(24 days)
The PowerCross .018" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
The PowerCrossTM .018" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.018" coaxial catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.018". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 and 200 mm devices, two additional marker bands denote the middle of the balloon body. The PowerCross .018" OTW PTA Dilatation Catheter is available in multiple balloon sizes. Nominal balloon diameter and length are printed on the strain relief.
The provided document, K093286, is a 510(k) Summary for the PowerCross™ .018" OTW PTA Dilatation Catheter. This type of submission is for medical device clearance, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested criteria related to AI studies, like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
The document primarily focuses on bench testing to support the claim of substantial equivalence.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a PTA Dilatation Catheter), the "acceptance criteria" are typically the successful completion of various bench tests demonstrating physical and performance characteristics, and the "reported device performance" is the successful outcome of those tests, showing the device meets its design specifications and is comparable to predicate devices. Specific quantitative criteria and results are generally not detailed in the 510(k) summary but would be found in the full 510(k) submission.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Conformance to requirements for its intended use, demonstrating substantial equivalence to predicate devices. Specific tests would include (but are not limited to) burst pressure, guidewire compatibility, shaft tensile strength, balloon inflation/deflation, tip tensile strength, bond strength, flexural rigidity, marker band visibility, lubricity, etc. The summary states "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the 510(k) summary, as this refers to bench testing of the device itself, not a clinical study involving a test set of data. The "test set" in this context would be the physical devices manufactured and subjected to various engineering tests.
- Data Provenance: Not applicable in the context of data used for an AI algorithm. The performance data is from bench testing of the manufactured medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant to a 510(k) summary for a physical medical device based on bench testing. The "ground truth" for device performance is typically engineering specifications and established test methodologies.
4. Adjudication method for the test set
- Not applicable. "Adjudication method" usually refers to reconciling differences among expert annotators in an AI study. This submission is about a physical device and its engineering performance.
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. An MRMC study is specific to AI-assisted interpretation tasks. This submission is for a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This applies to AI algorithms, not a PTA dilatation catheter.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by engineering specifications and validated bench test methods. For example, a balloon must inflate to a certain diameter at a certain pressure without bursting, and this is verified through specific tests.
8. The sample size for the training set
- Not applicable. There is no AI training set involved in this submission.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set involved in this submission.
Summary of the Study (Bench Testing):
The study was not a clinical trial or an AI performance study. It was a series of bench tests conducted to evaluate the physical and functional performance of the PowerCross™ .018" OTW PTA Dilatation Catheter. The purpose of these tests was to demonstrate that the proposed device performs as intended and is "substantially equivalent" to already legally marketed predicate devices (NanoCrossTM .014" OTW PTA Dilatation Catheter (K090849) and EverCrossTM .035" OTW PTA Dilatation Catheter (K082579)). The 510(k) summary states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." The specific details of these bench tests (e.g., number of devices tested for each parameter, the exact test protocols) are not included in the provided summary but would be part of the full 510(k) submission.
§ 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).