The IRI™ Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.

Device Description

Medivision's IRI™ Integrated Retinal Imager System is a retinal camera, which is designed to perform digital fundus imaging. IRI™, as other fundus cameras, uses light photography to obtain clinical information. Using light sources (LEDs of different colours, a set of lenses and filters, and digital camera sensors, an image from the eye's retina is captured and later displayed for review. The device comprises a main console, a PC, a touch screen (as part of the main console) and a monitor. Digital image storage is available to several storage media.

AI/ML Overview

Here's an analysis of the provided text regarding the IRI™ INTEGRATED RETINAL IMAGER SYSTEM, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a table of reported device performance metrics related to diagnostic accuracy.

Instead, it focuses on general safety, performance, and validation tests, and compliance with industry standards. The statement on "Substantial Equivalence" indicates that its performance is considered similar to predicate devices, but specific quantitative measurements are not provided.

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance
Device met all its functional specifications	Test performed to ensure compliance
Complies with industry and safety standards	Test performed to ensure compliance
Light energy outputs within limits set by ISO15004 and other standards	Outputs analyzed to confirm compliance
Optical specifications similar to predicate devices	Stated as similar
Image processing and storage capabilities similar to predicate devices	Stated as similar
Substantially equivalent in safety and efficacy to predicate devices	Stated as "Conclusión"

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

The document does not specify the sample size used for any performance testing, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or image-based test sets.

3. Number of Experts Used and Qualifications:

The document does not mention the number or qualifications of any experts used to establish ground truth for a test set.

4. Adjudication Method:

The document does not describe an adjudication method for establishing ground truth, as evidence of image-based test sets or expert review is absent.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size for human readers' improvement with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The device is described as an imager, and while it has "image processing," there's no mention of an algorithm making diagnostic decisions independently.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data), as no detailed study on diagnostic performance is described. The device's purpose is "documentation of findings in a clinical setting," implying that ground truth would be what a clinician observes and documents.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This information would typically be relevant if the device incorporated machine learning or AI algorithms requiring training, which is not explicitly detailed beyond "image processing."

9. How Ground Truth for the Training Set Was Established:

Since no training set is mentioned, the document does not describe how ground truth for a training set was established.

Summary of Device and Study Information from the Provided Text:

The IRI™ Integrated Retinal Imager System is a fundus camera designed for digital imaging of the retina, intended for routine clinical use and documentation. Its regulatory submission (K062295) highlights its substantial equivalence to existing predicate devices (Topcon TRC-NW200, Carl Zeiss VisuCam Lite, Canon CF-60DSi) in terms of safety, efficacy, optical specifications, and image processing/storage capabilities.

The "study" described in the document is a series of "extensive safety, performance testing, and validation" before release, focusing on:

Ensuring the device met all functional specifications.
Software validation tests.
Compliance with industry and safety standards (e.g., IEC/EN-60601-1, IEC/EN 60601-1-2, ISO 15004, ANSI/IESNA RP-27 series).
Verifying that light energy outputs are within established safety limits.

Crucially, the provided 510(k) summary does not detail any clinical trial, diagnostic accuracy study, or performance evaluation that would typically involve specific acceptance criteria for diagnostic metrics (like sensitivity or specificity), defined test sets, expert ground truth, or comparative effectiveness with or without AI. The primary evidence presented for clearance is the device's functional and safety compliance and its substantial equivalence to predicate devices, which already have established uses as retinal imagers.

Summary

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510(K) SUMMARY

IRI™ INTEGRATED RETINAL IMAGER SYSTEM

510(k) Number K_062295

Applicant's Name:	MediVision Medical Imaging Ltd.Tabor BuildingIndustrial Park P.O.Box 45Yokneam Elit 20692IsraelTel: +972-4-9894884Fax: +972-4-9894883e-mail:david@medivision-ois.com
Contact Person:	Ahava Stein/ Ofer HornickA. Stein - Regulatory Affairs Consulting20 Hata'as St.Kfar Saba 44425IsraelTel. + 972-9-7670002Fax. +972-9-7668534e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il
Date Prepared:	October 2006
Trade Name:	IRI™ Integrated Retinal Image
Classification Name:	CFR Classification section 886.1120 (Product code HKI)CFR Classification section 892.2010 (Product code NFF)CFR Classification section 892.2020 (Product code NFG)
Classification:	Class II medical Device

