(109 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 also intended for post-dilatation of balloon-expandable peripheral vascular stents.
The ATB All-Terrain™ Balloon Dilatation Catheter is comprised of a nylon balloon and a nylon shaft. It is used percutaneously over a pre-positioned wire guide. The and a nylen bhat. Tela connector which provides access to the end hole proximal ona mer connector which permits access to the balloon inflation lumen.
The catheter component of this device measures a nominal 5.0 French in outside diameter. The overall catheter lengths of 40, 80 and 120 cm are available. The catheter is offered with inflated balloon diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 2, 3, 4, 6 and 8 cm. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.
The provided document describes the "ATB All-Terrain™ Balloon PTA Dilatation Catheter" and its equivalence to predicate devices, but does not contain the detailed information requested regarding specific acceptance criteria, a comprehensive study for performance validation, or specifics on ground truth establishment from expert opinions.
This document is a 510(k) premarket notification summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a detailed performance study with quantitative acceptance criteria and ground truth analysis as typically found in clinical trials or AI/software validation studies.
However, based on the information provided, here's what can be extracted and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance (Implied) | Meets requirements for its use for peripheral angioplasty and post-dilatation of peripheral vascular stents. |
| Balloon Minimum Burst Strength | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Balloon Compliance | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Balloon Inflation/Deflation Performance | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Balloon Fatigue | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Bond Strength | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Catheter Hub Tensile Strength | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Diameter and Profile | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Balloon Minimum Burst Strength within a Stent | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
| Balloon Fatigue within a Stent | Tests performed, results "provide reasonable assurance that the device has been designed and tested to assure conformance." (Specific values not provided) |
Missing Information/Cannot Answer based on provided text:
While the document states that tests were performed to evaluate the ATB All-Terrain™ Balloon PTA Dilatation Catheter and provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," it does not provide the specific quantitative acceptance criteria or the actual performance results (e.g., minimum burst pressure values, fatigue cycles passed, tensile strength in Newtons, etc.) for each test mentioned.
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 does not specify sample sizes for any of the tests mentioned.
- Data Provenance: Not applicable in the context of this document, as the "performance data" refers to in-vitro engineering tests (e.g., burst strength, fatigue) rather than clinical data or patient data.
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. The "performance data" described are engineering tests. There is no mention of experts establishing a "ground truth" for a test set in the clinical or diagnostic sense within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of adjudication methods as this document does not describe a study involving expert review or diagnostic assessment.
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
- No MRMC comparative effectiveness study was done. This document pertains to a medical device (dilatation catheter), not an AI or diagnostic imaging system that would typically involve human readers.
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, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the engineering tests would be established by physical measurement standards and established engineering principles (e.g., material properties, pressure sensors, force gauges).
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, a training set and its ground truth are not relevant to this device and its documentation.
§ 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).