(92 days)
Not Found
No
The document describes standard image processing and display functionalities, a timer mechanism, and basic user interface features. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent decision-making based on data. The image processing described appears to be for display and recording purposes, not for analysis or interpretation using AI/ML techniques.
Yes
The device is described as being able to be used "in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract." This explicitly states its capability for therapeutic use.
Yes
The Intended Use / Indications for Use section explicitly states that the device can be used "to perform various diagnostic and therapeutic procedures in the urinary tract." The visualization aspect (visualizing organs, cavities, and canals) is a key part of diagnosis.
No
The device is a system that includes both hardware components (ureteroscope, CCU, accessory port cover) and software. While software is integral to the device's function (image processing, display, timer), it is not a software-only medical device.
Based on the provided information, the Uretero1™ Ureteroscope System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to visualize organs, cavities, and canals within the urinary tract and to facilitate diagnostic and therapeutic procedures in vivo (within the living body). This is a direct interaction with the patient's anatomy.
- Device Description: The device is a ureteroscope, which is an endoscopic instrument used to view the urinary tract. It captures images directly from inside the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The Uretero1™ Ureteroscope System does not perform any analysis on such specimens. It is a tool for direct visualization and intervention within the body.
While the device involves image processing and display, this is for the purpose of visualizing the internal anatomy during a procedure, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The single use Uretero1TM 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.
Product codes
FGB
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing consisted of the following:
Software: Functional and Regression Testing (Pass), Optical Color Performance Testing (Pass), White Balance Testing (Pass).
Hardware Changes: Optical Performance Testing (Pass), Review of Prior Testing (Pass), Software Regression Testing (Pass).
Material Change (Adhesive): Workmanship, functionality and performance (Pass), Biocompatibility (Pass).
Dimensional Changes: Device passage, lumen output and tensile testing (Pass), Electrical Testing (Pass).
Labeling Changes: Labeling Review (Pass).
Extension of Expiration Date: Functional/performance testing (Pass), Packaging testing (Pass).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
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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3
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
4
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 System
K211347 | Uretero1™ Ureteroscope
System (Modified Device) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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. | 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. | Identical |
| Ureteroscope
Construction /
Components | Handle
Articulation Lever
Handle Button
Accessory Port
Irrigation Port
Connector Cable
Connector Cable Plug
Flexible Shaft
Articulation Section
Distal Tip (camera, illumination
optics, and the working channel,
video signal cables, articulation
wires and light fiber)
Instrument Channel
Light (illumination fiber)
Camera | Handle
Articulation Lever
Handle Button
Accessory Port
Irrigation Port
Connector Cable
Connector Cable Plug
Flexible Shaft
Articulation Section
Distal Tip (camera, illumination
optics, and the working channel,
video signal cables, articulation
wires and light fiber)
Instrument Channel
Light (illumination fiber)
Camera | Identical |
| Monitor Components | Frame
Touchscreen with Antiglare
USB Ports
Scope Connector
Power Button
HDMI In
HDMI Out
USB Type B Port
AD/DC Power Cable | Frame
Touchscreen with Antiglare
USB Ports
Scope Connector
Power Button
HDMI In
HDMI Out
USB Type B Port
AD/DC Power Cable | Identical |
| Sterile/Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization
Assurance Level | 10-6 | 10-6 | Identical |
| Usage | Single use, disposable | Single use, disposable | Identical |
| Features | Uretero1TM Ureteroscope System
K211347 | Uretero1TM Ureteroscope
System (Modified Device) | Comparison |
| Page 3 of 1 | | | |
| Functionality | Irrigation capability through
irrigation port
Ability to use endoscopic tools
through instrument port
