Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101

K231878 · STERIS Corporation · FGB · Jul 25, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231878
• Device Name: Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
• Applicant: STERIS Corporation
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jul 25, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use digital flexible ureteroscope system; includes ureteroscope and Vision1 Imaging Console (CCU). Ureteroscope features distal tip camera, illumination fiber, working channel for instruments/irrigation, and articulation lever. CCU processes video from ureteroscope for display on external monitors. Used in clinical settings by physicians for urinary tract visualization and procedures. Ureteroscope has 4-hour usage limit with automated countdown notifications. CCU supports image/video capture to encrypted USB. No ePHI storage; no network connectivity. Benefits include sterile, single-use design eliminating reprocessing needs and consistent visualization for diagnostic/therapeutic urological interventions.

Clinical Evidence

Bench testing only. Functional and regression testing, optical color performance testing, and white balance testing were performed to validate software updates. All tests passed.

Technological Characteristics

Single-use flexible ureteroscope with 6.6F tip, 9.5F outer diameter, 3.6F working channel, 270-degree deflection. CCU uses NXP i.MX8MQ processor and LATTICE ECP5 FPGA. Software built with YOCTO/Linux, QT5 GUI, g-streamer video pipeline. Sterilization: Ethylene Oxide (10^-6 SAL). Connectivity: HDMI, USB data export. No wireless/network capability.

Indications for Use

Indicated for patients undergoing urological endoscopic procedures for visualization of the urinary tract (urethra, bladder, ureter, calyces, renal papillae) and performance of diagnostic/therapeutic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Uretero1 Ureteroscope System (K223466)

Submission Summary (Full Text)

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July 25, 2023

STERIS Corporation Carroll Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060

Re: K231878

> Trade/Device Name: Uretero1TM Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: June 23, 2023 Received: June 26, 2023

Dear Carroll 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 ([e-mail]) or phone [phone] 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) K231878

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)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M5.44444 11.8889L14.2222 3.11108L12.8889 1.77776L5.44444 9.22221L3.11111 6.88888L1.77778 8.22221L5.44444 11.8889Z" fill="black" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="0.533333"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="13.3333" stroke="black" stroke-width="0.533333" width="13.3333" x="1.33325" y="1.33325"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K231878

Page 1 of 7

# 510(k) Summary for the Uretero1™ Ureteroscope System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

| Contact: | Carroll Martin |
|------------------|----------------------------------|
| | Regulatory Affairs Director |
| | Tel: [phone] |
| | Email: [e-mail] |
| Submission Date: | July 19, 2023 |
| 510(k) : | K231878 |

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 1. Device Name

| Trade Name: | Uretero1™ 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, K223466 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 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 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

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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 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.

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.

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#### 5. Comparison of Technological Characteristics with the Predicate Device

