(252 days)
Not Found
No
The description focuses on hardware components, basic image capture, and standard medical device testing. There is no mention of AI, ML, image processing for analysis, or training/test data sets.
No.
The device is used for endoscopic diagnosis and infusion of irrigating fluid, which are diagnostic and procedural functions, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" statement explicitly states that the device "has been designed for endoscopic diagnosis."
No
The device description explicitly details hardware components including a handle, disposable cannula, CMOS camera, LED, display unit, battery, and various electronics. The performance studies also include extensive hardware testing.
Based on the provided information, the Uro-V cystoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra." This describes a procedure performed directly on the patient for visualization and fluid delivery.
- Device Description: The device is a cystoscope, which is an instrument used to visualize the inside of the bladder and urethra. It uses a camera and light to provide images of the anatomical structures.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The Uro-V cystoscope does not perform any analysis on such specimens. It is used for direct visualization within the body.
Therefore, the Uro-V cystoscope falls under the category of a medical device used for direct visualization and intervention within the body, not an IVD device.
N/A
Intended Use / Indications for Use
The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Product codes
FAJ
Device Description
The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder and urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and physician offices
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
All necessary performance testing was conducted with bench testing and included:
- Design verification and validation studies; ●
- Packaging and shelf-life studies: ●
- Transit testing;
- Biocompatibility testing;
- Sterilization procedure validation;
- . Software verification and validation;
- Surface and edges evaluation;
- Cannula dimensions (maximum insertion width, minimum instrument ● channel width);
- . Electrical safety, electromagnetic compatibility, and laser safety testing;
- Temperature testing of the surface of the insertion of the device; and ●
- Optical tests ●
- o Field of view accuracy
- Direction of view accuracy O
- O Optical resolution.
Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1. The device was found to meet the compliance requirements for electrical safety as specified in ISO 60601-1 including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment -- Part 2-18: "Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety. Mechanical characteristics were also tested, with successful results. Due to the cannula being labeled as sterile, the cannula underwent sterilization validation and shelf life testing to confirm the label shelf life complies with the following standards:
- ISO 11135-1 Sterilization of health care products -- Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical device;
- ISO 11607 Packaging for Terminally Sterilized Medical Devices; ●
- AAMI TIR12:2010 Designing, testing, and labeling ● reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers; and
- AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
Key Metrics
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.
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 30, 2018
UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 14th Place SE Bellevue, WA 98006
Re: K171500
Trade/Device Name: Uro-V Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: December 21, 2017 Received: December 22, 2017
Dear Thomas Lawson:
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 "Benjamin R. Fisher -S" in a simple, sans-serif font. The text is black and appears to be against a white background. The letters are clear and easy to read, with consistent spacing between the words and characters.
Division 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) K171500
Device Name Uro-V Cystoscope
Indications for Use (Describe)
The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
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
510(k) Summary
I. SUBMITER:
UroViu Corporation 5337 14th Place SE Bellevue, WA 98006 Phone: 650 397 5174 Fax: 888 388 1420
Contact Person: Thomas Lawson, PhD
Phone: 510 206 1794 eMail: thom@urosee.com
May 11, 2017 Submission Date:
II. DEVICE
Device Name: Uro-V Cystoscope Common Name: Cystoscope Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: FAJ Classification Panel: 78
III. PREDICATE DEVICE
VISCERA Cystovideoscope Type CYF V, Olympus American, Inc. K021074
DEVICE DESCRIPTION IV.
The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
4
V. INDICATIONS FOR USE
The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
VI. SUBSTANTIAL EQUIVALENCE
The Uro-V device is substantially equivalent to the VISCERA cystovideoscope Type CYF V manufactured by Olympus America, Inc. (K021074) in terms of indications for use, route the devices are introduced and advanced within the body, capability to view the urethra and bladder, having a working channel to allow instillation of fluids and introduction of endourological tools, and being made from biocompatible materials.
| | Subject device
Uro-V cystoscope
(this submission) | Predicate device
VISCERA Cystovideoscope Type
CYF V
Olympus America, Inc.
(K021074) |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | For endoscopic diagnosis and
infusion of fluids within the
bladder and urethra. | This instrument has been
designed to be used with an
Olympus video system center,
light source, documentation
equipment, display monitor,
endo-therapy accessories, and
other ancillary equipment for
endoscopic diagnosis and
treatment within the bladder and
urethra. |
| Intended Use | The Uro-V cystoscope has been
designed for endoscopic
diagnosis and infusion of
irrigating fluid within the bladder
and urethra. | The cystovideoscope is used for
endoscopic diagnosis and
treatment within the bladder and
urethra. |
| Route of
Advancement | Advanced to the bladder via the
urethra | Advanced to the bladder via the
urethra |
| Site of use | Hospitals and physician offices | Hospitals and physician offices |
| Device Features | | |
| Components | Reusable handle with video
screen | Optic component with an
insertion tube that has one
working channel |
| | Attachable cannula with a
working channel along its length
and an illumination source and
camera at its tip | Additional components necessary
for the visualization of the
procedure are a light source,
video system center, and display
monitor, which are provided
separately from the
cystovideoscope itself |
| Cannula / Insertion
Tube Outer Diameter | 4.2 mm | 5.5 mm |
| Working length | 254 mm | 380 mm |
| Working channel
internal diameter | 2.8 mm | 2.2 mm |
| Illumination light
source | LEDs | Xenon short-arc lamp |
| Image transmission | Image transmitted from a video
camera at the tip of the cannula to
a video monitor on the handle | Either the physician will view by
looking through the cystoscope's
eyepiece or by attaching a
coupling lens to the eyepiece of
the scope and sending that image
to a video monitor in the
procedure room |
| LCD display size | 3.5 inches (diagonal) on the
handle | 26 inches (diagonal) on the
system tower |
| Field of View | 140 degrees | 120 degrees |
| Focal Length | 5 to 25 mm | 3 to 50 mm |
| Direction of View
from Center Axis | 30 degrees | 0 degrees (forward viewing) |
| Adjust brightness of
illumination | Adjust by depressing a button on
the handle to change settings | Adjust by changing settings on
the ancillary light source
equipment |
| Capture still images
or video images
during the procedure | Capture still images or video
during procedure by depressing a
camera button on the handle | Capture still images or video
during procedure by use of an
ancillary video system center
equipment |
| Duration of use |