(113 days)
Not Found
No
The summary describes a retinal camera for capturing images and mentions improvements in hardware and user comfort, but there is no mention of AI or ML for image analysis or processing.
No
The device is described as an imaging tool that captures and saves fundus images, rather than providing or assisting with therapy.
No
The KOWA GENESIS-Df is described as a device that captures and saves fundus images; it does not claim to interpret or diagnose based on these images.
No
The device description explicitly states it is a "hand-held mydriatic retinal camera" and describes hardware components like a CCD camera, flash light, and LED light.
Based on the provided information, the KOWA GENESIS-Df is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The KOWA GENESIS-Df captures images of the fundus (the back of the eye), which is a direct imaging of a part of the body, not an analysis of a biological sample taken from the body.
- The intended use is to capture and save fundus images. This is a diagnostic imaging function, not an in vitro test.
- The device description focuses on imaging technology and user comfort. It describes a camera and its features for capturing images.
Therefore, the KOWA GENESIS-Df falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
Product codes
HKI
Device Description
KOWA GENESIS-Df is a hand-held mydriatic retinal camera which captures fundus images. 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. It uses a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease. The reflectance of the reflective mirror of a flash lamp and the transmissivity of the optical pass system of an optical fiber were raised by having added the function of Fluorescent angiography (PA). Moreover, design change of electrical circuit and capacitance were enlarged compared with KOWA GENESIS-D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
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
5100k) notification
5.0 510(k) Summary
Applicant:
Contact:
AUG 0-7 2009
Kowa Company, Ltd. 4-14, Nihonbashi-honcho 3-Chome Chuo-ku, Tokyo, 103-8433 Japan
Akihiro Fujita
April 10 , 2009
KOWA GENESIS-Df
Date Summary Prepared:
Device Trade Name:
Classification name:
Product Code:
CAMERA, OPHTHALMIC, AC-POWERED HKI
Intended use:
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
Comparison:
KOWA GENESIS Df makes basics structures are the same as that of KOWA GENESIS-D. The reflectance of the reflective mirror of a flash lamp and the transmissivity of the optical pass system of an optical fiber were raised by having added the function of Fluorescent angiography (PA). Moreover, design change of electrical circuit and capacitance were enlarged compared with KOWA GENESIS-D. Therefore, evaluation of light hazard, electrical safety, and EMC was performed, and it was checked that device safety is a level equivalent to KOWA GENESIS-D.
The KOWA GENESIS-Df is similar to the KOWA GENESIS-D 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. Both devices are equipped with highly sensitive CCD cameras, and use a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort.
Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting.
Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.
The function comparison of KOWAGENESIS-Df and the predicate devices is shown in the comparison table below:
Kowa Company, Lid., KOWA GENESIS-Df
1
51000 notification
| Predicate Device | Manufacturer | 510(k)No. | Date Cleared |
|---|---|---|---|
| KOWA GENESIS-D | Kowa Company, Ltd. | K050271 | Nov. 03, 2005 |
Table 5-2: Predicate device comparison table
| KOWA GENESIS-Df | KOWA GENESIS-D | |
|---|---|---|
| Intended use | A hand-held mydriatic retinal camera which captures fundus image. | A hand-held mydriatic retinal camera which captures fundus image. |
| Use condition | SAME to GENESIS-D | with mydriatic |
| Picture angle | SAME to GENESIS-D | Horizontal: 30 degree |
| Vertical: 25 degree | ||
| Working distance | SAME to GENESIS-D | 5mm |
| Observation | SAME to GENESIS-D | Visual observation |
| Storage media | SAME to GENESIS-D | Flash memory card |
| Camera spec. | SAME to GENESIS-D | Color CCD camera |
| 2,000,000 pixels | ||
| Image data format | SAME to GENESIS-D | JPEG and uncompressed format |
| Diopter compensation | SAME to GENESIS-D | $-15D~+35D$ |
| Observation Light Source | SAME to GENESIS-D | Visible LED |
| 4VA(approx. 1W) | ||
| Photographing Light Source | Xenon flash lamp | |
| 23WS | ||
| with improved optical system* | Xenon flash lamp | |
| 23WS | ||
| Power consumption | 150VA | 60VA |
| Weight of Camera unit | approx. 1kg | approx. 1kg |
- The maximum rated of the flash bulb currently used is using the KOWA GENESIS-D. For fluorescence photographing function loading, capacity of the power supply was enlarged, inputs energy was enlarged, and amount of luminescence was increased by improving the efficiency of optical systems.
Conclusion:
The KOWA GENESIS-Df is equipped with the same fundamental technology as the predicate devices 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 GENESIS-Df and the predicate devices.
Kowa Company, Ltd., KOWA GENESIS-DJ
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
KOWA Company, Ltd. c/o Mr. Akihiro Fujita General Manager 4-14, Nihonbashihoncho 3-chome Chuo-ku, Tokyo Japan 103-8433
AUG 0-7 2009
Re: K091098
Trade Name: KOWA Genesis-Df Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: July 3, 2009 Received: July 6, 2009
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 adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander Jr.
Malyina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) notification
Indication for Use
510(k) Number (if known):
$\qquad K09/098$
Device Name: KOWA GENESIS-Df
Indication For Use: KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or Over the Counter Use … (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
8/7/2009
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Kowa Company, Ltd., KOWA GENESIS-Df
SIS-D/
510(k) Number K091098