(99 days)
The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries.
The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.
The Ebony® PTA .035 Peripheral Dilatation Catheter is a standard Over the Wire (OTW) PTA Catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing tight stenoses.
It is a double lumen catheter, one lumen for the guide wire used for inflation/deflation of the balloon and one lumen for the guide wire used to access to the distal tip of the catheter (max/0.035″). A luer lock fitting allows the connection with an inflation device (Y hub). The balloon has two radiopaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.
The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics.
The balloon material expands to a known diameter at specific pressure defined in a compliance chart supplied with the catheter. The device is available in balloon. diameters of 5, 6, 7, 8, 9, 10 or 12 mm, balloon lengths of 20, 40, 60, or 80 mm and catheter lengths of 80, 130, or 150 cm.
lt will be supplied sterile and is intended for one time use.
This is a 510(k) premarket notification for a medical device, the Ebony® PTA .035 Peripheral Dilatation Catheter, not a typical AI/ML device, therefore the information you requested like samples size for the test set, provenance of data, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set size and ground truth for training set are not available in the provided document. The study described focuses on nonclinical, bench-top testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies.
Here's the available information presented in the requested format:
Acceptance Criteria and Device Performance Study for Ebony® PTA .035 Peripheral Dilatation Catheter
This submission refers to non-clinical bench testing to demonstrate substantial equivalence, rather than a clinical study with human patients. As such, many of the typical acceptance criteria and study details relevant to AI/ML device performance or clinical trials are not applicable or not provided in this document.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally understood to be met if the device performs equivalently to the predicate device in a series of in vitro bench tests. The document states that the subject device met all predetermined acceptance criteria.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00, 21 CFR 58 (GLP) | All materials are biocompatible (based on testing results) |
| Performance Data | Balloon compliance | Equivalent performance to predicate device |
| Balloon burst pressure | Equivalent performance to predicate device | |
| Balloon fatigue | Equivalent performance to predicate device | |
| Shaft resistance | Equivalent performance to predicate device | |
| Bond strength | Equivalent performance to predicate device | |
| Catheter dimensions | Equivalent performance to predicate device | |
| Deflation time | Equivalent performance to predicate device | |
| Guide wire and introducer compatibility | Equivalent performance to predicate device |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in the provided document. The tests are "in vitro bench tests and analyses."
- Data Provenance: The data is generated from in vitro bench tests conducted by Natec Medical Ltd. or its contracted laboratories. No country of origin for the data is specified beyond the company's location in Mauritius. These are experimental, non-clinical tests rather than retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For this type of submission involving physical device performance, "ground truth" is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance, rather than expert human interpretation of data.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data. This submission focuses on objective physical and chemical properties of a medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this type of device submission. This pertains to evaluating the effectiveness of a diagnostic tool or intervention with human readers, which is not the purpose of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Engineering specifications, validated test methods, and performance of a legally marketed predicate device (ADMIRAL XTREME™ PTA Catheter). The "ground truth" for the tests is adherence to predefined engineering specifications and demonstrating performance comparable to the predicate device.
8. The Sample Size for the Training Set
- Not Applicable. This submission does not involve an AI/ML algorithm that requires a "training set."
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).