The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.

Device Description

The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°).

AI/ML Overview

This document is a 510(k) Premarket Notification for the OptoMedic Laparoscope, signifying its clearance by the FDA based on substantial equivalence to predicate devices. The information provided is primarily focused on the device's technical specifications and comparisons, rather than a clinical study demonstrating performance against specific acceptance criteria in the context of AI/ML.

Therefore, for the request regarding acceptance criteria and a study proving the device meets them, it's important to understand that this submission is for a medical device (a laparoscope), not an AI/ML diagnostic tool. As such, the typical metrics and study designs for AI/ML performance (like those related to sensitivity, specificity, reader studies, etc.) are not directly applicable or provided in this document.

However, I can extract the information related to the device's performance testing as described for regulatory clearance, which serves a similar purpose to demonstrating that the device meets its design specifications and is safe and effective for its intended use.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are generally derived from recognized industry standards and regulatory requirements for safety, performance, and functionality. The "reported device performance" is the demonstration that the device complies with these standards.

Acceptance Criteria Category (Derived from Standards)	Reported Device Performance (Compliance Statement)
Electrical Safety	Complies with ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 (General requirements for basic safety and essential performance).
Endoscopic Equipment Safety	Complies with IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
General Endoscope Requirements	Complies with ISO 8600-1-2015 (General requirements for endoscopes).
Optical Characteristics (Field of View & Direction)	Complies with ISO 8600-3-2019 (Determination of field of view and direction of view of endoscopes with optics).
Physical Characteristics (Maximum Width)	Complies with ISO 8600-4-2014 (Determination of maximum width of insertion portion).
Optical Characteristics (Resolution)	Complies with ISO 8600-5-2020 (Determination of optical resolution of rigid endoscopes with optics).
Biocompatibility (Cytotoxicity)	Complies with ISO 10993-5:2009 (Tests for in vitro cytotoxicity).
Biocompatibility (Sensitization)	Complies with ISO 10993-10:2021 (Tests for skin sensitization).
Biocompatibility (Systemic Toxicity)	Complies with ISO 10993-11:2017 (Tests for systemic toxicity).
Biocompatibility (Irritation)	Complies with ISO 10993-23:2021 (Tests for irritation).
Reprocessing (Cleaning)	Complies with AAMI TIR 30:2016 (Cleaning reusable medical devices) and AAMI TIR 12:2020 (Designing, testing, and labeling).
Overall Performance & Intended Functionality	"Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended."

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "sample sizes" in the context of clinical or AI/ML test sets. The performance evaluation primarily involved non-clinical tests conducted to verify compliance with national and international standards. These tests typically involve physical and functional evaluations of the device itself rather than patient data.

Sample Size: Not applicable in the context of AI/ML test sets. For device testing, it would involve a representative number of device units.
Data Provenance: Not applicable in the context of clinical data. The testing involves the physical device and its components, complying with engineering and safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device clearance. Ground truth, in the context of image analysis or diagnostic performance, is not established for a rigid laparoscope in this document. The "ground truth" for this device's performance is its adherence to the technical specifications defined by the relevant standards (e.g., whether its field of view is indeed 68°, its resolution meets the specified criteria, or its materials are biocompatible). These are verified through engineering and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (often medical images) to establish a consensus ground truth. This document describes non-clinical engineering and bench testing, not clinical data review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not mention any MRMC comparative effectiveness study. These studies are typically conducted for AI/ML diagnostic tools to evaluate how AI assistance impacts human reader performance. The OptoMedic Laparoscope is a physical medical instrument, not an AI system.

6. If a Standalone (Algorithm Only) Performance Study was Done

No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used

The "ground truth" used for this device's regulatory clearance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) as verified through non-clinical laboratory testing. This is distinct from clinical ground truth based on pathology, expert consensus, or outcomes data, which would be relevant for diagnostic devices or AI algorithms.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI/ML training set for this device.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 6, 2023

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

Re: K231003

Trade/Device Name: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 9, 2023 Received: June 9, 2023

Dear Weijuan 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.

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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.07.06
10:45:39-04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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K231003

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231003

Device Name

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of the word "OptoMedic" in a bold, sans-serif font. The "Opto" portion of the word is in a lighter shade of green, while the "Medic" portion is in black. To the left of the word "OptoMedic" is a green circle that is not fully closed.

Traditional 510(k) Premarket Notification K231003 Laparoscope

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Date Prepared: March 31, 2023

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
Contact Person:	Jane Guo
	Regulatory Affairs Engineer
	Tel: +86 (757) 8670 2920
	Email: guoweijuan@optomedic.com

II. Device Identification

Device Trade Name:	Laparoscope
Common or Usual Name:	Laparoscope
Model:	21033FA, 21033FC, 21033WA, 21033WC,
	20533WA, 20533WC, 20533FA, 20533FC
Regulation Name:	Endoscopes and accessories
Regulation Number:	21 CFR 876.1500
Regulatory Class:	Class II
Product Code:	GCJ

III. Predicate Device

Primary Predicate Device	510(k) Number:	K223923
	Product Name:	HOPKINS Telescopes
Secondary Predicate Device	510(k) Number:	K201151
	Product Name:	O-Mec Laparoscopes 690 Series

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Image /page/4/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular design on the left, followed by the word "OptoMedic" in bold, black letters. The circular design appears to be an abstract representation of an eye or lens.

