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510(k) Data Aggregation
(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 (< 0.062, 0.074, 0.087 or 0.100 inch Profile).) | Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with a 4, 5, 6, or 7 Fr sheath (< 0.062, 0.074, 0.087 or 0.100 inch profile). The predetermined acceptance criteria were met. |
| 4. Balloon Fatigue (Balloons must be free from leakage and damage after 10 cycles of inflation/deflation to rated burst pressure.) | Testing shows that balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation/deflation (inflating to rated burst pressure, holding for 30 seconds and deflating). The predetermined acceptance criteria were met. |
| 5. Inflation/Deflation (Balloon must inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds.) | Testing shows that the balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met. |
| 6. Sheath Compatibility (Balloon catheters must be compatible with 4, 5, 6, or 7 Fr sheath.) | Testing shows that the balloon catheters are compatible with a 4, 5, 6, or 7 Fr sheath. The predetermined acceptance criteria were met. |
| 7. Balloon and Catheter Bond Strength (Tensile force during proper clinical use should not fracture or rupture the balloon catheter bond, per ISO 10555-1.) | Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bond. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met. |
| 8. Shaft Selection Burst Strength (Shaft must not burst before the balloon.) | Testing shows the shaft will not burst before the balloon. The predetermined acceptance criteria were met. |
| 9. Kink Radius (Catheter kinked at a radius less than 13 millimeters.) | Testing shows that the catheters kinked at a radius less than 13 millimeters. The predetermined acceptance criteria were met. |
| 10. Torque Strength (Catheters must withstand no less than two rotations before failure.) | Testing shows that the catheters withstood no less than two rotations before failure. The predetermined acceptance criteria were met. |
| 11. Biocompatibility (Device must be biocompatible based on cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, per ISO 10993-1.) | Testing (i.e., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met. |
| 12. Sterilization (Sterility, bioburden, and residuals testing results must meet predetermined acceptance criteria.) | Sterility, bioburden, and residuals testing results met the predetermined acceptance criteria. |
Regarding AI/Software-Specific Evaluation Criteria (Not Applicable for this Device):
The provided document describes a physical medical device (PTA Balloon Catheter) and its engineering performance testing for a 510(k) submission, not an AI or software algorithm. Therefore, the following requested items, which are standard for AI/software evaluation, are not present or applicable in this context:
2. Sample size used for the test set and the data provenance:
- This refers to physical testing of components and device function, not a "data test set" in the AI sense. The number of physical units tested for each criterion is implied to be sufficient for regulatory purposes, but specific sample sizes (e.g., how many balloons were burst, or how many catheters were fatigued) are not explicitly stated in this summary.
- Data provenance (country of origin, retrospective/prospective) is not applicable; these are laboratory and bench tests of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground truth here is established by engineering specifications, physical measurements, and industry standards (e.g., ISO 10555-1, ISO 10993-1), not by expert human interpretation of data (like radiologists marking images). The "experts" would be the engineers and technicians conducting the tests and verifying compliance with the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is for human review or labeling disagreement in data sets, not physical device testing.
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 device is a physical catheter, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm. The performance tested is the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is derived from pre-defined engineering specifications, international standards (e.g., ISO), and physical measurements/observations during bench testing.
8. The sample size for the training set:
- Not applicable. This is not an AI model, 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 physical device.
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