Ability to record images (picture
and video)
Ability to record to external media
(USB flash)
Audio (notifications to the user) | Irrigation capability through
irrigation port
Ability to use endoscopic tools
through instrument port
Ability to record images (picture
and video)
Ability to record to external
media (USB flash)
Audio (notifications to the user) | Identical |
| Ureteroscope
Working Distance | 2mm – 50mm | 2mm – 50mm | Identical |
| Dimensions | Tip Diameter: 6.6F (2.2mm)
Outer Diameter: 9.5F (3.2mm)
Instrument Channel internal
diameter: 3.6F (1.2mm) | Tip Diameter: 6.6F (2.2mm)
Outer Diameter: 9.5F (3.2mm)
Instrument Channel internal
diameter: 3.6F (1.2mm) | Identical |
| Ureteroscope Tip
Deflection | 270° in both directions | 270° in both directions | Identical |
| Target Population | Patients undergoing a urological
endoscopic procedure | Patients undergoing a urological
endoscopic procedure | Identical |
| Energy
Used/Delivered | None | None | Identical |
| Accessories Provided | Accessory port cover | Accessory port cover | Identical |
| Method of
Application | Manual | Manual | Identical |
| Software System | 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 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 a streamer | Identical |
| Features | Uretero1™
Ureteroscope System | Uretero1™
Ureteroscope System
(Modified Device) | Comparison |
| | K211347 | | |
| Software Update:
Allow unlimited
addresses for scope
detection. | Has finite number of
addresses for scope
detection. | Has unlimited addresses
for scope detection. | Similar. No impact on
safety, effectiveness or how
the device is used. This
software change is a
convenience feature for the
user. |
| Software Update:
Synchronization check on
incoming video frame. | Synchronization check
not performed on
incoming video. | Synchronization check
performed on incoming
video. | Similar. No impact on
safety, effectiveness or how
the device is used by the
user. Change is intended to
increase manufacturability. |
| Software Update:
Modification in Image
Signal Processing (ISP) | Image Signal Processing
(ISP) utilizes an external
clock source as a root
clock. | Image Signal Processing
(ISP) utilizes an internal
clock source as a root
clock | Similar. No impact on
safety, effectiveness or how
the device is used by the
user. Change is intended to
increase manufacturability. |
| Software Update:
Modification in behavior
of HDMI output to
external monitors | Use of an incompatible
monitor causes a "stutter"
effect. | Use of an incompatible
monitor results in no
video from the
ureteroscope. | Different. No impact on
safety, effectiveness or how
the device is used by the
user. The Uretero1 System
allows a user to connect a
monitor other than the
Vision1. The change is for
the convenience of the user. |
| Software Update:
Turn off scope LED drive
when the scope is not
connected. | LED drive remains on
when scope is
disconnected. | LED drive is turned off
when the scope is
disconnected. | Different. No impact on
safety, effectiveness or how
the device is used by the
user. This change is to
extend the life of the LED
driver chip. |
| Software Update:
Update initialization for
Hardware Chip | Error checks performed
only at boot up | Additional error checks
performed at boot up and
screen transitions. | Similar. No impact on
safety, effectiveness or how
the device is used by the
user. This change improves
the boot up performance of
the system. |
| Software Update:
Remove dormant
software class objects
from memory | Dormant software class
objects remain in
memory. | Dormant software class
objects removed from
memory. | Different. No impact on
safety, effectiveness or how
the device is used by the
user. This change improves
memory usage of the
system. |
| Software Update:
Update the Uretero1
System application to
eliminate the digital
artifact | Sensor registers are not
monitored once they are
set. | Sensor registers are
constantly monitored
once they are set. | Different. No impact on
safety, effectiveness or how
the device is used by the
user. This change returns the
device to its original
specifications. |
| Features | Uretero1TM
Ureteroscope System
K211347 | Uretero1TM
Ureteroscope System
(Modified Device) | Comparison |
| Software Update:
Provide the user the ability
to disable the scope buttons
in the Settings menu of the
console. | Scope button is always
enabled. | Option given to the user
to disable the scope
button. | Different. This change does
not impact safety or
effectiveness. This change is
for the convenience of the
user. |
| Software Update:
Implement on-screen
annotation of Left vs. Right
kidney. | No ability to annotate
left and right kidney. | Ability for user to
