(219 days)
The HP PTA Balloon Dilation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, popliteal, tibial, peroneal, 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 0.0350" HP PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, double-lumen tube, stress diffusion tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to different dimensions by inflating to different pressures. The soft tip at the end of the balloon is intended to make the balloon catheter more easy to push to the stenosis position. The inner tube which connects to the tip tube is for guide wire passage and the pushing rod. The two marker bands wrapped around the inner tube are for positioning the balloon location with the use of in vitro monitoring equipment. The proximal end of the double-lumen tube is connected with the hub, which is used as the balloon filling channel and also as the push rod of the catheter. The hub is used to connect with the external pressure equipment for balloon filling. The stress diffusion tube can prevent the double-lumen tube from being folded.
The provided text is a 510(k) Summary for the HP PTA Balloon Dilatation Catheter (K231402). It outlines the device description, indications for use, technological characteristics, and performance data from bench and biocompatibility testing. The document states that the device met all acceptance criteria, but it does not contain information about a clinical study involving human patients or a standalone AI algorithm. Therefore, I cannot provide details on sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or ground truth establishment for such studies.
Here's the information that can be extracted from the provided text regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020)."
Below are the types of tests performed and the general statement of compliance, as specific numerical acceptance criteria and performance results for each test are not detailed in this summary.
| Test Category | Specific Tests Performed | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Bench Testing | Visual inspection | Suited for intended use and in accordance with FDA guidance for Peripheral PTA and Specialty Catheters. Specific criteria for each test (e.g., absence of defects, specific dimensions, time ranges, pressure tolerances, strength values) would have been defined. | "The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020)." |
| Dimensional verification | |||
| Hydration test | |||
| Leakage test | |||
| Balloon inflation and deflation time | |||
| Balloon fatigue | |||
| Radiopacity | |||
| Simulated use test/guidewire and introducer sheath compatibility test | |||
| Tip pull strength | |||
| Catheter bond strength | |||
| Torque strength | |||
| Balloon rated burst pressure | |||
| Balloon compliance | |||
| Catheter body burst pressure | |||
| Flexibility and kinking | |||
| Corrosion resistance test | |||
| Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility) | |||
| Shelf-life testing | |||
| Biocompatibility Testing | Cytotoxicity | Met acceptance criteria as per ISO 10993-1, ASTM F2888-19, and FDA guidance. Specific biological endpoints and acceptable limits would have been defined for each test. | "The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible." |
| Sensitization | |||
| Intracutaneous reactivity | |||
| Acute systemic toxicity | |||
| Hemocompatibility (hemolysis, partial thromboplastin time, complement activation, in vivo thromboresistance and thrombus electron microscope scanning) | |||
| Material-mediated pyrogenicity | |||
| Platelet leukocyte count study |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The approval is based on bench and biocompatibility testing, not human clinical 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. Ground truth from human experts is not relevant for bench and biocompatibility testing. The "ground truth" for these tests comes from established engineering and biological standards and methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in clinical studies with expert reviewers, not for bench and biocompatibility testing.
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 device is a physical medical device (balloon catheter), not an AI-powered diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the bench testing is based on established engineering principles, material science standards, and performance specifications derived from relevant FDA guidance documents and industry standards (e.g., ISO, ASTM). For biocompatibility, the ground truth refers to compliance with international standards such as ISO 10993-1 and ASTM F2888-19, which define acceptable biological responses and safety profiles for medical device materials.
8. The sample size for the training set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI algorithm requiring a training set.
§ 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).