KOWA NONMYD ALPHA-D

K062356 · Kowa Co. , Ltd. · HKI · Sep 27, 2006 · Ophthalmic

Device Facts

• Record ID: K062356
• Device Name: KOWA NONMYD ALPHA-D
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

KOWA nonmyd α-D (Type G), fundus camera, is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.

Device Story

KOWA nonmyd α-D (Type G) is a non-mydriatic fundus camera used by clinicians to capture retinal images without pupil dilation. The device utilizes a halogen lamp for observation and a xenon flash for photography. It features a 2/3 inch 5-megapixel CCD camera for image acquisition. The system displays images on an external monitor and allows storage to an image filing drive via an IEEE1394 serial interface. The device is a tabletop unit operated by a clinician; it assists in ophthalmic diagnostics by providing immediate, high-resolution digital retinal images, eliminating the need for film and reducing the flash intensity required for imaging compared to traditional film-based cameras. This facilitates efficient patient screening and documentation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of specifications.

Technological Characteristics

Tabletop ophthalmic camera; 2/3 inch 5-megapixel CCD sensor; halogen lamp (observation) and xenon flash (photography) light sources; IEEE1394 connectivity; dioptric compensation -33D to +40D; 45-degree/20-degree picture angle; manual focusing via split luminous bars; joystick-controlled shutter release; complies with EN60601-1-2: 2001 for EMC.

Indications for Use

Indicated for retinal image capturing without mydriatic in patients requiring fundus examination.

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 nonmyd α-D (Type D) (K053026)

Submission Summary (Full Text)

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K062356

## Summary for public disclosure

### Submitter information:

| Applicant: | Kowa Company, Ltd.<br>4-14, Nihonbashi-honcho 3-Chome<br>Chuo-ku, Tokyo, 103-8433 Japan<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Satohiko Takanashi, PE |
| E-mail address: | [e-mail] |
| Date summary prepared: | August 11, 2006 |

## Device identification:

| Device trade name: | KOWA nonmyd α-D (Type G) |
|----------------------|-------------------------------|
| Classification name: | CAMERA, OPTHALMIC, AC-POWERED |
| Product code: | HKI |

#### Intended use:

KOWA nonmyd α-D is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.

# Comparison:

The KOWA nonmyd o -D (Type D) was chosen as a substantially equivalent device. The predicate device is non-mydriatic fundus camera and they are equipped with highly resolution CCD camera, so it do not require any film and can display images immediately after image capture. Also, because it uses a highly sensitive CCD camera the flash required for filming is reduced compared to previous fundus cameras which use film.

Similar to the predicate device the KOWA nonmyd a-D (Type G) is equipped with a highly sensitive CCD camera so they do not require film and can display images immediately after image capture.

KOWA nonmyd a-D(Type G) has the same picture angle as the predicate device.

A comparison table between the KOWA nonmyd a-D(Type G) and predicate device are provided in Table B and C. The KOWA nonmyd a-D(Type G) has incorporated similar technical characteristics to the predicate device.

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# Conclusion:

KOWA nonmyd α-D(Type G) is equipped with the same fundamental technology features, which are equivalent to the predicate device, and also delivers the equivalent level safety and effectiveness. Thus it is concluded that there is no significant difference in the basic functions, safety and effectiveness between KOWA nonmyd α-D (Type G) and the predicate device.

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------------|--------------------|------------|--------------|
| KOWA nonmyd α-D<br>(Type D) | Kowa Company, Ltd. | K053026 | Nov.10,2005 |

| | KOWA nonmyd α-D (Type G) | KOWA nonmyd α-D (Type D) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>For Use | KOWA nonmyd α-D (Type G) is<br>intended for use with retinal image<br>capturing without mydriatic. The<br>retina image can be stored to an<br>image filing drive through serial<br>interface. | The KOWA nonmyd series, non-<br>mydriatic fundus cameras, are intended<br>for use with retina image capturing. The<br>retinal image can be stored to an external<br>hard disk drive or transferred in other<br>formats through memory card or serial<br>interface depending on the output<br>interface available for each device. |
| Saved image format | Same | BMP, JPEG |
| Picture angle | Same | 45degree/20degree |
| Working distance | Same | .30 mm |
| Working distance<br>detection method | Same | Anterior (Observation)<br>Fundus (Focusing on blight spots) |
| CCD camera for<br>observation | Same | 1/3 inch CCD camera |
| CCD camera for<br>photographing | 2/3 inch 5mega pixels CCD | Type D:<br>1/2 inch 2.1mega pixels CCD |
| Observation Display<br>(B/W) | Same | 5.6 inch LCD Monitor |
| Display | Same | Outer Monitor Use |
| Dioptric<br>compensation | Same | Total -33D to +40D |
| Focusing | Same | Sprit luminous bars coincidence |

### Table B. Predicate device comparison

The state of the state of the state of the states and the season

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# 662356

:

| Table C. Predicate Device Comparison | | |
|-----------------------------------------------------------|----------------------------------|-----------------------------------------------------|
| | KOWA nonmyd α-D (Type G) | KOWA nonmyd α-D (Type D) |
| Observation Light<br>Source | Same | Halogen lamp (Max 12V 100W) with<br>infrared filter |
| Photographing<br>Light Source | Same | Xenon flash (Max 50WS) |
| Internal Fixation<br>Navigation | Same | Fixed fixator selecting |
| Switching light path<br>of observation &<br>photographing | Same | Same pathway, no beam split |
| Observation light<br>adjustment | Same | Volume adjustment style |
| Photographing light<br>adjustment | Same | Step adjustment style (5 step) |
| Camera stand (Base) | | |
| Type | Same | Tabletop; power source built in |
| Horizontal<br>Movement | Same | Forward/Backward: 40mm<br>Leftward/Rightward: 100mm |
| Vertical Movement | Same | 30mm |
| Shutter Release | Same | Joystick upper button |
| Signal outlet | IEEE1394 | Type D: USB |
| Chinrest | | |
| Vertical Movement<br>of chinrest | Same | 60mm |
| External Fixation<br>Targets | Same | Free-arm style (Option) |
| | | |
| | Compliance with safety standards | |
| EMC | Same | EN60601-1-2: 2001 |
| Dimension | | |
| Size | Same | Type D:310mm(W)x504mm(D)x548mm(H) |
| Weight | Same | Type D: 21kg |

:

# Table C. Predicate Device Comparison

.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 27 2006

KOWA Company, Ltd. c/o Satohiko Takanashi, PE 4-14. Nihonbashi-Honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan

Re: K062356

Trade/Device Name: Kowa nonmyd α-D (type G) Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 11, 2006 Received: September 12, 2006

Dear Takanashi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as stated in the encreations of the enactment date of the Medical Device Amendments, or to Connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rice, inc. that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the act include requirements for annual registration, listing of general controls provincitive, 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 If your device is classified (see are roy als. Existing major regulations affecting your device can may be subject to suell additions, 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 i least of advised that I Dr overan that your device complies with other requirements of the Act mat I Dri has made a acternmentations administered by other Federal agencies. You must or any I caetar statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I ratt 0077, lacemig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Satohiko Takanashi, PE

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,

M.B. Eychler-SiMD

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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Indications for Use

510(k) Number (if know):

\$

Device Name:

Indications for Use:

KOWA nonmyd α-D (Type G), fundus camera, is intended for use with retinal image capturing without mydriatic. The retina image can be stored to an image filing drive through serial interface.

> Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

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

(?).EASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Dexendis 9/22/2006
(Division Sign-Off)

510(k) Number K062356