(70 days)
The EverCross 0.035" 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 EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and a flush cut tip to aid in crossing tight stenoses. The distal portion of the catheter shaft has a hydrophilic coating for lubricity. The catheter manifold includes two lumens. The lumen marked "THRU" 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 outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The EverCross .035" OTW Dilatation Catheter uses the following materials: Nylon 12, Nylon/Pebax, Platinum/Iridium alloy, Thermoplastic Polyester Elastomer, Polycarbonate, hydrophilic coating.
This document does not describe a study involving an AI/ML medical device. It describes a conventional medical device (a dilatation catheter) and its clearance through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to a predicate device.
Therefore, many of the questions asked, which pertain to AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth for training set), are not applicable to this document.
However, I can extract information related to the device's performance testing and how it met acceptance criteria for a conventional medical device.
Here's an analysis based on the provided text, addressing the applicable points:
The document describes the EverCross™ .035" OTW PTA Dilatation Catheter. This is a physical medical device used to dilate stenoses in various arteries and for stent post-dilatation. Its clearance is based on substantial equivalence to existing predicate devices (K082579, K103322).
The core of the acceptance criteria and proof of meeting them for this type of device lies in design verification testing to ensure the new device performs comparably to its predicate and adheres to established safety and effectiveness standards for such catheters.
Acceptance Criteria and Reported Device Performance (Applicable Information)
The document primarily focuses on demonstrating that the modified EverCross™ catheter (with new balloon sizes, a balloon design modification, and a change in tip) meets the same acceptance criteria as the predicate devices. The acceptance criteria themselves are explicitly stated as "identical to or based on predicate device acceptance criteria."
| Acceptance Criteria Category (from document) | Reported Device Performance (from document) |
|---|---|
| Design Verification Testing | "Design verification testing was performed to demonstrate the proposed devices met acceptance criteria identical to or based on predicate device acceptance criteria." |
| In vitro tests performed: | "The following in vitro tests were performed: |
- Balloon Outer Diameter at Operating Pressure
- Balloon Length
- Balloon Compliance
- Balloon Burst Strength
- Balloon Fatigue" |
| Predicate Device Testing (In-vitro & In-vivo) | "In-vitro and in-vivo testing was completed on the predicate device to support a determination of substantial equivalence. Testing included dimensional, performance, radiopacity, coating integrity and durability, biocompatibility, packaging, shelf-life and sterilization." (Results from predicate devices K082579 and K103322 were used). |
| Overall Performance & Equivalence | "Test results met the specified acceptance criteria and were included in K082579 and K103322."
"The results from these tests demonstrate that the technological characteristics and performance criteria of the EverCross .035" OTW PTA Dilatation Catheter are comparable to the predicate device and performs in a manner equivalent to the predicate device currently on the market for the same intended use." |
Non-Applicable Questions for this Document:
The following questions are designed for AI/ML device evaluations and are not addressed or relevant in this 510(k) summary for a physical medical device:
- Sample size used for the test set and the data provenance: Not applicable. This refers to a dataset for an AI model. The "testing" here is physical and material properties testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are concepts for diagnostic AI, not for mechanical device testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to human review of AI output.
- 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. This is for AI-assisted human performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. This relates to diagnostic accuracy, not physical device performance.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance Proof:
The proof that the EverCross™ .035" OTW PTA Dilatation Catheter meets acceptance criteria is based on a comparative approach to predicate devices. The company performed a series of in vitro (bench) tests on the new device, as listed in the table above, to ensure it performs identically or equivalently to the predicate devices. The results of these tests, combined with the previously cleared in-vitro and in-vivo testing results for the predicate devices (K082579 and K103322), demonstrate that the modified catheter maintains the same safety and effectiveness profile. The ground truth in this context is the established performance and safety specifications of the predicate devices and general standards for PTA dilatation catheters.
§ 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).