The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.

Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Description

The subject device, Scivita 4KINSIGHT ICG Imaging System is consisting of a 4KINSIGHT UHD Fluorescence Imaging System including a 4K Fluorescence Camera Control Unit and a 4K Fluorescence camera head, a Near-Infrared LED Light Source and a 4K UHD Laparoscope.

The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.

The component, 4KINSIGHT UHD Fluorescence Imaging System, is designed to be used with endoscopes, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. It is comprised of a 4K Fluorescence Camera Control Unit (model: 4KIR321, 4KIR311) and a 4K Fluorescence camera head (model 4KIR320C). The only difference between 4KIR321 and 4KIR3114K is: two HDMI output signal of 4KIR321 both are 4096×2160p; two HDMI output signal of 4KIR311 are respectively 4096×2160p and 1920×1080p.

The component, 4K UHD Laparoscope, is a rigid endoscope intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities. The subject device is also indicated for visualization of transanal and transvaginal applications.

The 4K UHD Laparoscope has 18 models which are available in two insertion widths (5.5 mm and 10 mm), four working lengths (290mm, 424mm, 450mm) and three different directions of view (0 ; 30 ° 45 9. The 4K UHD Laparoscope is a reusable device that is cleaned and sterilized before first use and each use.

AI/ML Overview

The provided text is a 510(k) Summary for the Scivita 4KINSIGHT ICG Imaging System. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606) to demonstrate substantial equivalence.

Here's an analysis to extract the requested information about acceptance criteria and the study proving the device meets them:

Crucial Finding: The document explicitly states: "No clinical study is included in this submission." This means that the device's performance was not proven through a clinical study with human data. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical (engineering and lab-based) tests.

Therefore, for many of the requested points, direct answers regarding clinical study acceptance criteria, ground truth from human experts, MRMC studies, etc., cannot be provided from this document.

Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "acceptance criteria" here refer to the performance characteristics compared against the predicate device to establish substantial equivalence based on non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (based on comparison to predicate)

The document primarily compares various technical specifications of the subject device to the predicate device to argue substantial equivalence. The "acceptance criteria" are implicitly that the subject device's performance is either "Same" as the predicate, "Better" than the predicate, or that any "Different" aspect does not affect safety or effectiveness.

Performance Metric (Acceptance Criteria)	Subject Device Performance	Predicate Device Performance (K182606)	Remark / Conclusion for Equivalence
Product Name	Scivita 4KINSIGHT ICG imaging system	PINPOINT Endoscopic Fluorescence Imaging System	/
Regulation No.	21 CFR 876.1500, 21 CFR 892.1600	21 CFR 876.1500, 21 CFR 892.1600	Same
Product Code	GCJ, IZI	GCJ, IZI	Same
Class	II	II	Same
Indications for Use	Broadly similar across multiple applications (angiography, biliary ducts, lymphatic system) with TRADENAME (ICG drug product) in both intravenous and interstitial administration.	Broadly similar across multiple applications (angiography, biliary ducts, lymphatic system) with TRADENAME (ICG drug product) in both intravenous and interstitial administration.	Same
Main Configuration	4K UHD Laparoscope, Near-Infrared LED Light Source, 4K Fluorescence Camera Head, 4K Fluorescence Camera Control Unit	Surgical laparoscope, Illuminator (VPI), Camera head, Endoscopic video processor	Different naming, but claimed to have the "same main configuration." This difference won't affect safety and effectiveness.
Label/Labeling Compliance	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same
Prescription Use/OTC	Prescription Use	Prescription Use	Same
Endoscope Direction of View	0°, 30°, 45°	0°, 30°, 45°	Same
Endoscope Working Length	29cm (5.5mm, 0°, 30°, 45°), 32cm (10mm, 0°, 30°, 45°)	300 mm, 302 mm, 320 mm, 323 mm, 330 mm, 420 mm	Different, but subject device lengths are "included in the scope of the predicate device" and clinical choice is based on surgeon experience. Does not affect substantial equivalence.
Camera Head Imager Type	CMOS	CMOS	Same
Camera Head Zoom	1x~ 2.5x	1x~ 2.5x	Same
Camera Control Unit Digital Outputs	HDMI×2, SDI-1 BNC terminal ×4, SDI-2 BNC terminal ×1	HD-SDI, 3G-SDI, DVI	Different. Subject device supports 4K (2160p), implying better picture quality. "Performance should be better." Does not affect substantial equivalence.
Light Source Type	White light LED and near-infrared light LED	Laser infrared light source	Different. LED is described as "safer" than laser. Therefore, the subject device is "better" in this aspect.
Imaging Mechanism	Uses Near-Infrared LED Light Source for excitation of ICG, captured by CMOS, processed by control unit, and displayed; detailed process described.	Uses Laser infrared light source for excitation of ICG, captured by CMOS, processed by control unit, and displayed; detailed process described.	Different light source (LED vs. Laser) leads to a different type of light source, but the fundamental mechanism of ICG fluorescence imaging is claimed to be the same ("same imaging mechanism").
Contrast Agent	Need	Need	Same
Contrast Agent Type	ICG	ICG	Same
Image Intensity (Ucorner)	52.5%	53.7%	Different. "Almost same." Does not affect substantial equivalence.
Image Intensity (Uside)	80.9%	67.2%	Different. Subject device is "better" (higher uniformity). Does not affect substantial equivalence.
Depth of Field (Close view - 3mm)	80.6 lp/mm	71.8 lp/mm	Different. Subject device is better. Both meet criteria for 3mm-250mm ("almost same depth of field performance"). Does not affect substantial equivalence.
Depth of Field (Distant view - 250mm)	1.26 lp/mm	1.26 lp/mm	Same. Both meet criteria for 3mm-250mm ("almost same depth of field performance"). Does not affect substantial equivalence.
Image Resolution (Near DOF - 3mm, on-axis)	80.6 lp/mm	71.8 lp/mm	Different. "Almost the same." Does not affect substantial equivalence.
Image Resolution (Near DOF - 3mm, off-axis)	57.20 lp/mm	46.80 lp/mm	Different. "Almost the same." Does not affect substantial equivalence.
Image Resolution (Working distance - 40mm, on-axis)	8.98 lp/mm	8.98 lp/mm	Same. "Almost the same." Does not affect substantial equivalence.
Image Resolution (Working distance - 40mm, off-axis)	6.59 lp/mm	6.37 lp/mm	Different. "Almost the same." Does not affect substantial equivalence.
Image Resolution (Far DOF - 250mm, on-axis)	1.26 lp/mm	1.26 lp/mm	Same. "Almost the same." Does not affect substantial equivalence.
Image Resolution (Far DOF - 250mm, off-axis)	1.16 lp/mm	1.12 lp/mm	Different. "Almost the same." Does not affect substantial equivalence.
Light Source for Fluorescent excitation	Near-Infrared LED Light Source	Laser source	Different. LED is safer. See Imaging Mechanism remark.
Wavelength	785nm	805 nm	Different. Due to different light source type. However, both are within the ICG absorption spectrum (650nm-850nm), and 765nm is noted as optimal in a separate study. This difference "does not affect substantially equivalence."

Study Information (Based on the document provided):

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document explicitly states: "No clinical study is included in this submission." The evaluation is based on non-clinical (laboratory/bench) testing and comparison to a predicate device's specifications.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Scivita Medical Technology Co., Ltd. (China-based company).
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical study was performed, no expert ground truth was established for a test set of clinical images. The "ground truth" for non-clinical performance (e.g., resolution measurements) would be established by standard engineering measurement techniques and equipment.
Adjudication Method for the Test Set:
- Not applicable. No human-read clinical test set.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imaging system (hardware and software for image acquisition and display), not an AI algorithm intended to perform standalone diagnostic tasks. Its performance is evaluated fundamentally on image quality metrics and compliance with standards.
The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" implicitly comes from established engineering standards and measurement methodologies for optical performance, electrical safety, EMC, etc. (e.g., light intensity measured by a photometer, resolution determined by test charts and lenses, etc.). This is not clinical ground truth (e.g., pathology, expert consensus).
The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a medical imaging hardware system.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical testing and direct comparison of technical specifications to a predicate device. It explicitly states that no clinical study was conducted. Therefore, questions related to clinical performance, human readers, ground truth establishment for clinical data, and AI/ML specific criteria are not addressed by this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

