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.

Device Description

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.

AI/ML Overview

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.

Summary

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Your endovascular company. 7

K110319 APR 1 4 2011

510(k) Summary

EverCross™ .035" OTW PTA Dilatation Catheter

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R § 807.92.

1. Submitter Information

Applicant	ev3 Inc.3033 Campus DrivePlymouth, MN 55441-2651Tel: 763-398-7000Fax: 763-591-3248
Contact Person	Paula Cordero, RACManager, Regulatory Affairs
Date Prepared	March 8th, 2011
2. Device Information
Device Trade Name	EverCross™ .035" OTW PTA Dilatation Catheter
Device Common Name	PTA Dilatation Catheter
Classification Name	21 CFR 870.1250- Percutaneous CatheterProduct Code: LIT - Catheter, Angioplasty, Peripheral, TransluminalDQY- Catheter, Percutaneous
Classification Panel	Cardiovascular
3. Predicate Devices
Device Trade Name	EverCross™ .035" OTW PTA Dilatation Catheter
510(k) Number	K082579, K103322
510(k) Clearance Date	November 20, 2008, December 6th, 2010
4. Device Description	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

ev3 Corporate World Headquarters / Peripheral Vascular - 3033 Campus Drive, Phynouth, MN 55441, USA • Ph +1 763 398 7000

ev3 Neurovascular • 9775 Toledo Way, Invine, CA 92618 • Ph +1 949 837 3700

ev3 Europe / International Headquarters - 106/108 rus La Boétte, 75008 Park, France - Ph +33 156 88 59 10

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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. The EverCross .035" OTW PTA Dilatation Catheter is intended to 5. Indications for Use dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, 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 PTA Dilatation Catheter has the following similarities 6. Comparison of to the predicate device: Technological Characteristics- Add . Identical intended use more detail-

. Identical indications for use
Identical indication for post stent dilatation ●
. Identical materials
. Identical operating principle

The differences include addition of 10x20mm and 12x20mm balloon sizes, a balloon design modification, a change from bevel-cut tip to flush-cut tip and a stronger monolumen. Design verification testing was performed to demonstrate the proposed devices met acceptance criteria identical to or based on predicate device acceptance criteria.

Performance To demonstrate substantial equivalence of the proposed device, to the predicate device, the technological characteristics and performance Testing Summary criteria were evaluated. Using FDA Guidance Documents on nonclinical testing of medical devices and internal Risk Analysis procedures, the following in vitro tests were performed:

Balloon Outer Diameter at Operating Pressure �.
Balloon Length .
. Balloon Compliance
Balloon Burst Strength .
t Balloon Fatigue

In-vitro and in-vivo testing was completed on the predicate device to

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EverCross™ .035" OTW PTA Dilatation Catheter Summary

support a determination of substantial equivalence. Testing included dimensional, performance, radiopacity, coating integrity and durability, biocompatibility, packaging, shelf-life and sterilization. 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.

8. Conclusions

Based on the intended use, technological characteristics, safety and performance testing included in this submission and in previously cleared submissions for this product, ev3 considers the EverCross .035" OTW PTA Dilatation Catheter to be substantially equivalent to the predicate device EverCross .035" OTW PTA Dilatation Catheter (K082579, K103322).

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Indications for Use Statement

510(k) Number (if known):

Device Name: EverCross™ .035" OTW PTA_Dilatation Catheter

Indications for Use:

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ev3. Inc. c/o Paula Cordero, RAC Manager, Global Regulatory Affairs 3033 Campus Drive Plymouth, MN 55441

APR 1 4 2011

Re: K110319

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: April 08, 2011 Received: April 11, 2011

Dear Ms. Cordero:

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 indicions 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 Amendontic or to devices that have been reclassified in accordance with the provisions of the Fedral 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. The general controls provisions of the Act include requirements for annual registration, instition, instition, fi 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 machay,

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

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Page 2 -- Ms. Paula Cordero, RAC

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of modical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as st forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the election product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1178017, plcase the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFP 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofree no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Dina R. Vahner

Image /page/5/Picture/8 description: The image shows a handwritten symbol or character. It consists of a vertical line that curves to the right at the top, forming a loop-like structure. Below the loop, there are two connected, rounded humps, resembling a stylized 'm' shape. A horizontal line is drawn beneath the entire figure, adding a base or grounding element to the symbol.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 __

Indications for Use Statement

510(k) Number (if known):

Device Name: EverCross™ .035" OTW PTA Dilatation Catheter

Indications for Use:

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.V. hmin

Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of 1

510(k) Number K110319

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).