HD-550 Video Endoscope System

K211882 · Sonoscape Medical Corp. · NWB · Apr 1, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211882
• Device Name: HD-550 Video Endoscope System
• Applicant: Sonoscape Medical Corp.
• Product Code: NWB · Gastroenterology, Urology
• Decision Date: Apr 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

Device Story

HD-550 Video Endoscope System comprises flexible video gastroscopes/colonoscopes, image processor, light source, and monitor. System captures real-time video of GI tract via distal CMOS sensor; light source provides illumination. Image processor receives signals, performs image enhancement (WL, EWL, SFI, VIST modes), and outputs video to monitor for physician observation. Used in clinical settings by physicians for diagnosis and treatment of GI conditions. Output enables visual assessment of mucosal surfaces, biopsy, or therapeutic intervention. Benefits include high-definition visualization for improved diagnostic accuracy and procedural guidance.

Clinical Evidence

No clinical data included. Substantial equivalence established via bench testing only, including optical performance (color reproduction, resolution, depth of field, magnification, distortion, intensity uniformity), physical/functional performance (angulation, handle strength, sealing, bending angle), and biocompatibility (cytotoxicity, sensitization, irritation).

Technological Characteristics

System uses CMOS sensor technology for imaging and LED illumination (50W examination, 14W emergency). Materials include PEEK, sapphire crystal, SUS 304, PU, and fluoroelastomer. Connectivity includes DVI, VGA, SDI, CVBS, and S-Video outputs. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, ISO 8600-7, and ISO 10993 standards.

Indications for Use

Indicated for endoscopic examination, diagnosis, and treatment of the upper (esophagus, stomach, duodenum) and lower (anus, rectum, colon, ileocecal segment) gastrointestinal tract in patients requiring endoscopic observation.

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

• HD-500 Video Endoscope System (K173921)

Submission Summary (Full Text)

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April 1, 2022

Sonoscape Medical Corp. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 CHINA

Re: K211882

Trade/Device Name: HD-550 Video Endoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NWB. FDF. FDS Dated: March 25, 2022 Received: March 29, 2022

Dear Diana Hong:

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

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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 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 (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 medical devices and radiation-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,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K211882

Device Name HD-550 Video Endoscope System

### Indications for Use (Describe)

## HD-550 Video Endoscope System

The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

## EG-550 Series Video Gastroscope

The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

## EC-550 Series Video Colonoscope

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

## HD-550 Series Image Processor

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

## VLS-55 Series Light Source

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K211882

- 1. Date of Preparation: 03/28/2022
- 2. Sponsor Identification

## SONOSCAPE MEDICAL CORP.

Client Address: Room 201 & 202, 12 th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2 nd Road, Yuehai Subdistrict, Nanshan District, Shenzhen, 518057, Guangdong, China Establishment Registration Number: 3004705634

Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: HD-550 Video Endoscope System Common Name: Endoscopic Video Imaging System

Primary Components and Component Models:

| HD-550<br>Video<br>Endoscope System | EG-550 Series Video Gastroscope | EG-550, EG-550L |
|-------------------------------------|---------------------------------|--------------------------------------------------------------|
| | EC-550 Series Video Colonoscope | EC-550, EC-550T,<br>EC-550L, EC-550L/T |
| | HD-550 Series Image Processor | HD-550Exp, HD-550, HD-550Pro,<br>HD-550S, HD-510, HD-500Plus |
| | VLS-55 Series Light Source | VLS-55Q, VLS-55T,<br>VLS-51T, VLS-51D |

#### Regulatory Information

Classification Name: Endoscope and accessories Classification: II Product Code: NWB, FDF and FDS Regulation Number: 21 CFR 876.1500 Review Panel: Gastroenterology/Urology

Indications for Use:

HD-550 Video Endoscope System

The HD-550 video endoscope system, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.

#### EG-550 Series Video Gastroscope

The EG-550 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).

#### EC-550 Series Video Colonoscope

The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

#### HD-550 Series Image Processor

The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.

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VLS-55 Series Light Source

The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.

- 5. Device Description
The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.

HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components

The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.

The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.

The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.

- 6. Identification of Predicate Device
510(k) Number: K173921

Product Name: HD-500 Video Endoscope System.

