(60 days)
No
The summary describes a standard fundus camera for image capture and storage, with no mention of AI, ML, or advanced image processing beyond basic storage.
No
The device is described as a "fundus camera" used for "retinal image capturing without mydriatic." Its purpose is to take images, which can then be stored, but there is no mention of it treating or preventing any condition.
No
The device is a fundus camera intended for capturing retinal images and storing them. It does not perform any analysis or diagnosis of the images.
No
The device description explicitly states it is a "fundus camera," which is a hardware device used for retinal image capturing.
Based on the provided information, the KOWA nonmyd ct-DIII fundus camera 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 KOWA nonmyd ct-DIII is a fundus camera that captures images of the retina. This is an in vivo process (performed on a living organism), not an in vitro process (performed outside the body).
- Intended Use: The intended use is for "retinal image capturing," which is a diagnostic imaging procedure, not an in vitro test.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
Product codes
HKI, NFJ
Device Description
The KOWA nonmyd a-DIII is similar to the predicate device in that it is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured.
The modifications that are made are:
- Change the power supply
- Change the CCD camera to the same resolution, 8.3M pixels, and the same sensitivity camera by the other manufacturer
- Add the montage function in the associated software
- Add the advanced search function in the associated software
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Retinal image capturing
Anatomical Site
Retinal / fundus
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)
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
va) Kowa Company. Ltd.
ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHIHONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN
510 k N: K083387
| Applicant | Kowa Company, Ltd
4-14, Nihonbashi-honcho 3-Chome
Chuo-ku, Tokyo, 103-8433 Japan | JAN 1 6 2009 |
|-----------------------|----------------------------------------------------------------------------------------|--------------|
| Contact | Akihıro Fujita | |
| Date Summary Prepared | November 14, 2008 | |
| Device Trade Name | KOWA nonmyd α-DIII | |
| Classification name | CAMERA, OPTHALMIC, AC-POWERED
SYSTEM, IMAGE MANAGEMENT, OPHTALMIC | |
| Product Code | HKI
NFJ | |
Intended use
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic The retinal image can be stored to an image filing drive through serial ınterface
Comparison
The KOWA nonmyd a-DIII(Type 1) was chosen as a substantially equivalent device
The KOWA nonmyd a-DIII is similar to the predicate device in that it is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured
The modifications that are made are
- Change the power supply
- Change the CCD camera to the same resolution, 8 3M pixels, and the same sensitivity camera by the other manufacturer
- Add the montage function in the associated software
- Add the advanced search function in the associated software
ﺮ ﻋﻠﻰ ﺍ
1
510(k) notification
な
k 093397 が 510k
| Table A: Predicate device | ||||
|---|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |
| KOWA nonmyd α-DIII (Type 1) | Kowa Company, Ltd | K082767 | Oct 21,2008 |
Conclusion
The KOWA nonmyd x-DIII is equipped with the same fundamental technology as the predicate device and maintains the same level of safety performance Therefore it has been concluded that there are no significant differences in the fundamental function or safety between KOWA nonmyd a-DIII and the predicate devices
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kowa Company, LTD c/o Akıhıro Fujıta, General Manager Electronics & Optics Division 4-14, Nihonbashihoncho 3-Chome, Chou-Ku. Tokyo Japan 103-8433
JAN 1 6 2009
Re K083387
Trade/Device Name KOWA nonmyd a-DIII (Type 2) Regulation Number 21 CFR 886 1120 Regulation Name Ophthalmic Camara Regulatory Class Class II Product Code HKI, NFJ Dated December 16, 2008 Received December 18, 2008
Dear Mr Fujita
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 adulteratıon
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
(
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Dryision of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the DIVISION of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
M. B. Egleston, mD
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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4 Ks
4
510(k) notification
Indications for Use
510(k) Number (if know) KOB3387
Device Name _ KOWA nonmyd a-DIII (Type 2)
Indications for Use
KOWA nonmyd ct-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retimal image can be stored to an image filing drive through serial ınterface
Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
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510(k) Number K093387
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