KOWAGENESIS-DF

K091098 · Kowa Co. , Ltd. · HKI · Aug 7, 2009 · Ophthalmic

Device Facts

• Record ID: K091098
• Device Name: KOWAGENESIS-DF
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.

Device Story

KOWA GENESIS-Df is a hand-held, AC-powered ophthalmic camera used to capture and save fundus images. It utilizes a highly sensitive CCD camera and a Xenon flash lamp for illumination, with a visible LED light source for observation. The device is designed for use with mydriatic agents. It features an improved optical system compared to its predecessor to support fluorescent angiography (FA) and increased luminescence. The device is operated by a clinician to visualize the retina; images are stored on a flash memory card in JPEG or uncompressed formats for immediate viewing. The device provides a non-invasive method for retinal documentation, aiding in the diagnosis and monitoring of ocular conditions. It is designed for ease of use, allowing one-handed operation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including evaluation of light hazard, electrical safety, and electromagnetic compatibility (EMC).

Technological Characteristics

Hand-held ophthalmic camera; Xenon flash lamp (23WS) and visible LED observation light; CCD sensor (2,000,000 pixels); 30-degree horizontal/25-degree vertical field of view; diopter compensation -15D to +35D; storage via flash memory card; AC-powered (150VA); connectivity via digital image output (JPEG/uncompressed).

Indications for Use

Indicated for use as a hand-held mydriatic retinal camera to capture and save fundus images in patients requiring mydriasis.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• KOWA GENESIS-D (K050271)

Submission Summary (Full Text)

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5100k) notification

5.0 510(k) Summary

Applicant:

Contact:

K091098

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

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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<br>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<br>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<br>4VA(approx. 1W) |
| Photographing Light Source | Xenon flash lamp<br>23WS<br>with improved optical system* | Xenon flash lamp<br>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

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## 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.

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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 [phone] or [phone] 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

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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