "ground truth" for these tests are the established scientific and engineering principles, material specifications, and validated test methods. The "experts" involved would be the engineers, scientists, and technicians who designed, conducted, and analyzed these tests, following recognized standards (e.g., ISO for biocompatibility). Their qualifications would be in engineering, materials science, toxicology, and other relevant scientific disciplines, but specific numbers and qualifications are not stated in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This 510(k) submission primarily relies on non-clinical (bench and biocompatibility) data to demonstrate substantial equivalence for a medical device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images, often with and without AI assistance, to assess performance improvement.

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

Not applicable. This device is a physical medical instrument (a balloon dilatation catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used:

• For biocompatibility tests: The ground truth is based on established biological safety standards and validated test methodologies (e.g., ISO 10993 series). The "truth" is whether the materials elicit specific biological responses per the standard.
• For in-vitro performance tests: The ground truth is based on engineering specifications, design requirements, and validated test methods (e.g., measuring dimensions, burst pressures, fatigue cycles against predefined limits). The "truth" is whether the device meets those quantifiable engineering parameters.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As above, there is no training set for this type of device.

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