(127 days)
The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.
The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.
The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.
Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | "All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended." |
| - Device functions according to its Instructions for Use. | |
| Biocompatibility: | "The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..." |
| - Materials are acceptable for contact duration A-Limited ( |
§ 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).