(91 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. This catheter is not for use in coronary arteries.
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 describes the premarket notification (510(k)) for the Chameleon PTA Balloon Catheter. It outlines the device's characteristics and the nonclinical performance data submitted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement regarding acceptance criteria and performance rather than a specific table.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Established specifications necessary for consistent performance during intended use, as specified by applicable standards and test protocols. | "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." |
| "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols." |
2. Sample size 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 the sample sizes used for the test sets in the bench tests, biocompatibility tests, or simulated use tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes technical device performance testing (biocompatibility, bench, and simulated use tests), not clinical studies involving human patients where expert-established ground truth would typically be needed for diagnostic or prognostic accuracy. Therefore, this information is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this document focuses on technical device performance testing, not human-read clinical data.
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 not an AI-assisted device, and the document describes the substantial equivalence of a medical device (PTA balloon catheter), not a diagnostic or AI-driven system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device. The document details the physical and functional performance of a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical performance data (biocompatibility, bench, and simulated use tests), the "ground truth" would be established by:
- Biocompatibility: Adherence to ISO standards and guidelines for biological evaluation of medical devices.
- Bench testing: Engineering specifications, design requirements, and relevant industry standards for balloon catheters (e.g., burst pressure, tensile strength, inflation time, etc.).
- Simulated use testing: Performance against predefined functional criteria in a simulated environment, often mimicking physiological conditions.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).