(64 days)
Not Found
No
The document describes image acquisition, storage, and transmission, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function.
No
The device is described as an automated imaging device intended to capture, store, and transmit images of the fundus for examination of pathologies, not to treat them.
No
Explanation: The device captures, stores, and transmits images for display, but it does not perform any analysis or interpretation of these images to aid in diagnosis. It is an imaging device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components: a video camera, an imaging system, a computer, and a monitor, in addition to the software.
Based on the provided information, the Digiscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Digiscope's Function: The Digiscope is an imaging device that captures images of the fundus (the back of the eye) in vivo (within the living body). It does not analyze biological specimens.
- Intended Use: The intended use is to capture, store, and transmit images of the fundus for examination for pathologies. This is a form of medical imaging, not in vitro testing.
The device description and intended use clearly indicate that the Digiscope is an ophthalmic camera used for imaging the eye directly, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
EyeTel's ("EyeTel") Digiscope, the Tomey Corporation ImageScape Digital Retinal Image System and the Topcon. Inc. ImageNet Digital Imaging System and are intended to capture and store images of the retina taken by a fundus camera. The Digiscope is an automated imaging device of the fundus that is intended to capture, store, and transmit images of the fundus using lossless compression to a distant location for display. The Digiscope requires minimal operator training and intervention during the imaging process. It is indicated for individuals where examination of the fundus for pathologies is requested. The predicate devices are likewise comprised of fundus cameras and computer hardware/software systems intended to capture, store, and transmit images of the fundus. Thus, the Digiscope ophthalmic camera has the same intended use and indications as these predicate devices.
The Digiscope is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Digiscope Ophthalmic camera consists of: (1) a video camera; (2) an imaging system: (3) a computer with image acquisition and hardware control capabilities; (4) a monitor; and (5) EyeTel's Digiscope software. The Digiscope is intended to capture, store, and transmit images of the fundus and is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested. The images of the fundus are digitized, stored on the Digiscope's hard drive, and transmitted via lossless compression for display at distant locations.
The Digiscope's user/software interface allows the images of the eye to be acquired, monitored, stored, and retrieved. Data is input into the Digiscope software via a touchscreen. Imaging, focusing, and camera orientation in relation to the retina are controlled by the software with verification and monitoring by the user. The software allows the user to monitor the image capture process and verify that the device is operating appropriately.
The image of the fundus is acquired by the Digiscope and stored in individual image data files in an uncompressed state on the hard drive of the computer system and displayed electronically. The images may then be transmitted via lossless compression to distant locations for display using a modem and standard telecommunications connections.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fundus camera
Anatomical Site
Fundus (retina)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K990205
EyeTel's Digiscope Ophthalmic Camera
| Name of Device | Digiscope ophthalmic camera |
|---|---|
| Common or Usual Name | Camera, Ophthalmic (AC Powered) |
| Classification Name | Ophthalmic camera |
| (per 21 C.F.R. 866.1120) | |
| Product Code | HKI |
| Submitter | EyeTel Imaging. Inc. |
| 15078 Stillfield Place | |
| Centreville, Virginia 20120 | |
| Phone: | (703) 803-8584 |
| Facsimile: | (703) 815-3721 |
| Contact Person: | Kevin T. Quinn |
| Date Prepared: |
Predicate Devices
| Trade name | Manufacturer | 510(k) |
|---|---|---|
| ImageScape Digital Retinal Imaging System | Tomey Corporation | K971685 |
| ImageNet Digital Ophthalmic Imaging System | Topcon | K870039 |
Intended Use
EyeTel's ("EyeTel") Digiscope, the Tomey Corporation ImageScape Digital Retinal Image System and the Topcon. Inc. ImageNet Digital Imaging System and are intended to capture and store images of the retina taken by a fundus camera. The Digiscope is an automated imaging device of the fundus that is intended to capture, store, and transmit images of the fundus using lossless compression to a distant location for display. The Digiscope requires minimal operator training and intervention during the imaging process. It is indicated for individuals where examination of the fundus for pathologies is requested. The predicate devices are likewise comprised of fundus cameras and computer hardware/software systems intended to capture, store, and transmit images of the fundus. Thus, the Digiscope ophthalmic camera has the same intended use and indications as these predicate devices.
