(267 days)
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
Generally recognized indications for cystoscopy include:
• Symptomatic voiding dysfunction
• Hematuria
• Bladder tumor surveillance
• Recurrent lower urinary tract infections
• Pelvic pain syndromes
The Uro-G HD Flexible Cystoscope System 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. The fully assembled Uro-G HD Cystoscope System—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 is a 510(k) Premarket Notification for the Uro-G HD Flexible Cystoscope, seeking to prove substantial equivalence to a predicate device (Uro-G Flexible Cystoscope, K202921). As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the demonstration that the modified device (Uro-G HD) is as safe and effective as the predicate device, not necessarily a performance study against a specific clinical endpoint. The primary method for proving this is through comparative testing and analysis of technological characteristics.
Here's an analysis of the provided text in the context of acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in a table format within the provided text. Instead, the document uses a comparative approach against a predicate device. The "reported device performance" is essentially the Uro-G HD's characteristics, and "meeting acceptance criteria" means demonstrating that these characteristics are equivalent to or improve upon the predicate without introducing new risks.
Here’s a table summarizing the key characteristics and the comparison to the predicate device, highlighting what could be implicitly considered an "acceptance criterion" (i.e., equivalence or improvement):
| Characteristic | Predicate Device (Uro-G, K202921) Performance | Subject Device (Uro-G HD) Performance | Acceptance Criteria (Implicit) | Met? |
|---|---|---|---|---|
| Cannula | ||||
| Working length | 380.2 mm | 380.2 mm | Not Changed (Equivalent) | Yes |
| Total length (tip to connector) | 406 mm | 406 mm | Not Changed (Equivalent) | Yes |
| Number of ports | 2 | 2 | Not Changed (Equivalent) | Yes |
| Working channel minimum width | 2.2 mm | 2.2 mm | Not Changed (Equivalent) | Yes |
| Maximum insertion width (OD) | 5.5 mm | 5.6 mm | Equivalent (Increased by 0.1mm, deemed not to introduce new risk, as human urethral diameter is larger) | Yes |
| Tip OD | 4 mm | 4 mm | Not Changed (Equivalent) | Yes |
| Camera | ||||
| CMOS module pixels | 0.3 million pixels | 0.7 million pixels | Equivalent (Higher pixels for HD imaging, does not introduce new risk) | Yes |
| Focal length | 5 mm to 50 mm | 5 mm to 50 mm | Not Changed (Equivalent) | Yes |
| Field of view (in air) | 120 ° ± 5 ° | 100 ° ± 5 ° | Equivalent (Smaller FOV but sufficient for HD imaging in confined spaces, does not introduce new risk) | Yes |
| Direction of view from center axis | 0 ° (Forward Viewing) | 0 ° (Forward Viewing) | Not Changed (Equivalent) | Yes |
| Image resolution | 3 lp/mm on 1551 USAF test chart in air | 3 lp/mm on 1551 USAF test chart in air | Not Changed (Equivalent) | Yes |
| Image distortion | < 15% at x and y direction | < 15% at x and y direction | Not Changed (Equivalent) | Yes |
| Sensor on CMOS camera | 640 x 480 pixels | 1280 x 720 pixels | Equivalent (Higher resolution for HD, does not introduce new risk or increase established risk) | Yes |
| Tip Angulation | ||||
| Range | Up 210 ° ± 5 °, Down 130 ° ± 5 ° | Up 210 ° ± 5 °, Down 130 ° ± 5 ° | Not Changed (Equivalent) | Yes |
| Radius | Up < 15 mm, Down < 20 mm | Up < 15 mm, Down < 20 mm | Not Changed (Equivalent) | Yes |
| Lever force for angulation | < 2.2 lbs | < 2.2 lbs | Not Changed (Equivalent) | Yes |
| Rotation torque | < 3.5 inch-lb | < 3.5 inch-lb | Not Changed (Equivalent) | Yes |
| Rotation angle | < 90 ° (clockwise and counter-clockwise) | < 90 ° (clockwise and counter-clockwise) | Not Changed (Equivalent) | Yes |
| Fluid & Light | ||||
