The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Device Description

The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time.

The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage.

The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module.

Optical Module
The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module.

1. The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting.
1. The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably.

Mobile Platform Module
This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module.

Power Supply Module
Power supply to each module through medical switching power supply.

Control Module
To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally.

There is a computer system integrated in the product, the input and output function are realized by touch screen display.

Chin Rest Module
To place the patient's head and keep the patient's eyes stable and easy to observe.

AI/ML Overview

The provided document is a 510(k) summary for the Fundus Camera RetiCam 3100. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.

Here's a breakdown of why many of your requested items cannot be found in this document:

This document describes a medical device (a fundus camera) for image capture, not an AI/algorithm for diagnosis. Therefore, the concepts of "acceptance criteria for an AI algorithm," "AI vs. without AI assistance," "standalone algorithm performance," and "ground truth for test/training sets" are not applicable to the content presented.

However, I can extract information related to the performance specifications and the study (non-clinical testing) conducted for the device itself.

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Acceptance Criteria (Specification per ISO 10940)	Reported Device Performance	Study Basis
Resolving Power (Field of view > 30° )		4.2 of ISO 10940
Centre: 60 lp/mm	60 lp/mm
Middle (r/2): 40 lp/mm	40 lp/mm
Periphery (r): 25 lp/mm	25 lp/mm
Tolerance of angular field of view	48.0°
50° ±5%
Tolerance of pixel pitch	6.59 um
6.45 um ±7%
Range of Focus	Meet the specification
-15D to +15D

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical test conducted by Chongqing Bio NewVision Medical Equipment Ltd. This testing aimed to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device.

Here's what can be inferred/extracted about the "study":

Sample size used for the test set and the data provenance: Not applicable/Not provided. This was not a study involving human data or labeled datasets for an algorithm. It was a performance validation of a hardware device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This was a technical performance test of a camera, not a diagnostic assessment requiring expert ground truth.
Adjudication method for the test set: Not applicable/Not provided.
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: No. This document explicitly states, "No clinical study is included in this submission." Furthermore, the device is a fundus camera, not an AI algorithm, so the concept of human readers improving with AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a fundus camera, not a standalone algorithm.
The type of ground truth used: For the performance parameters (resolving power, field of view, pixel pitch, range of focus), the "ground truth" was established by technical specifications and measurement standards, specifically ISO 10940, rather than clinical outcomes or expert consensus.
The sample size for the training set: Not applicable/Not provided. This is a hardware device; there is no training set for an AI algorithm.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary of Non-Clinical Testing:

The non-clinical tests involved verifying compliance with several international and national standards, including:

AAMI/ANSI/ES 60601-1:2005+A1:2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
IEC 60601-1-2:2014 (EMC for Medical Electrical Equipment)
ISO 15004-1:2006 (Ophthalmic instruments - General requirements)
ISO 15004-2:2007 (Ophthalmic instruments - Light hazard protection)
ISO 10940:2009 (Ophthalmic instruments - Fundus cameras)
ISO 10993-5:2009 & ISO 10993-10:2010 (Biological Evaluation of Medical Device - Cytotoxicity, Irritation, and Hypersensitivity)
ANSI Z80.36-2016 (American National Standard for Ophthalmics - Light Hazard Protection)

The results demonstrated that the proposed device complies with these standards, specifically meeting or exceeding the resolving power, field of view, pixel pitch, and focus range specifications outlined in ISO 10940.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Chongqing Bio NewVision Medical Equipment Ltd. % Ray Wang Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 CHINA

Re: K190954

Trade/Device Name: Fundus Camera RetiCam 3100 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: December 13, 2019 Received: December 16, 2019

Dear Ray Wang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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): K190954

Device Name Fundus Camera RetiCam 3100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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 information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

APPLICANT INFORMATION

Date of Preparation: 01/20/2020

Sponsor Identification

Chongqing Bio NewVision Medical Equipment Ltd.

#1-10, Floor 9th of building #4, Group 2N of 2nd Project, Fulicheng Zhihuiguoji, Shapingba District, 401331 Chongqing, PEOPLE'S REPUBLIC OF CHINA

Contact Person: Wang Hao, Quality Manager Tel: 86-13657617625 Fax: 86-23-65456482 Email: wh(@fortune-newvision.com

Designated Submission Correspondent: Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, China 102401Tel: +86-18910677558 Fax: +86-10- 56335780 Email: ray.wang@believe-med.com

IDENTIFICATION OF SUBJECT DEVICE

Trade Name: Fundus Camera RetiCam 3100 Regulation Number:21 CFR 886.1120 Regulation Name: camera, ophthalmic, ac-powered Classification: II Product Code: HKI

INDICATIONS FOR USE

DEVICE DESCRIPTION

The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time.

The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus

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digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage.

The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module.

Optical Module

The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module.

1. The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting.
1. The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably.

Mobile Platform Module

This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module.

Power Supply Module

Power supply to each module through medical switching power supply.

Control Module

To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally.

There is a computer system integrated in the product, the input and output function are realized by touch screen display.

Chin Rest Module

To place the patient's head and keep the patient's eyes stable and easy to observe.

IDENTIFICATION OF PREDICATE DEVICE(S)

Primary Predicate Device 510(k) Number: K122572 Product Name: iCam Fundus Camera Manufacturer: Optovue, Inc.

