Stellar Imaging System

K241530 · Guangdong Optomedic Technologies, Inc. · GCJ · Aug 7, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241530
• Device Name: Stellar Imaging System
• Applicant: Guangdong Optomedic Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures. Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts. Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Story

Stellar Imaging System provides real-time visible and near-infrared (NIR) fluorescence imaging for minimally invasive surgery. System components include an image processing unit, light source, camera heads (2D/3D, fluorescence/non-fluorescence), laparoscope, and exoscope. The light source emits visible light and NIR laser (805 nm) to excite ICG dye in the surgical field. Camera heads capture emission signals; the processing unit displays white light and fluorescence images in parallel to the surgeon. Used in hospitals by physicians to visualize blood flow, tissue perfusion, bile ducts, and lymphatic structures. Output aids intraoperative decision-making by providing anatomical and physiological visualization. Supports recording and playback of procedures.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified through compliance with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60825-1, and IEC 62471. Cleaning and reprocessing validation performed per AAMI ST98 and AAMI TIR 12:2020.

Technological Characteristics

System includes image processing unit, LED/laser light source, CMOS camera heads, and laparoscope/exoscope. NIR excitation at 805 nm. Connectivity via DVI, HDMI, 3G-SDI, 12G-SDI. Sterilization: low-temperature plasma for camera heads, autoclave for light guide cables. Electrical safety: Class I, CF-type. Laser classification: Class 3R. LED classification: Risk Group 2.

Indications for Use

Indicated for patients undergoing minimally invasive procedures requiring real-time visible and near-infrared fluorescence imaging for visualization of vessels, blood flow, tissue perfusion, extra-hepatic bile ducts, and the lymphatic system (vessels/nodes) using ICG dye.

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

• FloNavi Endoscopic Fluorescence Imaging System (K221861)

Reference Devices

• 3DHD Video Camera System (K101810)

Submission Summary (Full Text)

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August 7, 2024 Guangdong OptoMedic Technologies, Inc. Minghua Wu Regulatory Affairs Engineer Suite 503, Building A. Golden Valley Intellicreation Community, No. 2 Yonganbei Street Foshan, 528200 China

Re: K241530

Trade/Device Name: Stellar Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: Mav 29, 2024 Received: May 30, 2024

Dear Minghua Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

for

Yan Fu -S Digitally signed by Yan Fu -S
Date: 2024.08.07 11:03:48
-04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K241530

Device Name Stellar Imaging System

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> <span style="text-decoration: underline;"></span> <span style="text-decoration: line-through;"></span> <span style="font-family: DejaVu Sans, sans-serif;">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="text-decoration: underline;"></span> <span style="text-decoration: line-through;"></span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Indications for Use (Describe)

UseStellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

FORM FDA 3881 (8/23)

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PRAStaff(@fda.hhs.gov

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Image /page/3/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circle on the left, followed by the word "OptoMedic" in black, bold letters. The circle is a gradient of green and yellow, with the green on the bottom and the yellow on the top.

# 510(k) Summary K241530

# Prepared in accordance with the requirements of 21 CFR Part 807.92

The assigned 510(k) Number: K241530

Date Prepared: July 26, 2024

### I. General Information

| 510(k) Submitter/Owner: | Guangdong OptoMedic Technologies, Inc. |
|---------------------------|-----------------------------------------------------------------|
| | Suite 503, Building A, Golden Valley Intellicreation Community, |
| | No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai, Foshan, |
| | Guangdong, 528200, P.R. China |
| | Establishment Registration Number: 3029968414 |
| Primary Contact Person: | Minghua Wu |
| | Regulatory Affairs Engineer |
| | Tel: [phone] |
| | Email: [e-mail] |
| Secondary Contact Person: | Weijuan Guo |
| | Regulatory Affairs Engineer |
| | Tel: [phone] |
| | Email: [e-mail] |

## II. Device Identification

| Device Trade Name: | Stellar Imaging System |
|-----------------------|--------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Stellar Imaging System |
| Model: | Stellar Image Processing Unit:SI10E |
| | Stellar Camera Head: SC10E |
| | Stellar Fluorescence Camera Head: SC20E |
| | Stellar3D 3D Camera Head: SC10D |
| | Stellar3D 3D Fluorescence Camera Head: SC20D |
| | Stellar Exoscope: 31103FA |
| | Stellar Light Source: SL10 |
| | Stellar Light Source: SL20 |
| | OptoMedic Laparoscope: 21033FA, 21033FC,<br>21033WA, 21033WC, 20533FA, 20533FC,<br>20533WA, 20533WC(K231003) |
| | Stellar3D Laparoscope 21033SA,21033SC |

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Image /page/4/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the word "OptoMedic" in black, bold font. The circular graphic has a gradient of green and yellow, with the green being darker at the bottom and the yellow being lighter at the top.