Substantial Equivalence
The EyeTel Digiscope, Tomey Corporation's ImageScape system, and the Topcon ImageNet system have the same intended use: to capture, store, and transmit images of the fundus. The Digiscope and the predicate devices have similar principles of operation and technological characteristics. Each of the devices is an ophthalmic camera. The user views the patient's retina through a slit lamp or fundus camera. A light source is then used to generate images of the retina which are captured by the camera. The images are then digitized and
1
stored. Successive images are taken to permit viewing of a larger area of the retina. The stored images may be viewed on a monitor.
The technological differences between the Digiscope ophthalmic camera and its predicate devices are the degree of automation of Digiscope's fundus camera and its targeting and focusing, the storage system, and the media on which the images may be captured (digital electronic display vs. film or printed image). However, these differences do not raise any new questions of safety or effectiveness. The Digiscope uses a dedicated camera and an automated illumination system, while the predicate devices use non-dedicated fundus cameras or slit lamps that rely on manual targeting and focusing. In each device, the data is acquired in a noncompressed format and is capable of being stored in individual image data files. The minor differences in data storage are the type of storage media. For the Digiscope and the ImageScape, the data is stored in an uncompressed state on the hard drive of the computer system. The ImageScape system then permits downloading of the data with compression to a 1 gigabyte JAZ drive, while the Digiscope permits transmission of the data via lossless compression to remote locations for display. The Topcon ImageNet utilizes a read/write CD-ROM recorder to store the images.
Performance Characteristics
The Digiscope Ophthalmic camera consists of: (1) a video camera; (2) an imaging system: (3) a computer with image acquisition and hardware control capabilities; (4) a monitor; and (5) EyeTel's Digiscope software. The Digiscope is intended to capture, store, and transmit images of the fundus and is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested. The images of the fundus are digitized, stored on the Digiscope's hard drive, and transmitted via lossless compression for display at distant locations.
The Digiscope's user/software interface allows the images of the eye to be acquired, monitored, stored, and retrieved. Data is input into the Digiscope software via a touchscreen. Imaging, focusing, and camera orientation in relation to the retina are controlled by the software with verification and monitoring by the user. The software allows the user to monitor the image capture process and verify that the device is operating appropriately.
The image of the fundus is acquired by the Digiscope and stored in individual image data files in an uncompressed state on the hard drive of the computer system and displayed electronically. The images may then be transmitted via lossless compression to distant locations for display using a modem and standard telecommunications connections.
Conclusion
The Digiscope has the same intended use and indications, and very similar principles of operation and technological characteristics as the Tomey Corporation ImageScape Digital Retinal Image System and the Topcon, Inc. ImageNet Digital Imaging System. The minor differences between the Digiscope and the predicate devices do not raise any new questions of safety or effectiveness. Thus, the EyeTel Digiscope ophthalmic camera is substantially equivalent to legally marketed ophthalmic cameras.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of three stylized human profiles facing right, with three curved lines above them, possibly representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 26 1999
Mr. Kevin T. Quinn President EyeTel Imaging, Inc. 15078 Stillfield Place Centreville, VA 20120
Re: K990205 Trade Name: Digiscope Ophthalmic Camera Regulatory Class: II Product Code: 86 HKI Dated: March 16, 1999 Received: March 17, 1999
Dear Mr.Quinn:
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 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 (QS) 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 .
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Page 2 - Mr. Kevin T. Quinn, President
··· 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
. ・ .
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: EyeTel Digiscope Ophthalmic Camera
Indications for Use:
The Digiscope is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K990205 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |