Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.

Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.

Device Description

The Endoscopic Camera System comprises the Image Processing Unit, the Camera Head (including the objective lens), power supply cord and video cables. The Camera Head with integrated cable can be connected to the Image Processing Unit through the LEMO interface.

During surgical procedures, the Endoscopic Camera System is used to provide real-time visible imaging similar to that provided by conventional imaging system used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflected light is collected by a variety of laparoscopes that are attached to the camera head via equipment coupler. The camera head receives optical image from the connected laparoscope and converts optical image into electronic signal using the incorporated image sensor. The Image Processing Unit serves as the control center of the system and should be connected to a compatible light source in order to provide visualization. It can be connected to a 4K video monitor via one of the video cables provided to display image in real time: DVI cable, HDMI cable, 12G-SDI cable, and 3G-SDI cable.

The proposed system is a reusable device and provided non-sterile. The Camera Head should be cleaned and high-level disinfected prior to the first use and after every subsequent use. The recommended compatible Light Source is OPTO-LED104K (510k exempted, product code: NTN).

AI/ML Overview

This FDA 510(k) summary describes the "Image Processing Unit, Model: OPTO-CAM104K; Camera Head, Model: OPTO-CHD104KH" device. However, it does not contain specific acceptance criteria, detailed study designs, or performance results from any clinical or standalone studies conducted to prove the device meets acceptance criteria. The sumamry focuses on non-clinical testing for safety and electrical compatibilty, and the statement of substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, study sizes, ground truth, and expert involvement cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria in a table or directly report device performance against defined criteria in a way that would be typical for clinical effectiveness studies. It primarily focuses on compliance with general safety and EMC standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Performance testing" but does not detail the nature of these tests in terms of sample size or data collection methodology relevant to clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The filing is for an endoscopic camera system, not an AI-powered diagnostic device that typically relies on expert-established ground truth for performance evaluation in the context of diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not performed or reported as part of this 510(k) submission. This is not an AI-assisted diagnostic device, but rather an imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an imaging system (hardware), not an algorithm or AI that operates standalone for diagnostic purposes. Its function is to provide visualization for humans during laparoscopic procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided and is not directly relevant for a device whose primary function is visualization during procedures rather than automated diagnosis. The "performance testing" mentioned likely refers to technical specifications of image quality, resolution, latency, etc., compared to design specifications.

8. The sample size for the training set

This information is not provided and is not applicable. The device is a hardware imaging system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons mentioned above.

Summary of what is provided:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Image1 SPIES, K131953) through:

Non-clinical tests: Verifying compliance with various electrical safety, electromagnetic compatibility, and equipment-specific standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, ASTM D4169-16, AAMI TIR 30:2016, AAMI TIR 12:2020).
Software Validation: The software of the proposed device was validated as having a "Moderate level of concern (LoC)" according to FDA guidance.
Performance testing: Stated that performance testing was conducted to demonstrate the system "performs according to specifications and functions as intended," but specific details of these tests, including acceptance criteria and results, are not elaborated.

The provided information establishes the device's technical safety and fundamental functionality in accordance with relevant standards, rather than clinical performance against specific diagnostic or intervention-related acceptance criteria.

Summary

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Guangdong OptoMedic Technologies, Inc. Jane Guo Regulatory Affairs Manager Suite 503, Building A. Golden Valley Intellicreation Community. No. 2 Yonganbei Street Foshan, Guangdong 528200 China

February 2, 2023

Re: K221781

Trade/Device Name: Image Processing Unit, Model: OPTO-CAM104K; Camera Head, Model: OPTO-CHD104KH Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 4, 2023 Received: January 5, 2023

Dear Jane Guo:

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

Sincerely,

Colin K. Chen -S

for

Long Chen, Ph.D. 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) K221781

Device Name Image Processing Unit: OPTO-CAM104K; Camera Head: OPTO-CHD104KH

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow swirl on the left, followed by the word "OptoMedic" in black, bold font. The logo is simple and modern, and it is likely used to represent a company that specializes in eye care.

