(81 days)
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Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as an imager used to produce images of the retina and anterior segment, which is a diagnostic function rather than a therapeutic one.
No
The device is used to produce images of the retina and anterior segment for imaging purposes, but the provided text does not state that it performs diagnosis, only captures images.
No
The description explicitly states the device is a "Retinal Imager," which is a type of hardware (fundus camera). The intended use also describes producing images, which requires a physical imaging device. There is no mention of the device being solely software that processes images from an external source.
Based on the provided information, the WinStation Retinal Imager™ 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.
- Device Function: The WinStation Retinal Imager™ is described as a device that produces images of the retina and anterior segment of the eye. This is a form of in vivo imaging, meaning it is performed directly on the living body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "fundus imaging" and "slit lamp imaging," which are procedures performed directly on the eye.
Therefore, the WinStation Retinal Imager™ falls under the category of medical imaging devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
Product codes
86 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
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Anatomical Site
retina (fundus imaging) and anterior segment (slit lamp imaging)
Indicated Patient Age Range
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Intended User / Care Setting
operated by doctors and technicians in ophthalmic and optometric offices and other locations that are under the direction of a licensed physician in which it is appropriate to perform ocular imaging procedures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles or stylized birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1998
Mr. Steven R. Verdooner President Ophthalmic Imaging Systems, Inc. 221 Lathrop Way Suite I Sacramento, CA 95815
Re: K982689 Trade Name: WinStation Retinal Imager Regulatory Class: II Product Code: 86 HKI Dated: September 29, 1998 Received: September 30, 1998
Dear Mr. Verdooner:
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. Steven R. Verdooner, 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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| Page_ of of | ||
|---|---|---|
| 510(k) Number (if known):K982689 · · · ¹ ¹ · · | ||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| WinStation Retinal Imager | ||
| Device Name: _________________________________________________________________________________________________________________________________________________________________ | ||
| Status Canada Career Station Company Company Come of Children |
Indications For Use:
STATEMENT OF INDICATIONS FOR USE
The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
The WinStation Retinal Imager™ will be operated by doctors and technicians in ophthalmic and optometric offices and other locations that are under the direction of a licensed physician in which it is appropriate to perform ocular imaging procedures. Fundus photography and slit lamp imaging is the standard of care for documentation of the patient's eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Denis L. McCarthy
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number .