(114 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance 18LP Low Profile PTA Balloon Dilatation Catheter is an over-the-wire catheter. The 4 Fr balloon catheter will be compatible with a 0.018 inch wire guide. The balloon catheter will be supplied sterile, intended for one-time use.
The provided document describes the acceptance criteria and performance study for a medical device, specifically the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter, not an AI or software device. Therefore, many of the typical criteria for evaluating AI/software performance, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable here.
The study focuses on the physical and functional performance of the balloon catheter to demonstrate its substantial equivalence to a predicate device for a 510(k) submission.
Here's an analysis of the provided information, framed within the requested categories where applicable, with an emphasis on what is present and what is not for a medical device (as opposed to an AI/software device):
Acceptance Criteria and Device Performance for the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. Balloon Minimum Burst Strength (Balloon must burst at or above minimum rated burst pressure, with linear tears.) | Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met. |
| 2. Balloon Compliance (Balloon must meet labeled diameter within tolerance at nominal pressure under simulated body temperature.) | Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met. |
| 3. Balloon Profile (Catheter shaft, bonds, and folded balloon must be compatible with 4, 5, 6, or 7 Fr sheath profiles ( |
§ 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).