(73 days)
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
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.
This document describes a Special 510(k) submission for the Uro-G HD Flexible Cystoscope, focusing on a minor modification to its surface disinfection process. There is NO mention of an AI/ML device or algorithm. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI/ML.
The provided text only discusses the equivalence of the modified device to its predicate, based on unchanged intended use, indications for use, and technological characteristics, except for the disinfection process.
Here's what I can extract regarding the device performance and the "study" mentioned, which is not an AI/ML study but rather microbiology testing for disinfection:
1. A table of acceptance criteria and the reported device performance:
Since the document focuses on a change in the disinfection process and asserts that other performance characteristics remain unchanged from the predicate, and does not provide specific acceptance criteria values for the disinfection, I cannot create a table with specific numbers. Instead, I can describe the nature of the change and the demonstrated outcome.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Surface Disinfection | • Efficacy: Achieve sufficient log reductions of tested pathogens. • Compatibility: Allow the use of Super Sani-Cloth or CaviWipe towelettes. • Process Efficiency: Potentially reduce contact and air-dry times while maintaining disinfection efficacy. | • Efficacy: "Testing found that 3 minutes contact with the disinfecting agent on the wipes was sufficient for log reductions of ≥ 3 and ≥ 6 of tested pathogens." • Compatibility: The Super Sani-Cloth is now an approved option in addition to CaviWipe. • Process Efficiency: Contact time reduced from 6 minutes to 3 minutes, and air dry time reduced from 20 minutes to 5 minutes. The document implies these reduced times are now sufficient for effective disinfection. |
| Other Performance | (Implicitly aligned with Predicate Device's performance, as no changes were made) • Tip angulation • Tip angulation radius • Lever force for tip angulation • Rotation torque • Rotation angles • Distention flow rate • Cannula leaking • Tip temperature • Field of view • Direction of view • Image quality • Electrical Safety (IEC 60601-2-18 compliant) • EMC Safety (IEC 60601-1-2 and IEC 60601-2-18 compliant) | "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 and EMC. |
Regarding the study that proves the device meets the acceptance criteria:
The study referenced is a microbiology testing study conducted to evaluate the effectiveness of the revised surface disinfection process for the reusable handle of the Uro-G HD Flexible Cystoscope.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified in the provided text. The document refers to "testing" that "found" specific results for log reductions.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable to a microbiology disinfection study. The "ground truth" would be established by the standardized protocols and results of the microbiological tests themselves, rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to a microbiology disinfection study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device, and no MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the disinfection efficacy, the "ground truth" was established through microbiology testing results demonstrating "log reductions of ≥ 3 and ≥ 6 of tested pathogens." This is a quantitative measure of antimicrobial effectiveness.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
In summary, the provided document describes a regulatory submission for a medical device (a cystoscope) focusing on a change in its disinfection instructions. The "study" mentioned is a microbiology test to validate the effectiveness of the new disinfection protocol. There is no information related to AI/ML or an algorithm in the provided text.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
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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 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.
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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
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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 Corporation4546 El Camino RealSuite 214Los Altos, CA 94022 |
| FDA Registration Number | 3015042209 |
| Correspondence Person | Thomas Lawson, PhD |
| Contact Information | Email: thom@uroviu.comPhone: 510-206-1794 |
| Date Prepared | 12 December 2024 |
Subject Device
| Trade Name | Uro-G HD Flexible Cystoscope |
|---|---|
| Common Name | Uro-G HD |
| Regulation Number andClassification 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-GHD Flexible Cystoscope System. |
Predicate Device
| Trade Name | Uro-G HD Flexible Cystoscope |
|---|---|
| Common Name | Uro-G HD |
| Premarket Notification | K232837 |
| Regulation Number andClassification 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
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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
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-