January 13, 2023

Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K221252

Trade/Device Name: Scivita 4KINSIGHT ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: December 12, 2022 Received: December 15, 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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jianting Wang -S

Jianting Wang, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K221252

Device Name

Scivita 4KINSIGHT ICG Imaging System

Indications for Use (Describe)

The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

The assigned 510(k) Number: K221252

1. Date of Preparation: 12/12/2022
1. Sponsor Identification

Scivita Medical Technology Co., Ltd. No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China.

Establishment Registration Number: Not yet registered.

Contact Person: Ruqin Wu Position: Regulation Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com

1. 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: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net

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1. Identification of Subject device
  Trade Name: Scivita 4KINSIGHT ICG imaging system Common Name: 4K Fluorescence Imaging System

Regulatory Information Classification Name: Gastroenterology-urology device Classification: II; Product Code: GCJ Regulation Number: 21 CFR 876.1500 Review Panel: General & Plastic Surgery

Classification Name: Angiographic x-ray system Classification: II; Product Code: IZI Regulation Number: 21 CFR 892.1600 Review Panel: Radiology

Indication for Use:

The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.

Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSICHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

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Device Description:

The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.

System name	Component name and Model	Subcomponent/ Model
Scivita4KINSIGHT ICGImaging System	4KINSIGHTUHDFluorescenceImaging System	4KIR01	4K Fluorescence Camera ControlUnit/4KIR321
			4K Fluorescence CameraHead/4KIR320C
		4KIR07	4K Fluorescence Camera ControlUnit/4KIR311
			4K Fluorescence CameraHead/4KIR320C
	Near-InfraredLED LightSource	LSIR330	/
	4K UHDLaparoscope	4K5500R, 4K5530R,4K5545R, 4K1000R,4K1030R, 4K1045(these models have beencleared in K203255 )	/
		4K5500L, 4K5530L,4K5545L, 4K1000L,4K1030L, 4K1045L,	/
		4K5500LR, 4K5530LR,4K5545LR, 4K1000LR,4K1030LR, 4K1045LR	/

Table 1 System Configuration

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Identification of Predicate Device న్.
510(k) Number: K182606 PINPOINT Endoscopic Fluorescence Imaging System Product Name: Manufacturer: Novadaq Technologies ULC (now a part of Stryker)
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences
A IEC 60601-1-2:2014 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 requirements for the basic safety and essential performanc
ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices-part 1: General requirements
ISO 8600-5:2005 Endoscopes -Medical endoscopes and endotherapy devices--Part 5: Determination of optical resolution of rigid endoscopes with optics
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and System
IEC 62471:2006 Photobiological safety of lamps and lamp systems
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Summary of Technological Characteristics

ITEM	Subject Device	Predicate DeviceK182606	Remark
Product name	Scivita 4KINSIGHT ICG imaging system	PINPOINT EndoscopicFluorescence ImagingSystem	/
RegulationNo.	21 CFR 876.150021 CFR 892.1600	21 CFR 876.150021 CFR 892.1600	Same
Product Code	GCJ, IZI	GCJ, IZI	Same
Class	II	II	Same
Indication for Use	The Scivita 4KINSIGHT ICGImaging System consists of a4KINSIGHT UHD FluorescenceImaging System, a Near-InfraredLED Light Source, and a 4K UHDLAPAROSCOPE.Upon intravenousadministration of TRADENAME(ICG drug product), the Scivita4KINSIGHT ICG Imaging System isused with TRADENAME to performintraoperative fluorescenceangiography, and it is also indicatedfor use in fluorescence imaging ofbiliary ducts, and when indicated,during intraoperativecholangiography.The Scivita 4KINSIGHT ICGImaging System is indicated for useto provide real time endoscopicvisible and near-infrared fluorescenceimaging. The Scivita 4KINSIGHTICG Imaging System enablessurgeons to perform minimallyinvasive surgery using standardendoscope visible light as well asvisual assessment of vessels blood	Upon intravenous administration ofTRADENAME (ICG drug product),the PINPOINT EndoscopicFluorescence Imaging System is usedwith TRADENAME to performintraoperative fluorescenceangiography, and it is also indicatedfor use in fluorescence imaging ofbiliary ducts, and when indicated,during intraoperativecholangiography.The PINPOINT EndoscopicFluorescence Imaging System isindicated for use to provide real timeendoscopic visible and near-infraredfluorescence imaging. ThePINPOINT System enables surgeonsto perform minimally invasivesurgery using standard endoscopevisible light as well as visualassessment of vessels blood flow	Same

