(56 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch quidewire. It will be supplied sterile. intended for one-time use.
The provided text describes a 510(k) premarket notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It outlines the device's intended use, its similarity to predicate devices, and the tests performed to ensure its safety and performance. However, it does not contain a specific table of acceptance criteria with corresponding performance statistics. The document confirms that the device was deemed substantially equivalent to predicate devices based on these tests.
Given the information provided, here's a breakdown of the requested points, focusing on what can be extracted and noting what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile strength | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Balloon deflation | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Balloon burst pressure | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Balloon compliance | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Balloon fatigue | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Accelerated aging | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
| Biocompatibility | "Results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." (Specific quantitative criteria and results are not provided in this document.) |
Explanation: The document lists several types of tests performed. For each, it states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum burst pressure variation) and the exact quantitative results achieved by the device are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document lists the types of tests performed but does not state the number of units or samples tested for each.
- Data Provenance: The tests were conducted by Cook Incorporated (the manufacturer). The country of origin and whether the data was retrospective or prospective are not explicitly stated, but it can be inferred that these were controlled, prospective engineering and laboratory tests conducted to support regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The tests described (tensile, burst, fatigue, etc.) are engineering and material science tests for device performance, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., diagnosis of medical conditions). The "ground truth" here would be established by the performance metrics defined by engineering standards and internal specifications. The document does not mention any medical experts involved in validating the results of these specific performance tests.
4. Adjudication Method for the Test Set
- Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a medical outcome or image. For in-vitro device performance tests like those listed, an adjudication method for establishing ground truth is not relevant. The results are typically objectively measured against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document describes laboratory and engineering tests for device performance and safety (e.g., tensile strength, balloon burst). It does not mention any clinical studies, MRMC studies, or human reader performance evaluations, with or without AI assistance. The device in question is a medical catheter, not an AI diagnostic tool.
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 catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- Engineering Specifications and Industry Standards: For the device performance tests (tensile, burst, fatigue, etc.), the "ground truth" would be the predefined engineering specifications and relevant industry standards that the device must meet to be considered safe and effective for its intended use. This is implicitly what "conformance to the requirements for its use" refers to.
8. The Sample Size for the Training Set
- Not applicable. The document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to predicate devices and performance testing. There is no mention of an algorithm or AI system requiring a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an algorithm, there is no ground truth to be established for it.
§ 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).