Primary Components and Component Models:

| EG-500 Series Video Gastroscope | EG-500, EG-500L |
|---------------------------------|-------------------------------------|
| EC-500 Series Video Colonoscope | EC-500, EC-500T, EC-500L, EC-500L/T |
| HD-500 Series Image Processor | HD-500, HD-500S, HD-330Plus |
| HDL-500 Series Light Source | HDL-500E, HDL-500X |

#### 7. Non-Clinical Test Conclusion

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

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- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: > General requirements for basic safety and essential performance, including the US National Differences
- > IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- > IEC 60601-2-18:2009. Medical electrical equipment - Part 2-18: Particular reguirements for the basic safety and essential performance of endoscopic equipment
- > ISO 8600-1:2015 Endoscopes--Medical endoscopes and endotherapy devices - part 1: General requirements
- ISO 8600-7:2012 Endoscopes --Medical endoscopes and endotherapy devices part 7: Basic > requirements for medical endoscopes of water-resistant type
- > ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

#### Optical performance testing

The following testing was conducted to evaluate the optical performance characteristics for each endoscopic system mode.

- > Photobiological safety
- A Color Reproduction (test results comparison between the proposed device and predicate device)
- > Resolution (test results comparison between the proposed device and predicate device)
- > Depth of field (test results comparison between the proposed device and predicate device)
- > Optical magnification and distortion (test results comparison between the proposed device and predicate device)
- A Image intensity uniformity (test results comparison between the proposed device and predicate device)

#### Physical/functional performance testing

The endoscope performance test was conducted to evaluate the ability of proposed endoscope to maintain the maximum angulation/deflection when in use, the physical/functional performance of the proposed device, including a) Appearance visual inspection and handle strength inspection, b) Image function visual inspection, c) Sealing performance, and d) Maximum bending angle measurement and body model testing.

#### Imaging performance testing

The imaging performance testing was conducted to demonstrate that the imaging quality of the proposed device is still in a better condition when the device is over its lifetime of clinical use. The degradations of imaging performance are very little which will not affect the normal use of the endoscope.

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- 8. Clinical Test Conclusion
No clinical study is included in this submission.

- 9. Substantially Equivalent (SE) Comparison
The whole system and components of the proposed device is basically identical to its predicate device in indication for use, and similar in specification. Comparisons between the proposed device and predicate device are shown in Table 1 to Table 6.

| ITEM | Proposed Device | Predicate Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K173921 |
| Product Code | NWB, FDF and FDS | NWB, FDF and FDS |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Class | II | II |
| Indications for<br>Use | HD-550 Video Endoscope System<br>The HD-550 video endoscope system,<br>which includes a video gastroscope<br>/video colonoscope, image processor,<br>light source, monitor, accessories and<br>other peripheral devices, is intended for<br>endoscopic examination, diagnosis and<br>treatment of the upper and lower<br>gastrointestinal tract. | HD-500 Video Endoscope System<br>The HD-500 Video Endoscope System,<br>which includes a video gastroscope<br>/video colonoscope, image processor,<br>light source, monitor, accessories and<br>other peripheral devices, is intended for<br>endoscopies examination, diagnosis<br>and treatment of the disease of the<br>upper and lower gastrointestinal tract. |
| | VLS-55 Series Light Source,<br>The VLS-55 Series Light Source has<br>been designed to be used with the<br>endoscope, image processor and other<br>peripheral devices for endoscopic<br>observation, diagnosis and treatment. | HDL-500 Series Light Source,<br>HDL-500E, HDL-500X<br>The HDL-500 Series Light Source has<br>been designed to be used with the<br>endoscope, image processor and other<br>peripheral devices for endoscopic<br>observation, diagnosis and treatment. |
| | HD-550 Series Image Processor,<br>The HD-550 Series Image Processor<br>has been designed to be used with the<br>endoscope, light source, monitor and<br>other peripheral devices for endoscopic<br>observation, diagnosis, treatment, and | HD-500 Series Image Processor,<br>HD-500, HD-500S, HD-330Plus<br>The HD-500 Series Image Processor<br>has been designed to be used with the<br>endoscope, light source, monitor and<br>other peripheral devices for endoscopic |

