(159 days)
The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.
The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature. The modified Ebony® PTA 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.
Here's a breakdown of the acceptance criteria and the study information based on the provided document.
It's important to note that this document is a 510(k) premarket notification summary for a medical device. For such devices, the "study" demonstrating that the device meets acceptance criteria often refers to non-clinical bench testing to show substantial equivalence to a predicate device, rather than a clinical trial with human participants if the changes are minor. This is the case here.
Acceptance Criteria and Device Performance for Ebony® PTA 0.035 Peripheral Dilatation Catheter (K143036)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Balloon Compliance | Met verification/validation acceptance criteria |
| Balloon Burst Pressure | Met verification/validation acceptance criteria |
| Balloon Fatigue | Met verification/validation acceptance criteria |
| Biocompatibility Testing | Results demonstrated substantial equivalence; summary provided in file 002 |
| Shaft Resistance (Torque Test) | Met verification/validation acceptance criteria |
| Bond Strength | Met verification/validation acceptance criteria |
| Catheter Dimensions | Met verification/validation acceptance criteria |
| Coating Integrity (Visual Inspection) | Met verification/validation acceptance criteria |
| Deflation Time | Met verification/validation acceptance criteria |
| Guide Wire and Introducer Compatibility | Met verification/validation acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical bench test. It generally states that the "new balloon sizes met all of the verification/validation acceptance criteria."
- Data Provenance: The data provenance is from non-clinical bench testing. It's not human data and therefore does not have a country of origin in the typical sense; these tests are performed in a laboratory setting. These were retrospective in relation to the original K103354 device, as the tests were performed on the modified device to show equivalence to the previously cleared predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- N/A. For non-clinical bench testing (like mechanical and material properties of a catheter), "expert ground truth" in the way it's described for image analysis or clinical outcomes is not applicable. The "ground truth" for these tests is based on established engineering principles, material science, and regulatory standards for device performance, which are evaluated by qualified engineers and scientists.
4. Adjudication Method for the Test Set:
- N/A. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical or image-based studies. For bench testing, the results are typically quantitative measurements against predefined specifications; there's no "adjudication" of expert opinions involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a physical medical device (a catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This question is typically relevant for AI algorithms. Since this is a physical medical device (catheter), the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is based on regulatory standards and established engineering specifications for the physical and functional performance of a PTA catheter. This includes parameters like balloon burst pressure, fatigue, material biocompatibility, and physical dimensions, all of which are defined and verified through objective measurements and tests. The predicate device (K103354) served as the benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely refined through engineering development and quality control, but this isn't analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As there is no "training set" in the AI sense, this question is not applicable. The performance characteristics and specifications for the device are derived from engineering design, material properties, and regulatory requirements for safe and effective medical devices.
§ 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).