MODIFICATION TO KOWA NONMYD ALPHA-DIII

K083387 · Kowa Co. , Ltd. · HKI · Jan 16, 2009 · Ophthalmic

Device Facts

• Record ID: K083387
• Device Name: MODIFICATION TO KOWA NONMYD ALPHA-DIII
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.

Device Story

KOWA nonmyd α-DIII is an AC-powered ophthalmic fundus camera used for capturing retinal images without requiring pupil dilation (mydriasis). The device utilizes a high-sensitivity CCD camera to acquire images, which are then transmitted via a serial interface to an external image filing drive for storage and immediate viewing. Operated by eye care professionals in clinical settings, the device assists in the documentation and assessment of retinal conditions. Modifications from the predicate include a power supply change, a different manufacturer for the 8.3M pixel CCD sensor (maintaining equivalent resolution and sensitivity), and the addition of montage and advanced search functions within the associated software. The device provides clinicians with high-resolution digital fundus images, facilitating efficient diagnostic workflows and patient monitoring.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ophthalmic fundus camera; AC-powered; 8.3M pixel CCD sensor; serial interface for data output; software-based image management including montage and advanced search functions.

Indications for Use

Indicated for non-mydriatic retinal image capturing 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-DIII (Type 1) (K082767)

Submission Summary (Full Text)

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# va) Kowa Company. Ltd.

ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHIHONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN

## 510 k N: K083387

| Applicant | Kowa Company, Ltd<br>4-14, Nihonbashi-honcho 3-Chome<br>Chuo-ku, Tokyo, 103-8433 Japan | JAN 1 6 2009 |
|-----------------------|----------------------------------------------------------------------------------------|--------------|
| Contact | Akihıro Fujita | |
| Date Summary Prepared | November 14, 2008 | |
| Device Trade Name | KOWA nonmyd α-DIII | |
| Classification name | CAMERA, OPTHALMIC, AC-POWERED<br>SYSTEM, IMAGE MANAGEMENT, OPHTALMIC | |
| Product Code | HKI<br>NFJ | |

Intended use

KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic The retinal image can be stored to an image filing drive through serial ınterface

### Comparison

The KOWA nonmyd a-DIII(Type 1) was chosen as a substantially equivalent device

The KOWA nonmyd a-DIII is similar to the predicate device 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

The modifications that are made are

- Change the power supply
- Change the CCD camera to the same resolution, 8 3M pixels, and the same sensitivity camera by the other manufacturer
- Add the montage function in the associated software
- Add the advanced search function in the associated software

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510(k) notification

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#### k 093397 が 510k

| Table A: Predicate device | | | | |
|-----------------------------|-------------------|------------|--------------|--|
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |
| KOWA nonmyd α-DIII (Type 1) | Kowa Company, Ltd | K082767 | Oct 21,2008 | |

Conclusion

The KOWA nonmyd x-DIII is equipped with the same fundamental technology as the predicate device 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 nonmyd a-DIII and the predicate devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, LTD c/o Akıhıro Fujıta, General Manager Electronics & Optics Division 4-14, Nihonbashihoncho 3-Chome, Chou-Ku. Tokyo Japan 103-8433

JAN 1 6 2009

Re K083387

Trade/Device Name KOWA nonmyd a-DIII (Type 2) Regulation Number 21 CFR 886 1120 Regulation Name Ophthalmic Camara Regulatory Class Class II Product Code HKI, NFJ Dated December 16, 2008 Received December 18, 2008

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 adulteratıon

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] 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 Brometric'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 Dryision 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 [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

M. B. Egleston, mD

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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510(k) notification

## Indications for Use

510(k) Number (if know) KOB3387

Device Name _ KOWA nonmyd a-DIII (Type 2)

Indications for Use

KOWA nonmyd ct-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retimal image can be stored to an image filing drive through serial ınterface

Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device

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**510(k) Number** *k093387*

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