Secondary Predicate Device 510(k) Number: K101935 Product Name: Digital Retinography System (DRS) Manufacturer: CENTERVUE SPA

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NON-CLINICAL TESTING

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

AAMI/ANSI/ES 60601-1:2005+A1:2012, 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 ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods -Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection
ISO 10940:2009 Ophthalmic instruments Fundus cameras ●
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
. ANSI Z80.36-2016 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments

	Specification	Test Results	Testing Basis
Resolving Power (Fieldof view > 30° )	Centre 2: 60lp/mmMiddle (r/2) 2: 40lp/mmPeriphery (r) 2: 25lp/mm	60 lp/mm40 lp/mm25 lp/mm	4.2 of ISO 10940
Tolerance of angularfield of view	50° ±5%	48.0°
Tolerance of pixel pitch	6.45 um ±7%	6.59
Range of Focus	-15D to +15D	Meet thespecification

Summary of the results of performance testing and the device requirements based on ISO 10940

CLINICAL TEST CONCLUSION

No clinical study is included in this submission.

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SUBSTANTIALLY EQUIVALENT (SE) COMPARISON

Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Primary Predicate Device (K122572)	Secondary Predicate Device (K101935)	Remark
Device name	Fundus CameraRetiCam 3100	iCam Fundus Camera	Digital Retinography System (DRS)	/
Classification Name	Ophthalmic Camera	Ophthalmic Camera	Ophthalmic Camera	SAME
Product Code	HKI	HKI	HKI	SAME
Regulation Number	886.1120	886.1120	886.1120	SAME
ComparisonStatement	The proposed device has same classification information as the predicate device.
Intended Use	The Fundus Camera RetiCam 3100 isintended to capture digital images of theposterior and external structures of the eyewithout the use of a mydriatic agent and isintended for use as an aid to clinicians inthe evaluation, diagnosis anddocumentation of ocular health.	The iCam takes digital images of theposterior and external structures of the eyewithout the use of a mydriatic agent and isintended for use as an aid to clinicians in theevaluation, diagnosis and documentation ofocular health.	The CenterVue Digital RetinographySystem DRS is intended for takingdigital images of a human retinawithout the use of a mydriatic agent.	SAME
Usage	Prescription Use	Prescription Use	Prescription Use	SAME
ComparisonStatement	The proposed device has similar intended use as the predicate device.
Main Unit Technical Specifications
Operation Principle	The optical design of fundus camera is based on the principle of monocular indirect ophthalmoscopy.1. Fundus observationA build in light ray from the infrared light LED source to illuminate the fundus. Alignment of the device is performed by build in eyetracking indicator and working distance indicator to adjust system to best XYZ position automatically.

	2. Image capture:
	System use split-image technique to do image focus adjustment automatically to capture the best quality of image. White light from
	LEDs Flash module irradiates the fundus. The light reflected from eye portions forms an image, and the image is captured by built-in
	color CMOS camera module for fundus image capture.
Light Source	Observation: Infrared LED			SAME
		Image capture: White LED
Eye Fixation	Internal 9 points	Internal 6 points	Not Available	Analysis 1
Alignment	Manual focus tracking	Manual focus tracking	Automatic	SAME
Image Resolution	2304 x 1728 (4 MP)	1.3 MP	2592 x 1944 (5 MP)	Analysis 2
Field of view	50 degrees	45 degrees	45 degrees	Analysis 3
Operation Range	From -15 D to +15D	From -15 D to +15D	From -15 D to +15D	SAME
Interface	USB2.0, VGA, Network Port	USB 2.0	USB 2.0	Analysis 4
Minimum Pupil Size	3.0 mm	4.0 mm	4.0 mm	Analysis 5
Working Distance	35 mm	25 mm	37 mm	Analysis 6
Power Supplier	A.C. 100-240 V, 50/60 Hz, 220 VA	AC100V to 240V, 50/60Hz	100-240 VAC, 50/60 Hz	SAME
Comparison Statement:	The proposed device has the similar main unit specifications with the predicate device. Please refer to the difference analysis below the table
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10	ISO10993-5&ISO10993-10	ISO10993-5&ISO10993-10	SAME
Electrical Safety	IEC60601-1	IEC60601-1	IEC60601-1	SAME
EMC	IEC60601-1-2	IEC60601-1-2	IEC60601-1-2	SAME
Performance	ISO 15004-1ISO 15004-2ISO 10940ANSI Z80.36-2016	ISO 15004-1ISO 15004-2ISO 10940	ISO 15004-2ISO 10940	SAME

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Substantially Equivalent (SE) Conclusion

The subject device has differences with predicate device, the difference analysis shown as followings:

1. The eye fixation points are more than predicate device, it provides more different angle of fundus images.
1. The higher pixel provides high resolution image, it does not adversely affect safety and effectiveness.
The larger field view provides bigger observation range, it does not adversely affect safety and 3. effectiveness.
More options are available for data transfer interface, all interface used are international standard 4. interface, it does not adversely affect safety and effectiveness.
న్. The smaller minimum pupil size could be applied to more wider patient population with same quality fundus images.
The working distance is changed by the different framework of device, it does not adversely affect 6. safety and effectiveness.

Therefore, the above differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. There is no new technology used in the subject device.

Conclusion: The proposed device is Substantially Equivalent (SE) in safety and effectiveness to the selected predicate devices

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.