WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH

K040324 · Wilson-Cook Medical, Inc. · FDX · May 20, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040324
• Device Name: WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FDX · Gastroenterology, Urology
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Wilson-Cook's Double Lumen Biliary Cytology Brush is intended to collect cells in the biliary system.

Device Story

Double Lumen Biliary Cytology Brush; sterile, single-use device. Used for collecting cells within the biliary system. Operated by clinicians during endoscopic procedures. Device functions as a mechanical brush to retrieve cytological samples. Output is a collected cell sample for diagnostic analysis. Benefits include facilitating minimally invasive tissue sampling for biliary pathology assessment.

Clinical Evidence

No clinical data; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Mechanical cytology brush; double lumen design; supplied sterile for single use. Materials of construction are identical to the predicate device (k896318).

Indications for Use

Indicated for the collection of cells in the biliary system. Intended for single use only.

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 Cytology Brushes (k896318)

Submission Summary (Full Text)

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# MAY 2 0 2004

:

# ATTACHMENT B-1: 510(k) Summary

KO40324
PAGE 1 OF 1

| SPONSOR: | Wilson-Cook Medical<br>4900 Bethania Station Road<br>Winston-Salem, NC 27105 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker<br>Requlatory Affairs Specialist<br>[336] 744-0157 Ex.290 |
| DATE OF SUBMISSION: | February 6, 2004 |
| DEVICE: | Double Lumen Biliary Cytology Brush |
| Trade Name:<br>Common Name:<br>Classification: | Double Lumen Biliary Cytology Brush<br>Cytology Brush<br>Brush, Cytology for Endoscope, Class II<br>21 CFR § 876.1500 78 FDX |
| PREDICATE DEVICES: | Wilson-Cook Cytology Brushes (k896318) |
| INTENDED USE: | Wilson-Cook's Double Lumen Biliary Cytology<br>Brush is intended to collect cells in the biliary<br>system. |
| DEVICE DESCRIPTION: | The proposed Cytology Brush is a modification<br>to existing cytology brushes currently marketed<br>by Wilson-Cook. The Double Lumen Cytology<br>Brush is supplied sterile and intended for single<br>use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be<br>substantially equivalent to currently marketed<br>Wilson-Cook cytology brushes as cleared by<br>k896318. Both devices share identical materials<br>of basic composition, the same operating<br>principal and the same technological<br>characteristics. |
| PERFORMANCE DATA: | We believe the proposed device to be<br>substantially equivalent to the named predicate<br>in terms of Intended Use, performance<br>characteristics tested and biocompatibility. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2004

Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K040324

Trade/Device Name: Wilson-Cook Double Lumen Biliary Cytology Brush Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDX Dated: April 2, 2004 Received: April 5, 2004

Dear Ms. Walls-Walker:

We have reviewed your Scction 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 for assumerous 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.

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 found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, I'DA 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 r 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 l'ederal 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA intuitig of basification 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 specific advice for your device on our last to good on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion the regulation entitled, "Misbranding Othce of Compliance at [phone]. Taxa, produkt (1) you may obtain. Other general by reference to premarked notification (21 cm ray be obtained from the Division of Small
information on your responsibilities under the Act may be of the surpher (800) 633, 2 information on your responsionalities und reserved its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-fremospain bron Manufacturers, International and Collidation - Letters http://www.fda.gov/cdch/dsmall.html.
[phone] or at its Internet address http://www.fda.gov/cdch/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon.

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K

# Device Name: Wilson-Cook Double Lumen Biliary Cytology Brush

#### Indications for Use:

The Wilson-Cook Double Lumen Biliary Cytology Brush is intended for the collection of cells in The Wilson Oook Double is supplied sterile and 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)

Prescription Use Only
(Per 21 CFR § 801.109

OR
David R. Lymm

Over-the-Counter______________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number