(204 days)
Not Found
No
The description focuses on standard image processing, hardware components, and basic software functionalities like timers and notifications. There is no mention of AI, ML, or any advanced image analysis or decision-making capabilities that would typically indicate the presence of such technologies.
Yes
The device's "Intended Use / Indications for Use" states that it "can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract." The device description mentions a working channel to "allow surgical accessories and procedural solutions to be delivered through the distal tip to the surgical field," further indicating its role in therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract." The primary function of visualizing internal organs and collecting images/videos also serves a diagnostic purpose.
No
The device description clearly outlines hardware components including the ureteroscope itself (flexible shaft, handle, articulation lever, working channel, ports), the Camera Control Unit (CCU) which contains a processor, FPGA, and other electronics, and the required physical connection between the ureteroscope and the CCU. While software is a critical part of the system (image processing, GUI, timer), it is inextricably linked to and dependent on the described hardware for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to visualize organs, cavities, and canals in the urinary tract and to perform 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 system that provides a live image of the urinary tract. It is used for direct visualization and to facilitate procedures within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnostic purposes. This device does not process or analyze such specimens.
The device is an endoscopic system used for direct visualization and intervention within the patient's urinary tract, which falls under the category of medical devices used for in vivo procedures, not IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 to 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 Uretero1™ 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 OT5. 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 ther 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: Uretero1TM Ureteroscope (Standard Deflection) and Uretero1TM 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.
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:
- Width of Insertion Portion (Distal Face) - Pass
- Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) - Pass
- Working Length - Pass
- Working Channel Length - Pass
- Deflection Direction Marking (Visual test) - Pass
- Printing Legibility (Visual test) - Pass
- Ink Integrity (Handle Print Adhesion/Legibility – Visual test) - Pass
- Surface and Edges (Visual test) - Pass
- Maximum Angle of Deflection - Pass
- Bend Radius - Pass
- Direction of View - Pass
- Image Orientation - Pass
- Image Latency - Pass
- Lumen Output - Pass
- Lever Deflection Force - Pass
- Working Channel Freedom from Leakage - Pass
- Aspiration Flow/Working Channel Collapse - Pass
- Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) - Pass
- Aspiration Flow/Working Channel Collapse (Scope and Accessory Cap (accessory port cover)) - Pass
- Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) - Pass
- Button Resistance after Conditioning - Pass
- Minimum Working Distance after Conditioning - Pass
- Image Latency after Conditioning - Pass
- Lumen Output after Conditioning - Pass
- Lever Deflection Force after Conditioning - Pass
- Working Channel Freedom from Leakage (Scope and Accessory) after Conditioning - Pass
- Torsional Resistance at Tip - Pass
- Tip Column Strength - Pass
- Shaft to Handle Tensile Strength - Pass
- Umbilicus to Handle Tensile Strength - Pass
- Umbilicus to Connector Tensile Strength - Pass
- Tip to Shaft Tensile Strength - Pass
- Critical Shaft Bend Radius - Pass
- 3-Point Bend (Shaft Flexural Resistance) - Pass
- Single Use Device Handle Temp. During Procedure - Pass
- Control Body must be able to change the axis of tip deflection - Pass
- Single Use Device Use Time Tracking/ Single Use Device Remaining Use Time - Pass
- Button Functions - Pass
- Laser Aiming Beam/Laser Lithotripsy Compatibility - Pass
- Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) – Testing conducted after 3-month accelerated aging - Pass
- Image Latency - Testing conducted after 3-month accelerated aging - Pass
- Lumen Output - Testing conducted after 3-month accelerated aging - Pass
- Maximum Angle of Deflection - Testing conducted after 3-month accelerated aging - Pass
- Bend Radius - Testing conducted after 3-month accelerated aging - Pass
- Lever Deflection Force - Testing conducted after 3-month accelerated aging - Pass
- SUD Working Channel Freedom from Leakage (Scope and Accessory Cap) - Testing conducted after 3-month accelerated aging - Pass
- Shaft to Handle Tensile Strength - Testing conducted after 3-month accelerated aging - Pass
- Umbilicus to Handle Tensile Strength - Testing conducted after 3-month accelerated aging - Pass
- Umbilicus to Connector Tensile Strength - Testing conducted after 3-month accelerated aging - Pass
- Connector Retention Strength - Testing conducted after 3-month accelerated aging - Pass
- Tip to Shaft Tensile Strength - Testing conducted after 3-month accelerated aging - Pass
- Shaft Leakage conducted after 3-month accelerated aging - Pass
- Radiopacity Testing - Pass
- Luer Testing - Pass
- Accessory Channel Minimum Width Assessment - Pass
- Handle to Active Deflection Torque Angle at Break - Pass
- Packaging Age Testing (Integrity and Seal Strength) - Pass
- Software verification and validation - Pass
- Radiopacity Testing - Pass
- Working Channel Connection Compatibility - Pass
- Packaging Integrity - Pass
- Package Seal Strength - Pass
- Software verification and validation - Pass
Biocompatibility of the Uretero1 Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (. All evaluation acceptance criteria were met.
Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3.1, IEC 60601-1-2 (2014) Edition 4, IEC 60601-1-6 (2010), Edition 3.1 and IEC 60601-2-18:2009 Edition 3. All evaluation acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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November 23, 2021
STERIS Corporation Caroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060
Re: K211347
Trade/Device Name: Ureterol Ureteroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: FGB Dated: October 25, 2021 Received: October 27, 2021
Dear Caroll 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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, 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) K211347
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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K211347 Page 1 of 7
510(k) Summary for the Uretero1TM 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
April 30, 2021 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
LithoVue System, K153049
3. 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 to 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 Uretero1™ 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 OT5. 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
5
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 ther 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: Uretero1TM Ureteroscope (Standard Deflection) and Uretero1TM 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.
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
5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | LithoVue System
Predicate Device
K153049 | Uretero1™ Ureteroscope
System (Proposed
Device) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LithoVue 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
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 | Similar. The predicate
device does not have a
handle button to allow
the user to take photos,
record video or zoom
in/out. This does not
affect safety and
effectiveness in that this
feature in the proposed
device gives the user
options to capture data. |
| Monitor Components | Frame
Touchscreen
Scope Connector
AD/DC Power Cable
DVI Input | Frame
Touchscreen with
Antiglare
USB Ports
Scope Connector
Power Button
HDMI In
HDMI Out
USB Type B Port
AD/DC Power Cable | Similar. The DVI
Digital Visual Interface
of the predicate is
similar to the HDMI
Output of Uretero1 as
they both allow transfer
of video signal to an
external display. The
HDMI input allows a
user to display image
from an external display |
| Features | LithoVue System
Predicate Device
K153049 | Uretero1™ Ureteroscope
System (Proposed
Device) | Comparison |
| Sterile/Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization Assurance
Level | 106 | 106 | Identical |
| Usage | Single use, disposable | Single use, disposable | Identical |
| Functionality | Irrigation capability
through irrigation port
Ability to use endoscopic
tools through instrument
port. | 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) | Similar. The listed
differences between the
proposed and predicate
devices do not impact
safety/effectiveness of
the device in that the
additional functionality
of the proposed device is
a convenience to the
user. |
| Ureteroscope Working
Distance | 2mm - 50mm | 2mm - 50mm | Identical |
| Dimensions | Max. Width of Insertion
Portion (Distal Face): ≤2.6
mm
Max. Width of Insertion
Portion: ≤3.23 mm
Working Length: 680 ± 2
mm
Minimum Instrument
Channel Width: ≥1.12 mm | Max. Width of Insertion
Portion (Distal Tip): ≤2.6
mm
Max. Width of Insertion
Portion: ≤3.23 mm
Working Length: 680 ± 2
mm
Minimum Instrument
Channel Width: ≥1.12 mm | 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 | None | Accessory port cover | Different. The proposed
device offers an
accessory port cover for
the convenience of the
user. The cover
facilitates the passage of
instruments during a
procedure. |
Table 1. Technological Characteristics Comparison Table
7
8
6. Summary of Non-Clinical Performance Testing
Non-clinical testing consisted of the following:
| Testing | Results |
|---|---|
| Width of Insertion Portion (Distal Face) | Pass |
| Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) | Pass |
| Working Length | Pass |
| Working Channel Length | Pass |
| Deflection Direction Marking (Visual test) | Pass |
| Printing Legibility (Visual test) | Pass |
| Ink Integrity (Handle Print Adhesion/Legibility – Visual test) | Pass |
| Surface and Edges (Visual test) | Pass |
| Maximum Angle of Deflection | Pass |
| Bend Radius | Pass |
| Direction of View | Pass |
| Image Orientation | Pass |
| Image Latency | Pass |
| Lumen Output | Pass |
| Lever Deflection Force | Pass |
| Working Channel Freedom from Leakage | Pass |
| Aspiration Flow/Working Channel Collapse | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) | Pass |
| Aspiration Flow/Working Channel Collapse (Scope and Accessory Cap (accessory port cover)) | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) | Pass |
| Button Resistance after Conditioning | Pass |
| Minimum Working Distance after Conditioning | Pass |
| Image Latency after Conditioning | Pass |
| Lumen Output after Conditioning | Pass |
| Lever Deflection Force after Conditioning | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory) after Conditioning | Pass |
| Torsional Resistance at Tip | Pass |
| Tip Column Strength | Pass |
| Shaft to Handle Tensile Strength | Pass |
| Umbilicus to Handle Tensile Strength | Pass |
| Umbilicus to Connector Tensile Strength | Pass |
| Tip to Shaft Tensile Strength | Pass |
| Critical Shaft Bend Radius | Pass |
| 3-Point Bend (Shaft Flexural Resistance) | Pass |
| Single Use Device Handle Temp. During Procedure | Pass |
| Control Body must be able to change the axis of tip deflection | Pass |
| Single Use Device Use Time Tracking/ Single Use Device Remaining Use Time | Pass |
| Button Functions | Pass |
| Laser Aiming Beam/Laser Lithotripsy Compatibility | Pass |
| Testing | Results |
| Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) – | |
| Testing conducted after 3-month accelerated aging | Pass |
| Image Latency - Testing conducted after 3-month accelerated aging | Pass |
| Lumen Output - Testing conducted after 3-month accelerated aging | Pass |
| Maximum Angle of Deflection - Testing conducted after 3-month | |
| accelerated aging | Pass |
| Bend Radius - Testing conducted after 3-month accelerated aging | Pass |
| Lever Deflection Force - Testing conducted after 3-month accelerated aging | Pass |
| SUD Working Channel Freedom from Leakage (Scope and Accessory Cap) - | |
| Testing conducted after 3-month accelerated aging | Pass |
| Shaft to Handle Tensile Strength - Testing conducted after 3-month | |
| accelerated aging | Pass |
| Umbilicus to Handle Tensile Strength - Testing conducted after 3-month | |
| accelerated aging | Pass |
| Umbilicus to Connector Tensile Strength - Testing conducted after 3-month | |
| accelerated aging | Pass |
| Connector Retention Strength - Testing conducted after 3-month accelerated | |
| aging | Pass |
| Tip to Shaft Tensile Strength - Testing conducted after 3-month accelerated | |
| aging | Pass |
| Shaft Leakage conducted after 3-month accelerated aging | Pass |
| Radiopacity Testing | Pass |
| Luer Testing | Pass |
| Accessory Channel Minimum Width Assessment | Pass |
| Handle to Active Deflection Torque Angle at Break | Pass |
| Packaging Age Testing (Integrity and Seal Strength) | Pass |
| Software verification and validation | Pass |
| Radiopacity Testing | Pass |
| Working Channel Connection Compatibility | Pass |
| Packaging Integrity | Pass |
| Package Seal Strength | Pass |
| Software verification and validation | Pass |
9
Biocompatibility of the Uretero1 Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (. All evaluation acceptance criteria were met.
Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3.1, IEC 60601-1-2 (2014) Edition 4, IEC 60601-1-6 (2010), Edition 3.1 and IEC 60601-2-18:2009 Edition 3. All evaluation acceptance criteria were met.
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K153049), Class II (21 CFR 876.1500), product code FGB.