The SKIPPER and SKIPPER RACE are 0.014" diameter stainless steel guidewires in usable lengths of 175, 195, and 300cm. The guidewires are designed for use in interventional surgical iongallo or 170, 1999, it is introduced percutaneously into the blood vasculature and advanced to a diseased area. The SKIPPER and SKIPPER RACE guidewires contain a silicone or a hydrophilic coating.

AI/ML Overview

The provided text is a 510(k) summary for the SKIPPER™ and SKIPPER™ RACE guidewires. This type of document is for medical device clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria, study sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

Summary of available information related to your prompt:

Acceptance Criteria and Reported Device Performance: Not applicable/not explicitly stated in the context of specific quantitative criteria for device performance. The "performance data" section states that "Bench testing pertaining to performance characteristics was conducted on the SKIPPER and SKIPPER RACE guidewires and compared to the predicate device testing to demonstrate equivalency." This implies the acceptance criterion was "demonstration of equivalency" to the predicate device through bench tests, but no specific numerical criteria or results are provided.
Sample Size Used for the Test Set and Data Provenance: Not applicable. Performance was assessed through "bench testing," not a clinical study with a test set of patient data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable, as this was bench testing.
Adjudication Method for the Test Set: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical medical device, not an AI/software device, and no MRMC study is mentioned.
Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device.
Type of Ground Truth Used: Not applicable. Performance was assessed via bench testing, likely against established engineering standards or the predicate device's performance, not against "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.
Sample Size for the Training Set: Not applicable. This is a physical medical device, and there is no mention of a "training set" in the context of an AI/ML algorithm.
How the Ground Truth for the Training Set Was Established: Not applicable.

Additional Information from the Document:

Device Type: Guidewires (physical medical device).
Intended Use: For use in peripheral and coronary vasculature.
Predicate Device: ev3 Nitrex™ Nitinol Guidewire (K024021, K031864, K040345).
Testing Done: Biocompatibility testing (in accordance with ISO 10993 Part 1 and FDA Memorandum #G95-1) and performance bench testing.
Conclusion: The guidewires are substantially equivalent to the predicate device in intended use, materials, technological characteristics, and performance.

Summary

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MAY - 5 2005 510(k) Summary SKIPPER™ and SKIPPER™ RACE guidewires

510(k) Number: KO50756

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR క్తి807.92.

Submitter/Contact Person:Applicant(Manufacturer):	Invatec Innovative TechnologiesVia Martiri della Libertà, 725030 Roncadelle (BS) ItalyTel: +39 030 258 93 11Fax: +39 030 258 93 12
Submitter's Name:	ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200
Official Contact:	Melissa SommerfeldInternational Regulatory Affairs Specialistev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7612Fax: (763) 398-7200msommerfeld@ev3.net
Summary Preparation Date:	March 22, 2005
Device Name and Classification:Trade Name:Common Name/Usual Name:Classification Name:Class:	SKIPPERTM and SKIPPERTM RACE GuidewireGuidewireCatheter, GuidewireClass II, 21 CFR 870.1330

Predicate Device:

ev3 Nitrex™ Nitinol Guidewire (K024021, K031864, K040345)

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.

Device Description:

SKIPPER and SKIPPER RACE Guidewires

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Intended Use:

The SKIPPER and SKIPPE RACE guidewires are intended for use in the peripheral and coronary vasculature.

Summary of Testing:

Biocompatibility: Biocompatibility testing in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices" was provided.

Performance Data: Bench testing pertaining to performance characteristics was conducted on the SKIPPER and SKIPPER RACE guidewires and compared to the predicate device testing to demonstrate equivalency.

Statement of Equivalence:

The SKIPPER and SKIPPER RACE guidewires are substantially equivalent to the ev3 Nitrex™ Nitinol Guidewire (K024021, K031864, K040345) in intended use, materials, technological characteristics and performance.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ev3, Inc. c/o Ms. Melissa Sommerfeld International Regulatory Specialist 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K050756

SKIPPER and SKIPPER RACE Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: March 22, 2005 Received: March 23, 2005

Dear Ms. Sommerfeld:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematically equivalent (for the indications for the indications for referenced above and have decimined the ace a vices marketed in interstate comments, or to devices that use stated in the enclosure) to legally many in the Medice Amendments, or to devices that proof to May 28, 1976, the enactions date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federation (PMA) - You may have been reclassified in accordance with the provisions of the Act. The next Act (Act) that do not require approval of a premainconspisions of the Act. The general
therefore, market the device, subject to the general controls provisions of devices p therefore, market the device, subject to the general sons and registration, list and advances, good
controls provisions of the Act include requirements for annual registerior controls provisions of the Act morder requiritions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Entile regulations affecting your device can be
may be subject to such additional controls. The 2004 - addition, FDA may woblish may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Peasa ening your device in the Federal Register.

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Page 2 -- Ms. Melissa Sommerfeld

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast be advised made a determination that your device complies with other requirements of the Act or that FDF has made a docemination administered by other Federal agencies. You must comply with ally rederal statutes and regulations annum timited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) instructions practice requirements as set forth in the quality labeling (21 CFR Part 807) good 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) This letter will and w you've ough finding of substantial equivalence of your device to a legally prematice notification - 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 If you desire of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general invermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (201) 115 0977 6da.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dana R. Vines

Image /page/3/Picture/6 description: The image shows a signature or symbol that appears to be handwritten. It consists of a combination of curved and angular lines, with a prominent loop-like structure on the left side. To the right of the signature, there are two words stacked vertically, with the top word being "Bra" and the bottom word being "Dir". The overall impression is that of a signed document or a marked piece of paper.

A 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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Indications For Use

510(k) Number (if known): KO50756

Device Name: SKIPPER™ and SKIPPER™ RACE Guidewires

Indications for Use:

The SKIPPER and SKIPPER RACE guidewires are intended for use in the coronary and peripheral vasculature.

ﻴ

Over-The-Counter Use X Prescription Use _ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwayne R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k 050756

Page 1 of 1

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.