| Fluid lumen cross-section | 4.84 mm² | 4.84 mm² | Not Changed (Equivalent) | Yes |
| Distension flow through channel | > 120 mL/min | > 120 mL/min | Not Changed (Equivalent) | Yes |
| Light source | LED, 520 lumens at 25 mm focal length | LED, 520 lumens at 25 mm focal length | Not Changed (Equivalent) | Yes |
| Tip temperature when LEDs are on | < 41° C | < 41° C | Not Changed (Equivalent) | Yes |
| Power rating of source | 90 mW | 90 mW | Not Changed (Equivalent) | Yes |
| Sterilization & Biocompatibility | ||||
| Provided Sterile | Yes | Yes | Not Changed (Equivalent) | Yes |
| Sterilization method | Ethylene oxide | Ethylene oxide | Not Changed (Equivalent) | Yes |
| Sterility Assurance Level | 10^-6 | 10^-6 | Not Changed (Equivalent) | Yes |
| Biocompatibility of Materials | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Not Changed (Equivalent) | Yes |
| Single Use | Yes | Yes | Not Changed (Equivalent) | Yes |
| Handle | ||||
| Device Identity | 3500 | 4500 | N/A (New model but functional equivalence demonstrated) | Yes |
| Length | 135 mm | 176 mm | Equivalent (Increased length does not affect performance) | Yes |
| Diameter | 37 mm | 36 mm | Equivalent (1 mm reduction does not impact risk or performance) | Yes |
| Weight | 220 g | 264 g | Equivalent (Increased weight does not introduce new risk or affect usability) | Yes |
| Video Monitor | ||||
| Screen size | 3.5 inches diagonal | 4.3 inches diagonal | Equivalent (Larger size makes viewing easier, no new risk) | Yes |
| Input format | RGB | RGB | Not Changed (Equivalent) | Yes |
| Effective pixels | 640 x 480 | 1280 x 720 | Equivalent (Higher resolution for HD, no new risk) | Yes |
| LCD resolution | 480 x 320 | 800 x 480 | Equivalent (Higher resolution for HD, no new risk, sharper image) | Yes |
| LCD display resolution | 0.15 million pixels | 0.4 million pixels | Equivalent (Higher resolution for HD, no new risk, sharper image) | Yes |
| Power | ||||
| Power supply | 18650 Lithium Ion rechargeable | 18650 Lithium Ion rechargeable | Not Changed (Equivalent) | Yes |
| Voltage of fully charged battery | 3.7 V | 3.7 V | Not Changed (Equivalent) | Yes |
| Operating time after fully charged | 2 hours | 2 hours | Not Changed (Equivalent) | Yes |
| Battery capacity | 3100 mA | 3100 mA | Not Changed (Equivalent) | Yes |
| Operational Characteristics | ||||
| Electrical Safety | IEC 60601-2-18 compliant | IEC 60601-2-18 compliant | Not Changed (Equivalent) | Yes |
| EMC | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant | Not Changed (Equivalent) | Yes |
| Adjust brightness | By depressing button on handle | By depressing button on handle | Not Changed (Equivalent) | Yes |
| Image/video capture | By depressing camera button on handle | By depressing camera button on handle | Not Changed (Equivalent) | Yes |
| Cleaning/disinfection | Handle cleaned/disinfected per IFU | Handle cleaned/disinfected per IFU | Equivalent (Modified instruction for air dry time, but efficacy remains) | Yes |
| Disposal | Cannula sterile, single use, disposed after procedure | Cannula sterile, single use, disposed after procedure | Not Changed (Equivalent) | Yes |
| Frequency of use | Handle reusable, Cannula single use | Handle reusable, Cannula single use | Not Changed (Equivalent) | Yes |
| Duration of use | < 24 hours | < 24 hours | Not Changed (Equivalent) | Yes |
| Site of Use | Hospitals and physician offices | Hospitals and physician offices | Not Changed (Equivalent) | Yes |
| Software | ||||
| SW version | 2.0 | 4.1 | N/A (New version, but updates do not introduce new risks to operation) | Yes |
| Level of Concern | Moderate | Moderate | Not Changed (Equivalent) | Yes |
| General Functions | Initialize/setup video, LCD, UI, recording | Initialize/setup video, LCD, UI, recording, storage, playback | Not Changed (Equivalent) | Yes |
| General Parameters of Action | Transfer of sensor data to LCD display | Transfer of sensor data to LCD display | Not Changed (Equivalent) | Yes |
