(27 days)
The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.
The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the 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 0.014" RX Dilatation Catheter has a new hydrophilic coating, applicable to all lengths to the currently available sizes.
The provided document is a 510(k) Pre-market Notification for a medical device, the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic device.
Therefore, many of the requested sections related to AI device evaluation (e.g., sample sizes for test/training sets, expert qualifications, MRMC study, ground truth types) are not applicable or cannot be extracted from this document, as it describes a physical medical device (a catheter) with a changed hydrophilic coating.
However, I can extract information related to the performance data and conclusion of the substantial equivalence review.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance / Evaluation |
|---|---|
| Coating Integrity | Bench testing performed. (Specific acceptance criteria not detailed in this summary.) |
| Particulate Evaluation | Bench testing performed. (Specific acceptance criteria not detailed in this summary.) |
| Biocompatibility | Bench testing performed. (Specific acceptance criteria not detailed in this summary.) |
| Intended Use | Same as predicate devices (K112513 and K142459). Intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. Not for use in coronary or neuro-vasculature. |
| Materials | Same as predicate devices. |
| RX Design | Same as predicate devices. |
| Overall Equivalence | Met all verification/validation acceptance criteria, demonstrating substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes bench testing on physical devices. It does not mention "test sets" or "data provenance" in the context of clinical data for an AI device. The tests were performed on the modified Ebony PTA .014" RX Catheter or leveraged from similar catheters. The specific number of catheters tested for each bench test is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is for a physical medical device, not an AI diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This document refers to engineering and biocompatibility testing where "ground truth" would be established by physical measurements and accepted industry standards, not clinical expert consensus or pathology.
8. The sample size for the training set
Not applicable. There is no AI algorithm being described, so no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).