	flow and related tissue perfusion, andat least one of the major extra-hepaticbile ducts (cystic duct, common bileduct or common hepatic duct), usingnear-infrared imaging.Fluorescence imaging of biliaryducts with the Scivita 4KINSIGHTICG Imaging System is intended foruse with standard of care white light,and when indicated, intraoperativecholangiography. The device is notintended for standalone use forbiliary duct visualization.Upon interstitial administration ofTRADENAME (ICG drug product),the Scivita 4KINSIGHT ICGImaging System is used to performintraoperative fluorescence imagingand visualization of the lymphaticsystem, including lymphatic vesselsand lymph nodes.	and related tissue perfusion, and atleast one of the major extra-hepaticbile ducts (cystic duct, common bileduct or common hepatic duct), usingnearinfrared imaging.Fluorescence imaging of biliary ductswith the PINPOINT System isintended for use with standard of carewhite light, and when indicated,intraoperative cholangiography. Thedevice is not intended for standaloneuse for biliary duct visualization.Upon interstitial administration ofTRADENAME (ICG drug product),the PINPOINT System is used toperform intraoperative fluorescenceimaging and visualization of thelymphatic system, includinglymphatic vessels and lymph nodes.
MainConfiguration	4K UHD LaparoscopeNear-Infrared LED Light Source4K Fluorescence Camera Head4K Fluorescence Camera ControlUnit	Surgical laparoscopeIlluminator (VPI)Camera headEndoscopic video processor	Different
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same
PrescriptionUse/OTC	Prescription Use	Prescription Use	Same

Table 2 General Comparison

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Different - Main Configuration

The naming of main configuration of the subject device is different from the predicate device, while they have the same main configuration. Therefore, the difference on naming of main configuration will not affect the safety and effectiveness of the subject device.

ITEM		Subject Device	Predicate DeviceK182606	Remark
Endoscopes	Direction of View	0°, 30°, 45°	0°, 30°, 45°	Same
	Working Length	29cm (5.5mm, 0°, 30°, 45°)	300 mm	Different

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		32cm (10mm, 0 °, 30 °, 45 °)	302 mm
			320 mm
			323 mm
			330 mm
			420 mm
Camera Head	Imager Type	CMOS	CMOS	Same
	Zoom	1x~ 2.5x	1x~ 2.5x	Same
CameraControlUnit	Digital Outputs	HDMI×2SDI-1 BNC terminal ×4SDI-2 BNC terminal ×1	HD-SDI, 3G-SDI, DVI	Different
LightSource	LightSourceType	White light LED andnear-infrared light LED	Laser infrared light source	Different
Imaging Mechanism		The patient is injected withICG imaging agent.Indocyanine green enters theblood through humanintravenous injection andreaches various organs andtissues of the human bodythrough human bloodcirculation. The ICGfluoresces when illuminatedthrough the laparoscope withnear-infrared excitation lightfrom the near-infrared LEDlight source. The 4Kfluorescence camera headcaptures the white lightimages reflected by humanorgans or tissues and thefluorescence images excitedby indocyanine green. Thelight signals are collectedand converted into electricalsignals by theComplementary Metal OxideSemiconductor (CMOS)inside the 4K fluorescence	The patient is injected withICG imaging agent.Indocyanine green enters theblood through humanintravenous injection andreaches various organs andtissues of the human bodythrough human bloodcirculation. The ICGfluoresces when illuminatedthrough the laparoscope withexcitation light from the laserlight source. The 4Kfluorescence camera headcaptures the white lightimages reflected by humanorgans or tissues and thefluorescence images excitedby indocyanine green. Thelight signals are collectedand converted into electricalsignals by theComplementary Metal OxideSemiconductor (CMOS)inside the 4K fluorescenceCamera Head and then	Different

