KOWA NONMYD WX

K101628 · Kowa Co. , Ltd. · HKI · Jan 26, 2011 · Ophthalmic

Device Facts

• Record ID: K101628
• Device Name: KOWA NONMYD WX
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.

Device Story

KOWA nonmyd WX is a non-mydriatic retinal camera for capturing plane and stereo retinal images. Device utilizes a Xenon flash lamp for image capture and an Infrared LED lamp for observation. It integrates an external digital SLR camera to acquire images, which are transferred via USB to an external image filing system (e.g., KOWA portable VK-2). Stereo images are captured simultaneously in a single shot without parallax shifts. Designed for use in clinical settings by eye care professionals; output allows clinicians to visualize and store retinal images for diagnostic review. Benefits include non-invasive retinal documentation without the need for pupil dilation, provided the pupil diameter is at least 3.7mm.

Clinical Evidence

Bench testing only. Device evaluated for electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), optical safety (ISO15004-2), and software validation per FDA 2005 guidance. Risk management performed per ISO14971:2007. No clinical data presented.

Technological Characteristics

Non-mydriatic retinal camera; Xenon flash lamp (capture) and Infrared LED (observation); external digital SLR camera integration; USB connectivity; IEC60601-1, IEC60601-1-2, ISO15004-2, and ISO14971 compliant; embedded software (minor level of concern).

Indications for Use

Indicated for non-mydriatic plane and stereo retinal image capturing in patients with pupils at least 3.7mm in diameter.

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 7 (K053026)
• Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras (K973533)

Submission Summary (Full Text)

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K101628

# owar Kowa Company. Ltd.

ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: [phone] FAX: [phone]

### 510(k) Summary

JAN 26 201

Submitter information: Applicant:

Kowa Company, Ltd. 4-14, Nihonbashi-honcho 3-Chome Chuo-ku, Tokyo, 103-8433 Japan Phone: [phone] [phone] Fax:

Contact:

Date summary prepared:

June 9, 2010

Satohiko Takanashi, PE

#### Device identification:

Device trade name: Classification name: Product code:

KOWA nonmyd WX Camera, Ophthalmic, AC-powered HKI, NFJ

#### Identification of predicate devices:

Kowa Company believes that this device is substantially equivalent to: KOWA nonmyd 7 manufactured by Kowa, 510(k)# K053026, Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras manufactured by Nidek, 510(k)# K973533.

#### Device description:

The KOWA nonmyd WX is a retinal camera without mydriatic. Plane retinal image capturing function, that is normal image capturing, is equipped and furthermore, stereo image capturing function is done. The stereo images are able to take simultaneously in shingle shot, as these images are captured without image/parallax shifts.

The KOWA nonmyd WX consists of a device body and external digital SLR camera, Single-Lens Reflex camera.

The KOWA nonmed WX uses Xenon flash lamp as an image capturing light and Infrared LED lamp as an observation light.

The KOWA nonmyd WX can be sued even in case which pupil has not been completely dilated in plane image capture mode, if it is more than 3.7mm in diameter.

The KOWA nonmyd WX is equipped with a USB port to be able to transfer images to a computer.

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The KOWA nonmyd WX is designed to be able to link up to a filling system (KOWA portable VK-2), which can manage the digital images.

#### Intended use:

KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.

## Technical characteristics:

#### Electrical safety

To guarantee Electrical safety, IEC60601-1 test was performed. The nonmyd WX met all requirements of the standard.

#### Electromagnetic compatibility

To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The nonmyd WX met all requirements of the standard.

#### Optical safety

To guarantee Optical safety, evaluation based on ISO15004-2 was performed. The nonmyd WX met all requirements of Group 1 instrument in the standard.

#### Software evaluation

To make sure Software validity of the nonmyd WX embedded software and filing software, evaluation based on FDA guidance, Guidance for the content of premarket submissions for software contained in medical devices, 2005, was performed. The levels of concern of these software items are minor.

The validation of these software items is performed as a part of system function test. All functions are tested and confirmed good working to required items.

#### Biocompatibility

To guarantee biocompatibility, biocompatibility assessment was performed. All materials were used the same of the other legally marked devices in US.

#### Risk Management

The nonmyd WX was evaluated in accordance with ISO14971: 2007, and met to all requirements of standard. The risk management of the device was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

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## Conclusion

COWA nonmyd WX is equipped with the fundamental technology to the predicate device for retinal image capturing and also deliver the equivalent level of safety. Therefore, it is concluded that there is no difference in the basic functions and safety between KOWA nonmyd WX and the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Kowa Co. Ltd. c/o Mr. Satohiko Takanashi 4-14, Nihonbashi-honcho 3-chome Chuo-ku Tokyo, 103-8433 Japan

Re: K101628

Trade/Device Name: Kowa nonmyd WX Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: II Product Code: HKI Dated: October 13, 2010 Received: October 14, 2010

JAN 2 6 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic

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product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ReportaProblem/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, 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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## Indications for Use

510(k) Number (if know):______________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: KOWA nonmyd WX

Indications for Use:

KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.

X Prescription Use_ (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device

Feson.

(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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