(92 days)
The single use Uretero1™ Ureteroscope System is intended to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Uretero1™ Ureteroscope System contains an all-in-one camera control unit (CCU) for image processing and display. The CCU operates at 110 V - 230V ~ 50 - 60 Hz and has a simple graphical user interface that prompts the clinician through actions to get a live view via the Ureteroscope. After unpackaging the sterile, single-use ureteroscope, the user is required to plug in the single-use ureteroscope device via a 16-pin male connector inserted into the CCU to obtain a live image. There is a process of authentication, in which the CCU recognizes the firmware of the inserted product, and the image from the ureteroscope is displayed on live view. The Uretero1TM CCU software platform is based on i.MX8MQ processor from NXP and LATTICE ECP5 FPGA. The ECP5 provides the camera interface plus ISP functionality. The CCU software is based on Linux board support package provided by NXP. The board support package and Linux distribution are configured and built using YOCTO. The main functionality of the system is to capture the video from an external camera and display it to an external display. Graphical user interface is developed using QT5. Video pipeline is implemented through g-streamer.
The ureteroscope is disposable and can be utilized for up to 4 hours. The ureteroscope possesses a 4-hour countdown timer and after 4 hours of usage, the ureteroscope will no longer produce a live image and a use notification message will be displayed on the screen informing the user that the ureteroscope usage time has expired. The ureteroscope has 3 use notification messages. One occurs at 60 minutes left on the timer and appears on the side menu bar of the display screen on the CCU. A second occurs with 30 minutes left on the timer and also appears on the side menu bar. The final notification message appears with 5 minutes of time remaining on the ureteroscope and it is in the middle of the screen and requires user interaction to acknowledge the use notification message by pressing OK. When the duration of time has elapsed, the ureteroscope will no longer produce a live image and the user will be directed to a screen that states the ureteroscope no longer has any usable time remaining and to insert new ureteroscope.
Once the flexible shaft is inserted into the patient, the distal tip is steered via the articulation lever on the ureteroscope handle. The flexible shaft allows for passive secondary deflection while accessing the patient's urinary tract. The flexible shaft contains a working channel to allow surgical accessories and procedural solutions to be delivered through the distal tip to the surgical field. The handle button allows the user to take photos, record video and zoom in and out. In addition to the articulation lever and the handle button, the handle contains an accessory access port and a connection port for procedural solutions. An irrigation system (irrigation tubing and an irrigation source) can be attached to one port and the biopsy port cover can be attached to the other port. In this way, the user can use endoscopic instruments through the biopsy port cover and irrigate at the same time. The Uretero1TM Single-Use Digital Flexible Ureteroscope must be used in conjunction with the Vision1™ Imaging Console and Display System (CCU).
In addition to image processing, the CCU supports video connectivity in two additional ways. The user is allowed to mirror image from the CCU to an external display which produces the same image the user sees on the CCU screen on any other compatible display system that accepts HDMI input. In addition, the CCU can accept an HDMI input signal from an external HDMI output and the CCU can act as a dummy display panel for the external HDMI imaging source. There are two USB data ports to provide data export (photos and video taken during procedure) or allow connection of selected accessories (printer). No data, including Electronic Protected Health Information (ePHI) data is stored on this device (e.g., last name, SSN, DOB, MRN) and there is no ethernet, Wi-Fi or Blue Tooth capability.
The ureteroscope will be offered in two different models: UreterolTM Ureteroscope (Standard Deflection) and UreterolTM Ureteroscope (Reverse Deflection). To save procedural photo or video, a proprietary system encrypted USB drive is provided to Customers with the purchase of the CCU. The Vision1™ Imaging Console and Display System communicate with the encrypted USB drive, the Uretero1TM Single-Use Digital Flexible Ureteroscope, and the external printer.
The Uretero1 Ureteroscope System comes packaged with single-use, disposable accessory port cover. The accessory port cover is adjustable and is intended to resist the backflow of fluid around an instrument inserted through the working channel of the ureteroscope. It is designed to facilitate the passage of instruments during a procedure. It has a cap feature to allow instruments to be inserted and secured. A clicking mechanism is used to facilitate the open, semi-closed and closed position of the valve. It also has a side arm y-port with a luer cap to allow for irrigation or other procedural solutions, if needed. This accessory attaches to the instrument port of the Uretero1 Ureteroscope via a distal luer connection.
