(213 days)
Not Found
No
The device description focuses on the mechanical components and function of a cytology brush for cell collection. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies described are non-clinical and relate to shelf life, packaging, and biocompatibility, not algorithmic performance.
No
The device is described as a collection tool for cells in the biliary system, not a device intended to treat or cure a disease or condition.
Yes
The device is used for "collection of cells in the biliary system," which are then analyzed to "diagnose" conditions. Therefore, it serves a diagnostic purpose by collecting samples essential for diagnosis.
No
The device description clearly outlines physical components such as a catheter, brush assembly, handle, and connecting tube, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for collection of cells in the biliary system." This describes a specimen collection device, not a device that performs a diagnostic test on a specimen in vitro (outside the body).
- Device Description: The description details a physical brush and catheter system used for obtaining a sample. It does not mention any reagents, analytical components, or processes for analyzing the collected cells.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of analysis, measurement, or interpretation of the collected cells to provide diagnostic information.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is limited to the collection of the specimen.
N/A
Intended Use / Indications for Use
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are 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 (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.
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
Not Found
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)
Non-clinical bench testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended. Specific tests included:
- 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."
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
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.
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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.
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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,
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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
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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)
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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 Road |
| Winston-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 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 Device: | Wilson-Cook Double Lumen Biliary Cytology Brush, K040324, cleared May 20, |
-
|
| Intended Use: | The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush
are used for collection of cells in the biliary system. |
Device Description:
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
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.