| Block Diagram | Main Board performs imaging functionality | Main Board performs imaging functionality | Equivalent (Same except for specific sensor model, which handles HD output) | Yes |
| Specific Parameters of Action | v2.0 updates | v4.1 updates (including v2.0) | Equivalent (Updates do not introduce a new risk; e.g., improved logo, zoom, file saving, etc.) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing and comparative analysis of the device's technological characteristics. It does not refer to a "test set" in the sense of a dataset of clinical cases for an AI algorithm. The performance data listed (e.g., measurement of outer diameter, image quality, image distortion) are conducted on the device hardware itself.
- Sample Size for Test Set: Not applicable in the context of an AI/algorithm-based "test set." The testing involved physical devices and their components. The number of physical units tested is not specified but is typically determined by manufacturing quality control and regulatory submission requirements for non-AI devices.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable for the type of testing described (bench testing of a medical device). This is a hardware device submission, not an AI/software submission that relies on clinical image data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of diagnostic performance typically associated with AI/algorithm submissions, is not directly established through expert consensus on clinical cases for this device. The "ground truth" for this device's performance data relates to engineering specifications and physical measurements (e.g., true dimensions, known test chart patterns).
- Qualifications of Experts: Not applicable beyond the implicit expertise of engineers and technicians performing the stated bench tests, and the FDA's regulatory reviewers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical "test set" requiring adjudication by multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size.
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a hardware cystoscope, not an AI-assisted diagnostic tool for which such studies are typically conducted to evaluate reader performance with and without AI assistance.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Standalone Performance: Not applicable. This is a hardware device. While it contains software, the "software verification testing" mentioned is to ensure the software properly controls the device's functions (e.g., displaying HD images, recording). There is no standalone algorithm whose diagnostic performance is being evaluated independent of human use.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications: The design parameters and expected performance of the device (e.g., specified focal length, field of view, angulation range, lumen cross-section, electrical safety standards).
- Physical Measurements: Direct measurements of the device's components against design specifications (e.g., outer diameter, image quality against a known test chart, image distortion against a known pattern).
- Biocompatibility Standards: Compliance with ISO 10993 requirements, verified through specific biocompatibility tests (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity).
- Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (Uro-G Flexible Cystoscope, K202921) serve as the primary reference for demonstrating equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission is for a hardware medical device with embedded software controlling its functions, not an AI/machine learning algorithm trained on a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this hardware device.
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Image /page/0/Picture/0 description: The image shows 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.
