Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

K192908 · Wilson-Cook Medical, Inc. · FDX · Nov 14, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192908
• Device Name: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FDX · Gastroenterology, Urology
• Decision Date: Nov 14, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Used for collection of cells in the biliary system.

Device Story

The Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush are endoscopic accessories used for biliary cell collection. The device consists of a nylon brush mounted on a stainless-steel drive wire with a stainless-steel tip, housed within a double lumen catheter featuring radiopaque markers and ink markings. It includes a wire guide hub, an optional detachable extension line with a luer lock for flushing, and a proximal pin-vise handle. The device is passed through an endoscope over a prepositioned wire guide to the target biliary site. The clinician operates the device by pushing the pin-vise handle to extend the brush and pulling it to retract the brush for sample collection. The modification from predicate versions involves the removal of a cannula proximal to the brush. The device is intended for use by physicians in a clinical or endoscopic setting.

Clinical Evidence

No clinical data. Performance is supported by non-clinical bench testing, specifically tensile strength testing of the device and handle, demonstrating that the modified device meets performance requirements.

Technological Characteristics

Materials: nylon brush, stainless-steel drive wire, stainless-steel tip. Components: double lumen catheter, radiopaque markers, wire guide hub, pin-vise handle. Operation: mechanical extension/retraction of brush via handle. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for the collection of cells in the biliary system.

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

• Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush (K171573)
• Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush (K181317)

Submission Summary (Full Text)

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November 14, 2019

Wilson-Cook Medical, Inc./Cook Endoscopy Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K192908

> Trade/Device Name: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDX Dated: October 10, 2019 Received: October 15, 2019

Dear Tiffanny Thomas:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Angel A. Soler-Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192908

Device Name Fusion Cytology Brush CytoMax II Double Lumen Cytology Brush

Indications for Use (Describe) Used for collection of cells in the biliary system.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4900 Bethania Station Road<br>Winston-Salem, North Carolina 27105 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist<br>Theresa de Prat, Regulatory Affairs Specialist II |
| Date: | October 10, 2019 |
| Trade Names: | Fusion Cytology Brush<br>CytoMax II Double Lumen Cytology Brush |
| Common Name: | Endoscopic Cytology Brush |
| Classification Name: | Endoscope and Accessories 21 CFR §876.1500, FDX, Class II |
| Predicate Devices: | Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared<br>December 29, 2018 (k171573)<br>Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared<br>February 8, 2019 (k181317) |

Intended Use: Used for collection of cells in the biliary system.

# Device Description:

The Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush (predicate devices) cleared via k171573 on 12/29/2018 as well as k181317 on 2/8/2019 have been modified from their original design as described on this submission. The subject devices have indications for use, methods of operation, and the fundamental technological characteristics as their cleared predication to the subject devices is the removal of a cannula proximal to the brush.

The subject devices, the Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush, consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or and IDE port, a detachable extension line with a luer lock for optional flushing of the wire guide hub and a pin-vise handle.

The Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

# Substantial Equivalence:

A modification was made to the currently cleared predicate devices cleared under k181317 and k171573. The modification is a device design change, removing a cannula proximal to the brush.

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# Performance Data:

Performance testing consisting of non-clinical bench testing demonstrates the subject devices met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices.

# Summary of non-clinical testing:

The following non-clinical testing was conducted to demonstrate the performance of the subject devices and confirms that the subject devices perform as intended.

- Tensile Strength Testing ●
- Tensile Strength of Handle

### Conclusion:

We believe that the subject devices are substantially equivalent to the predicate devices with respect to intended use, key operating principles, materials of construction, and technological characteristics. We consider the risks associated with the modifications to the subject devices to have been adequately addressed through our Design Control Processes and do not affect the safety or effectiveness of the devices.