WILSON-COOK STRICTURE MEASURING CATHETER

K973205 · Wilson-Cook Medical, Inc. · ODD · Nov 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973205
• Device Name: WILSON-COOK STRICTURE MEASURING CATHETER
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: ODD · Gastroenterology, Urology
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

The Wilson-Cook Stricture Measuring Catheter is a single-use, sterile medical device used during endoscopic retrograde cholangiopancreatography (ERCP) procedures. It consists of a catheter and a stylet wire. The device is operated by a physician in a clinical setting. The catheter is inserted into the biliary or pancreatic duct to provide wire guide access and allow for the injection of contrast media. By measuring the stricture, the device assists the physician in determining the appropriate size of a stent for subsequent placement. The device is designed to facilitate diagnostic and therapeutic interventions in the biliary and pancreatic systems.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through visual, dimensional, and functional analysis of samples, all of which met established specifications.

Technological Characteristics

Materials: PTFE (catheter), stainless steel (stylet). Dimensions: 5 French, 200 cm length. Sterilization: Ethylene Oxide (EO) validated to SAL 10^-6 per AAMI Overkill Method. Single-use, disposable design.

Indications for Use

Indicated for patients requiring measurement of biliary and pancreatic strictures to determine appropriate stent size, and for whom contrast injection and wire guide access to the duct are clinically necessary.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wilson-Cook Glo-Tip ERCP Catheters (K851964)

Submission Summary (Full Text)

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ాస్లు...

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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:

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.

| 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<br>§878.4200. This device falls within the purview of the<br>Gastroenterology and Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for<br>this device do not exist. |
| Sterility: | Validated EO cycle, following the AAMI Overkill Method<br>to SAL 10-6. |
| Intended Use: | The Wilson-Cook Stricture Measuring Catheter is used to<br>measure biliary and pancreatic strictures to determine<br>stent size through injection of contrast, and provides wire<br>guide access. |

## Predicate Devices:

| Wilson-Cook Glo-Tip<br>ERCP Catheters | Wilson-Cook Medical Inc. | K851964 |
|---------------------------------------|--------------------------|---------|
|---------------------------------------|--------------------------|---------|

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.

| DEVICE<br>CHARACTERISTIC | WILSON-COOK<br>STRICTURE<br>MEASURING<br>CATHETER [Subject of<br>510(k)] | WILSON COOK ERCP<br>CATHETER (K851964) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Measure biliary and<br>pancreatic strictures,<br>injection of contrast and<br>provides ability to maintain<br>wire guide access. | Injection of contrast and<br>provides wire guide access,<br>includes measurement<br>system. |
| Stylet Material | Stainless Steel | Stainless Steel |
| Catheter Material | PTFE | PTFE |
| French Size | Catheter: 5 French | Catheter: 5-5.5 French<br>Catheter 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

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

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

(Optional Format 1-2-96)