The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush (predicate device) currently cleared to market via 510K K040324 by Wilson-Cook Medical, Inc.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a double lumen catheter with ink markings, a cytology brush assembly with either a coil spring or bullet tip, a pin vise handle, wire guide hub, and a detachable connecting tube, which can be used for flushing of the wire guide hub. The endoscopic cytology brush is used by passing the device through an endoscope, over a prepositioned wire guide to the target location. The endoscopic cytology brush assembly is located at the distal (patient contacting) end with the pin vise handle located at the proximal (non-patient contacting) end. The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two cytology brushes, the Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a study to prove acceptance criteria for device performance in a clinical setting.

Therefore, many of the requested details regarding clinical study design, acceptance criteria, and performance metrics are not available in the provided text.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document mentions "performance requirements" were met through non-clinical bench testing. However, specific numerical acceptance criteria or reported performance values are not provided in the text. The non-clinical tests performed include:

Test Type	Reported Outcome (General)
Shelf Life Testing	Met performance requirements (specifics not provided)
Packaging Validation	Met performance requirements (specifics not provided)
Biocompatibility	Performed in accordance with ISO 10993-1
Bench Testing (General)	Demonstrated the subject device performs as intended

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the document. The testing mentioned is "non-clinical bench testing."
Data Provenance: Not applicable as no clinical study or patient data is reported. The tests are benchtop tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth.

4. Adjudication method for the test set:

Not applicable. This pertains to clinical studies involving expert review and is not relevant to the described non-clinical bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document describes a 510(k) submission for cytology brushes, not an AI-powered device, and no MRMC study is mentioned.

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

No. This is not an AI device.

7. The type of ground truth used:

Not applicable. For the non-clinical tests mentioned (shelf life, packaging validation, biocompatibility, and other performance bench tests), the "ground truth" would be established by the defined test methods and specifications for the device's physical and material properties, not from clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set:

Not applicable. This is not an AI device and no "training set" is mentioned or implied.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

December 29, 2017

Wilson-Cook Medical, Inc. Sierra Lowe Regulatory Affairs Specialist - I 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K171573

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: November 29, 2017 Received: December 4, 2017

Dear Sierra Lowe:

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 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.

{1}------------------------------------------------

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); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned. The name appears to be a title or heading.

For 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K171573

Device Name Fusion® Cytology Brush CytoMax II® Double Lumen Cytology Brush

Indications for Use (Describe)

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collection of cells in the biliary system.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters, and the word "MEDICAL" is in smaller letters below it.

COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

510(k) Summary

Name:	Wilson-Cook Medical, Inc. /Cook Endoscopy
Address:	4900 Bethania Station RoadWinston-Salem, North Carolina 27105
Phone:	(336) 744-0157 (x396506)
Fax:	(336) 201-5994
Contact:	Sierra Lowe, Regulatory Affairs Specialist I
Date:	May 26, 2017
Trade Names:	Fusion® Cytology BrushCytoMax II® Double Lumen Cytology Brush
Common Name:	Endoscopic Cytology Brush
Classification Name:	Endoscope and accessories 21 CFR §876.1500, FDX, Class II
Predicate Device:	Wilson-Cook Double Lumen Biliary Cytology Brush, K040324, cleared May 20,2004.
Intended Use:	The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushare used for collection of cells in the biliary system.

Device Description:

{4}------------------------------------------------

prepositioned wire guide to the target location. The endoscopic cytology brush assembly is located at the distal (patient contacting) end with the pin vise handle located at the proximal (non-patient contacting) end. 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:

Changes have been made to the currently cleared Double Lumen Biliary Cytology Brushes (K040324). These changes include: catheter length labeling to reflect working length, additional catheter diameters, brush tip diameters and lengths, removal of a 6cm ink marking, removal of radiopaque markers, modified wire guide access port, removal of wire guide port with extension, updated wire guide compatibility, and modified catheter materials. Performance testing consisting of non-clinical bench testing demonstrates that the subject devices met the performance requirements to fulfill their intended uses. The results of this testing provide 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 their respective predicate devices.

Summary of non-clinical testing:

The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.

0 Shelf Life Testing
Packaging Validation .

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process."

Conclusion:

We believe that the subject devices are substantially equivalent to the predicate device in terms of intended use, key operating principles, materials 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 safety or effectiveness of the devices.

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.