annotate left and right
kidney. | Different. This change does
not impact safety or
effectiveness. This change is
to aid the user |
| Software Update:
Change email address
listed in HELP menu from
vision1@steris.com to
urology@steris.com. | Email address is
vision1@steris.com | Email address is
urology@steris.com | Different. This change does
not impact safety,
effectiveness or how the
device is used. The change is
for the convenience of the
user |
| Software Update:
Remove the red static text
"Insert Thumb drive to
take photos or videos" in
the patient data box. | Red static text remains
regardless of whether
or not the thumb drive
has been inserted. | The red static text is
removed. | Different. This change does
not impact safety,
effectiveness or how the
device is used. The change is
for the convenience of the
user. |
| Software Update:
Make the pop-up message
"Photo or video not saved,
insert USB drive"
disappear after 5 seconds,
without requiring user
intervention. | User intervention is
required to remove the
pop-up message. | User intervention is not
required to remove the
pop-up message. | Different. This change does
not impact safety,
effectiveness or how the
device is used. The change is
for the convenience of the
user. |
| Software Update:
Grey out all languages
except English. | All languages appear
available. | Only English appears
available. | Different. This change does
not impact safety,
effectiveness or how the
device is used. The change is
for the convenience of the
user. |
| Software Update:
Refactor device power
board software code and
GUI software code. | Unoptimized code
structure and memory
usage. | Improved code structure
and memory usage. | Different. This change does
not impact safety,
effectiveness or how the
device is used. |
| Features | Uretero1TM
Ureteroscope System
K211347 | Uretero1TM
Ureteroscope System
(Modified Device) | Comparison |
| Software Update:
Lock the HDMI output
resolution to 1080p/60. | HDMI output capable
of 720p and 1080p | HDMI output capable of
1080p/60 | Different. This change does
not impact safety,
effectiveness or how the
device is used. This change is
to ensure monitor
compatibility. |
| Software Update:
Provide a selection button
on the monitor that allows
the user to print a snapshot
of the live view during a
procedure to a printer. | No printer functionality
available. | Printer functionality
available. | Different. This change does
not impact safety or
effectiveness, but does have
an impact on how the device
is used. The new button is an
added feature. It's for the
convenience of the user |
| Debug port | Closed | Open | Different. This change does
not impact safety,
effectiveness or how the
device is used. This change is
for the convenience of
STERIS technicians. |
| Connector on the console
(Gumby) main board | Present | Present | Identical. This change does not
impact safety, effectiveness or
how the device is used. The
original connector is being
replaced by an alternative
supplier's connector that is
identical in form, fit and
function. |
| Ureteroscope camera
sensor | Present | Present | Similar. Replacement of the
original camera sensor with a
similar one due to
obsolescence. |
| Ureteroscope tip adhesive | Loctite 4902 | Loctite 4311 | Similar. This change does not
impact safety, effectiveness or
how the device is used.
Change is intended to increase
manufacturability |
Table 1. Technological Characteristics Comparison Table
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| Features | Uretero1TM | Uretero1TM | Comparison | |
|---|---|---|---|---|
| Ureteroscope System | ||||
| K211347 | Ureteroscope System | |||
| (Modified Device) | ||||
| Distal end of | ||||
| ureteroscope | ||||
| adhesive. | No adhesive in the gap | |||
| at the distal end | Adhesive (Dymax) | |||
| added to gap at distal | ||||
| end. | Different. This change does not impact | |||
| safety, effectiveness or how the device | ||||
| is used. This change is for aesthetics | ||||
| only. | ||||
| Insertion Tube to | ||||
| Handle Adhesive | Loctite 4902 | Loctite 4311 | Similar. This change does not impact | |
| safety, effectiveness or how the device | ||||
| is used. Change is intended to increase | ||||
| manufacturability | ||||
| Instrument | ||||
| Channel to Luer | ||||
| Adhesive | Loctite 4902 | Loctite 4311 | Similar. This change does not impact | |
| safety, effectiveness or how the device | ||||
| is used. Change is intended to increase | ||||
| manufacturability | ||||
| Light Fiber and | ||||
| Light Fiber | ||||
| Bracket Adhesive | Loctite 4902 | Loctite 3321 | Similar. This change does not impact | |
| safety, effectiveness or how the device | ||||