- 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 HDFlexibleCystoscope(UroViu Corp.)(K243196) | Uro-G HDFlexibleCystoscope(UroViu Corp.)(K232837) | Changed orNot Changed | ||
| Device Overview | ||||
| Device Class | II | II | Not Changed | |
| FDA ProductCode | FAJ | FAJ | Not Changed | |
| ProductClassification | 21 CFR 876.1500 | 21 CFR 876.1500 | Not Changed | |
| Indication forUse | The Uro-G HDFlexibleCystoscope isintended forendoscopicdiagnosis andinfusion ofirrigating fluidswithin thebladder andurethra | The Uro-G HDFlexibleCystoscope isintended forendoscopicdiagnosis andinfusion ofirrigating fluidswithin thebladder andurethra | Not Changed | |
| Intended use | Endoscopicdiagnosis andinfusion ofirrigating fluidswithin the bladderand urethra | Endoscopicdiagnosis andinfusion ofirrigating fluidswithin the bladderand urethra | Not Changed | |
| Contraindications | • Evidence ofongoing UTI• Overwhelmingcoagulopathy• Impassableurethralstructures | • Evidence ofongoing UTI• Overwhelmingcoagulopathy• Impassableurethralstructures | Not Changed | |
| AnatomicalSite of Use | Lower urinarytract – urethra &bladder | Lower urinarytract – urethra &bladder | Not Changed | |
| Route ofAdvancement | Advanced to thebladder via theurethra | Advanced to thebladder via theurethra | Not Changed | |
| Components | Reusable Handlewith a video screenintegrated intohandle's body | Reusable Handlewith a video screenintegrated into thehandle's body | Not Changed | |
| Disposable Cannulawith a workingchannel and anillumination sourceand camera at its tip | Disposable Cannulawith a workingchannel and anillumination sourceand camera at its tip | Not Changed | ||
| Technical Characteristics | ||||
| Cannula | ||||
| Device Identity | Uro-G HDFlexibleCystoscope | Uro-G HDFlexibleCystoscope | Not Changed | |
| Cannulaworkinglength | 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 | < 15% at x and y direction | < 15% at x and y direction | Not Changed | |
| Sensor on the CMOS camera | 1280 x 720 pixels | 1280 x 720 pixels | Not Changed | |
| Tip angulation range | Up $210° ± 5°$Down $130° ± 5°$ | Up $210° ± 5°$Down $130° ± 5°$ | Not Changed | |
| Tip angulation radius | Up less than 15 mmDown less than 20 mm | Up less than 15 mmDown less than 20 mm | Not Changed | |
| Lever force for angulation | < 2.2 lbs | < 2.2 lbs | Not Changed | |
| Rotation torque | < 3.5 inch-lb | < 3.5 inch-lb | Not Changed | |
| Rotation angle | Cannula torques when rotate clockwise and counter-clockwise less than $90°$ | Cannula torques when rotate clockwise and counter-clockwise less than $90°$ | Not Changed | |
| Fluid lumen cross-section | 4.84 mm² | 4.84 mm² | Not Changed | |
| Distension flowthrough theworkingchannel | >120 mL/min | >120 mL/min | Not Changed | |
| Light source | LEDLuminous flux at 25mm focal length:520 lumens | LEDLuminous flux at 25mm focal length:520 lumens | Not Changed | |
| Tip temperaturewhen LEDs areon | < 41° C | < 41° C | Not Changed | |
| Power rating ofsource | 90 mW | 90 mW | Not Changed | |
| Provided Sterile | Yes | Yes | Not Changed | |
| Sterilizationmethod | Ethylene oxide | Ethylene oxide | Not Changed | |
| SterilityAssurance Levelof the Cannula | 10-6 | 10-6 | Not Changed | |
| Biocompatibilityof Materials | Meets ISO 10993requirements forexternalcommunicatingdevice with < 24hours of tissuecontact | Meets ISO 10993requirements forexternalcommunicatingdevice with < 24hours of tissuecontact | Not Changed | |
| Single Use | Yes | Yes | Not Changed | |
| Packaging | Tyvek pouch | Tyvek pouch | Not Changed | |
| Handle | ||||
| Device Identity | 4500 | 4500 | N/A | |
| Length | 176 mm | 176 mm | Not Changed | |
| Diameter | 36 mm | 36 mm | Not Changed | |
| Weight | 264 g | 264 g | Not Changed | |
| Uro-G HD Flexible Cystoscope | ||||
| Video Monitor | Screen: 4.3 inchesdiagonal | Screen: 4.3 inchesdiagonal | Not Changed | |
| Horizontal: 122.2mm | Horizontal: 122.2mm | |||
| Vertical: 73.9 mm | Vertical: 73.9 mm | |||
| Input format | RGB | RGB | Not Changed | |
| Effective pixels | 1280 x 720 | 1280 x 720 | Not Changed | |
| LCD resolution | 800 x 480 | 800 x 480 | Not Changed | |
| LCD displayresolution | 0.4 million pixels | 0.4 million pixels | Not Changed | |
| Power supply | 18650 Lithium Ionrechargeable | 18650 Lithium Ionrechargeable | Not Changed | |
| Voltage of fullycharged battery | 3.7 V | 3.7 V | Not Changed | |
| Operating timeafter fullycharged | 2 hours | 2 hours | Not Changed | |
| Battery capacity | 3100 mA | 3100 mA | Not Changed | |
| Biocompatibility | N/ADoes not contactthe patient & theuser wears gloveswhile using thedevice | N/ADoes not contactthe patient & theuser wears gloveswhile using thedevice | Not Changed | |
| Operational Characteristics | ||||
| Electrical Safety | IEC 60601-2-18compliant | IEC 60601-2-18compliant | Not Changed | |
| EMC | IEC 60601-1-2compliant | IEC 60601-1-2compliant | Not Changed | |
| Adjustbrightness ofillumination ofthe LEDs | Adjust bydepressing a buttonon the handle tochange settings | Adjust bydepressing a buttonon the handle tochange settings | Not Changed | |
| Images or videocapture | Capture still images(photo) or videoduring a procedureby depressing thecamera button onthe handle | Capture still images(photo) or videoduring a procedureby depressing thecamera button onthe handle | Not Changed | |