The provided FDA 510(k) summary for the Uretero1™ Ureteroscope System (K223466) describes a device that is substantially equivalent to a previously cleared device (K211347). As such, the submission primarily focuses on comparing the modified device to its predicate and demonstrating that the changes do not raise new questions of safety or effectiveness. This type of submission generally does not include extensive clinical study data with acceptance criteria for a novel AI algorithm's performance with ground truth. Instead, it relies on non-clinical performance testing to ensure that the modified device continues to meet established standards and functions as intended.
Therefore, the requested information about acceptance criteria and a study that proves the device meets them, particularly regarding AI performance metrics, sample sizes, expert qualifications, and ground truth establishment, is largely not applicable in the context of this 510(k) summary. The document does not describe the device as incorporating an AI algorithm that would require such performance evaluation.
However, I can extract the information that is present regarding the non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or numerical reported performance values. Instead, it states that various tests "Pass" or that changes have "No impact on safety, effectiveness or how the device is used."
| Change Type | Testing Type | Acceptance Criteria Implicit (e.g., "Pass") | Reported Device Performance |
|---|---|---|---|
| Software | Functional and Regression Testing | Pass | Pass |
| Optical Color Performance Testing | Pass | Pass | |
| White Balance Testing | Pass | Pass | |
| Hardware Changes | Optical Performance Testing | Pass | Pass |
| Review of Prior Testing | Pass | Pass | |
| Software Regression Testing | Pass | Pass | |
| Material Change (Adhesive) | Workmanship, functionality and performance | Pass | Pass |
| Biocompatibility | Pass | Pass | |
| Dimensional Changes | Device passage, lumen output and tensile testing | Pass | Pass |
| Electrical Testing | Pass | Pass | |
| Labeling Changes | Labeling Review | Pass | Pass |
| Extension of Expiration Date | Functional/performance testing | Pass | Pass |
| Packaging testing | Pass | Pass | |
| Software Update (various changes) | "No impact on safety, effectiveness or how the device is used." | No new safety/effectiveness concerns | No new safety/effectiveness concerns |
| Hardware Changes (connector, sensor, adhesive, dimensions) | "No impact on safety, effectiveness or how the device is used." | No new safety/effectiveness concerns | No new safety/effectiveness concerns |
2. Sample size used for the test set and the data provenance
Not explicitly stated in the provided document. The testing described is non-clinical performance testing (e.g., electrical, optical, mechanical, software functionality), which typically involves testing of the device hardware and software rather than a clinical dataset. Thus, concepts like country of origin for patient data are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an endoscope system, and the testing described is non-clinical performance testing. The "ground truth" here would be objective engineering specifications and functional requirements rather than expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set
Not applicable. As described above, the testing is non-clinical performance testing.
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. The document does not mention the inclusion of any AI assistance features in the Uretero1™ Ureteroscope System, nor does it present any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document describes an endoscope system and its modifications; it does not present a standalone algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" would be established engineering standards, specifications, and functional requirements as outlined in the referenced ISO standards (e.g., ISO 8600-3:2019, ISO 8600-5:2020, ISO 12233:2017, ISO 9039:2008, ISO 15739:2017, IEC 62304:2006/A1:2016, IEC 60601-1:2012, ISO 10993-1:2018, ISO 15223-1, ASTM F1886, ASTM F2096, ASTM F88).
8. The sample size for the training set
Not applicable. There is no mention of a machine learning or AI algorithm requiring a training set in this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As there is no mention of a training set for an AI algorithm, this question is not relevant to the provided document.
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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.
February 17, 2023
STERIS Corporation Carroll L. Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060
Re: K223466
Trade/Device Name: Uretero1TM Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: January 13, 2023 Received: January 19, 2023
Dear Carroll L. Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 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.
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.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K223466
Device Name Uretero1TM Ureteroscope System
Indications for Use (Describe)
The single use Uretero1™ Ureteroscope System is intended to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
| 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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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all capital letters and in a bold, sans-serif font. Below the word STERIS is a graphic of several horizontal, wavy lines in a light blue color. The registered trademark symbol is to the right of the word STERIS.