Regulation Name: Regulation Number: Regulatory Class: Product Code:

Endoscope and accessories 21 CFR § 876.1500 Class II GCJ

### III. Predicate Device

Table 1 Predicate device and reference device

| Item | Predicate device | Reference device |
|----------------|------------------------------------------------------|-----------------------------|
| 510(k) Number: | K221861 | K101810 |
| Product Name: | FloNavi Endoscopic<br>Fluorescence Imaging<br>System | 3DHD Video<br>Camera System |

## IV. Device Description

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope, Exoscope and relevant accessories.

During surgical procedures, Stellar Imaging System is used to provide real-time visible and fluorescence imaging similar to that provided by conventional imaging system used in endoscopic surgery and innovative 3D visible and fluorescence imaging in endoscopic surgery. Besides, Stellar Imaging System is also used to provide real-time fluorescence confirmation in open field.

The Stellar Imaging System including the laparoscope and the exoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using a camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

### V. Indications for Use

Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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Image /page/5/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circle on the left, with the word "OptoMedic" in black letters to the right of the circle. The circle is a gradient of green, with the top being a lighter shade of green and the bottom being a darker shade of green. The word "OptoMedic" is in a sans-serif font.

.

# VI. Comparison of Technological Characteristics with The Predicate Device

| Comparison items | Subject Device | Predicate Device (K221861) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR § 876.1500 | 21 CFR § 876.1500 |
| Product Code | GCJ | GCJ |
| Device class | Class II | Class II |
| Type of use | Prescription Use | Prescription Use |
| Intended use & Indication<br>for use | Stellar Imaging System is intended<br>to provide real-time visible and<br>near-infrared imaging in minimally<br>invasive procedures.<br>Upon intravenous administration<br>and use of an ICG agent consistent<br>with its approved label, Stellar<br>Imaging System is used to perform<br>fluorescence imaging visualization<br>of vessels, blood flow and related<br>tissue perfusion, and at least one of<br>the major extra-hepatic bile ducts.<br>Upon interstitial administration and<br>use of an ICG agent consistent with<br>its approved label, the Stellar<br>Imaging System is used to perform<br>intraoperative<br>fluorescence<br>imaging and visualization of the<br>lymphatic system, including<br>lymphatic vessels and lymph nodes. | Upon intravenous<br>administration and use of an<br>ICG consistent with its<br>approved label, the FloNavi<br>Endoscopic Fluorescence<br>Imaging System is intended to<br>provide real-time endoscopic<br>visible and near-infrared<br>fluorescence imaging. During<br>minimally invasive surgery, the<br>FloNavi Endoscopic<br>Fluorescence Imaging System<br>enables surgeons to perform<br>minimally invasive surgery<br>using standard endoscopic<br>visible light as well as visual<br>assessment of vessels, blood<br>flow and related tissue<br>perfusion, and at least one of the<br>major extra-hepatic bile ducts,<br>using near-infrared imaging.<br>Upon interstitial administration<br>and use of an ICG consistent<br>with its approved label, the<br>FloNavi Endoscopic<br>Fluorescence Imaging System is<br>used to perform intraoperative<br>fluorescence imaging and<br>visualization of the lymphatic<br>system, including lymphatic<br>vessels and lymph nodes. |
| Applicable user | Physicians | Physicians |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single use /Reusable | Reusable | Reusable |
| Sterile /nonsterile | Marketed as non-sterile | Marketed as non-sterile |

Table 2 General Comparison with predicate device

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Image /page/6/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular design on the left, followed by the word "OptoMedic" in a bold, sans-serif font. The word is black, and the letters are closely spaced together.