Table 1 General Comparison

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| | video recording. | observation, diagnosis, treatment, and video recording. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EG-550 Series Video Gastroscope | EG-500 Series Video Gastroscope,<br>EG-500, EG-500L |
| | The EG-550 Series Video Gastroscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the upper digestive tract<br>(including the esophagus, stomach and<br>duodenum). | The EG-500 Series Video Gastroscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the upper digestive tract<br>(including the esophagus, stomach and<br>duodenum). |
| | EC-550 Series Video Colonoscope | EC-500 Series Video Colonoscope,<br>EC-500, EC-500T, EC-500L,<br>EC-500L/T |
| | The EC-550 Series Video Colonoscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the lower digestive tract<br>(including the anus, rectum, colon and<br>ileocecal segment). | The EC-500 Series Video Colonoscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the lower digestive tract<br>(including the anus, rectum, colon and<br>ileocecal segment) |
| Configuration<br>(primary<br>components) | Light Source | Light Source |
| | Image processor | Image processor |
| | Video Gastroscope | Video Gastroscope |
| | Video Colonoscope | Video Colonoscope |
| | Accessories and peripheral devices | Accessories and peripheral devices |

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| ITEM | Proposed Device | | | | | | Predicate Device |
|-------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|---------|---------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | HD-550Exp | HD-550 | HD-550Pro | HD-550S | HD-510 | HD-500Plus | K173921<br>HD-500 |
| Power supply | 100-240V AC, 50/60Hz | | | | | | 100-240V AC, 50/60Hz |
| Over-current protection | Fuse type | | | | | | Fuse type |
| Size | 370(W)×124(H)×500(D)mm | | | | | | 370(W)×124(H)×455(D)mm |
| Weight | 11.1 Kg | 11.1 Kg | 11.1 Kg | 11.1 Kg | 11.1 Kg | 11.1 Kg | 9.5 Kg |
| compatible endoscope | Videoscope | | | | | | Videoscope |
| Observation | Video signal output | DVI (high definition)<br>VGA (high definition)<br>SDI (high definition)<br>CVBS (standard definition)<br>S-Video (standard definition) | | | | | DVI<br>VGA<br>SDI<br>VBS<br>Y/C |
| | Auto white balance | Automatically adjusted using the white balance switch. At the time of connection with the scope in which the scope ID is provide, compensation is performed automatically | | | | | Automatically adjusted using the white balance switch. At the time of connection with the scope in which the scope ID is provide, compensation is performed automatically |
| | Standard color char output | Color bar image | | | | | Color bar image |
| | color tone | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | | | | | R:±8 steps B:±8 steps |

## Table 2 Specifications Comparison of Image Processor

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| | adjustment | | chroma:±8 steps |
|----------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| | automatic<br>gain control | Provided | Provided |
| Image<br>enhancement | Edge enhancement | | Edge enhancement |
| | Structure enhancement: | | Structure enhancement: |
| | Contrast enhancement | | Contrast enhancement |
| | Color enhancement: | | Color enhancement: |
| | IRIS mode<br>selection | Peak/AVE/Auto photometry mode | Peak/AVE/Auto<br>photometry mode |
| | Zoom | 1.0 - 4.0 | $\times$ 1.4 / $\times$ 1.6/ $\times$ 1.8 |
| | Imaging<br>modes | White light (WL) imaging mode, Enhanced white light (EWL) imaging mode, Spectral focused<br>(SFI mode) imaging mode and Intelligent staining technology mode (VIST mode)NOTE | WL imaging mode,<br>VIST observation mode |
| | Foot switch connector | Provided | Provided |
| | record to memory card | Provided | Provided |

# NOTE:

The prospective clinical value of the enhanced imaging modes has not been demonstrated, and no clinical claims are made.

