(120 days)
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.
The RX VIATRACTM 14 Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel which provides support and flexibility to the shaft and is attached at the proximal end.
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.
The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is available in 75 cm and 135 cm catheter lengths and with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.
The provided text describes the 510(k) summary for the RX VIATRACTM 14 Peripheral Dilatation Catheter. The study conducted to demonstrate the device meets acceptance criteria is a bench testing study, not a clinical study involving human or AI performance. Therefore, many of the requested elements are not applicable in this context.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Bench testing was performed to demonstrate that the [device] met the acceptance criteria and performed similar to the predicate Cordis Jupiter™ and OPTA 5™ PTA Catheters." It further concludes, "The results from the bench tests showed that the new RX VIATRAC™ 14 Peripheral Dilatation Catheter met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters."
However, the specific acceptance criteria (e.g., burst pressure thresholds, flexibility, trackability, etc.) for each test and the precise numerical results from the RX VIATRAC™ 14 are not detailed in this 510(k) summary. The summary only provides a high-level statement of compliance.
Example Table (Conceptual, as specific details are missing):
| Test Performed | Acceptance Criteria (Illustrative) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Not specified | To be equivalent or superior to predicate devices | Met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters |
| Not specified | No new safety or effectiveness issues raised | No new safety or effectiveness issues were raised during the testing program. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. Bench testing typically involves multiple samples of the manufactured device.
- Data provenance: Not applicable in the context of clinical data. This refers to laboratory bench test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to the defined engineering specifications or performance characteristics of the device being tested on a bench. The "ground truth" for bench testing is established by engineering design specifications and industry standards for similar devices.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically for clinical studies with expert reviewers. Bench testing results are objectively measured against predefined 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
No. This is a bench testing study for a physical medical device (catheter), not an AI algorithm. Therefore, MRMC studies and AI-assisted human performance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not a standalone AI algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" is defined by engineering specifications, design requirements, and industry standards for device performance (e.g., burst pressure, tensile strength, flexibility, lubricity, deliverability, etc.). The comparator is also the performance of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI study, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI study, so there is no "training set" or corresponding ground truth establishment process 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).