| Device System<br>components | | - Image Processing Unit<br>- Camera Head<br>- Light Source<br>-Laparoscope<br>- Light Guide Cable | - Image Processing Unit<br>- Camera Head<br>- Light Source<br>-Laparoscope<br>- Light Guide Cable |
|----------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Image<br>processing<br>Unit<br>(SI10E) | Video output<br>signals | DVI, HDMI, 4×3G-SDI, 12G-SDI | OPTO-CAM214K: DVI,<br>HDMI, 4×3G-SDI, 12G-SDI<br>OPTO-CAM 2100: SDI, DVI,<br>CVBS, SVIDEO |
| | Video output<br>resolution | 2D: 1920×1080p/<br>UHD(3840x2160)/<br>4K(4096x2160); | OPTO-CAM214K:<br>4096×2160p; 3840×2160p;<br>1920×1080p<br>OPTO-CAM2100: 1920×<br>1080p; 720×576i |
| | Aspect ratio | 16:9 | 16:9 |
| | Electrical<br>Power | 110-240V~, 50/60 Hz, 150VA | 110-240V~, 50/60 Hz, 150VA |
| | Type of<br>protection<br>against<br>electric<br>shock | Class I (as per IEC 60601-1) | Class I (as per IEC 60601-1) |
| Camera<br>Head<br>(SC10E,<br>SC20E) | Sensor | 4K CMOS | 4K CMOS |
| | Aspect ratio: | 16:9 | 16:9 |
| | Ingress of<br>water | IPX7 | IPX7 |
| | Sterilization | Low temperature plasma<br>sterilization | Glutaraldehyde |
| | Imaging<br>mode | SC10E: Support 2D white light<br>imaging.<br>SC10D: Support 3D white light<br>imaging.<br>SC20E: Support 2D white light<br>imaging and fluorescence imaging.<br>SC20D: Support 3D white light<br>imaging and fluorescence imaging. | Support 2D white light imaging<br>and fluorescence imaging. |
| Light<br>source | Light Source | Visible (VIS): Light-emitting diode | Visible (VIS): Light emitting<br>diode array |
| (SL10,<br>SL20) | | Near infrared (NIR): NIR laser diode | Near infrared (NIR): NIR laser diode |
| | Electrical<br>Power | 110-240V~, 50/60 Hz, 200VA | 110-240V~, 50/60 Hz, 200VA |
| | Type of<br>protection<br>against<br>electric shock | Class I (as per IEC 60601-1) | Class I (as per IEC 60601-1) |
| Light<br>source<br>(SL20) | NIR<br>Wavelength: | $805 nm±10 nm$ | $805 nm±10 nm$ |
| | Pulse<br>Pattern: | CW laser | CW laser |
| | Embedded<br>laser source | Class 4, invisible | Class 4, invisible |
| | Laser<br>classification | Class 3R (as per IEC 60825-1) | Class 3R (as per IEC 60825-1) |
| Light<br>source<br>(SL10) | LED<br>classification | RISK GROUP 2<br>400 nm to 780 nm Retinal blue light<br>or thermal hazard (as per IEC/TR 62471-2) | RISK GROUP 2<br>400 nm to 780 nm Retinal blue<br>light or thermal hazard (as per<br>IEC/TR 62471-2) |
| Light<br>guide<br>cable | Transmission<br>spectrum | Visible + NIR | Visible + NIR |
| | Sterilization | Autoclave | Autoclave |
| | Degree of<br>protection<br>against<br>electric<br>shocks | CF-type (as per IEC 60601-1) | CF-type (as per IEC 60601-1) |

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Image /page/7/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular graphic on the left, followed by the text "OptoMedic" in a bold, sans-serif font. The word "Opto" is in a lighter shade of green, while the word "Medic" is in black.

The differences technological characteristics do not raise different questions of safety and effectiveness.

### VII. Performance data

Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device & reference device. The test results demonstrated that the proposed device complies with the following standards:

- ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 Medical Electrical Equipment- Part 1: . General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 Medical electrical equipment Part 1-2: General requirements for • basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment Part 2-18: Particular IEC .

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Image /page/8/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circle on the left side of the word "OptoMedic". The word "OptoMedic" is written in black, bold letters.

requirements for the basic safety and essential performance of endoscopic equipment

- AAMI ST98 Cleaning validation of health care products-Requirements for development and . validation of a cleaning process for medical devices.
- AAMI TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing . in health care facilities: A guide for medical device manufacturers
- IEC 60825-1 Edition 2.0 2007-03 Safety of laser products Part 1: Equipment classification, . and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems .

Performance comparison testing are also conducted on the subject device and predicate/reference device, demonstrate that the proposed system performs according to specifications and functions as intended.

## VIII. Conclusions

The performance testing summarized above supports a substantial equivalence determination. The performance testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device/reference device.