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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2
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
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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) 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 andClassification 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 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. |
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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 DeviceUro-G(UroViu Corp.)K202921 | Subject DeviceUro-G HD(UroViu Corp.)This Submission | ChangedorNot Changed |
|---|---|---|---|
| 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 | Generallyrecognizedindications forcystoscopy include:• Symptomaticvoidingdysfunction• Hematuria• Bladder tumorsurveillance• Recurrentlower urinarytract infections• Pelvic painsyndromes | Generallyrecognizedindications forcystoscopy include:• Symptomaticvoidingdysfunction• Hematuria• Bladder tumorsurveillance• Recurrentlower urinarytract infections• Pelvic painsyndromes | Not Changed |
| Intended use | Endoscopicdiagnosis andinfusion ofirrigating fluidswithin the bladderand urethra | Endoscopicdiagnosis andinfusion ofirrigating fluidswithin the bladderand urethra | Not Changed |
| Contraindications | • Evidence ofongoing UTI | • Evidence ofongoing UTI | |
| Uro-G HD Flexible Cystoscope | |||
| • Overwhelming coagulopathy• Impassable urethral structures | • Overwhelming coagulopathy• Impassable urethral structures | Not Changed | |
| Anatomical Siteof Use | Lower urinary tract—urethra &bladder | Lower urinary tract—urethra &bladder | Not Changed |
| Route ofAdvancement | Advanced to thebladder via theurethra | Advanced to thebladder via theurethra | Not Changed |
| Components ofthe System | Reusable Handlewith a video screenintegrated in itsbody | Reusable Handlewith a video screenintegrated in itsbody | Not Changed |
| Attachable Cannulawith a workingchannel and anillumination sourceand camera at its tip | Attachable Cannulawith a workingchannel and anillumination sourceand camera at its tip | Not Changed | |
| Technical Characteristics | |||
| Cannula | |||
| Device Identity | Uro-G | Uro-G HD | N/A |
| Cannulaworking length | 380.2 mm | 380.2 mm | Not Changed |
| Total length (tipto connector) | 406 mm | 406 mm | Not Changed |
| Number of ports | 2 | 2 | Not Changed |
| Workingchannelminimum width | 2.2 mm | 2.2 mm | Not Changed |
| Maximuminsertion widthof the cannula | 5.5 mm | 5.6 mm | EquivalentThe extra 0.1 mm inwidth does notintroduce a new riskto use of the cannula |
| Tip OD | 4 mm | 4 mm | Not Changed |
| Camera | |||
| CMOS module | 0.3 million pixels | 0.7 million pixels | EquivalentThe higher number ofpixels results in anHD image, but HDdoes not introduce |
| SD image providedby 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 ° | EquivalentWith HD imaging,the field of view canbe more narrow inorder to capturedetails in theconfined spaceswithin the urinarytract |
| Direction ofview from centeraxis | 0 °(ForwardViewing) | 0 °(ForwardViewing) | Not Changed |
| Image resolution | 3 lp/mm on the1551 USAF testchart in air | 3 lp/mm on the1551 USAF testchart in air | Not Changed |
| Image distortion | < 15% at x and ydirection | < 15% at x and ydirection | Not Changed |
| Sensor on theCMOS camera | 640 x 480 pixels | 1280 x 720 | EquivalentThe higher numbersare the basis for theimaging being HDbut an HD imagedoes not introduce anew risk nor increasean established risk |
| Tip angulationrange | Up 210 ° ± 5 °Down 130 ° ± 5 ° | Up 210 ° ± 5 °Down 130 ° ± 5 ° | Not Changed |
| Tip angulationradius | Up less than 15 mmDown less than20 mm | Up less than 15 mmDown less than20 mm | Not Changed |
| Lever force forangulation | < 2.2 lbs | < 2.2 lbs | Not Changed |
| Rotation torque | < 3.5 inch-lb | < 3.5 inch-lb | Not Changed |
| Rotation angle | Cannula torqueswhen rotateclockwise andcounter-clockwiseless than 90 ° | Cannula torqueswhen rotateclockwise andcounter-clockwiseless than 90 ° | Not Changed |
| Fluid lumencross-section | 4.84 mm² | 4.84 mm² | Not Changed |
| Distension flowthrough theworking channel | >120 mL/min | >120 mL/min | Not Changed |
| Uro-G HD Flexible Cystoscope | |||
