(176 days)
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5 mm with balloon lengths of 2 and 4 cm and balloon diameters of 2, 2.5, and 3 mm with balloon lengths of 2, 3, 4, 6, 8, 10, and 12 cm. The catheter is 2.5 French in outer diameter with a length of 50, 90, or 150 cm. The catheter is compatible with a 0.014 inch (0.36 mm) diameter wire guide. It will be supplied sterile, intended for one-time use.
The provided text describes the regulatory submission for the "Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter," a medical device. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device through a series of engineering and performance tests, not clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested fields related to clinical trials, AI, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Predetermined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength | Balloons burst at or above the minimum rated burst pressure, with linear tears as the failure mode. | "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." |
| Balloon Preparation and Simulated Use | Materials withstand contact with saline/heparin and contrast medium (1:1 ratio); compatible with recommended introducer and wire guide; perform according to instructions for use. | "All materials withstand contact with saline/heparin and contrast medium (1:1 ratio) during simulated use. Simulated use testing shows the devices are compatible with the recommended introducer and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met." |
| Catheter Diameter and Balloon Profile | Device profile is less than 1.016 mm (0.040 inch). | "Measurement of the diameter of catheter shaft. bonds, and folded balloon shows that the device profile is less than 1.016 mm (0.040 inch). The predetermined acceptance criteria were met." |
| Balloon Compliance | Under simulated body temperature, each balloon meets its labeled diameter within tolerance at nominal pressure. | "Under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met." |
| Balloon Fatigue | Balloons free from leakage and damage on inflation; withstand 10 cycles of inflation. | "Balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation. The predetermined acceptance criteria were met." |
| Bond Strength | Tensile force during proper clinical use should not fracture or rupture balloon catheter bonds (in conformance with ISO 10555-1). | "The tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met." |
| Inflation / Deflation Time | Balloon inflates to rated burst pressure within 60 seconds; fully deflates within 60 seconds. | "The balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of catheters or balloons) used for each physical and mechanical test. It only mentions that "the predetermined acceptance criteria were met" for all tests.
- Data Provenance: The tests are described as in vitro or simulated use laboratory tests conducted by the manufacturer, Cook Incorporated. There is no mention of clinical data, human subjects, or country of origin for patient data as this is a device performance evaluation, not a clinical trial. The testing presumably occurred at Cook's facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes engineering and performance tests on a physical medical device. "Ground truth" in the context of expert consensus, pathology, or clinical outcomes is not relevant here. The "ground truth" for these tests is defined by the physical properties of the material and device, as measured by standard laboratory methods against pre-defined engineering specifications.
4. Adjudication method for the test set:
- Not Applicable. As these are physical and mechanical tests, there is no "adjudication method" in the sense of reconciling differing expert opinions. The results are objective measurements against defined criteria.
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 PTA Balloon Catheter, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical instrument, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is established by engineering specifications and industry standards (e.g., ISO 10555-1 mentioned for bond strength) for device performance. It is based on objective physical and mechanical measurements conducted in a laboratory setting.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning study. There is no concept of a "training set" in the context of this device's performance evaluation.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).