Page 1 of 11
510(k) Summary for the Uretero1™ Ureteroscope System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
| Contact: | Carroll Martin |
|---|---|
| Regulatory Affairs Director | |
| Tel: 440-358-6259 | |
| Email: Carroll_Martin@steris.com |
February 6, 2023 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Uretero1TM Ureteroscope System |
|---|---|
| Device Class: | Class II |
| Regulation Name: | Endoscope and Accessories |
| Common/usual Name: | Ureteroscope |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FGB |
2. Predicate Device
Uretero1 Ureteroscope System, K211347 Class II (21 CFR 876.1500), product code FGB
Device Description 3.
The Uretero1™ Ureteroscope System contains an all-in-one camera control unit (CCU) for image processing and display. The CCU operates at 110 V - 230V ~ 50 - 60 Hz and has a simple graphical user interface that prompts the clinician through actions to get a live view via the Ureteroscope. After unpackaging the sterile, single-use ureteroscope, the user is required to plug in the single-use ureteroscope device via a 16-pin male connector inserted into the CCU to obtain a live image. There is a process of authentication, in which the CCU recognizes the firmware of the inserted product, and the image from the ureteroscope is displayed on live view. The Uretero1TM CCU software platform is based on i.MX8MQ processor from NXP and LATTICE ECP5 FPGA. The ECP5 provides the camera interface plus ISP functionality. The CCU software is based on Linux board support package provided by NXP. The board support package and Linux distribution are configured and built using YOCTO. The main functionality of the system is to capture the video from an external camera and display it to an external display. Graphical user interface is developed using QT5. Video pipeline is implemented through g-streamer.
The ureteroscope is disposable and can be utilized for up to 4 hours. The ureteroscope possesses a 4-hour countdown timer and after 4 hours of usage, the ureteroscope will no longer produce a live image and a use notification message will be displayed on the screen informing the user that the ureteroscope usage time has expired. The ureteroscope has 3 use notification messages. One occurs at 60 minutes left on the timer and appears on the side menu bar of the display screen on the CCU. A second occurs with 30 minutes left on the timer and also appears on the side menu bar. The final notification message appears with 5 minutes of time remaining on the ureteroscope and it is in the middle of the screen and requires user interaction to acknowledge the use notification message by pressing OK. When the duration of time has elapsed, the ureteroscope will no longer produce a live image and the user will be directed to a screen that states the ureteroscope no longer has any usable time remaining and to insert new ureteroscope.
Once the flexible shaft is inserted into the patient, the distal tip is steered via the articulation lever on the ureteroscope handle. The flexible shaft allows for passive secondary deflection while accessing the patient's urinary tract. The flexible shaft contains a working channel to allow surgical accessories and procedural solutions to be delivered through the distal tip to the surgical field. The handle button allows the user to take photos, record video and zoom
{5}------------------------------------------------
in and out. In addition to the articulation lever and the handle button, the handle contains an accessory access port and a connection port for procedural solutions. An irrigation system (irrigation tubing and an irrigation source) can be attached to one port and the biopsy port cover can be attached to the other port. In this way, the user can use endoscopic instruments through the biopsy port cover and irrigate at the same time. The Uretero1TM Single-Use Digital Flexible Ureteroscope must be used in conjunction with the Vision1™ Imaging Console and Display System (CCU).
In addition to image processing, the CCU supports video connectivity in two additional ways. The user is allowed to mirror image from the CCU to an external display which produces the same image the user sees on the CCU screen on any other compatible display system that accepts HDMI input. In addition, the CCU can accept an HDMI input signal from an external HDMI output and the CCU can act as a dummy display panel for the external HDMI imaging source. There are two USB data ports to provide data export (photos and video taken during procedure) or allow connection of selected accessories (printer). No data, including Electronic Protected Health Information (ePHI) data is stored on this device (e.g., last name, SSN, DOB, MRN) and there is no ethernet, Wi-Fi or Blue Tooth capability.
The ureteroscope will be offered in two different models: UreterolTM Ureteroscope (Standard Deflection) and UreterolTM Ureteroscope (Reverse Deflection). To save procedural photo or video, a proprietary system encrypted USB drive is provided to Customers with the purchase of the CCU. The Vision1™ Imaging Console and Display System communicate with the encrypted USB drive, the Uretero1TM Single-Use Digital Flexible Ureteroscope, and the external printer.
The Uretero1 Ureteroscope System comes packaged with single-use, disposable accessory port cover. The accessory port cover is adjustable and is intended to resist the backflow of fluid around an instrument inserted through the working channel of the ureteroscope. It is designed to facilitate the passage of instruments during a procedure. It has a cap feature to allow instruments to be inserted and secured. A clicking mechanism is used to facilitate the open, semi-closed and closed position of the valve. It also has a side arm y-port with a luer cap to allow for irrigation or other procedural solutions, if needed. This accessory attaches to the instrument port of the Uretero1 Ureteroscope via a distal luer connection.
4. Indications for Use
The single use Uretero1™ Ureteroscope System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
{6}------------------------------------------------
Comparison of Technological Characteristics with the Predicate Device 5.
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | Uretero1™ Ureteroscope SystemK211347 | Uretero1™ UreteroscopeSystem (Modified Device) | Comparison |
|---|---|---|---|
| Intended Use | The single use Uretero1™Ureteroscope System is intendedto be used to visualize organs,cavities and canals in the urinarytract (urethra, bladder,ureter, calyces and renal papillae)via transurethral or percutaneousaccess routes. It can also be usedin conjunction with endoscopicaccessories to perform variousdiagnostic and therapeuticprocedures in the urinary tract. | The single use Uretero1™Ureteroscope System isintended to be used to visualizeorgans, cavities and canals inthe urinary tract (urethra,bladder,ureter, calyces and renalpapillae) via transurethral orpercutaneous access routes. Itcan also be used in conjunctionwith endoscopic accessories toperform various diagnostic andtherapeutic procedures in theurinary tract. | Identical |
| UreteroscopeConstruction /Components | HandleArticulation LeverHandle ButtonAccessory PortIrrigation PortConnector CableConnector Cable PlugFlexible ShaftArticulation SectionDistal Tip (camera, illuminationoptics, and the working channel,video signal cables, articulationwires and light fiber)Instrument ChannelLight (illumination fiber)Camera | HandleArticulation LeverHandle ButtonAccessory PortIrrigation PortConnector CableConnector Cable PlugFlexible ShaftArticulation SectionDistal Tip (camera, illuminationoptics, and the working channel,video signal cables, articulationwires and light fiber)Instrument ChannelLight (illumination fiber)Camera | Identical |
| Monitor Components | FrameTouchscreen with AntiglareUSB PortsScope ConnectorPower ButtonHDMI InHDMI OutUSB Type B PortAD/DC Power Cable | FrameTouchscreen with AntiglareUSB PortsScope ConnectorPower ButtonHDMI InHDMI OutUSB Type B PortAD/DC Power Cable | Identical |
| Sterile/Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| SterilizationAssurance Level | 10-6 | 10-6 | Identical |
| Usage | Single use, disposable | Single use, disposable | Identical |
| Features | Uretero1TM Ureteroscope SystemK211347 | Uretero1TM UreteroscopeSystem (Modified Device) | Comparison |
| Page 3 of 1 | |||
| Functionality | Irrigation capability throughirrigation portAbility to use endoscopic toolsthrough instrument portAbility to record images (pictureand video)Ability to record to external media(USB flash)Audio (notifications to the user) | Irrigation capability throughirrigation portAbility to use endoscopic toolsthrough instrument portAbility to record images (pictureand video)Ability to record to externalmedia (USB flash)Audio (notifications to the user) | Identical |
| UreteroscopeWorking Distance | 2mm – 50mm | 2mm – 50mm | Identical |
| Dimensions | Tip Diameter: 6.6F (2.2mm)Outer Diameter: 9.5F (3.2mm)Instrument Channel internaldiameter: 3.6F (1.2mm) | Tip Diameter: 6.6F (2.2mm)Outer Diameter: 9.5F (3.2mm)Instrument Channel internaldiameter: 3.6F (1.2mm) | Identical |
| Ureteroscope TipDeflection | 270° in both directions | 270° in both directions | Identical |
| Target Population | Patients undergoing a urologicalendoscopic procedure | Patients undergoing a urologicalendoscopic procedure | Identical |
| EnergyUsed/Delivered | None | None | Identical |
| Accessories Provided | Accessory port cover | Accessory port cover | Identical |
| Method ofApplication | Manual | Manual | Identical |
