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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2019

Medtronic, Inc. Breanna Hessler Regulatory Affairs Specialist 3033 Campus Drive, Suite N550 Plymouth, MN 55441

Re: K190753

Trade/Device Name: EverCross™ 0.035" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: March 22, 2019 Received: March 25, 2019

Dear Ms. Hessler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hajira F. Ahmad -S Ahmad For Date: 2019.04.23 14:25:19 -04 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190753

Device Name EverCross™ 0.035" OTW PTA Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

K190753

EverCross™ 0.035" OTW PTA Dilatation Catheter

510(k) Summary	This 510(k) summary is being submitted in accordancewith the requirements of 21 C.F.R § 807.92.
Applicant/ Submitter	Medtronic, Inc.3033 Campus DrivePlymouth, MN 55441-2651Tel: 763-398-7000
Contact Person	Breanna HesslerRegulatory Affairs SpecialistTel: 763-591-3530Email: Breanna.Hessler@medtronic.com
Date Prepared	March 22, 2019
Device Trade Name	EverCross™ 0.035" OTW PTA Dilatation Catheter
Device Common Name	PTA Dilatation Catheter
Classification Name	Percutaneous catheter, Cardiovascular
Regulation Number	21 CFR 870.1250
Classification	Class II
Classification Panel	Cardiovascular
Product Code	LIT, DQY
Predicate Device	EverCross™ .035'' OTW PTA Dilatation Catheter(K110319)

{4}------------------------------------------------

Reference Device Fortrex™ 0.035" OTW PTA Balloon Catheter (K142654)
Indications for Use The EverCross 0.889 mm (0.035 in) 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.
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 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.

Performance data To demonstrate substantial equivalence of the subject device, the EverCross™ 0.035" OTW PTA Dilatation Catheter to the predicate and reference devices, the technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" on non-clinical testing of medical devices and internal Risk Analysis procedures, the following in vitro tests were performed:

{5}------------------------------------------------

Kink
Kink Extreme
Inflation time ●
Deflation Time/ No deflate
Trackability
Manifold Bond Tensile ●
Torque to Failure

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.

The subject EverCross™ 0.035" OTW PTA Dilatation Summary of Substantial Equivalence Catheter has the following equivalencies to the predicate device:

Intended use ●
Indications for use
Fundamental scientific technology
Operating principle
Materials of construction ●
Balloon design and rated burst pressure
Sterilization method
Conclusion Based on the intended use, technological characteristics and performance testing included in this submission and in previously cleared submissions for this product, Medtronic concludes the EverCross 0.035" OTW PTA Dilatation Catheter to be substantially equivalent to the EverCross .035" OTW PTA Dilatation Catheter, K110319 (predicate) and Fortrex™ 0.035" OTW PTA Balloon Catheter, K142654 (reference).

Regulation Number and Section

§ 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).