The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.

Device Description

The Wilson-Cook Stricture Measuring Catheter consists of a stylet wire and catheter. This device is designed for injection of contrast and to measure biliary and pancreatic strictures to determine stent size. This device is supplied sterile and is intended for single use only.

AI/ML Overview

This document describes the premarket notification for the Wilson-Cook Stricture Measuring Catheter. Based on the provided text, here's a summary of the acceptance criteria and supporting study information:

Description of Acceptance Criteria and Study for the Wilson-Cook Stricture Measuring Catheter

The Wilson-Cook Stricture Measuring Catheter is designed for injecting contrast and measuring biliary and pancreatic strictures to determine stent size. The provided document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Wilson-Cook Glo-Tip ERCP Catheters, K851964) rather than presenting a performance study with specific acceptance criteria directly comparable to a disease detection or measurement algorithm.

The "acceptance criteria" here are implicitly related to the device meeting its stated performance characteristics and being safe and effective for its intended use, as validated by visual, dimensional, and functional analysis.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic/Criterion	Acceptance Criterion (Implicit)	Reported Device Performance
Visual Analysis	No visual defects	All samples deemed acceptable, meeting test specifications
Dimensional Analysis	Conformance to specified dimensions (e.g., French size, length)	All samples deemed acceptable, meeting test specifications
Functional Analysis	Proper operation for intended use (e.g., contrast injection, wire guide access, stricture measurement capability)	All samples deemed acceptable, meeting test specifications
Biocompatibility	Established history of safe use in similar medical devices	Established through history of use in other similar devices
Sterility	Achieves SAL 10^-6^	Validated EO cycle following AAMI Overkill Method to SAL 10^-6^

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data or patient cases. The testing mentioned refers to performance characteristic studies of the device itself.

Sample Size: "Samples" were subjected to visual, dimensional, and functional analysis. The exact number of samples is not specified, but it implies a representative number of units from the manufacturing process.
Data Provenance: This is not applicable in the context of clinical data, as the tests relate to device characteristics. The tests were likely conducted internally by Wilson-Cook Medical Inc. as part of their product development and regulatory submission process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of device performance testing described. Ground truth in this context would refer to accurate physical measurements or functional capabilities of the catheter, which are determined by engineering specifications and testing, not expert clinical interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable. The device performance testing involved direct measurement and verification against engineering specifications, rather than subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted or reported in this document. The submission is for a medical device (catheter) for its physical and functional capabilities, not for an algorithm that interprets or assists human readers with clinical cases.

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

This is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance characteristics (visual, dimensional, functional) would be the established engineering specifications and manufacturing standards for the catheter components and its overall assembly. For sterility, the ground truth is the successful validation of the sterilization process to achieve a specified sterility assurance level (SAL). For biocompatibility, the ground truth is the history of safe use of the materials in similar medical devices.

8. The Sample Size for the Training Set

This is not applicable. The concept of "training set" applies to machine learning algorithms. This document describes a physical medical device.

9. How the Ground Truth for the Training Set was Established

This is not applicable.

Summary

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RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK STRIC MEASURING DEVICE

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS J.

Submitted By:

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

Device Description:

Trade Name:	Wilson-Cook Stricture Measuring Catheter
Common/Usual Name:	Stricture Measuring Catheter
Classification Name:	Catheter, Cholangiography 79 GBZ
Classification:	FDA has classified similar devices as Class I as per 21 CFR§878.4200. This device falls within the purview of theGastroenterology and Urology Device Panel.
Performance Standards:	To the best of our knowledge, performance standards forthis device do not exist.
Sterility:	Validated EO cycle, following the AAMI Overkill Methodto SAL 10-6.
Intended Use:	The Wilson-Cook Stricture Measuring Catheter is used tomeasure biliary and pancreatic strictures to determinestent size through injection of contrast, and provides wireguide access.

Predicate Devices:

Wilson-Cook Glo-TipERCP Catheters	Wilson-Cook Medical Inc.	K851964
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NOV 2 4 1997

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PREMARKET NOTIFICATION FOR THE WILSON-COOK STRICTURE RE: MEASURING DEVICE

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) J.

DEVICECHARACTERISTIC	WILSON-COOKSTRICTUREMEASURINGCATHETER [Subject of510(k)]	WILSON COOK ERCPCATHETER (K851964)
Intended Use	Measure biliary andpancreatic strictures,injection of contrast andprovides ability to maintainwire guide access.	Injection of contrast andprovides wire guide access,includes measurementsystem.
Stylet Material	Stainless Steel	Stainless Steel
Catheter Material	PTFE	PTFE
French Size	Catheter: 5 French	Catheter: 5-5.5 FrenchCatheter Tip: 3-4.5 French
Catheter Length	200 cm	200 cm
Sterility	Sterile, disposable	Sterile

Biocompatibility has been established for the patient contacting Testing: components of this device through a history of use in other similar medical devices.

The Wilson-Cook Stricture Measuring Catheter has been tested to established performance characteristics. Samples were subjected to visual, dimensional and functional analysis. All samples were deemed acceptable, in that test specifications were met.

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Public Health Service .

Image /page/2/Picture/16 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1997

Paula Joyce Regulatory Affairs Manager Wilson-Cook® Medical, Inc. 4900 Bethania Station Road Winston-Salem, North Carolina 27105 Re: K973205 Wilson-Cook Stricture Measuring Catheter Dated: August 25, 1997 Received: August 26, 1997 Regulatory class: II 21 CFR 8876.1500/Product code: 78 KOG

Dear Ms. Joyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name: Wilson-Cook Stricture Measuring Catheter

Indications For Use: The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Peter D. Rithling/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K973205

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

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.