| Software System | The Uretero1TM CCU softwareplatform is based on i.MX8MQprocessor from NXP and LATTICEECP5 FPGA. The ECP5 providesthe camera interface plus ISPfunctionality. The CCU software isbased on Linux board supportpackage provided by NXP. Theboard support package and Linuxdistribution are configured and builtusing YOCTO. The mainfunctionality of the system is tocapture the video from an externalcamera and display it to an externaldisplay. Graphical user interface isdeveloped using QT5. Videopipeline is implemented through g-streamer. | The Uretero1TM CCU softwareplatform is based on i.MX8MQprocessor from NXP andLATTICE ECP5 FPGA. TheECP5 provides the camerainterface plus ISP functionality.The CCU software is based onLinux board support packageprovided by NXP. The boardsupport package and Linuxdistribution are configured andbuilt using YOCTO. The mainfunctionality of the system is tocapture the video from anexternal camera and display it toan external display. Graphicaluser interface is developed usingQT5. Video pipeline isimplemented through a streamer | Identical |
| Features | Uretero1™Ureteroscope System | Uretero1™Ureteroscope System(Modified Device) | Comparison |
| K211347 | |||
| Software Update:Allow unlimitedaddresses for scopedetection. | Has finite number ofaddresses for scopedetection. | Has unlimited addressesfor scope detection. | Similar. No impact onsafety, effectiveness or howthe device is used. Thissoftware change is aconvenience feature for theuser. |
| Software Update:Synchronization check onincoming video frame. | Synchronization checknot performed onincoming video. | Synchronization checkperformed on incomingvideo. | Similar. No impact onsafety, effectiveness or howthe device is used by theuser. Change is intended toincrease manufacturability. |
| Software Update:Modification in ImageSignal Processing (ISP) | Image Signal Processing(ISP) utilizes an externalclock source as a rootclock. | Image Signal Processing(ISP) utilizes an internalclock source as a rootclock | Similar. No impact onsafety, effectiveness or howthe device is used by theuser. Change is intended toincrease manufacturability. |
| Software Update:Modification in behaviorof HDMI output toexternal monitors | Use of an incompatiblemonitor causes a "stutter"effect. | Use of an incompatiblemonitor results in novideo from theureteroscope. | Different. No impact onsafety, effectiveness or howthe device is used by theuser. The Uretero1 Systemallows a user to connect amonitor other than theVision1. The change is forthe convenience of the user. |
| Software Update:Turn off scope LED drivewhen the scope is notconnected. | LED drive remains onwhen scope isdisconnected. | LED drive is turned offwhen the scope isdisconnected. | Different. No impact onsafety, effectiveness or howthe device is used by theuser. This change is toextend the life of the LEDdriver chip. |
| Software Update:Update initialization forHardware Chip | Error checks performedonly at boot up | Additional error checksperformed at boot up andscreen transitions. | Similar. No impact onsafety, effectiveness or howthe device is used by theuser. This change improvesthe boot up performance ofthe system. |
| Software Update:Remove dormantsoftware class objectsfrom memory | Dormant software classobjects remain inmemory. | Dormant software classobjects removed frommemory. | Different. No impact onsafety, effectiveness or howthe device is used by theuser. This change improvesmemory usage of thesystem. |
| Software Update:Update the Uretero1System application toeliminate the digitalartifact | Sensor registers are notmonitored once they areset. | Sensor registers areconstantly monitoredonce they are set. | Different. No impact onsafety, effectiveness or howthe device is used by theuser. This change returns thedevice to its originalspecifications. |
| Features | Uretero1TMUreteroscope SystemK211347 | Uretero1TMUreteroscope System(Modified Device) | Comparison |
| Software Update:Provide the user the abilityto disable the scope buttonsin the Settings menu of theconsole. | Scope button is alwaysenabled. | Option given to the userto disable the scopebutton. | Different. This change doesnot impact safety oreffectiveness. This change isfor the convenience of theuser. |
