(73 days)
No
The document describes a hardware modification (surface disinfection process) to a previously cleared device. There is no mention of AI/ML in the intended use, device description, or performance studies. While it mentions "video processing hardware," this is a standard component of video endoscopes and does not inherently imply AI/ML.
No
The device is described for "endoscopic diagnosis and infusion of irrigating fluids," which indicates diagnostic rather than therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis."
No
The device description explicitly states it is a handheld, battery-operated portable cystoscope consisting of a disposable cannula and a reusable handle with a video monitor, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "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, not a test performed on a sample taken from the body.
- Device Description: The description details a flexible cystoscope with a camera and a channel for fluid. This is a medical device used for direct examination of internal body structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The "diagnosis" mentioned in the intended use refers to the visual diagnosis made by the physician during the endoscopic procedure.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
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
FAJ
Device Description
This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated 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. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula 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
- Initialize and setup video processing hardware
- Capture still images (photo) or video during a procedure by depressing the camera button on the handle
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)
Performance tests reviewed in K232837 were not repeated for this submission since the minor change in the surface disinfection process of the handle does not affect device performance. The device continues 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.
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 13, 2024
UroViu Corporation Thomas Lawson, Ph.D. Director, Regulatory Affairs 4546 El Camino Real, Suite 214 Los Altos, CA 94022
Re: K243196
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 25, 2024 Received: October 1, 2024
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 (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).
1
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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,
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) K243196
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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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 | 12 December 2024 |
Subject 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 second submission for this model 4500 handle that is part of the Uro-G | |
| HD Flexible Cystoscope System. |
Predicate Device
| Trade Name | Uro-G HD Flexible Cystoscope |
|---|---|
| Common Name | Uro-G HD |
| Premarket Notification | K232837 |
| 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. |
Device Description
This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic
5
cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula 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 is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
Comparison of Technological Characteristics with the Predicate Device
The focus of this Special 510(k) are the steps to follow to complete surface sterilization of the reusable handle component of the Uro-G HD Flexible Cystoscope. UroViu Corp. has identified the Uro-G HD Flexible Cystoscope (K232837, 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 subject device 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;
-
- Both devices have a working channel to allow infusion of fluids and introduction of instruments; and
6
-
- Both devices are made from biocompatible materials.
The specific topic of this Special 510(k) are the steps to take when surface disinfecting the model 4500 handle of the Uro-G HD Flexible Cystoscope. There are no changes to intended use, materials used in construction, software, biocompatibility of materials, EMC and electrical safety, or performance. The only change is in one paragraph in the instructions for use (IFU) concerning surface disinfection of the reusable handle.
- Both devices are made from biocompatible materials.
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
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Uro-G HD | ||||
| Flexible | ||||
| Cystoscope | ||||
| (UroViu Corp.) | ||||
| (K243196) | Uro-G HD | |||
| Flexible | ||||
| Cystoscope | ||||
| (UroViu Corp.) | ||||
| (K232837) | Changed or | |||
| Not Changed | ||||
| Device Overview | ||||
| 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 | The Uro-G HD | |||
| Flexible | ||||
| Cystoscope is | ||||
| intended for | ||||
| endoscopic | ||||
| diagnosis and | ||||
| infusion of | ||||
| irrigating fluids | ||||
| within the | ||||
| bladder and | ||||
| urethra | The Uro-G HD | |||
| Flexible | ||||
| Cystoscope is | ||||
| intended for | ||||
| endoscopic | ||||
| diagnosis and | ||||
| infusion of | ||||
| irrigating fluids | ||||
| within the | ||||
| bladder and | ||||
| urethra | 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 | ||||
| • Overwhelming | ||||
| coagulopathy | ||||
| • Impassable | ||||
| urethral | ||||
| structures | • Evidence of | |||
| ongoing UTI | ||||
| • 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 | Reusable Handle | |||
| with a video screen | ||||
| integrated into | ||||
| handle's body | Reusable Handle | |||
| with a video screen | ||||
| integrated into the | ||||
| handle's body | Not Changed | |||
| Disposable Cannula | ||||
| with a working | ||||
| channel and an | ||||
| illumination source | ||||
| and camera at its tip | Disposable Cannula | |||
| with a working | ||||
| channel and an | ||||
| illumination source | ||||
| and camera at its tip | Not Changed | |||
| Technical Characteristics | ||||
| Cannula | ||||
| Device Identity | Uro-G HD | |||
| Flexible | ||||
| Cystoscope | Uro-G HD | |||
| Flexible | ||||
| Cystoscope | Not Changed | |||
| Cannula | ||||
| working | ||||
| length | 380.2 mm | 380.2 mm | Not Changed | |
| Total length (tip | 406 mm | 406 mm | Not Changed | |
| Working channel minimum width | 2.2 mm | 2.2 mm | Not Changed | |
| Maximum insertion width of the cannula | 5.6 mm | 5.6 mm | Not Changed | |
| Tip OD | 4 mm | 4 mm | Not Changed | |
| Camera | ||||
| CMOS module | 0.7 million pixels | 0.7 million pixels | Not Changed | |
| Focal length | 5 mm to 50 mm | 5 mm to 50 mm | Not Changed | |
| Field of view (in air) | $100° ± 5°$ | $100° ± 5°$ | Not Changed | |
| 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 | |
| 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 |