K Number
K221252
Device Name
Scivita 4KINSIGHT ICG Imaging System
Date Cleared
2023-01-13

(256 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

No
The document describes a fluorescence imaging system and its components, focusing on image acquisition and display. There is no mention of AI, ML, or any algorithms that would suggest the use of such technologies for image analysis, interpretation, or decision support. The image processing mentioned is for transmitting and presenting the acquired images.

No
This device is an imaging system designed to visualize anatomical structures, not to treat a disease or condition. While it aids surgeons in performing procedures, its primary function is diagnostic and observational imaging.

Yes

The device is used to "perform intraoperative fluorescence angiography," "fluorescence imaging of biliary ducts," and "fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes." These are all activities that involve visualizing internal structures to determine their condition or function, which falls under the definition of diagnostic imaging.

No

The device description explicitly lists hardware components such as a camera control unit, camera head, LED light source, and laparoscope. While it includes image processing software, it is an integral part of a larger hardware system.

Based on the provided information, the Scivita 4KINSIGHT ICG Imaging System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
  • Scivita 4KINSIGHT ICG Imaging System Function: This device is used during surgery to visualize structures within the body in real-time using fluorescence imaging with an intravenously or interstitially administered drug (ICG). It's a surgical imaging system, not a laboratory testing device.
  • Intended Use: The intended use clearly describes its application in intraoperative fluorescence angiography, imaging of biliary ducts, and visualization of the lymphatic system during surgical procedures.
  • Device Description: The components (camera, light source, laparoscope) are all designed for direct visualization and imaging within the body.

Therefore, the Scivita 4KINSIGHT ICG Imaging System falls under the category of a surgical imaging system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications 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 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 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 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.

Product codes (comma separated list FDA assigned to the subject device)

GCJ, IZI

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found.

Input Imaging Modality

Endoscopic visible light, Near-infrared fluorescence imaging

Anatomical Site

vessels, blood flow and related tissue perfusion, at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct, lymphatic system, including lymphatic vessels and lymph nodes, thoracic and peritoneal cavities, transanal and transvaginal applications.

Indicated Patient Age Range

Not Found.

Intended User / Care Setting

Surgeons performing minimally invasive surgery.

Description of the training set, sample size, data source, and annotation protocol

Not Found.

Description of the test set, sample size, data source, and annotation protocol

Not Found.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical 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
    No clinical study is included in this submission.

Key Results from comparison table:

  • Image Intensity:
    • Subject Device Ucorner: 52.5%, Predicate Device Ucorner: 53.7% (Different)
    • Subject Device Uside: 80.9%, Predicate Device Uside: 67.2% (Different)
  • Depth of Field:
    • Close view (3mm): Subject Device 80.6 lp/mm, Predicate Device 71.8 lp/mm (Different)
    • Distant view (250mm): Subject Device 1.26 lp/mm, Predicate Device 1.26 lp/mm (Same)
  • Image resolution:
    • Near DOF (3mm): Subject Device on-axis optical resolution 80.6 lp/mm, Predicate Device 71.8 lp/mm (Different)
    • Near DOF (3mm): Subject Device off-axis optical resolution 57.20 lp/mm, Predicate Device 46.80 lp/mm (Different)
    • Working distance (40mm): Subject Device on-axis optical resolution 8.98 lp/mm, Predicate Device 8.98 lp/mm (Same)
    • Working distance (40mm): Subject Device off-axis optical resolution 6.59 lp/mm, Predicate Device 6.37 lp/mm (Different)
    • Far DOF (250mm): Subject Device on-axis optical resolution 1.26 lp/mm, Predicate Device 1.26 lp/mm (Same)
    • Far DOF (250mm): Subject Device off-axis optical resolution 1.16 lp/mm, Predicate Device 1.12 lp/mm (Different)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182606

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K203255

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found.

§ 876.1500 Endoscope and accessories.

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

0

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.

1

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

2

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.

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.

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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3

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

4

    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.

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.

5

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.

System nameComponent name and ModelSubcomponent/ Model
Scivita
4KINSIGHT ICG
Imaging System4KINSIGHT
UHD
Fluorescence
Imaging System4KIR014K Fluorescence Camera Control
Unit/4KIR321
4K Fluorescence Camera
Head/4KIR320C
4KIR074K Fluorescence Camera Control
Unit/4KIR311
4K Fluorescence Camera
Head/4KIR320C
Near-Infrared
LED Light
SourceLSIR330/
4K UHD
Laparoscope4K5500R, 4K5530R,
4K5545R, 4K1000R,
4K1030R, 4K1045
(these models have been
cleared in K203255 )/
4K5500L, 4K5530L,
4K5545L, 4K1000L,
4K1030L, 4K1045L,/
4K5500LR, 4K5530LR,
4K5545LR, 4K1000LR,
4K1030LR, 4K1045LR/

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.

