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The Gladiator 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.

The Gladiator Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Boston Scientific Gladiator™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an Over-the-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" 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 two radiopaque markerbands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.

· The Gladiator Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 100 mm, and with shaft lengths of 40 cm and 75 cm.

The provided text focuses on the 510(k) summary for the Boston Scientific Gladiator™ PTA Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to an already approved device rather than clinical trials with specific acceptance criteria as might be seen for novel devices or AI/ML-based systems.

Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, MRMC studies, training set details, etc.) are not applicable to this 510(k) submission document.

Here's an analysis of the available information:

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

The document does not present specific quantitative acceptance criteria in numerical form, as would be typical for performance specifications for new devices or AI models. Instead, it relies on demonstrating that the Gladiator device is substantially equivalent to the predicate device (Mustang PTA Balloon Dilatation Catheters, K103751) based on technological characteristics and performance data from bench and biocompatibility testing.

Here's a summary derived from the "Comparison of Technological Characteristics" and "Performance Data" sections:

• Manifold Hub: Same material (different colorant/additive), same design, same function.
• Bumper Tip: Same material (different colorant), same design, same function.
• Strain Relief: Same material, same design, same function.
• Proximal Dual Lumen Shaft: Same material, same design, same function.
• Proximal Shaft Outer Diameter: Same.
• Balloon: Same balloon material, same design, same function, same fundamental technology.
• Balloon Protector: Same material, similar design, same function.
• Pinch-off Tube: Same material, same design, same function.
• Markerbands: Same component, same function.
• Coating: Same coating, same function.
• Packaging Design: Similar design, same function (same carrier tube materials, different configuration).
• Sterilization Method: Same method.
• SAL (Sterility Assurance Level): Same level of assurance.
• Lumens: Same lumens, same function.
• Recommended Guidewire: Same compatibility.
• Balloon Diameters: Same.
• Balloon Lengths: Within range of predicate.
• Effective Length: Within range of predicate.
• Rated Burst Pressure (RBP): Same. |
  | Biocompatibility Testing | All tests completed successfully:
• MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Rabbit Pyrogen
• Bacterial Mutagenicity (Ames Assay)
• Mouse Lymphoma Assay
• Hemolysis Direct Contact and Extract
• Partial Thromboplastin Time
• In Vitro Hemocompatibility Assay
• Complement Activation
• USP Physicochemical
• Natural Rubber Latex |
  | Bench/Performance Testing | Performed to assure conformance for intended use.
  (No new safety or performance issues raised.) |
  | Sterilization | Performed to assure conformance for intended use. |

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

This document discusses bench testing and biocompatibility testing, not clinical studies with "test sets" of patient data. The sample sizes for these engineering and lab tests are not specified in the summary. Data provenance for such engineering tests typically refers to laboratory conditions rather than patient data origin.

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)

Not applicable. Ground truth for clinical data is not relevant to a device submission based on substantial equivalence through engineering and biocompatibility testing. The "ground truth" here is adherence to engineering specifications and biological safety standards.

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

Not applicable. Adjudication methods are used in clinical studies, not for the type of testing described here.

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

Not applicable. This is for a physical medical device (balloon catheter), not an AI/ML system that assists human readers.

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

Not applicable. This is for a physical medical device.

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

For the Gladiator device, the "ground truth" relates to:

• Engineering Specifications: The design and material characteristics of the predicate device (Mustang PTA Balloon Dilatation Catheters) serve as the benchmark for comparison.
• Biocompatibility Standards: Established international and national standards for biocompatibility testing (e.g., ISO 10993 series) define the "ground truth" for safety in this area.
• Performance Standards: Industry-accepted test methods and performance criteria (e.g., for Rated Burst Pressure, guidewire compatibility) define the "ground truth" for bench testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

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