(74 days)
Not Found
No
The summary describes a standard digital fundus camera and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is described as an imager for documentation of findings, performing digital fundus imaging to capture and display images from the retina. This indicates a diagnostic or imaging purpose, not a therapeutic one.
No
The device is described as an imager for "documentation of findings" and "digital fundus imaging" to "capture" and "display" images from the retina. While it captures clinical information, its intended use does not state it provides a diagnosis or aids in making a diagnosis from the captured images.
No
The device description explicitly states it comprises hardware components such as a main console, PC, touch screen, monitor, light sources (LEDs), lenses, filters, and digital camera sensors, in addition to software for image capture and display.
Based on the provided information, the IRI™ Integrated Retinal Imager System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IRI™ Function: The IRI™ system is a retinal imager that uses light photography to capture images of the retina directly from the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "documentation of findings in a clinical setting," which aligns with imaging devices used for visual examination and record-keeping, not laboratory testing of biological samples.
Therefore, the IRI™ Integrated Retinal Imager System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
HKI, NFF, NFG
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light photography
Anatomical Site
Retina (Eye's fundus)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Routine use / Clinical setting
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) SUMMARY
IRI™ INTEGRATED RETINAL IMAGER SYSTEM
510(k) Number K_062295
| Applicant's Name: | MediVision Medical Imaging Ltd.
Tabor Building
Industrial Park P.O.Box 45
Yokneam Elit 20692
Israel
Tel: +972-4-9894884
Fax: +972-4-9894883
e-mail:david@medivision-ois.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ahava Stein/ Ofer Hornick
A. Stein - Regulatory Affairs Consulting
20 Hata'as St.
Kfar Saba 44425
Israel
Tel. + 972-9-7670002
Fax. +972-9-7668534
e-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.
2
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
3
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
4
Imager device is substantially equivalent in safety and efficacy to the predicate devices listed above.
.
5
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,
6
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)
OR
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