Search Results

The EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Description

EverCross 0.035" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant balloon and an atraumatic tapered tip. The distal portion of the catheter, proximal to the balloon, 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 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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.

The EverCross 0.035" OTW PTA Dilatation Catheter is available in multiple balloon sizes and three catheter working lengths. Nominal balloon diameter and length are printed on the strain relief.

AI/ML Overview

This document describes the regulatory clearance of a medical device, the EverCross™ 0.035" OTW PTA Dilatation Catheter (K190753), based on its substantial equivalence to previously cleared predicate and reference devices. The information provided outlines the non-clinical testing used to demonstrate this equivalence, rather than a clinical study evaluating the device's performance in humans or an AI-powered diagnostic tool.

Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, and human reader studies (MRMC, standalone AI performance) are not applicable to this submission as it focuses on in vitro (bench) testing of a physical medical device.

However, I can extract the relevant information from the provided text regarding the device and its testing.

Device Type: This is a physical medical device: a Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. It is a Class II medical device.

Purpose of the Submission: The submission (K190753) is a 510(k) premarket notification to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device (EverCross™ .035'' OTW PTA Dilatation Catheter, K110319) and a reference device (Fortrex™ 0.035" OTW PTA Balloon Catheter, K142654). This means the study does not aim to prove clinical efficacy or determine the performance of an AI model, but rather to show that the new device is as safe and effective as existing, cleared devices through non-clinical testing.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

The acceptance criteria for this type of device are typically based on engineering specifications and performance benchmarks derived from the predicate device and relevant guidance documents. The "reported device performance" would be the test results confirming the device met these specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implied / Based on Predicate Performance and Guidance)	Reported Device Performance (Summary from Document)
Kink	Not explicitly stated in the document, but implies the device should resist kinking under expected use conditions, comparable to predicate.	"The results from these tests demonstrate that the technological characteristics and performance criteria of the EverCross™ 0.035" OTW PTA Dilatation Catheter are comparable to the predicate and reference devices, and that the subject device performs in a manner equivalent to the predicate and reference devices currently on the market for the same intended use." This general statement implies all tests met their criteria.
Kink Extreme	Not explicitly stated, but implies resistance to kinking under more severe conditions.	As above.
Inflation Time	Not explicitly stated, but implies inflation time within an acceptable range for clinical use, comparable to predicate.	As above.
Deflation Time/No Deflate	Not explicitly stated, but implies the balloon deflates completely within an acceptable time frame, comparable to predicate.	As above.
Trackability	Not explicitly stated, but implies the catheter can be advanced through tortuous paths (e.g., simulated vessels) without excessive force or damage, comparable to predicate.	As above.
Manifold Bond Tensile	Not explicitly stated, but relates to the strength of the bond between the manifold and the catheter shaft, indicating it can withstand forces during use, comparable to predicate.	As above.
Torque to Failure	Not explicitly stated, but implies the device can withstand rotational forces without structural failure during manipulation, comparable to predicate.	As above.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as non-clinical in vitro testing.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample sizes for each in vitro test (e.g., number of catheters tested for kink resistance). However, for non-clinical bench testing, standardized test methods (e.g., ISO standards, ASTM standards) often dictate minimum sample sizes to ensure statistical validity for engineering tests.
Data Provenance: The tests are in vitro (bench testing) performed by Medtronic, Inc. (Plymouth, MN). This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the typical clinical sense. The tests were performed to compare the new device to established predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

N/A. For non-clinical bench testing of a physical device, "ground truth" is established by engineering specifications, validated test methods, and measurement equipment. It does not involve expert readers or clinical interpretation in the same way as an AI diagnostic device.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none):

N/A. Adjudication is not applicable as this is in vitro engineering testing, not clinical data review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI or diagnostic device that relies on human interpretation of images. Therefore, an MRMC study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through engineering specifications, validated test methodologies (in accordance with FDA Guidance Documents and internal Risk Analysis procedures), and comparison against the performance of the predicate and reference devices. For instance, a "kink" test has a measurable outcome (e.g., force to kink, angle of kink), which is compared to a defined acceptance limit.

8. The Sample Size for the Training Set:

N/A. This is not a machine learning/AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

N/A. As there is no training set for an AI model, this question is not applicable.

Summary of the Study:

The study described is a series of non-clinical bench tests designed to demonstrate that the EverCross™ 0.035" OTW PTA Dilatation Catheter (K190753) has technological characteristics and performance criteria comparable to its predicate (K110319) and reference (K142654) devices. The tests included: Kink, Kink Extreme, Inflation time, Deflation Time/No Deflate, Trackability, Manifold Bond Tensile, and Torque to Failure. The report states that the results of these tests confirm the subject device performs equivalently to the predicate and reference devices for the same intended use. This approach is standard for 510(k) submissions of physical medical devices demonstrating substantial equivalence based on engineering and performance characteristics.

Ask a Question

Ask a specific question about this device

Page 1 of 1