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Ref.: M10202020

| Table 3 Specifications Comparison of Video Gastroscope | | | | | |
|--------------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|--------|
| ITEM | Proposed device | | Predicate device | | Remark |
| Model | EG-550 | EG-550L | EG-500 | EG-500L | / |
| Field of view | 140° | 140° | 140° | 140° | SE |
| Depth of focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | SE |
| Front view | 0° | 0° | 0° | 0° | SE |
| Sensor type | color CMOS | color CMOS | color CMOS | color CMOS | SE |
| Distal end outer diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Insertion section outer diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Bend angle | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | SE |
| Insertion section length | 1050mm | 1050mm | 1050mm | 1050mm | SE |
| Total length | 1400mm | 1400mm | 1400mm | 1400mm | SE |
| Biopsy channel inner diameter | 2.8mm | 3.2mm | 2.8mm | 3.2mm | SE |

Table 3 Specifications Comparison of Video Gastroscope

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| Table 4 Specifications Comparison of Video Colonoscope | | | | | | |
|--------------------------------------------------------|--------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|---------------|
| ITEM | Proposed device | | | | Predicate device | Remark |
| Model | EC-550 | EC-550T | EC-550L | EC-550L/T | EC-500 | / |
| Field of view | 140° | 140° | 140° | 140° | 140° | SE |
| Depth of focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | SE |
| Front view | 0° | 0° | 0° | 0° | 0° | SE |
| Sensor type | color CMOS | color CMOS | color CMOS | color CMOS | color CMOS | SE |
| Distal end outer diameter | 12mm | 12mm | 12.9mm | 12.9mm | 12mm | SE analysis 6 |
| Insert section outer diameter | 12.5mm | 12.5mm | 12.9mm | 12.9mm | 12.5mm | SE analysis 6 |
| Bend angle | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160°" | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | SE |
| Insertion section length | 1350mm | 1700mm | 1350mm | 1700mm | 1350mm | SE analysis 7 |
| Total length | 1700mm | 2050mm | 1700mm | 2050mm | 1700mm | SE analysis 7 |
| Biopsy channel inner diameter | ≥ 3.8mm | ≥ 3.8mm | ≥ 4.2mm | ≥ 4.2mm | 3.8mm | SE analysis 6 |

Table 4 Specifications Comparison of Video Colonoscope

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| ITEM | VLS-55 Series Light<br>Source | HDL-500E Light<br>Source | Remark |
|--------------------------------|-------------------------------|--------------------------|---------------|
| Power supply | AC 100-240V<br>50Hz/60Hz | AC 100-240V<br>50Hz/60Hz | SE |
| Over-current protection | Fuse type | Fuse type | SE |
| Input current | 300VA | 160VA | SE Analysis 8 |
| Examination lamp | 50W LED | 50W LED | SE |
| Average lamp life | 50000 hours | 50000 hours | SE |
| Emergency lamp | 14W LED | 14W LED | SE |
| Average emergency<br>lamp life | 50000 hours | 50000 hours | SE |
| Brightness control | Automatic and manual | Automatic and manual | SE |
| Automatic exposure | 19 steps | 19 steps | SE |
| System connector | Provided | Provided | SE |
| Foot switch connector | Provided | Provided | SE |
| CV connector | Provided | Provided | SE |

Table 5 Specifications Comparison of Light Source

Table 6 Safety Comparison

| ITEM | Proposed Device | Predicate Device | Remark |
|----------------------------------------------|-------------------------------------------------|-------------------------------------------------|--------|
| | HD-550 Video Endoscope System | K173921<br>HD-500 Video Endoscope System | |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Particular<br>requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | SE |
| Product<br>Performance | Comply with ISO 8600-1 and ISO 8600-7 | Comply with ISO 8600-1 and ISO 8600-7 | SE |
| Patient-contact<br>component and<br>material | Insertion section<br>PU, fluoroelastomer | Insertion section<br>PU, fluoroelastomer | SE |
| | Distal end<br>PEEK, Sapphire crystal<br>SUS 304 | Distal end<br>PEEK, Sapphire crystal<br>SUS 304 | |
| | Adhesive<br>Epoxy resin | Adhesive<br>Epoxy resin | |
| | | | |
| Biocompatibility | Cytotoxicity, ISO 10993-5 | Cytotoxicity, ISO 10993-5 | SE |
| | Sensitization, ISO 10993-10 | Sensitization, ISO 10993-10 | |
| | Irritation, ISO 10993-10 | Irritation, ISO 10993-10 | |

10. Substantially Equivalent (SE) Conclusion

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Based on the comparison and analysis in section 9 and the side-by-side optical performance tests, the proposed device and the predicate device have the same intended use, comparable product specification and optical performance. Therefore, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.