(267 days)
Not Found
No
The summary mentions image processing but explicitly states that AI, DNN, or ML were not found. The performance studies focus on hardware, software verification, and biocompatibility, with no mention of AI/ML model training or testing.
No.
The device is strictly for diagnostic purposes (endoscopic diagnosis) and not for treating or preventing a disease, which would qualify it as a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis."
No
The device description clearly states it is a "handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula... and a reusable handle with a video monitor." This indicates significant hardware components beyond just software.
Based on the provided information, the Uro-G HD Flexible Cystoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra." This describes a procedure performed directly on the patient's body for visualization and fluid delivery.
- Device Description: The description details a physical instrument (cystoscope) used for internal examination.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The Uro-G HD Flexible Cystoscope does not perform any such analysis on specimens.
The device is an endoscopic device used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
This Special 510(k) discloses the modifications made to the Uro-G Flexible Cystoscope System (K202921) so that the user has an option for a flexible cystoscope with highdefinition imaging. The Uro-G HD Flexible Cystoscope System is a handheld, batteryoperated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope Systemcannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower urinary tract—urethra & bladder
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing was conducted with bench testing and included:
- Measurement of outer diameter of the cannula;
- Image quality against the 1951 USAF test chart;
- Image distortion against an Image Distortion Target chart;
- Specification review and analysis of CMOS camera;
- Field of view;
- Resolution of the LCD monitor;
- Disinfection procedure;
- Software verification testing.
- Software verification and validation; and
- Electrical safety and electromagnetic compatibility testing.
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.
Biocompatibility testing:
Testing was conducted on the cannula of the Uro-G cystoscope to verify that it is compliant with biocompatibility requirements for a short duration (
§ 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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June 7, 2024
UroViu Corporation Thom Lawson Director, Regulatory Affairs 4546 El Camino Real Suite 214 Los Altos, California 94022
Re: K232837
Trade/Device Name: Uro-G HD Flexible Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: September 10, 2023 Received: September 14, 2023
Dear Thom 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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
2
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,
Mark J. Antonino -S
Mark J. Antonino, M.S. 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
3
Indications for Use
510(k) Number (if known) K232837
Device Name Uro-G HD Flexible Cystoscope
Indications for Use (Describe)
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids 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)
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SECTION 5.
510(k) SUMMARY
General Information
| Submitter | UroViu Corporation |
|---|---|
| Address | UroViu Corporation |
| 4546 El Camino Real | |
| Suite 214 | |
| Los Altos, CA 94022 | |
| FDA Registration Number | 3015042209 |
| Correspondence Person | Thomas Lawson, PhD |
| Contact Information | Email: thom@uroviu.com |
| Phone: 510-206-1794 | |
| Date Prepared | 7 September 2023 |
Proposed Device
| Trade Name | Uro-G HD Flexible Cystoscope |
|---|---|
| Common Name | Uro-G HD |
| Regulation Number and | |
| Classification Name | 21 CFR§876.1500, Endoscope and Accessories |
| Product Code | FAJ |
| Regulatory Class | II |
| Note: This is the first submission for this model of UroViu cystoscope. |
Predicate Device
| Trade Name | Uro-G Flexible Cystoscope |
|---|---|
| Common Name | Uro-G |
| Premarket Notification | K202921 |
| Regulation Number and | |
| Classification Name | 21 CFR§876.1500, Endoscope and Accessories |
| Product Code | FAJ |
| Regulatory Class | II |
| Note: The predicate device has not been subject to a design-related recall. |
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Device Description
This Special 510(k) discloses the modifications made to the Uro-G Flexible Cystoscope System (K202921) so that the user has an option for a flexible cystoscope with highdefinition imaging. The Uro-G HD Flexible Cystoscope System is a handheld, batteryoperated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope Systemcannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.
Indications for Use
The indications for use statement for the Uro-G HD Flexible Cystoscope is:
The Uro-G HD Flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra
Comparison of Technological Characteristics with the Predicate Device
UroViu Corp. has identified the Uro-G Cystoscope (K202921, UroViu Corp.) as the predicate device. The Uro-G HD Flexible Cystoscope is substantially equivalent to the predicate device based upon the following similarities:
-
- The intended use of both devices is exactly the same.
-
- The indications for use of both the predicate device and the Uro-G HD cystoscope are exactly the same: symptomatic voiding dysfunction, hematuria, bladder tumor surveillance, recurrent lower urinary tract infection, and pelvic pain syndromes;
-
- Both devices are introduced into the body via the urethra and then advanced to the bladder under visualization (that is, not a blind advancement);
-
- Both devices have illumination and optic components to permit visualization of the urethra and bladder;
-
- Both devices have the capability to view the urethra and bladder via the video monitor mounted on the handle of the device;
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-
- Both devices have a working channel to allow infusion of fluids and introduction of instruments; and
-
- Both devices are made from biocompatible materials.
The specific modifications of Uro-G cannula and 3500 model handle to become the Uro-G HD cannula and 4500 model handle are:
-
- The cannula of the modified device is 0.1 mm wider than the predicate device-5.6 mm v. 5.5 mm-to accommodate the slightly larger cable that carries image information from the camera at the tip of the cannula to the handle's LCD monitor. Since the urethral diameter of males ranges from 8 to 9 mm and the diameter in females averages 6 mm, this OD does not increase any risk to the device's use. This risk is further reduced since it is standard practice to infuse fluid as a cystoscope is advanced so that the urethra dilates ahead of the tip's position.
