(90 days)
Not Found
Not Found
No
The summary only describes image capture, storage, and management, with no mention of AI, ML, or related concepts like analysis, interpretation, or algorithms beyond basic image handling.
No
The device is used to capture, store, and manage images for health professionals, which is an imaging management function, not a therapeutic one.
No
The device is described as an "Imaging System" used to "capture, store and manage output images," which indicates it is an image management system rather than a diagnostic device. It does not mention analyzing images or providing interpretations for diagnostic purposes.
Unknown
The summary describes a system that captures, stores, and manages images from hardware devices (Retinal Cameras, Fundus Cameras, Video Slit Lamps). While the "EyeCap Imaging System" itself might be primarily software, the description doesn't explicitly state that it is only software and does not include any hardware components or control of the imaging hardware beyond receiving the output.
Based on the provided information, the EyeCap Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EyeCap Imaging System's intended use is to capture, store, and manage images from cameras that image the eye (Retinal Cameras, Fundus Cameras, Video Slit Lamps). These are in vivo imaging modalities, meaning they image the body directly, not specimens taken from the body.
- The description focuses on image handling, not analysis of biological samples. The functions described are capturing, storing, and managing images, which are typical functions of medical imaging systems, not IVDs.
Therefore, the EyeCap Imaging System falls under the category of a medical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
Product codes
HKI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Retinal Cameras, Fundus Cameras and Video Slit Lamps
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with three stylized lines forming its body and wings, suggesting movement and flight. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Clement Clarke International, LTD c/o Mr. M. J. Wilkinson Edinburgh Way Harlow, Essex CM20 2TT United Kingdom
K000368 Re:
Trade Name: EyeCap Imaging System Regulatory Class: Class II Product Code: HKI Regulation: 886.1120 (Accessory to Ophthalmic Camera) Dated: January 25, 2000 Received: February 4, 2000
Dear Mr. Wilkinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely yours,
A. Joseph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the letters "HS" stacked on top of the word "INTERNATIONAL". The letters "HS" are in a bold, sans-serif font and are connected to each other. The word "INTERNATIONAL" is in a smaller, sans-serif font and is located below the letters "HS". The logo is black and white.
Clement Clar
A HAAG-STREIT COMPANY
APPENDIX 3
| 510(K) Number (if known) | : | Not yet allocated K000368 |
|---|---|---|
| -------------------------- | --- | --------------------------- |
:
Indications for Use :
Device Name
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
EyeCap Imaging System
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number K000368
Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)
(Optional Format 1-2-96)