| Light source | LEDLuminous flux at25 mm focal length:520 lumens | LEDLuminous flux at25 mm 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 Level | 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 | 3500 | 4500 | N/A |
| Length | 135 mm | 176 mm | EquivalentThe extra length doesnot affectperformance of thesystem. |
| Diameter | 37 mm | 36 mm | EquivalentThe 1 mm reductionin the diameter of thehandle has not impacton risk orperformance of thesystem. |
| Weight | 220 g | 264 g | EquivalentThe additional 44 g /1.6 oz in the subjectdevice does notintroduce a new risknor affect usability |
| Video Monitor | Screen: 3.5 inches diagonalHorizontal: 103 mmVertical: 72 mm | Screen: 4.3 inches diagonalHorizontal: 122.2 mmVertical: 73.9 mm | and for most userswill be imperceptibleEquivalentThe larger size of the monitor makes iteasier for the user to view the image as thedevice is being usedand does notintroduce a new riskor increase anestablished risk |
| Input format | RGB | RGB | Not Changed |
| Effective pixels | 640 x 480 | 1280 x 720 | EquivalentThe higher numbersare the basis for theimaging being HDbut an HD imagedoes not introduce anew risk nor increasean established risk |
| LCD resolution | 480 x 320 | 800 x 480 | EquivalentThe higher numbersare the basis for theimaging being HDbut an HD imagedoes not introduce anew risk nor increasean established risk |
| LCD displayresolution | 0.15 million pixels | 0.4 million pixels | EquivalentThe higher resolutionis what makes thesubject device HD;however, this doesnot introduce a newrisk to the Uro-Gcystoscope. Rather itprovides a sharperimage to the userduring the procedure,which allows the userto perform diagnosticsurveillance safely |
| Power supply | 18650 Lithium Ionrechargeable | 18650 Lithium Ionrechargeable | Not Changed |
| Uro-G HD Flexible Cystoscope | |||
| 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/A | N/A | Not Changed |
| Does not contactthe patient & theuser wears gloveswhile using thedevice | Does not contactthe patient & theuser wears gloveswhile using thedevice | N/A | |
| 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 handleis cleaned anddisinfectedfollowinginstructions in theinstructions for use(IFU) | The handle is notsterile. The handleis cleaned anddisinfectedfollowinginstructions in theinstructions for use(IFU) | EquivalentDisinfectioninstructions havebeen modified as to astatement to not useuntil the handle isdry, without thespecific time periodof 20 minutes. |
| 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 | following theinstitution'sproceduresHandle is reusableCannula is singleuse | following theinstitution'sproceduresHandle is reusableCannula is singleuse | Not Changed |
| Duration of use | < 24 hours | < 24 hours | Not Changed |
| Site of Use | Hospitals andphysician offices | Hospitals andphysician offices | Not Changed |
| Mechanism of Action | |||
| OperationalPrinciples | 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 to | 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 to | Not Changed |
| view the urethrabladder byrotating thecannula or bymodifying theangle of the tipmanually. | view the urethrabladder byrotating thecannula or bymodifying theangle of the tipmanually. | ||
| 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 | 2.0 | 4.1 | N/A |
| Level ofConcern | Moderate | Moderate | Not Changed |
| GeneralFunctions of theSoftware | • Initialize andsetup videoprocessinghardware• Initialize LCDdisplay control• Initialize userinterface (menus,touch screen)• Initializesrecording | • Initialize andsetup videoprocessinghardware• Initialize LCDdisplay control• Initialize userinterface (menus,touch screen)Initializesrecording, storage | Not Changed |
| Uro-G HD Flexible Cystoscope | |||
| storage, andplayback ofvideo and stillimages | and playback ofvideo and stillimages | ||
| GeneralParameters ofAction | The transfer ofsensor data (MIPI)to ISP for imageprocessing intodigital data (RGB)and then transfer tothe LCD modulefor visual display | The transfer ofsensor data (MIPI)to ISP for imageprocessing intodigital data (RGB)and then transfer tothe LCD modulefor visual display | Not Changed |