Page 2 of 5

IV. Device Description

The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°). The specifications of the proposed laparoscopes are listed in Table 1.

No.	Model	Direction of View	Maximum Insertion Portion Width	Working Length
1	21033FA	0°	10.1mm	330mm
2	21033FC	30°	10.1mm	330mm
3	21033WA	0°	10.1mm	330mm
4	21033WC	30°	10.1mm	330mm
5	20533FA	0°	5.6mm	310mm
6	20533FC	30°	5.6mm	310mm
7	20533WA	0°	5.6mm	310mm
8	20533WC	30°	5.6mm	310mm

	Table 1 Model Specifications
--	------------------------------

V. Indications for Use

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Image /page/5/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the word "OptoMedic" in black font. The font is sans-serif and appears to be bolded.

VI. Comparison of Technological Characteristics with The Predicate Device

Description	Subject Device (K231003)	Primary Predicate Device (K223923)	Secondary Predicate Device (K201151)
Regulation Number	21 CFR 876.1500	21 CFR 876.1500	21 CFR 876.1500
Product Code	GCJ, HET, NMH	GCJ	GCJ
Device class	Class II	Class II	Class II
Indication for use	The OptoMedic Laparoscopesare intended to be used forendoscopy andendoscopic surgery within thethoracic and peritoneal cavitiesincluding the femalereproductive organs.The OptoMedic Laparoscopesare intended to be used bytrained healthcare professionalin diagnostic and therapeuticprocedures.	For telescopes withdiameter ranging from3mm-5mm:The HOPKINS Telescopesare intended to providevisualization duringlaparoscopy, thoracoscopyand general surgery inadults and pediatrics.For telescopes withdiameter ranging from5.5mm- 11mm:The HOPKINS Telescopesare intended to providevisualization duringlaparoscopy, thoracoscopyand general surgery inadults.	The O-Mec Laparoscopes690 Series (Models, 90-331000H, 690-331030H,690-300500H, 690-300530H) are intended tobe used by surgeons indiagnostic and therapeuticprocedures. Laparoscopicminimally invasiveprocedures are performedin the abdominal cavity bymeans of small skinpunctures that allow theinsertion of the laparoscopeand laparoscopicinstruments.
Prescription/Over-the-counter use	Prescription	Prescription	Prescription
Single use /Reusable	Reusable	Reusable	Reusable
Principle ofoperation	The illumination light enters thelaparoscope from the light guidecable, and exits from objectivelens to irradiate the tissue. Thelight reflected by the tissue iscollected and transmitted by thelaparoscope compatible with acamera head. The imageinformation is converted into animage signal through the camerahead and finally displayed onthe monitor.	The HOPKINS Telescopesare rigid telescopes thatutilize the rod lenstechnology. At the distalend of the telescope's shaftis the lens and the otherend of the shaft is attachedto the eyepiece.Throughout the centrallumen of the HOPKINSTelescopes, optical glassrods are used to transmitand magnifythe image received from	The illumination lightenters the laparoscope fromthe light guide cable, andexits from objective lens toirradiate the tissue. Thelight reflected by the tissueis collected and transmittedby the laparoscopecompatible with a camerahead. The imageinformation is convertedinto an image signalthrough the camera headand finally displayed on the

		the lens.	monitor.
Physical Characteristics
Endoscope Type	Rigid endoscope	Rigid endoscope	Rigid endoscope
Working Length	310mm, 330mm	18cm- 50cm	331mm, 334mm, 301mm, 303mm
Maximum insertionportion width	5.6mm, 10.1mm	3mm- 11mm	10.1mm, 5.5mm
Optical Characteristics
Direction of View	0°, 30°	0°, 6°, 30°, 45°	0°, 30°
Field of View	68°, 75°	55°- 80°	75°
Light source	External	External	External
Reprocessing Methods
Cleaning	Manual, Automatic	Manual, Automatic	Manual
Sterilization	Steam sterilization/Low temperature plasmasterilization	Steam (prevacuum),STERRAD 100S,STERRAD NX,STERRAD 100NX,STERIS VPRO1, VPRO 1 Plus	Autoclavable

Table 2 General Comparison

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Image /page/6/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the word "OptoMedic" in bold, black letters. The circular graphic appears to be a stylized representation of an eye or lens.

Traditional 510(k) Premarket Notification K231003 Laparoscope

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 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for • the basic safety and essential performance of endoscopic equipment
ISO 8600-1-2015 General requirements ●
ISO 8600-3-2019 Determination of field of view and direction of view of endoscopes with . optics
ISO 8600-4-2014 Determination of maximum width of insertion portion .
ISO 8600-5-2020 Determination of optical resolution of rigid endoscopes with optics .
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin ● sensitization
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicity
ISO 10993-23:2021Biological evaluation of medical devices Part 23: Tests for irritation .

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K231003

Image /page/7/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic to the left of the company name. The company name is written in a bold, sans-serif font, with "Opto" in black and "Medic" in black.

Traditional 510(k) Premarket Notification K231003 Laparoscope

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

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.