(225 days)
The Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature.
The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature.
The Ebony ® PTA 0.014" over the wire catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated. Maximum guide wire diameter is 0.014" (0.36 mm). The usable catheter length for OTW is 120 cm and 150 cm.
In order to correctly position the balloon under fluoroscopy, two radiopaque markers are placed on the shaft under the balloon itself, defining its cylindrical area. The catheter includes a smooth, soft and atraumatic tip to facilitate advancement of the catheter through the stenosis. In order to facilitate advancing through the vasculature, a hydrophilic coating is present on the distal shaft and the balloon.
The Ebony ® PTA 0.014" over the wire catheter is available in 2 usable lengths: 120 and 150 cm; and in the balloon sizes shown in Table 1. The Ebony ® PTA 0.014" over the wire catheter will be supplied sterile and is intended for one time use.
The Ebony® PTA 0.018" over the wire Catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated and it ends at the tip of the catheter. Maximum guide wire diameter is 0.018" (0.46 mm).
The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The Ebony® PTA 0.018" over the wire Catheter is available in two catheter lengths and the balloon sizes shown in Table 2 below. The Ebony® PTA 0.018" over the wire Catheter is supplied sterile and is intended for one time use.
This document describes the performance testing for the Ebony® PTA 0.014" over the wire catheter and Ebony® PTA 0.018" over the wire catheter.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary states that "all catheter test samples met the acceptance criteria for each of the performance tests." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific numerical results obtained. It only provides a list of the tests performed and a general statement of compliance.
| Test Performed | Acceptance Criteria (Not explicitly stated quantitatively, but implied as "met") | Reported Device Performance |
|---|---|---|
| Balloon compliance | Met pre-determined criteria | All samples met criteria |
| Balloon burst pressure | Met pre-determined criteria | All samples met criteria |
| Balloon fatigue | Met pre-determined criteria | All samples met criteria |
| Shaft resistance | Met pre-determined criteria | All samples met criteria |
| Bond strength | Met pre-determined criteria | All samples met criteria |
| Catheter dimensions | Met pre-determined criteria | All samples met criteria |
| Deflation time | Met pre-determined criteria | All samples met criteria |
| Coating verification | Met pre-determined criteria | All samples met criteria |
| Kink testing | Met pre-determined criteria | All samples met criteria |
| Deployment testing | Met pre-determined criteria | All samples met criteria |
| Guide wire and introducer compatibility | Met pre-determined criteria | All samples met criteria |
| Biocompatibility | Passed tests as per ISO10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F75600, and 21 CFR 58 (GLP) | All materials were found to be biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for each performance test. It only states "all catheter test samples."
- Data Provenance: The tests are described as "in vitro bench tests and analyses." The country of origin for the data is implied to be Natec Medical Ltd. in Mauritius, where the applicant is located. The tests are prospective in nature, as they involve testing the manufactured devices against pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical instrument (catheter), and its performance is evaluated through objective engineering and biological bench tests, not through expert interpretation of data or images where "ground truth" would be established by human experts.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance is assessed through objective bench testing against pre-determined acceptance criteria, not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (catheter), not a diagnostic AI system or an imaging modality that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device. The performance tests are for the device itself, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance tests is established by industry standards, engineering specifications, and regulatory requirements (e.g., ISO, ASTM, FDA guidelines) for medical device performance. For biocompatibility, it's defined by the passing criteria within the specified ISO and ASTM standards.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set. The performance tests evaluate the device's physical and biological characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning algorithm, there is no "training set" or corresponding ground truth establishment in that context.
§ 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).