| Block Diagram(in text) | The Main Boardperforms imagingfunctionality. Thesensor in theCannula is a digitalcamera. This signalis passed down inthe Main Board tothe DSP processor,which is the mainprocessor. The MIPIsensor data (serial)is converted toparallel data throughSTMIPI. Theparallel data is thenfed to the DSP viaFPGA1. The outputimage data fromDSP is formattedinto serial RGB666signal andtransferred toFPGA2 whichconverts the signalto parallelRGB666 format tobe displayed on theLCD Monitor.Physically overlaidon the monitor is atouch screen. Thetouch screen data is | The Main Boardperforms imagingfunctionality. Thesensor in theCannula is a digitalcamera. This signalis passed down inthe Main Board tothe DSP processor,which is the mainprocessor. The MIPIsensor data (serial)is converted toparallel data throughSTMIPI. Theparallel data is thenfed to the DSP viaFPGA1. The outputimage data fromDSP is formattedinto serial RGB666signal andtransferred toFPGA2 whichconverts the signalto parallelRGB666 format tobe displayed on theLCD Monitor.Physically overlaidon the monitor is atouch screen. Thetouch screen data is | EquivalentThe block diagram isthe same except thatthe Sensor in the3500 handle is CI362and the Sensor in the4500 handle isCI1310. |
| the DSP processorover an I2C bus.On the Main Board,the DSP processor isattached to DDRRAM memory. TheMain Boardalso has the powerelectronics (BatteryCharger, voltageconverter/regulator,and power switch).There is also flashmemory for holdingimage data. | the DSP processorover an I2C bus.On the Main Board,the DSP processor isattached to DDRRAM memory. TheMain Boardalso has the powerelectronics (BatteryCharger, voltageconverter/regulator,and power switch).There is also flashmemory for holdingimage data. | ||
| SpecificParameters ofAction for theSoftwareVersion | v2.0 is an update tothe original v1.1that was completedunder internaldocumentation (i.e.,Letter to File)1. New added "noconnectionwarning" to bedisplayed asnecessary.2. When exitingpreview, the LEDwill turn off. Whenentering preview,the LED will firstturn on, and thenafter a 200msdelay, the sensorwill be initialized.3. Optimized theI2C read-writeprotocol to reducethe probability offreezing.4. Optimizedbattery leveldisplay increasing | All of theparameters listedfor v2.0 with thefollowing added:1. Updated thestartup logo.2. Updated theimageparameters forUro-G HD.3. Play files inreverse order.4. Duringrecording, if thesignal isinterrupted, thefile will besaved, and thesystem willreturn to liveview.5. Added zoom in/ zoom outfunctionality.6. Changed thereplay file list todisplay inreverse order(latest files atthe top). | EquivalentThe updates fromv2.0 to v4.1 do notintroduce a new riskto operation of theUro-G HD system |
| the refresh rate ofthe battery icon. | |||
| 5. Changed to a 2-second-long pressfor power-off, andwhen clicking thepower button, a'beep' sound promptwill occur. | |||
| 6. Fixed the bug onthe replay pagewhere the videowas not displayingthe recording time. | |||
| 7. Modified the 'NoConnection'warning message toallow input of CaseID without aconnected scope. | |||
| 8. Added hot-swappingfunctionality. | |||
| 9. Modified thestartup screen tofeature a dual-logonew startup screen. | |||
| 10. Added theHysterovue logo tothe home page onthe monitor. |
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Performance Data
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; .
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- 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 (< 24 hours) indwelling device, as specified in ISO 10993 - Part 1, for the following tests:
- o Cytotoxicity,
- o Irritation,
- O Sensitization, and
- Systemic Toxicity (acute). O
Animal Testing
No preclinical testing of the subject device was necessary; the bench top testing was sufficient to determine the performance of the device.
Clinical Studies
No clinical testing of the subject device was necessary; the bench top testing was sufficient to determine the performance of the device.
Conclusion
The Uro-G and Uro-G HD Flexible Cystoscopes have intended use, the same
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indications for use, and have equivalent technological characteristics. The minor differences between the Uro-G and the Uro-G HD cystoscopes 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.