K221781

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Date Prepared: July 13, 2022

I. General Information

510(k) Submitter/Owner:	Guangdong OptoMedic Technologies, Inc.
	Suite 503, Building A, Golden Valley Intellicreation Community,
	No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai, Foshan,
	Guangdong, 528200, P.R. China
Establishment Registration Number:	Not yet registered
Primary Contact Person:	Jane Guo
	Regulatory Affairs Engineer
	Tel: +86 (757) 8670 2920
	Email: guoweijuan@optomedic.com
Secondary Contact Person:	Alice Lau
	Regulatory Affairs Engineer
	Tel: +86 (757) 8670 2920
	Email: liuli@optomedic.com

II. Device Identification

Device Trade Name:	Image Processing Unit; Camera Head
Common or Usual Name:	Endoscopic Camera System
Model:	Image Processing Unit: OPTO-CAM104KCamera Head: OPTO-CHD104KH
Regulation Name:	Endoscopes and accessories
Regulation Number:	21 CFR 876.1500
Regulatory Class:	Class II
Product Code:	GCJ

III. Predicate Device

510(k) Number: K131953

006_6.0_510(k)_Summary

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Product Name: Imagel SPIES

The predicate device has not been subject to a design-related recall.

IV. Device Description

V. Indications for Use

Image Processing Unit (hereafter referred to as "IPU") is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.

Description	Subject Device	Predicate Device (K131953)
Regulation Number	21 CER 876.1500	21 CER 876.1500
Product Code	GCJ	FET
Device class	Class II	Class II
Indication for use	Image Processing Unit(hereafter referred to as “IPU”)is intended to be used withcompatible laparoscopes,camera heads, light sources,monitors, and other ancillaryequipment for visualization,	The Imagel SPIES is a camera controlunit (CCU) for use with camera heads orvideo endoscopes for visualization,image recording and documentationduring general endoscopic andmicroscopic procedures.

	image recording anddocumentation duringlaparoscopic procedures.Endoscopic Camera Head isintended to be used withcompatible laparoscopes,image processing unit, andother ancillary equipment forvisualization, image recordingand documentation duringlaparoscopic procedures.
Prescription/Over-the-counteruse	Prescription	Prescription
Testing	ANSI/AAMI ES 60601-1:2005+A2 (R2012) +A1IEC 60601-1-2:2014IEC 60601-2-18:2009ASTM D4169-16AAMI TIR 30:2016AAMI TIR 12:2020	IEC 60601-1IEC 60601-1-2
Dimensions	IPU:422mm(L)×370mm(W)×149mm(H)Camera Head:92mm(L)×39mm(W)×50mm(H)	Image1 S Connect TC200 :30.5cm×5.4cm×32.0cm (W×H×D)TH 100&TH 101:100mm×48mm×38mm(L×H×W)TH 103:88mm×47mm×35mm(L×H×W)TH 104:100mm×49mm×39mm(L×H×W)
Weight	IPU: 9Kg±15%Camera Head: 400(g)±20	Image1 S Connect TC200: 2.1kgImage1 S H3-Link TC300: 1.86kgImage1 S X-Link TC301: 1.86kgTH100: 270gTH101: 270gTH103: 227gTH104: 299g
Power supply	110-240V AC, 50/60Hz	100-120VAC, 50/60Hz200-240VAC, 50/60Hz
Video Output	3G-SDI×4HDMI ×1DVI ×1	2×DVI-D1×3G-SDI

		12G-SDI ×1
Signalformat	output	4096×2160p, 3840×2160p, 1920×1080p, 50/60Hz1920×1080p,50Hz/60Hz
Sensor		4K CMOS sensor assembly3×1/3"

VI. Comparison of Technological Characteristics with The Predicate Device

Table 1 General Comparison

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Image /page/6/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular design on the left, followed by the text "OptoMedic" in black. The circular design has a gradient of green, with the top being a lighter shade and the bottom being a darker shade. The text is in a bold, sans-serif font.

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

VII. Performance data

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

ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 Medical Electrical Equipment- Part 1: . General requirements for basic safety and essential performance.
IEC 60601-1-2:2014, 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 performance of endoscopic equipment
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and . Systems.
AAMI TIR 30:2016 A compendium of processes, materials, test methods, and acceptance . criteria for cleaning reusable medical devices
AAMI TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing . in health care facilities: A guide for medical device manufacturers

The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff

Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended.

VIII. Conclusions

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

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.