| Software Update:Implement on-screenannotation of Left vs. Rightkidney. | No ability to annotateleft and right kidney. | Ability for user toannotate left and rightkidney. | Different. This change doesnot impact safety oreffectiveness. This change isto aid the user |
| Software Update:Change email addresslisted in HELP menu fromvision1@steris.com tourology@steris.com. | Email address isvision1@steris.com | Email address isurology@steris.com | Different. This change doesnot impact safety,effectiveness or how thedevice is used. The change isfor the convenience of theuser |
| Software Update:Remove the red static text"Insert Thumb drive totake photos or videos" inthe patient data box. | Red static text remainsregardless of whetheror not the thumb drivehas been inserted. | The red static text isremoved. | Different. This change doesnot impact safety,effectiveness or how thedevice is used. The change isfor the convenience of theuser. |
| Software Update:Make the pop-up message"Photo or video not saved,insert USB drive"disappear after 5 seconds,without requiring userintervention. | User intervention isrequired to remove thepop-up message. | User intervention is notrequired to remove thepop-up message. | Different. This change doesnot impact safety,effectiveness or how thedevice is used. The change isfor the convenience of theuser. |
| Software Update:Grey out all languagesexcept English. | All languages appearavailable. | Only English appearsavailable. | Different. This change doesnot impact safety,effectiveness or how thedevice is used. The change isfor the convenience of theuser. |
| Software Update:Refactor device powerboard software code andGUI software code. | Unoptimized codestructure and memoryusage. | Improved code structureand memory usage. | Different. This change doesnot impact safety,effectiveness or how thedevice is used. |
| Features | Uretero1TMUreteroscope SystemK211347 | Uretero1TMUreteroscope System(Modified Device) | Comparison |
| Software Update:Lock the HDMI outputresolution to 1080p/60. | HDMI output capableof 720p and 1080p | HDMI output capable of1080p/60 | Different. This change doesnot impact safety,effectiveness or how thedevice is used. This change isto ensure monitorcompatibility. |
| Software Update:Provide a selection buttonon the monitor that allowsthe user to print a snapshotof the live view during aprocedure to a printer. | No printer functionalityavailable. | Printer functionalityavailable. | Different. This change doesnot impact safety oreffectiveness, but does havean impact on how the deviceis used. The new button is anadded feature. It's for theconvenience of the user |
| Debug port | Closed | Open | Different. This change doesnot impact safety,effectiveness or how thedevice is used. This change isfor the convenience ofSTERIS technicians. |
| Connector on the console(Gumby) main board | Present | Present | Identical. This change does notimpact safety, effectiveness orhow the device is used. Theoriginal connector is beingreplaced by an alternativesupplier's connector that isidentical in form, fit andfunction. |
| Ureteroscope camerasensor | Present | Present | Similar. Replacement of theoriginal camera sensor with asimilar one due toobsolescence. |
| Ureteroscope tip adhesive | Loctite 4902 | Loctite 4311 | Similar. This change does notimpact safety, effectiveness orhow the device is used.Change is intended to increasemanufacturability |
Table 1. Technological Characteristics Comparison Table
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| Features | Uretero1TM | Uretero1TM | Comparison | |
|---|---|---|---|---|
| Ureteroscope SystemK211347 | Ureteroscope System(Modified Device) | |||
| Distal end ofureteroscopeadhesive. | No adhesive in the gapat the distal end | Adhesive (Dymax)added to gap at distalend. | Different. This change does not impactsafety, effectiveness or how the deviceis used. This change is for aestheticsonly. | |
| Insertion Tube toHandle Adhesive | Loctite 4902 | Loctite 4311 | Similar. This change does not impactsafety, effectiveness or how the deviceis used. Change is intended to increasemanufacturability | |
| InstrumentChannel to LuerAdhesive | Loctite 4902 | Loctite 4311 | Similar. This change does not impactsafety, effectiveness or how the deviceis used. Change is intended to increasemanufacturability | |
| Light Fiber andLight FiberBracket Adhesive | Loctite 4902 | Loctite 3321 | Similar. This change does not impactsafety, effectiveness or how the deviceis used. Change is intended to increasemanufacturability | |
