(25 days)
K0530271
Not Found
No
The summary describes a standard retinal camera for capturing and saving images, with no mention of AI, ML, or any advanced image processing beyond basic capture and saving.
No
The device is a retinal camera used to capture and save fundus images, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
No
The device description states it is intended to "capture and save fundus images." It does not mention any analysis or interpretation of these images for diagnostic purposes.
No
The device description explicitly states it is a "hand-held retinal camera," which is a hardware device used to capture images. It also mentions a "Color CCD camera" as the input imaging modality, further confirming it is a hardware device.
Based on the provided information, the KOWA hand-held retinal camera, KOWA GENESIS-D 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The KOWA GENESIS-D is described as a device intended to capture and save fundus images. This is an imaging device that visualizes the inside of the eye. It does not perform any tests on biological samples.
Therefore, its function falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
The KOWA GENESIS-D 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 KOWA GENESIS-D and indirect diagnostic lens holder with lens has a color CCD camera with 2,000,000 pixels, image data format in JPEG and uncompressed format, Diopter compensation of -15D to +35D, Visible LED 4VA(approx. 1W) Observation Light Source, and Xenon flash lamp 23WS Photographing Light Source. It has a Picture angle of Horizontal: 30 degree, Vertical: 25 degree and a Working distance of 5mm. It is a hand-held mydriatic retinal camera which captures fundus image. It uses flash memory card for storage media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): 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.
K0530271
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
9. Certification 9.1 Summary for public disclosure
Submitter information:
'은 대한민국 대학교
| Applicant: | Kowa Company, Ltd.
4-14, Nihonbashi-honcho 3-Chome
Chuo-ku, Tokyo, 103-8433 Japan
Phone: +81-3-5623-8063
Fax: +81-3-5623-8060 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Satohiko Takanashi, PE |
| E-mail address: | s-takana@kowa.co.jp |
| Date summary prepared: | March 7, 2008 |
Device identification:
| Device trade name: | KOWA GENESIS-D |
|---|---|
| Classification name: | CAMERA, OPTHALMIC, AC-POWERED |
| Product code: | HKI |
Intended use:
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Comparison:
The KOWA GENESIS-D was chosen as a substantially equivalent device. This modification is addition of optional goods for the predicate device. The predicate device 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 KOWA GENESIS-D and indirect diagnostic lens holder with lens has the following similarities to those of the predicate device:
- has the same indicated use,
- uses the same operating principle,
- incorporates the same basic optical design without the lens holder and lens,
- incorporates the same materials,
- incorporates the same power supply parts and circuits,
- incorporates the same light source,
- is packaged.
Sunny of the country of
1
The only modification that was made is addition of the indirect diagnostic lens holder as an optional goods for the predicate device.
The comparison table of the predicate device and it with the indirect diagnostic lens holder is shown in Table B.
In summary, the predicate device with the indirect diagnostic lens holder described in this submission is substantially equivalent to the predicate device.
Conclusion:
:
The KOWA GENESIS-D and the indirect diagnostic lens holder with lens are equipped with the same fundamental technology and maintain the same level of safety performance. Therefore it has been concluded that there are no significant differences in the technological characteristics and safety of KOWA GENESIS-D that were cleared by addition the indirect diagnostic lens holder with lens.
Table A: Predicate device
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| KOWA GENESIS-D | Kowa Company, Ltd. | K0530271 | Nov. 3, 2005 |
2
| | Table B. Predicate device comparison
KOWA GENESIS-D and indirect
diagnostic lens holder, K9L-LH51 | KOWA GENESIS-D |
|-------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended use | Same | A hand-held mydriatic retinal camera
which captures fundus image. |
| Use condition | Same | with mydriatic |
| Picture angle | Same | Horizontal: 30 degree
Vertical: 25 degree |
| Working distance | Same | 5mm |
| Observation | Same | Visual observation |
| Storage media | Same | Flash memory card |
| Camera spec. | Same | Color CCD camera
2,000,000 pixels |
| Image data format | Same | JPEG and uncompressed format |
| Diopter
compensation | Same | $-15D~+35D$ |
| Observation Light
Source | Same | Visible LED
4VA(approx. 1W) |
| Photographing
Light Source | Same | Xenon flash lamp
23WS |
| Optional goods | Indirect diagnostic parts,
K9L-LH51 | Not applicable |
| Power
consumption | Same | 60VA |
| Weight of
Camera unit | Same | approx. 1kg |
.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
KOWA Company, Ltd. c/o Satohiko Takanashi, PE 4-14, Nihonbashi-Honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan
Re: K080681
Trade/Device Name: Kowa Genesis-D Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 7, 2008 Received: March 10, 2008
Dear Mr. Takanashi:
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 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.
4
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 Biometric'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 Division 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 vours.
Marina B. Egleston, und
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Notification
Indications for Use
K080681510(k) Number (if know):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device
Derexhl 3/25/2008
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
.
.
Kowa Company, Ltd., Modification of KOWA GENESIS-D
510(k) Number
12