(21 days)
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheters are peripheral (rapid) exchange balloon dilatation catheters that are available with inflated balloon diameters of 2, 2.5, 3, and 4 millimeters and balloon lengths of 20, 40, 60, 80, 120, 160, 200 millimeters. The catheters are supplied sterile and are intended for one-time use.
This is a 510(k) summary for a medical device called the "Advance 14LP Low Profile PTA Balloon Dilatation Catheter." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Catheter length within acceptable tolerance limits | Met |
| Balloon Burst Testing | Statistically, balloons burst at or above the minimum rated burst pressure | Met |
| Balloon Fatigue Testing | Balloons withstand ten inflation and deflation cycles to the rated burst pressure of 16 atm | Met |
Important Note: The provided text does not include specific numeric values for the "acceptable tolerance limits" for dimensional verification or the "minimum rated burst pressure" for balloon burst testing. It only states that the acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the dimensional verification, balloon burst, or balloon fatigue tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. These tests are typically benchtop engineering tests conducted during device development/validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of testing described. The "ground truth" for these engineering performance tests is established by specifications and engineering standards, not by expert medical interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or complex clinical outcomes. These are engineering performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests (dimensional, burst, fatigue) designed to demonstrate the device's physical properties, not its clinical efficacy or human reader performance. This premarket notification relies on "substantial equivalence" to a predicate device, meaning it is similar enough that new clinical trials are not required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. This is a physical medical device (a catheter), not a software algorithm or AI. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
The ground truth for these tests is based on engineering specifications and performance requirements. For example:
- Dimensional Verification: The design specifications for the catheter's length.
- Balloon Burst Testing: The specified rated burst pressure for the balloon.
- Balloon Fatigue Testing: The specified number of inflation/deflation cycles and rated burst pressure.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train an AI algorithm. As this device is a physical catheter, not an AI, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).