| is used. Change is intended to increase | ||||
| manufacturability | ||||
| Tip to Shaft | ||||
| (Backbone) | ||||
| Adhesive | Loctite EA 9017 | Loctite EA M-31 CL | Similar. This change does not impact | |
| safety, effectiveness or how the device | ||||
| is used. Change is intended to increase | ||||
| manufacturability. | ||||
| Features | Uretero1™ Ureteroscope | |||
| System K211347 | Uretero1™ Ureteroscope | |||
| System (Modified Device) | Comparison | Page | ||
| T-Luer | ||||
| Dimensions | Tubing Pocket | |||
| outside diameter: | ||||
| 1.17mm | ||||
| Minimum inside | ||||
| diameter of the T- | ||||
| Luer: 1.49mm | Tubing Pocket outside | |||
| diameter: 1.19mm | ||||
| Minimum inside diameter | ||||
| of the T-Luer: 1.59mm | Similar. These changes do not impact | |||
| safety, effectiveness or how the | ||||
| device is used. This change addresses | ||||
| the possibility that a user could | ||||
| encounter difficulties in passing | ||||
| instruments through the channel. | ||||
| Light bracket hole | ||||
| dimension | 0.51mm | 0.58mm | Similar. This change does not impact | |
| safety, effectiveness or how the | ||||
| device is used. Change is intended to | ||||
| increase manufacturability | ||||
| Shaft retention | ||||
| bracket | ||||
| dimension | 11mm | 8mm | Similar. This change does not impact | |
| safety, effectiveness or how the | ||||
| device is used. Change is intended to | ||||
| increase manufacturability | ||||
| Power cord | ||||
| length dimension | 3.5 feet | 10 feet | Similar. This change does not impact | |
| safety, effectiveness or how the | ||||
| device is used. Change is for the | ||||
| convenience of the user. | ||||
| Labeling Changes | "Manufactured for" | |||
| not present on the | ||||
| device labels | "Manufactured for" present | |||
| on device labels. | Different. This change does not | |||
| impact safety, effectiveness or how | ||||
| the device is used. | ||||
| Insertion tube outer | ||||
| diameter nominal | ||||
| dimensions: 9.5FR | ||||
| (3.23mm) | Insertion tube outer | |||
| diameter nominal | ||||
| dimensions: 8.9FR | ||||
| (2.98mm) | Different. This change does not | |||
| impact safety, effectiveness or how | ||||
| the device is used. It is information | ||||
| for the user. | ||||
| Information not | ||||
| present. | Provide the following | |||
| information directly on the | ||||
| label. | ||||
| • Maximum Insertion | ||||
| Portion Diameter: 3.23mm | ||||
| • Angle of Deflection: - | ||||
| 275° - +275° | ||||
| • Working length: 680mm | Different. This change does not | |||
| impact safety, effectiveness or how | ||||
| the device is used. It is information | ||||
| for the user. | ||||
| Information not | ||||
| present. | Added a description of the | |||
| screen icons for the | ||||
| Multifunction Scope | ||||
| Function button and for | ||||
| Kidney Location (for | ||||
| annotating "left" or "right" | ||||
| kidney). Also, added | ||||
| instruction for annotating | ||||
| "left" or "right" on the | ||||
| monitor screen and any | ||||
| saved images or video | Different. This change does not | |||
| impact safety, effectiveness or how | ||||
| the device is used. It is information | ||||
| for the user. | ||||
| Expiration dating | 3 months | 3 years | Different. This change does not | |
| impact safety, effectiveness or how | ||||
| the 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 Color | ||||
| Performance Testing | Pass | Not applicable | Not applicable | |
| White Balance Testing | Pass | Not applicable | Not applicable | |
| Hardware | ||||
| Changes | Optical Performance | |||
| Testing | Pass | ISO 8600-3:2019 | ||
| ISO 8600-5:2020 | ||||
| ISO 12233:2017 | ||||
| ISO 9039:2008 | ||||
| ISO 15739:2017 | Not applicable | |||
| Review of Prior Testing | Pass | Not applicable | Not applicable | |
| Software Regression | ||||
| Testing | Pass | IEC 62304:2006/A1:2016 | Not applicable | |
| Material | ||||
| Change | ||||
| (Adhesive) | Workmanship, | |||
| functionality and | ||||
| performance | Pass | Not applicable | Not applicable | |
| Biocompatibility | Pass | ISO 10993-1:2018 | Not applicable | |
| Dimensional | ||||
| Changes | Device passage, lumen | |||
| output and tensile testing | Pass | Not applicable | Not applicable | |
| Electrical Testing | Pass | IEC 60601-1:2012 | Not applicable | |
| Labeling | ||||
| Changes | Labeling Review | Pass | ISO 15223-1: | Not applicable |
| Extension of | ||||
| Expiration Date | Functional/performance | |||
| testing | Pass | Not applicable | Not applicable | |
| Packaging testing | Pass | ASTM F1886 | ||
| ASTM F2096 | ||||
| ASTM 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).