| Tip to Shaft(Backbone)Adhesive | Loctite EA 9017 | Loctite EA M-31 CL | Similar. This change does not impactsafety, effectiveness or how the deviceis used. Change is intended to increasemanufacturability. | |
| Features | Uretero1™ UreteroscopeSystem K211347 | Uretero1™ UreteroscopeSystem (Modified Device) | Comparison | Page |
| T-LuerDimensions | Tubing Pocketoutside diameter:1.17mmMinimum insidediameter of the T-Luer: 1.49mm | Tubing Pocket outsidediameter: 1.19mmMinimum inside diameterof the T-Luer: 1.59mm | Similar. These changes do not impactsafety, effectiveness or how thedevice is used. This change addressesthe possibility that a user couldencounter difficulties in passinginstruments through the channel. | |
| Light bracket holedimension | 0.51mm | 0.58mm | Similar. This change does not impactsafety, effectiveness or how thedevice is used. Change is intended toincrease manufacturability | |
| Shaft retentionbracketdimension | 11mm | 8mm | Similar. This change does not impactsafety, effectiveness or how thedevice is used. Change is intended toincrease manufacturability | |
| Power cordlength dimension | 3.5 feet | 10 feet | Similar. This change does not impactsafety, effectiveness or how thedevice is used. Change is for theconvenience of the user. | |
| Labeling Changes | "Manufactured for"not present on thedevice labels | "Manufactured for" presenton device labels. | Different. This change does notimpact safety, effectiveness or howthe device is used. | |
| Insertion tube outerdiameter nominaldimensions: 9.5FR(3.23mm) | Insertion tube outerdiameter nominaldimensions: 8.9FR(2.98mm) | Different. This change does notimpact safety, effectiveness or howthe device is used. It is informationfor the user. | ||
| Information notpresent. | Provide the followinginformation directly on thelabel.• Maximum InsertionPortion Diameter: 3.23mm• Angle of Deflection: -275° - +275°• Working length: 680mm | Different. This change does notimpact safety, effectiveness or howthe device is used. It is informationfor the user. | ||
| Information notpresent. | Added a description of thescreen icons for theMultifunction ScopeFunction button and forKidney Location (forannotating "left" or "right"kidney). Also, addedinstruction for annotating"left" or "right" on themonitor screen and anysaved images or video | Different. This change does notimpact safety, effectiveness or howthe device is used. It is informationfor the user. | ||
| Expiration dating | 3 months | 3 years | Different. This change does notimpact safety, effectiveness or howthe device is used. |
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6. Summarv of Non-Clinical Performance Testing
| Change Type | Testing Type | Results | Standard | FDA Guidance |
|---|---|---|---|---|
| Software | Functional and Regression Testing | Pass | IEC 62304:2006/A1:2016 | Not applicable |
| Optical ColorPerformance Testing | Pass | Not applicable | Not applicable | |
| White Balance Testing | Pass | Not applicable | Not applicable | |
| HardwareChanges | Optical PerformanceTesting | Pass | ISO 8600-3:2019ISO 8600-5:2020ISO 12233:2017ISO 9039:2008ISO 15739:2017 | Not applicable |
| Review of Prior Testing | Pass | Not applicable | Not applicable | |
| Software RegressionTesting | Pass | IEC 62304:2006/A1:2016 | Not applicable | |
| MaterialChange(Adhesive) | Workmanship,functionality andperformance | Pass | Not applicable | Not applicable |
| Biocompatibility | Pass | ISO 10993-1:2018 | Not applicable | |
| DimensionalChanges | Device passage, lumenoutput and tensile testing | Pass | Not applicable | Not applicable |
| Electrical Testing | Pass | IEC 60601-1:2012 | Not applicable | |
| LabelingChanges | Labeling Review | Pass | ISO 15223-1: | Not applicable |
| Extension ofExpiration Date | Functional/performancetesting | Pass | Not applicable | Not applicable |
| Packaging testing | Pass | ASTM F1886ASTM F2096ASTM F88 | Not applicable |
Non-clinical testing consisted of the following:
*Please note that all prior implemented changes were evaluated for their 510(k) implication in accordance with FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device'
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe and effective as and substantially equivalent to the legally marketed predicate device (K211347).
§ 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.