(30 days)
Not Found
No
The device description and performance testing focus on mechanical aspects of a cytology brush and catheter, with no mention of AI/ML, image processing, or data analysis capabilities.
No
This device is used for the collection of cells for diagnostic purposes, not for treating a disease or condition.
No
This device is used for the collection of cells (cytology brush), which is a sample collection function, not a diagnostic one. The collected cells would then be analyzed elsewhere for diagnosis.
No
The device description clearly outlines physical components such as a nylon brush, stainless-steel drive wire, catheter, and handle, indicating it is a hardware device used for cell collection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for collection of cells in the biliary system." This describes a sample collection device, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details a physical brush and catheter system designed to collect cells directly from the biliary system within the patient's body. It does not describe any components or processes for analyzing or testing a sample.
- Lack of Diagnostic Function: There is no mention of any diagnostic capabilities, such as analyzing biomarkers, detecting pathogens, or performing any kind of test on the collected cells. The device's function is solely to obtain the sample.
- Performance Studies: The performance studies described are focused on the physical integrity and function of the device itself (tensile strength), not on the accuracy or reliability of any diagnostic results.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's purpose is to collect the sample that might later be used for an IVD test, but the device itself is not the IVD.
N/A
Intended Use / Indications for Use
Used for collection of cells in the biliary system.
Product codes
FDX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist |
| Theresa de Prat, Regulatory Affairs Specialist II | |
| Date: | October 10, 2019 |
| Trade Names: | Fusion Cytology Brush |
| 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 |
| December 29, 2018 (K171573) | |
| Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared | |
| 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.
4
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.