The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and The Tracer Metro Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wilson-Cook's Tracer Metro Smart Wire Guide is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

Device Description

The proposed Tracer Metro Smart Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cock. The Tracer Metro Smart Wire Guide is .035" in diameter and is compatible with a full range of Wilson-Cook accessories.

AI/ML Overview

I apologize, but the provided text does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results.

Here's what I can infer from the text and why I cannot fully answer your request:

What the document does provide:

Device Name: TRACER METRO SMART WIRE GUIDE
Intended Use: "The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and pancreatic ducts and to aid in bridging difficult strictures during ERCP."
Predicate Device: Wilson-Cook Wire Guide (k9910497)
Basis for Clearance: Substantial equivalence to the predicate device.
Statement on Performance Data: "We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility."

What the document does not provide (and is needed for your request):

A specific table of acceptance criteria and reported device performance: The document states that the device is "substantially equivalent...in terms of performance characteristics tested and biocompatibility" but does not detail what these characteristics are, what the acceptance criteria for them were, or what the measured performance results were. This is common in 510(k) summaries where the focus is on equivalence, not necessarily on presenting a comprehensive performance study like a PMA submission might.
Details of "the study that proves the device meets the acceptance criteria": Since the acceptance criteria are not detailed, neither are the specifics of a study proving they were met. The document implies that some performance characteristics were tested to demonstrate substantial equivalence, but it doesn't describe the study design (sample size, data provenance, ground truth establishment, etc.).

Due to the limitations of the provided text, I cannot generate the detailed response you requested. If you have a document that specifically outlines performance studies with acceptance criteria and results, I would be happy to analyze it for you.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

Wilson-Cook Medical, Inc. Ms. Marge Walls-Walker Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

JUL 2 7 2015

K033754 Re:

Trade/Device Name: TRACER METRO SMART WIRE GUIDE Modification to Wilson-Cook Wire Guide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE ltr): November 25, 2003 Received (Date on orig SE ltr): December 1, 2003

Dear Ms. Walls-Walker,

This letter corrects our substantially equivalent letter of December 30, 2003.

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. 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

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K_033 75 4

Device Name: Wilson-Cook Tracer Metro Smart Wire Guide

Indications for Use:

The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and The Tracer Metro Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-FF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only
(Per 21 CFR § 801.109

Over-the-Counter_

Nancyc Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,

510(k) Number K033754

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DEC 3 0 2003

/<033754

ATTACHMENT F: 510(k) Summary of Safety and Effectiveness

SPONSOR:

CONTACT/SUBMITTER:

DATE OF SUBMISSION:

DEVICE:

Trade Name: Common Name: Classification:

PREDICATE DEVICES:

INTENDED USE:

DEVICE DESCRIPTION:

COMPARISON OF CHARACTERISITICS:

PERFORMANCE DATA:

Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105

Marge Walls-Walker Regulatory Affairs Specialist [336] 744-0157 Ex.290

November 25, 2003

Tracer Metro Smart Wire Guide

Tracer Metro Smart Wire Guide Wire Guide Endoscope and/or Accessories, Class II 21 CFR § 876.1500. 78 KOG

Wilson-Cook Wire Guide (k9910497)

Wilson-Cook's Tracer Metro Smart Wire Guide is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

We believe the proposed device to be substantially equivalent to currently marketed Wilson-Cook wire guides as cleared per K910497.

We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.