(61 days)
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
This document is a 510(k) premarket notification for the Chameleon PTA Balloon Catheter, and as such, it does not contain the detailed information about acceptance criteria and specific study results that would be found in a clinical study report or a more comprehensive technical document. The FDA 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.
However, based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." and "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."
This indicates that acceptance criteria were established and met, but the specific numerical criteria and the reported device performance values are not detailed in this summary. The summary mentions categories of bench tests performed but does not provide the quantitative acceptance criteria for each or the device's results against those criteria.
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: The document does not specify the sample size for any of the bench tests.
- Data Provenance: The tests described are "bench testing and simulated use test data." This implies the data is prospective in nature (generated specifically for this submission). The country of origin for the testing or data is not explicitly stated, but the manufacturer (AV Medical Technologies Ltd.) is located in Tel Aviv, Israel, suggesting the testing likely occurred there or under their supervision.
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 information is not applicable as the studies described are bench tests and simulated use, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the studies described are bench tests, not clinical studies involving human interpretation that would require adjudication.
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:
This is not applicable. The device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" would be established engineering specifications and applicable standards (e.g., ISO standards for medical devices). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This is not applicable as the device is not an AI/machine learning algorithm that requires a training set. The "Chameleon PTA Balloon Catheter" is an over-the-wire, multi-lumen balloon catheter.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
Summary of available and unavailable information:
| Category | Information Available in Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Acceptance Criteria: Stated that "predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols" were met. |
| Reported Performance: Stated that "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." | |
| However, specific numerical criteria and actual performance values for each test are not provided. | |
| 2. Sample Size (Test Set) & Data Provenance | Sample Size: Not specified. |
| Data Provenance: "bench testing and simulated use test data," implying prospective bench testing. Origin likely Israel (manufacturer location). | |
| 3. Number & Qualifications of Experts (Ground Truth) | Not applicable. (Bench testing, not clinical data requiring expert review for ground truth). |
| 4. Adjudication Method (Test Set) | Not applicable. (Bench testing). |
| 5. MRMC Comparative Effectiveness Study | Not applicable. (Device is a physical catheter, not AI). |
| 6. Standalone Algorithm Performance | Not applicable. (Device is a physical catheter, not an algorithm). |
| 7. Type of Ground Truth Used | Engineering specifications and applicable industry standards. |
| 8. Sample Size (Training Set) | Not applicable. (Device is not an AI/ML algorithm). |
| 9. How Ground Truth (Training Set) Established | Not applicable. (Device is not an AI/ML algorithm). |
§ 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).