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Predicate Device: The IRI™ Integrated Retinal Imager device is substantially equivalent to a combination of the following predicate devices:

TRC-NW200 (K041367) manufactured by Topcon. TRC-NW200 is a monocular ophthalmic non-mydriatic camera system intended for capturing, displaying and storing images. When combined with the IMAGENet™ 2000 (a software program that is a class I medical product and is listed as such on the FDA's database), the device performs digital recording and image processing of the captured images, similar to the IRI™ Integrated Retinal Imager device.
VisuCam Lite (K021787) manufactured by Carl Zeiss. VisuCam Lite is an Ophthalmic Camera system, which is intended to photograph the fundus, similar to the IRI™ Integrated Retinal Imager device.
Canon CF-60DSi (K041546), manufactured by Canon Inc. The CF-60DSi is a digital fundus camera used for taking digital images of human eye without a mydriatic, similar to the IRI™ Integrated Retinal Imager device.

Medivision's IRI™ Integrated Retinal Imager System is a retinal Device Description: camera, which is designed to perform digital fundus imaging. IRI™, as other fundus cameras, uses light photography to obtain clinical information. Using light sources (LEDs of different colours, a set of lenses and filters, and digital camera sensors, an image from the eye's retina is captured and later displayed for review. The device comprises a main console, a PC, a touch screen (as part of the main console) and a monitor. Digital image storage is available to several storage media.

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Intended Use / Indication for Use: The IRI™ Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.

Performance Standards: None.

The design of the IRI™ Integrated Retinal Imager Cardiac Scanner System conforms to the following voluntary standards:

. IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General Requirements for Safety. Second edition (1990), including amendments #1(1993), #2(1995), #13(1996).
. IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: Collateral Standard: Electromagnetic Compatibility-Requirements and Tests (2001)
. ISO 15004: 1997 Ophthalmic Instruments -- Fundamental requirements and test methods.
. David Sliney et al.: Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP), Applied optics, Vol. 44, pp 2162-2176. 2005.
ANSI/IESNA RP-27.1 -96 -- Recommended practice for I photobiological safety for lamps & lamp systems -General requirements.
ANSI/IESNA RP-27.2-00 Recommended practice for ■ photobiological safety for lamps & lamp systems -Measurement techniques.
. ANSI/IESNA RP-27.3-96
- Recommended practice

for photobiological safety

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MediVision 510(k)

for lamps and lamp systems - Risk group classification & Labeling.

Test Data: The IRI™ Integrated Retinal Imager System has been subjected to extensive safety, performance testing, and validation before release. Final testing of the IRI™ Integrated Retinal Imager System included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.

The IRI™ Integrated Retinal Imager System is similar to Substantial Equivalence: currently distributed retinal camera systems intended for fundus imaging applications. Similar to other predicate devices, the operating modes of the device include true color, fluorescein angiography, ICG angiography, red-free, red, blue and autofluorescence photography. The device uses LEDs as light sources instead of halogen and xenon lamps. Light energy outputs are within the limits set by ISO15004 and other standards for evaluating outputs of optical instruments (referenced above), Optical specifications are similar to those of predicate devices. Image processing and storage capabilities are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices.

The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices is that the IRI™ Integrated Retinal

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Imager device is substantially equivalent in safety and efficacy to the predicate devices listed above.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MediVision Medical Imaging Ltd. c/o Ahava Stein A. Stein Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425 Israel

OCT 2 0 2006

Re: K062295

Trade/Device Name: IRI™ Integrated Retinal Imager System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 10, 2006 Received: October 10, 2006

Dear Ms. Stein:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manisoning , your device of your device to a legally premarket nothleation. The PDF mailing of basification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at no 10-10-101 15. Also, please note the regulation entitled, Colliable of Comptancement (ket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oszess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K062295

IRI Integrated Retinal Imager System Device Name:

Indications for Use:

The IRI Integrated Retinal ImagerSystem is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.

Prescription Use ﮯ (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Derius Shi 10/19/2008

510(k) Number

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.