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 an atraumatic, tapered tip to aid in crossing tight stenoses. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating. 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.

AI/ML Overview

The provided document is a 510(k) Summary for the EverCross™ .035" OTW PTA Dilatation Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on bench testing and biocompatibility testing. The document does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance as one might expect for an AI/ML or diagnostic device.

This is a medical device submission for a physical dilatation catheter, not a software device or diagnostic tool. The "acceptance criteria" here refer to the performance standards met through bench testing and biocompatibility. There is no mention of a clinical study with human subjects, ground truth, or expert review in the way would be described for an AI/ML or diagnostic device.

Therefore, many of the requested fields cannot be filled.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. 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."

It does not provide specific quantitative acceptance criteria (e.g., burst pressure tolerance, flexural strength, etc.) nor specific quantitative results. It broadly refers to "conformance to the requirements for its intended use."

Therefore, a table of specific acceptance criteria and reported performance cannot be generated from the given text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The "test set" for this type of medical device refers to the physical units tested in bench and biocompatibility assays. No information is provided about the sample sizes for these tests, nor their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The concept of "experts establishing ground truth" as it applies to diagnostic or AI/ML devices is not relevant for this physical medical device. Performance is assessed through engineering and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is typically related to expert review of data for diagnostic or AI/ML devices.

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. This is a physical medical device (dilatation catheter), not an AI/ML or diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a physical medical device like this, performance is validated through bench testing (e.g., mechanical properties, fluid dynamics) and biocompatibility testing (e.g., cytotoxicity, irritation). The "ground truth" would be established by engineering specifications and industry standards for material and device performance.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this physical medical device submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this physical medical device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for EV3, a robotics kit. Above the logo are some handwritten characters that are difficult to decipher. The EV3 logo consists of three black circles arranged in a triangular formation, with the letters "ev3" in a stylized font below the circles. The "3" has a registered trademark symbol next to it.

NOV 20 2008

510(k) Summary

EverCross™ .035" OTW PTA Dilatation Catheter

510(k) Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R § 807.92.
Applicant	ev3 Inc.
Submitter	cv3 Inc.9600 54th Ave. NPlymouth, MN 55442Tel: 763-398-7000Fax: 763-398-7200
Contact Person	David Worrell, MS, RACDirector, Regulatory Affairs
Date Prepared	September 3rd, 2008
Device Trade Name	EverCrossTM .035" OTW PTA Dilatation Catheter
Device Common Name	PTA Dilatation Catheter
Classification Name	Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 800.1250,Product Code LIT
Classification Panel	Cardiovascular
Predicate Devices	Sterling OTW PTA Balloon Dilatation Catheter (K053116), AdmiralXtreme PTA Balloon Catheter OTW .035 (K062809), Savvy Long andSleek PTA Catheter (K072947), and Dorado PTA Balloon DilatationCatheter (K072283).
Intended use	The EverCross .035" OTW PTA Dilatation Catheter is intended todilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructivelesions of native or synthetic arteriovenous dialysis fistulae. Thisdevice is also indicated for stent post-dilatation in the peripheralvasculature.
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 an atraumatic, tapered tip to aid incrossing tight stenoses. The distal catheter, proximal to the balloon, iscovered with a hydrophilic coating. The catheter manifold includestwo lumens. The lumen marked "THRU" is the central lumen of the
	catheter which terminates at the distal tip. This lumen is used to passthe catheter over a guidewire with a maximum outer diameter of 0.035inches. The lumen, marked "BALLOON" is used to inflate anddeflate the dilatation balloon with a solution of contrast medium andsaline. The balloon has two radiopaque markers for positioning theballoon relative to the stenosis.
Performance data	Bench testing and biocompatibility testing were performed to supporta determination of substantial equivalence. Results from this testingprovide assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use.
Summary of SubstantialEquivalence	The EverCross .035" OTW PTA Dilatation Catheter has the followingsimilarities to the predicate devices:• Similar fundamental scientific technology (all predicates)• Similar operating principle (all predicates)• Similar balloon lengths (Savvy Long and Sleek K072947)• Similar rated burst pressures (Dorado K072283).
Conclusion	Based on the similar indications for use, technological characteristicsand performance testing, ev3 believes the EverCross .035" OTW PTADilatation Catheter is substantially equivalent to the Sterling OTWPTA Balloon Dilatation Catheter (K053116), the Admiral XtremePTA Balloon Catheter (K062809), the Savvy Long and Sleek PTACatheters (K072947) and the Dorado PTA Balloon Dilatation Catheter(K072283).

ev3 Corporate World Headquarters / Peripheral Vascular ● 9600 54th Avenue North ● Plymouth, MN 55442 ● PH +1 763 398 7000 ev3 Europe SAS  •  ¡06/108 rue La Boetie  •  75008 Paris, France  •  PH +33 156 88 59 10 Page 1 of 2 ev3 Neurovascular • 9775 Toledo Way • Irvine, CA 92618 • PH +1 949 837 3700 FoxHollow Technologies ● 740 Bay Road ● Redwood City, CA 94063 ● PH +1 650 421 8400

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is rendered in black, and the text is also in black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2008

ev3 Inc. c/o Mr. David Worrell 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K082579

EverCross 0.035" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: DQY Dated: November 12, 2008 Received: November 13, 2008

Dear Mr. Worrell:

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 dcvices 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

Pagc 2 - Mr. David Worrell

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 Fedcral 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, plcase contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

una R. Volmer

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

Enclosure

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

Page 1 of 1

Indications for Use Statement

K082579 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)

M. 2) Thell remmer

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko82579

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).