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Camera Head, and then transmitted to the 4K fluorescence camera control unit through the 4K fluorescence camera head cable. The 4K fluorescence camera control unit can process the image of the received electrical signal and transmit it to the 4K monitor through SDI and HDMI signal lines, and finally present the white light image and near infrared image on the display.			transmitted to the 4K fluorescence camera control unit through the 4K fluorescence camera head cable. The 4K fluorescence camera control unit can process the image of the received electrical signal and transmit it to the 4K monitor through SDI and HDMI signal lines, and finally present the white light image and near infrared image on the display.
Contrast agent	Need	Need	Same
Contrast agent type	ICG	ICG	Same
Image Intensity	Ucorner	52.5%	53.7%	Different
	Uside	80.9%	67.2%
Depth of Field	Close view (3mm)	80.6 lp/mm	71.8 lp/mm	Different
	Distant view (250mm)	1.26 lp/mm	1.26 lp/mm
Image resolution	Near DOF (3mm)	on-axis optical resolution	80.6 lp/mm		71.8 lp/mm
		off-axis optical resolution	57.20 lp/mm		46.80 lp/mm
		Working distance (40mm)	on-axis optical resolution		8.98 lp/mm	8.98 lp/mm
			off-axis optical resolution		6.59 lp/mm	6.37 lp/mm

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FarDOF(250mm)	on-axisopticalresolution	1.26 lp/mm	1.26 lp/mm
	off-axisopticalresolution	1.16 lp/mm	1.12 lp/mm
Light Source used forFluorescent excitation		Near-Infrared LED LightSource	Laser source	Same
Wavelength		785nm	805 nm	Different

Different- Working Length

Although the working length of the subject device is not the predicate device, the working length of the subject device is included in the scope of the predicate device. The surgeon will select the proper endoscope based on her/his experiences and clinical conditions. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.

Different- Digital Outputs

Although the Digital Outputs of the subject device is different from that of the predicate device, the DVI does not support the 4K signal of 2160mm 108060p, while the subject device belongs to the 4K camera, so the picture quality is higher. Therefore, the performance should be better. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.

Different- Light Source

The Light Source Type of the subject device is not the same as that of the predicate device. The subject device uses the LED infrared light source and the predicate device uses laser infrared light. LED is a low-energy light, which is safer than the laser infrared light. Therefore, the subject device than the predicate device on Light Source Type.

Different- Imaging Mechanism and Wavelength

The Light Source used for Fluorescent excitation for the subject device is LED infrared light source, and for the predicate device it is the Laser infrared light source. Because the light source type is different, the output wavelength is similar but not the same. The absorption spectrum of ICG in blood is 650nm-850nm, and in one Study, it shows that the infrared light near 765nm produces the most fluorescence. Therefore, we believe this difference on wavelength does not affect substantially equivalence between the subject device and predicate device, and the subject device and predicate device has the same imaging mechanism.

Different- Image Intensity

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The intensity uniformity of subject device is almost same with predicate device in Ucomer, the intensity uniformity of Uside of subject device is better than predicate device, which demonstrates that the intensity uniformity performance of subject device is better than predicate device. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.

Different- Depth of Field

The resolution of subject device and predicate device is almost the same in the testing distance scope (3mm-250mm), although the asserted depth of field of predicate device is 25mm-100mm, but the resolution of subject device and predicate device all meet the depth of field criteria (3mm-250mm), which demonstrates that subject device and predicate device almost have the same depth of field performance. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.

Different- Image resolution

Base on the compare analytical data, the on-axis optical resolution and the average off-axis optical resolution of subject device is almost the same with predicate device in the near DOF (3mm), working distance (40mm), far DOF (250mm) which demonstrates that the resolution performance of subject device is almost the same with predicate device. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.