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

| Features | Uretero1™ Ureteroscope<br>System K223466 | Uretero1™ Ureteroscope<br>System Modified Device | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The single use Uretero1™<br>Ureteroscope System is<br>intended to be used to visualize<br>organs, cavities and canals in<br>the urinary tract (urethra,<br>bladder, ureter, calyces and<br>renal papillae) via transurethral<br>or percutaneous access routes. It<br>can also be used in conjunction<br>with endoscopic accessories to<br>perform various diagnostic and<br>therapeutic procedures in the<br>urinary tract. | The single use Uretero1™<br>Ureteroscope System is<br>intended to be used to visualize<br>organs, cavities and canals in<br>the urinary tract (urethra,<br>bladder, ureter, calyces and<br>renal papillae) via transurethral<br>or percutaneous access routes.<br>It can also be used in<br>conjunction with endoscopic<br>accessories to perform various<br>diagnostic and therapeutic<br>procedures in the urinary tract. | Identical |
| Ureteroscope<br>Construction /<br>Components | Handle<br>Articulation Lever<br>Handle Button<br>Accessory Port<br>Irrigation Port<br>Connector Cable<br>Connector Cable Plug<br>Flexible Shaft<br>Articulation Section<br>Distal Tip (camera, illumination<br>optics, and the working channel,<br>video signal cables, articulation<br>wires and light fiber)<br>Instrument Channel<br>Light (illumination fiber)<br>Camera | Handle<br>Articulation Lever<br>Handle Button<br>Accessory Port<br>Irrigation Port<br>Connector Cable<br>Connector Cable Plug<br>Flexible Shaft<br>Articulation Section<br>Distal Tip (camera, illumination<br>optics, and the working channel,<br>video signal cables, articulation<br>wires and light fiber)<br>Instrument Channel<br>Light (illumination fiber)<br>Camera | Identical |
| Monitor Components | Frame<br>Touchscreen with Antiglare<br>USB Ports<br>Scope Connector<br>Power Button<br>HDMI In<br>HDMI Out<br>USB Type B Port<br>AD/DC Power Cable | Frame<br>Touchscreen with Antiglare<br>USB Ports<br>Scope Connector<br>Power Button<br>HDMI In<br>HDMI Out<br>USB Type B Port<br>AD/DC Power Cable | Identical |
| Sterile/Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization Assurance<br>Level | 10-6 | 10-6 | Identical |
| Usage | Single use, disposable | Single use, disposable | Identical |
| Features | Uretero1™ Ureteroscope<br>System K223466 | Uretero1™ Ureteroscope<br>System Modified Device | Page<br>Comparison |
| Functionality | Irrigation capability through<br>irrigation port<br>Ability to use endoscopic tools<br>through instrument port<br>Ability to record images (picture<br>and video)<br>Ability to record to external<br>media (USB flash)<br>Audio (notifications to the user) | Irrigation capability through<br>irrigation port<br>Ability to use endoscopic tools<br>through instrument port<br>Ability to record images (picture<br>and video)<br>Ability to record to external<br>media (USB flash)<br>Audio (notifications to the user) | Identical |
| Ureteroscope Working<br>Distance | 2mm – 50mm | 2mm – 50mm | Identical |
| Dimensions | Tip Diameter: 6.6F (2.2mm)<br>Outer Diameter: 9.5F (3.2mm)<br>Instrument Channel internal<br>diameter: 3.6F (1.2mm) | Tip Diameter: 6.6F (2.2mm)<br>Outer Diameter: 9.5F (3.2mm)<br>Instrument Channel internal<br>diameter: 3.6F (1.2mm) | Identical |
| Ureteroscope Tip<br>Deflection | 270° in both directions | 270° in both directions | Identical |
| Target Population | Patients undergoing a urological<br>endoscopic procedure | Patients undergoing a urological<br>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 Uretero1™ CCU software<br>platform is based on i.MX8MQ<br>processor from NXP and<br>LATTICE ECP5 FPGA. The<br>ECP5 provides the camera<br>interface plus ISP functionality.<br>The CCU software is based on<br>Linux board support package<br>provided by NXP. The board<br>support package and Linux<br>distribution are configured and<br>built using YOCTO. The main<br>functionality of the system is to<br>capture the video from an<br>external camera and display it to<br>an external display. Graphical<br>user interface is developed using<br>QT5. Video pipeline is<br>implemented through g-streamer. | The Uretero1™ CCU software<br>platform is based on i.MX8MQ<br>processor from NXP and<br>LATTICE ECP5 FPGA. The<br>ECP5 provides the camera<br>interface plus ISP functionality.<br>The CCU software is based on<br>Linux board support package<br>provided by NXP. The board<br>support package and Linux<br>distribution are configured and<br>built using YOCTO. The main<br>functionality of the system is to<br>capture the video from an<br>external camera and display it to<br>an external display. Graphical<br>user interface is developed using<br>QT5. Video pipeline is<br>implemented through g-<br>streamer. | Identical |
| Printer Compatible | Yes | Yes | Identical |
| Expiration Date | 3 years | 3 years | Identical |
| Features | Ureterol™ Ureteroscope<br>System K223466 | Ureterol™ Ureteroscope System<br>Modified Device | Comparison |
| Software Update<br>Update the software to<br>increase the number of<br>queries to the image<br>sensor (5 - 50). | Only 5 queries made to the<br>image sensor when the<br>scope is first plugged in | 50 queries made to the<br>image sensor when the<br>scope is first plugged in. | Similar. Queries to the<br>image sensor are still made<br>when the scope is first<br>plugged in but increasing<br>the number from 5 to 50<br>improves ISP boot<br>reliability. This change has<br>no impact on safety,<br>effectiveness or how the<br>device is used. |
| Software Update<br>Update to the software<br>to allow it to read the<br>calibration data of the<br>lumen output of the<br>scope LED. | The software in the<br>predicate could not read the<br>calibration data. | The software in the<br>subject device can read<br>the calibration data. | Different. This feature<br>allows the lumen<br>calibration algorithm to use<br>the calibration data stored<br>on the ureteroscope to<br>achieve a target<br>illumination level, thereby<br>achieving consistent<br>performance across<br>different ureteroscopes.<br>This change has no impact<br>on safety, effectiveness or<br>how the device is used. |
| Software Update<br>Update the software to<br>return the default LED<br>current to 400mA | The software in the<br>predicate could not address<br>the issue of the default LED<br>current. | The software in the<br>subject device has the<br>ability to return the<br>default LED current to<br>400mA | Different. This change is<br>intended to return the<br>device to its original design<br>specification. This change<br>has no impact on safety,<br>effectiveness or how the<br>device is used. |
| Software Update<br>Update the software to<br>set the default LED<br>brightness from 70% to<br>40%. | Default LED brightness set<br>at 70% | Default LED brightness<br>set at 40% | Different. This change was<br>implemented due to<br>customer preference. This<br>change has no impact on<br>safety, effectiveness or how<br>the device is used. |
| Software Update<br>Update the software to<br>address a yellowing<br>effect | A yellowing effect occurred<br>on the device monitor. | A yellowing effect does<br>not occur on the device<br>monitor | Different. This change was<br>implemented because a<br>yellowing effect occurred<br>with the predicate device in<br>instances of a high<br>concentration of red objects<br>(blood). The removal of the<br>yellowing effect is a<br>customer preference. This<br>change has no impact on<br>safety, effectiveness or how<br>the device is used. |

## Table 1. Technological Characteristics Comparison Table

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#### 6. Summary of Non-Clinical Performance Testing

| Change Type | Testing Type | Results | Standard | FDA Guidance |
|-------------|--------------------------------------|---------|----------------------------------------------------------------------------------------------------------------|----------------|
| Software | Functional and<br>Regression Testing | Pass | ES60601-1:2005/(R)2012<br>& A1:2012,<br>C1:2009/(R)2012 &<br>A2:2010/(R)2012 (Cons.<br>Text) [Incl. AMD2:2021] | Not applicable |
| | Optical Color<br>Performance Testing | Pass | Not applicable | Not applicable |
| | White Balance Testing | Pass | Not applicable | Not applicable |

Non-clinical testing consisted of the following:

#### 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 (K223466).