| Cleaning,disinfecting andsterilization | The handle is notsterile. | The handle is notsterile. | Equivalent | |
| The handle iscleaned anddisinfectedfollowingdirections in theinstructions for use(IFU):• Wipe the surfacewith a SuperSani-Cloth orCaviWipetowelette• Surface toremain visiblywet for 3minutes• After 3 minutesallow the handleto air dry for 5minutes | The handle iscleaned anddisinfectedfollowingdirections in theinstructions for use(IFU):• Wipe the surfacewith a CaviWipetowelette• Surface toremain visiblywet for 6minutes• After 6 minutesallow the handleto air dry for 20minutes | The use of a SuperSani-Cloth is anoption in additionto use of aCaviWipe indisinfecting thesurface.Testing found that3 minutes contactwith thedisinfecting agenton the wipes wassufficient for logreductions of ≥ 3and ≥ 6 of testedpathogens.The air dry timewas reduced from20 minutes to 5minutes | ||
| Wet a sterile padwith sterile waterand wipe allexposed surfacesof the handle | Wet a sterile padwith sterile waterand wipe allexposed surfacesof the handle | Not Changed | ||
| The disposablecannula is providedsterile and is forsingle use. It isdeposed after theprocedure | The disposablecannula is providedsterile and is forsingle use. It isdeposed after theprocedure | Not Changed | ||
| Frequency of use | Handle is reusableCannula is singleuse | Handle is reusableCannula is singleuse | Not Changed | |
| Duration of use | < 24 hours | < 24 hours | Not Changed | |
| Site of Use | Hospitals and physician offices | Hospitals and physician offices | Not Changed | |
| Mechanism of Action | ||||
| Operational Principles | Handle: Ratherthan run a cablefrom thecystoscope to aseparate videomonitor as isrequired of allother cystoscopes,an LCD display isintegrated into thehandle of UroViucystoscopes sothat the user cansee images of thetissue andanatomicalstructures directlyand in real time asthe cystoscope isbeing advanced toand while withinthe bladder.Cannula: the lightat the tipilluminates thefield so that thecamera cantransmit imagesback to the LCDdisplay on thehandle. It is aflexible shaft thatthe user canmanipulate toview the urethrabladder byrotating thecannula or bymodifying theangle of the tipmanually. | Handle: Ratherthan run a cablefrom thecystoscope to aseparate videomonitor as isrequired of allother cystoscopes,an LCD display isintegrated into thehandle of UroViucystoscopes sothat the user cansee images of thetissue andanatomicalstructures directlyand in real time asthe cystoscope isbeing advanced toand while withinthe bladder.Cannula: the lightat the tipilluminates thefield so that thecamera cantransmit imagesback to the LCDdisplay on thehandle. It is aflexible shaft thatthe user canmanipulate toview the urethrabladder byrotating thecannula or bymodifying theangle of the tipmanually. | Not Changed | |
| Performance Testing | ||||
| Testing for:• Tip angulation• Tip angulationradius• Lever force fortip angulation• Rotation torque• Rotation angles• Distention flowrate• Cannula leaking• Tip temperature• Field of view• Direction of view• Image quality | Testing for:• Tip angulation• Tip angulationradius• Lever force fortip angulation• Rotation torque• Rotation angles• Distention flowrate• Cannula leaking• Tip temperature• Field of view• Direction of view• Image quality | Not Changed | ||
| Manufacturing | ||||
| Manufactured at acontractmanufacturer withdesign control atUroViu Corp | Manufactured at acontractmanufacturer withdesign control atUroViu Corp | Not Changed | ||
| Software | ||||
| SW version | 4.1 | 4.1 | Not Changed | |
| Level ofConcern | Moderate | Moderate | Not Changed | |
| GeneralFunctions of theSoftware | • Initialize andsetup videoprocessinghardware• Initialize LCDdisplay control• Initialize userinterface (menus,touch screen)• Initializesrecording,storage, andplayback ofvideo and stillimages | • Initialize andsetup videoprocessinghardware• Initialize LCDdisplay control• Initialize userinterface (menus,touch screen)• Initializesrecording, storage,and playback ofvideo and stillimages | Not Changed |
Device.
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to connector)
Number of ports
2
2
Not Changed
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K243196 Page 7 of 11
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UroViu Corporation
Special 510(k) Notification Uro-G HD Flexible Cystoscope
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Performance Data
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.
Animal Testing
No preclinical testing of the subject device for this minor modification to the disinfection process was necessary; the microbiology testing was sufficient to determine the performance of the device.
Clinical Studies
No clinical testing of the subject device was necessary.
Conclusion
The Uro-G HD Flexible Cystoscope (subject device) and Uro-G HD Flexible Cystoscope (predicate device) have the same intended use, the same indications for use, and the same technological characteristics. The minor difference in the surface disinfection process of the model 4500 handle proposed in this submission do not raise any new issues of safety or effectiveness.
Therefore, the Uro-G HD Flexible Cystoscope is substantially equivalent to the identified predicate device.
§ 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.