KOWA GENESIS-D HAND-HELD RETINAL CAMERA

K050271 · Kowa Co. , Ltd. · HKI · Nov 3, 2005 · Ophthalmic

Device Facts

• Record ID: K050271
• Device Name: KOWA GENESIS-D HAND-HELD RETINAL CAMERA
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Device Story

KOWA GENESIS-D is a hand-held mydriatic retinal camera used by clinicians to capture and save fundus images. It utilizes a 2,000,000-pixel color CCD camera to acquire images, which are stored in JPEG or uncompressed formats. The device features a visible LED for observation lighting and a xenon flash lamp for photography. Designed for portability, it weighs approximately 1kg and is held in one hand during operation. The clinician views the retinal images electronically, facilitating immediate assessment. By replacing traditional film-based photography with digital capture and reducing flash intensity, the device improves user comfort and workflow efficiency. It is intended for use in clinical settings where fundus documentation is required.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison.

Technological Characteristics

Hand-held ophthalmic camera; 2,000,000-pixel color CCD sensor; visible LED (approx. 1W) for observation; xenon flash lamp (23WS) for photography; diopter compensation -15D to +35D; digital storage (JPEG/uncompressed); AC-powered (60VA); weight approx. 1kg.

Indications for Use

Indicated for patients requiring fundus imaging; requires mydriatic agent for use.

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
• Nidek Handy NM-100

Submission Summary (Full Text)

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510(k) Notification

. K050271

## NOV - 3 2005

## 9. Certification 9.1 Summary for Public Disclosure

| Applicant: | Kowa Company, Ltd.<br>4-14, Nihonbashi-honcho 3-Chome<br>Chuo-ku, Tokyo, 103-8433 Japan |
|------------------------|-----------------------------------------------------------------------------------------|
| Contact: | Satohiko Takanashi |
| Date Summary Prepared: | November 30, 2004 |
| 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:

Similar to the KOWA GENESIS, the KOWA GENESIS-D is a mydriatic retinal camera. In comparison with the KOWA GENESIS, it contains a similar optical system, and power supply system, and maintains the same level of safety performance.

The KOWA GENESIS-D is similar to the Nidek Handy NM-100 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-D uses less power during observation by using a visible LED light for observation lighting.

Various weight savings were achieved with the KOWA GENESIS-D camera to allow the user to be able to hold it in one hand with ease.

The function comparison of KOWAGENESIS-D and the predicate devices is shown in the comparison table below:

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| | KOWA GENESIS-D | KOWA GENESIS | Nidek Handy NM-100 |
|-------------------------------|-------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended use | A hand-held mydriatic<br>retinal camera which<br>captures fundus image. | A hand-held mydriatic<br>fundus camera. | A hand-held non-mydriatic<br>fundus camera which captures<br>images of the retinal<br>electronically. |
| Use condition | SAME to GENESIS | with mydriatic | without mydriatic |
| Picture angle | SAME to GENESIS | Horizontal: 30 degree<br>Vertical: 25 degree | 30 degree |
| Working<br>distance | SAME to GENESIS | 5mm | 8mm (form the examination<br>window to the cornea) |
| Observation | SAME to GENESIS | Visual observation | 5 inch Color LCD |
| Storage media | SAME to NM-100 | 35mm film | Flash memory card |
| Camera spec. | Color CCD camera<br>2,000,000 pixels | 35mm film camera | Color CCD camera<br>350,000 pixel |
| Image data<br>format | JPEG and uncompressed<br>format | N/A | JPEG |
| Diopter<br>compensation | SAME to the both | -15D~+35D | -15D~+35D |
| Observation<br>Light Source | Visible LED<br>4VA(approx. 1W) | Halogen lamp<br>12V, 50W | Infrared LED |
| Photographing<br>Light Source | Xenon flash lamp<br>23WS | Xenon flash lamp<br>150WS | Xenon flash lamp<br>25WS |
| Power<br>consumption | 60VA | 400VA | 200VA |
| Weight of<br>Camera unit | approx. 1kg | approx. 1kg | approx. 1.5kg |

# Predicate device comparison table

## Conclusion:

The KOWA GENESIS-D 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-D and the predicate devices.

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Public Health Service

NOV - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, Ltd. c/o Tamas Borsai Program Manager, Third Party Review Program TUV Rhelnland of North America, Inc. North America Headquarters 12 Commerce Road Newtown, CT 06470

Re: K050271

Trade/Device Name: Kowa Genesis-D Hand-Held Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: October 7, 2005 Received: October 11, 2005

Dear Mr. Borsai:

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.

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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.gov/cdrh/industry/support/index.html.

Sincerely yours.

David M. Whipple

David M. Whipple Acting 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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| | Indications for Use |
|--------------------------|---------------------|
| 510(k) Number (if know): | K050271 |

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.

6 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

QLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Everett R. Been

n of Ophthalmic Ea Nose and Throat D

510(k) Number.