(89 days)
The Mustang™ Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
The Mustang™ Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
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 20 cm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
The provided text describes a 510(k) premarket notification for the Mustang™ Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and performance data from bench and biocompatibility testing. The submission does not include a study involving human subjects or AI.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in a quantitative manner as would be typical for a clinical study with specific endpoints. Instead, it relies on demonstrating that the device meets safety and performance requirements through various tests and by comparing its characteristics to predicate devices. The "reported device performance" is essentially that the device passed all these tests.
| Test Category | Specific Tests Performed | Reported Performance / Acceptance Criteria (Implied) |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Latex, Direct Contact Hemolysis, Complement Activation, Partial Thromboplastin Time, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse Lymphoma Assays, USP Physicochemical | The submission states: "The following biocompatibility tests were completed on the Mustang™ Balloon Dilatation Catheter... No new safety or performance issues were raised during the testing." This implies that the device met the established safety standards for biocompatibility according to the methods used (e.g., ISO 10993 standards, although not explicitly stated). Specific numerical pass/fail criteria are not detailed in this summary. |
| In-vitro Performance | Effective Length, Shaft Outer Diameter, Balloon Crossing Profile, Sheath Insertion and Withdrawal Force, Balloon Rated Burst Pressure, Balloon Fatigue, Balloon Compliance & Distension, Coating Integrity, Balloon Inflation/Deflation Time, Device Tensile, Shaft Kink Resistance, Balloon Rated Burst Pressure in Stent, Torque Strength, Balloon Fatigue in Stent, Radiopacity, Particulate Evaluation | The submission states: "The following in-vitro performance tests were completed of the Mustang™ Balloon Dilatation Catheter... 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." This implies the device passed these functional and mechanical tests. For example, for "Rated Burst Pressure (RBP)", it notes: "tested to meet rated pressures with 95% confidence on 99.9% population." This indicates a specific statistical criterion was met for RBP, but exact numerical values for other tests are not provided in this summary. The implicit acceptance criteria are that the device performs equivalently or better than predicate devices in these aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test. For "Rated Burst Pressure (RBP)", it mentions "95% confidence on 99.9% population," which is a statistical threshold rather than a raw sample size. For other tests, sample sizes are not provided in this summary.
- Data Provenance: The tests are described as "Bench testing" and "biocompatibility testing." This indicates the data is from laboratory settings (in-vitro), not from human or animal studies. The country of origin of the testing is not specified, but the submitter is Boston Scientific Corporation in Maple Grove, MN, USA.
- Retrospective or Prospective: These are laboratory tests, not clinical studies, so the terms retrospective or prospective do not directly apply.
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. The submission describes testing of a physical medical device (balloon catheter) in a laboratory setting, not an AI or diagnostic imaging device that requires expert interpretation to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as #3.
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
There was no MRMC study done as this submission is for a physical medical device (balloon catheter), not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the submission is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable in the context of an AI device requiring ground truth. For the physical device, the "ground truth" is defined by established engineering and material science standards, specifications, and performance criteria that the device must meet (e.g., maximum burst pressure, tensile strength, biocompatibility standards).
8. The sample size for the training set
This section is not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established
This section is not applicable as there is no AI algorithm being trained.
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).