-
- The CMOS module has a higher resolution 0.7 million pixels-for HD imaging than the current module at 0.3 million pixels to facilitate HD imaging.
-
- The sensor on the CMOS camera has higher resolution - 1280 x 720 pixels than the camera on the Uro-G cannula (640 x 480) to facilitate HD imaging.
-
- The field of view is 20° smaller-100° in the Uro-G HD v. 120° in the Uro-G cystoscope, but within the range of endoscopes and other cystoscopes.
-
- The LCD monitor on the handle is slightly larger at 4.5 inches (diagonal) versus 3.5 inches of the 3500 handle. This larger monitor added 44 g/1.6 oz to the weight of the handle.
-
- The effective pixels and resolution of the LCD monitor on the handle are higher in order to accommodate HD imaging.
-
- The steps for surface disinfecting of the handle has been modified from allowing the handle to air dry for 20 minutes to an unspecified time by saying "Allow the handle to air dry." This does not affect the efficiency of the disinfection process.
-
- The instructions for use (IFU) and packaging labeling have been updated for changes in product parameters related to displaying an HD image.
-
- The software has been updated to perform the following:
- Updated the startup logo that is displayed on the screen.
- . Updated the image parameters for Uro-G HD v. standard definition.
- . Play files in reverse order.
- . During recording, if the signal is interrupted, the file will be saved, and the system will return to live view.
- . Added zoom in / zoom out functionality.
- . Changed the replay file list to display in reverse order (latest files at the top).
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Table 1. Summary of Indications for Use, Technological Characteristics, Mechanisms of Action, Anatomical Sites of Use, Performance Testing, Manufacturing and Software of the Subject Device Compared to the Predicate Device.
| Device Overview | Predicate Device
Uro-G
(UroViu Corp.)
K202921 | Subject Device
Uro-G HD
(UroViu Corp.)
This Submission | Changed
or
Not Changed |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Device Class | II | II | Not Changed |
| FDA Product
Code | FAJ | FAJ | Not Changed |
| Product
Classification | 21 CFR 876.1500 | 21 CFR 876.1500 | Not Changed |
| Indication for
Use | Generally
recognized
indications for
cystoscopy include:
• Symptomatic
voiding
dysfunction
• Hematuria
• Bladder tumor
surveillance
• Recurrent
lower urinary
tract infections
• Pelvic pain
syndromes | Generally
recognized
indications for
cystoscopy include:
• Symptomatic
voiding
dysfunction
• Hematuria
• Bladder tumor
surveillance
• Recurrent
lower urinary
tract infections
• Pelvic pain
syndromes | Not Changed |
| Intended use | Endoscopic
diagnosis and
infusion of
irrigating fluids
within the bladder
and urethra | Endoscopic
diagnosis and
infusion of
irrigating fluids
within the bladder
and urethra | Not Changed |
| Contraindications | • Evidence of
ongoing UTI | • Evidence of
ongoing UTI | |
| Uro-G HD Flexible Cystoscope | | | |
| | • Overwhelming coagulopathy
• Impassable urethral structures | • Overwhelming coagulopathy
• Impassable urethral structures | Not Changed |
| Anatomical Site
of Use | Lower urinary tract—urethra &
bladder | Lower urinary tract—urethra &
bladder | Not Changed |
| Route of
Advancement | Advanced to the
bladder via the
urethra | Advanced to the
bladder via the
urethra | Not Changed |
| Components of
the System | Reusable Handle
with a video screen
integrated in its
body | Reusable Handle
with a video screen
integrated in its
body | Not Changed |
| | Attachable Cannula
with a working
channel and an
illumination source
and camera at its tip | Attachable Cannula
with a working
channel and an
illumination source
and camera at its tip | Not Changed |
| Technical Characteristics | | | |
| Cannula | | | |
| Device Identity | Uro-G | Uro-G HD | N/A |
| Cannula
working length | 380.2 mm | 380.2 mm | Not Changed |
| Total length (tip
to connector) | 406 mm | 406 mm | Not Changed |
| Number of ports | 2 | 2 | Not Changed |
| Working
channel
minimum width | 2.2 mm | 2.2 mm | Not Changed |
| Maximum
insertion width
of the cannula | 5.5 mm | 5.6 mm | Equivalent
The extra 0.1 mm in
width does not
introduce a new risk
to use of the cannula |
| Tip OD | 4 mm | 4 mm | Not Changed |
| Camera | | | |
| CMOS module | 0.3 million pixels | 0.7 million pixels | Equivalent
The higher number of
pixels results in an
HD image, but HD
does not introduce |
| | | | |
| | | | SD image provided
by the predicate |
| Focal length | 5 mm to 50 mm | 5 mm to 50 mm | Not Changed |
| Field of view
(in air) | 120 ° ± 5 ° | 100 ° ± 5 ° | Equivalent
With HD imaging,
the field of view can
be more narrow in
order to capture
details in the
confined spaces
within the urinary
tract |
| Direction of
view from center
axis | 0 °
(Forward
Viewing) | 0 °
(Forward
Viewing) | Not Changed |
| Image resolution | 3 lp/mm on the
1551 USAF test
chart in air | 3 lp/mm on the
1551 USAF test
chart in air | Not Changed |
| Image distortion | 120 mL/min | >120 mL/min | Not Changed |
| Uro-G HD Flexible Cystoscope | | | |
| | | | |
| Light source | LED
Luminous flux at
25 mm focal length:
520 lumens | LED
Luminous flux at
25 mm focal length:
520 lumens | Not Changed |
| Tip temperature
when LEDs are
on |