(217 days)
No
The description focuses on standard video processing and hardware components without mentioning AI/ML capabilities or related performance metrics.
No
The device is designed for "endoscopic diagnosis and infusion of irrigating fluid," which indicates a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra."
No
The device description clearly outlines hardware components such as a handle, video monitor, camera, LED, battery, and electronics, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a cystoscope, which is an instrument used to visualize the inside of the bladder and urethra. It involves inserting the device into the body.
- Lack of mention of samples: There is no mention of collecting or analyzing biological samples (like urine, blood, tissue, etc.) which is a defining characteristic of IVD devices.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Product codes
FAJ
Device Description
The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. 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 video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
Mentions image processing
Yes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing was conducted with bench testing and included:
- Design verification and validation studies;
- Packaging and shelf-life studies;
- Biocompatibility testing;
- Sterilization procedure validation:
- 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. 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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May 4, 2021
UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 145th Place SE Bellevue, WA 98006
Re: K202921 Trade/Device Name: Uro-G Cystoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: April 1, 2021 Received: April 2, 2021
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. 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 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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,
for 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
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Indications for Use
510(k) Number (if known) K202921
Device Name Uro-G Cystoscope
Indications for Use (Describe)
The Uro-G flexible 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)
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510(k) SUMMARY
General Information
| Submitter | UroViu Corporation |
|---|---|
| Address | UroViu Corporation |
| 5337 145th Place SE | |
| Bellevue, WA 98006 | |
| FDA Registration Number | Not assigned yet |
| Correspondence Person | Thomas Lawson, PhD |
| Contact Information | Email: |
| thom@uroviu.com | |
| Date Prepared | 16 November 2020 |
Proposed Device
| Trade Name | Uro-G Cystoscope |
|---|---|
| Common Name | Uro-G |
| Regulation Number and | |
| Classification Name | 21 CFR§876.1500, Endoscope and Accessories |
| Product Code | FAJ |
| Regulatory Class | II |
Predicate Device
| Trade Name | Uro-V Cystoscope |
|---|---|
| Common Name | Uro-V |
| Premarket Notification | K171500 |
| Regulation Number | |
| and Classification | 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. |
Reference Device
| Trade Name | U-Scope 8000 System with HSC+EMB Cannula |
|---|---|
| Common Name | U-Scope 8000 |
| Premarket Notification | K132384 |
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| Regulation Number
| and Classification | 21 CFR§884.1690, Hysteroscope and accessories |
|---|---|
| Product Code | HIH |
| Regulatory Class | II |
| Note: The reference device has not been subject to a design-related recall. |
Device Description
The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. 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 video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
Indications for Use
The indications for use for the Uro-G Cystoscope is:
The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Comparison of Technological Characteristics with the Predicate Device
Uro Viu Corp. has identified the Uro-V Cystoscope (K171500, Uro Viu Corp.) as the predicate device. The Uro-V disposable cystoscope is substantially equivalent to the predicate device based upon the following similarities:
-
- The indications for use of both the predicate device and the Uro-G cystoscope are exactly the same: symptomatic voiding dysfunction, hematuria, bladder tumor surveillance, recurrent lower urinary tract infection, and pelvic pain syndromes;
5
-
- 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 video monitors;
-
- Both devices have a working channel to allow infusion of fluids; and
-
- Both devices are made from biocompatible materials.
These similarities are not surprising in that the subject and predicate devices are manufactured for Uro Viu Corporation by the same contract manufacturer and both use the same handle with an integrated video screen.
The U-Scope 8000 is a reference device since the same handle is used in the Uro-G cystoscope and so the electrical safety and EM compatibility testing performed in its review-K132384-is applicable for the handle of the Uro-G cystoscope. This is the only part of the submission applicable, so the U-Scope 8000 is not present in the SE comparison table.
| | Subject Device
Uro-G Cystoscope
(UroViu Corp.)
This Submission | Predicate
Device
Uro-V Cystoscope
(UroViu Corp.)
K171500 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| FDA Product Code | FAJ | SAME |
| Product
Classification | 876.1500 | SAME |
| Intended Use | The Uro-G Cystoscope has
been designed for endoscopic
diagnosis and infusion of
irrigating fluid within the
bladder and urethra. | The Uro-V cystoscope
has been designed for
endoscopic diagnosis
and infusion of irrigating
fluid within the bladder
and urethra. |
| Indications for Use | Symptomatic voiding dysfunction
Hematuria
Bladder tumor surveillance
Recurrent lower urinary tract
infection
Pelvic pain syndromes | SAME |
| Route of Advancement | Advanced to the bladder via the urethra. | SAME |
| Site of Use | Hospitals and physician offices | SAME |
| Technical Characteristics | | |
| Components of the Set | Reusable handle with video screen
Attachable cannula with a working channel and an illumination source and camera at its tip | SAME |
| Outer Diameter (OD) of Cannula | 5.5 mm | 4.2 mm |
| Working Length of the Cannula | 380 mm | 254 mm |
| Image Transmission | Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle | SAME |
| LCD Display Size | 3.5 inches (diagonal) on the handle | SAME |
| Field of View | 140 degrees | SAME |
| Focal Length | 5 to 50 mm | 3 to 50 mm |
| Direction of View from Center Axis | 0 degrees (forward viewing) | SAME |
| Operational Characteristics | | |
| Adjust Brightness of Illumination | Adjust by depressing a button on the handle to change settings | SAME |
| Images or Video | Capture still images or
video during a procedure
by depressing a camera
button on the handle | SAME |
| Cleaning, Disinfecting, and
Sterilization | The handle is not
provided sterile. The
handle is cleaned and
disinfected following
instructions in the user
manual (IFU).
The disposable cannula is
provided sterile following
exposure to ethylene
oxide (EO) and is for
single use. It is disposed
after the procedure
following the institution's
procedures. | SAME |
| Frequency of Use | Handle is reusable
Cannula is single patient
use | SAME |
| Duration of Use |