6

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.

  • 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.

7

8. Summary of Technological Characteristics

| ITEM | Subject Device | Predicate Device
K182606 | Remark |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 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 |
| 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
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 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 | Upon intravenous administration of
TRADENAME (ICG drug product),
the PINPOINT Endoscopic
Fluorescence 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 PINPOINT Endoscopic
Fluorescence Imaging System is
indicated for use to provide real time
endoscopic visible and near-infrared
fluorescence imaging. The
PINPOINT System enables surgeons
to perform minimally invasive
surgery using standard endoscope
visible light as well as visual
assessment of vessels blood flow | Same |
| | | | |
| | 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.
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. | 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
nearinfrared imaging.
Fluorescence imaging of biliary ducts
with the PINPOINT 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 PINPOINT System is used to
perform intraoperative fluorescence
imaging and visualization of the
lymphatic system, including
lymphatic vessels and lymph nodes. | |
| 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 |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Prescription
Use/OTC | Prescription Use | Prescription Use | Same |

Table 2 General Comparison

8

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 Device
K182606 | Remark |
|----------------|-------------------|----------------------------|-----------------------------|-----------|
| Endosco
pes | Direction of View | 0°, 30°, 45° | 0°, 30°, 45° | Same |
| | Working Length | 29cm (5.5mm, 0°, 30°, 45°) | 300 mm | Different |

9

32cm (10mm, 0 °, 30 °, 45 °)302 mm
320 mm
323 mm
330 mm
420 mm
Camera HeadImager TypeCMOSCMOSSame
Zoom1x~ 2.5x1x~ 2.5xSame
Camera
Control
UnitDigital OutputsHDMI×2
SDI-1 BNC terminal ×4
SDI-2 BNC terminal ×1HD-SDI, 3G-SDI, DVIDifferent
Light
SourceLight
Source
TypeWhite light LED and
near-infrared light LEDLaser infrared light sourceDifferent
Imaging MechanismThe patient is injected with
ICG imaging agent.
Indocyanine green enters the
blood through human
intravenous injection and
reaches various organs and
tissues of the human body
through human blood
circulation. The ICG
fluoresces when illuminated
through the laparoscope with
near-infrared excitation light
from the near-infrared LED
light source. The 4K
fluorescence camera head
captures the white light
images reflected by human
organs or tissues and the
fluorescence images excited
by indocyanine green. The
light signals are collected
and converted into electrical
signals by the
Complementary Metal Oxide
Semiconductor (CMOS)
inside the 4K fluorescenceThe patient is injected with
ICG imaging agent.
Indocyanine green enters the
blood through human
intravenous injection and
reaches various organs and
tissues of the human body
through human blood
circulation. The ICG
fluoresces when illuminated
through the laparoscope with
excitation light from the laser
light source. The 4K
fluorescence camera head
captures the white light
images reflected by human
organs or tissues and the
fluorescence images excited
by indocyanine green. The
light signals are collected
and converted into electrical
signals by the
Complementary Metal Oxide
Semiconductor (CMOS)
inside the 4K fluorescence
Camera Head and thenDifferent

10

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 agentNeedNeedSame
Contrast agent typeICGICGSame
Image IntensityUcorner52.5%53.7%Different
Uside80.9%67.2%
Depth of FieldClose view (3mm)80.6 lp/mm71.8 lp/mmDifferent
Distant view (250mm)1.26 lp/mm1.26 lp/mm
Image resolutionNear DOF (3mm)on-axis optical resolution80.6 lp/mm71.8 lp/mm
off-axis optical resolution57.20 lp/mm46.80 lp/mm
Working distance (40mm)on-axis optical resolution8.98 lp/mm8.98 lp/mm
off-axis optical resolution6.59 lp/mm6.37 lp/mm

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| Far
DOF
(250m
m) | on-axis
optical
resoluti
on | 1.26 lp/mm | 1.26 lp/mm | |
|-------------------------------------------------|---------------------------------------|-----------------------------------|--------------|-----------|
| | off-axis
optical
resoluti
on | 1.16 lp/mm | 1.12 lp/mm | |
| Light Source used for
Fluorescent excitation | | Near-Infrared LED Light
Source | 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.