KOWA NONMYD 7, KOWA NONMYD A-D

K053026 · Kowa Co. , Ltd. · HKI · Nov 10, 2005 · Ophthalmic

Device Facts

• Record ID: K053026
• Device Name: KOWA NONMYD 7, KOWA NONMYD A-D
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.

Device Story

KOWA nonmyd series (Type F and Type D) are non-mydriatic fundus cameras for capturing digital retinal images. Devices use infrared light for patient alignment; high-sensitivity CCD sensors allow image capture at lower flash intensities than traditional film cameras. Type D features internal CCD with USB export; Type F requires external CCD attachment with memory card/USB export. Operated by clinicians in clinical settings; images are stored/managed via application software. Optical variable power enables selection of picture angle (45/20 degrees). Digital capture eliminates film development, allowing immediate viewing. Benefits include reduced patient discomfort due to infrared alignment and lower flash intensity, and improved workflow efficiency.

Clinical Evidence

Bench testing only. The device was tested for electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), and ophthalmic instrument requirements (ISO15004). Risk management was evaluated per ISO14971. No clinical data was required or provided.

Technological Characteristics

Tabletop non-mydriatic fundus camera. Illumination: Halogen lamp (max 12V 100W) with infrared filter. Flash: Xenon (max 50WS). Sensors: 1/3 inch CCD (observation); 1/2 inch 2.1MP CCD (Type D) or APS-C 6MP CCD (Type F) for imaging. Connectivity: USB, memory card. Dioptric compensation: -33D to +40D. Focusing: Split luminous bars. Standards: IEC60601-1, IEC60601-1-2, ISO15004, ISO14971.

Indications for Use

Indicated for retina image capturing in patients, including those with non-dilated pupils (supports 4mm and 3.7mm pupil diameter modes).

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

• Nidek Non-Mydriatic Fundus Camera Model NM-1000 (K014274)

Submission Summary (Full Text)

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# NOV 1 0 2005

510(k) Notification

K 053026

### 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 |
|------------------------|-----------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Satohiko Takanashi |
| e-mail address: | [e-mail] |
| Date summary prepared: | January 11 , 2005 |
| Device trade name: | KOWA nonmyd 7 (Type F)<br>KOWA nonmyd a -D (Type D) |
| Classification name: | CAMERA, OPTHALMIC, AC-POWERED |
| Product code: | HKI |

Intended use:

The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.

### Device description:

KOWA nonmyd series of camera consist of non-mydriatic fundus cameras with a digital image capture system, which does not require 35mm film or instant film. It maintains the same functionalities of the previous fundus cameras, and by capturing digital images it eliminates film development time, allowing the user to view images immediately.

The KOWA nonmyd series cameras are all fundamentally the same noting exception only to their output interfaces. Type D (KOWA nonmyd a-D) contains an internal CCD camera and exports data via USB interface. Type F (KOWA nonmyd 7) requires a CCD camera to be attached to the device and exports data by both memory card and via USB.

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Application software for the KOWA nonmyd series contain a filing system, which can save, display, and manage the digital images.

For detailed observation, the KOWA nonmyd series have an optical variable power feature, which enables the viewer to select a picture angle. By selecting a picture angle it can achieve the same amount of image clarity as a conventional fundus camera.

In addition, the KOWA nonmyd series can be used even in cases where the pupil has not been completely dilated; in addition to the normal pupil diameter 4mm mode, there is also a small pupil diameter 3.7mm mode.

Similar to previous fundus cameras, the KOWA nonmyd series uses infrared light for illumination during alignment to provide a better patient experience. In addition, the devices are equipped with a highly sensitive CCD camera, and are therefore able to capture images at a much lower flash light intensity level than previous fundus cameras, further enhancing the patient experience.

#### Comparison:

The Nidek NM-1000 was chosen as a substantially equivalent device. The predicate device is a non-mydriatic fundus camera and it is equipped with a high resolution CCD camera so it does 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 conventional fundus cameras.

Similar to the predicate device, the KOWA nonmyd series cameras are equipped with a highly sensitive CCD so they do not require film and can display images immediately after image capture.

The KOWA nonmyd series, KOWA nonmyd 7 and KOWA nonmyd a-D, and the predicate device also share similar technical and safety characteristics. The result is show in the table below.

#### Performance testing:

KOWA nonmyd series, KOWA nonmyd 7 and KOWA nonmyd a-D, were tested to the following standards and conform to all specific requirements based on these standards. KOWA nonmyd series are equivalent to the predicate device.

#### Electrical safety

KOWA nonmyd series were tested in accordance with IEC60601-1: 1988. Amendment 1:1991 and Amendment 2: 1995, and met all requirements of standards.

#### Electromagnetic compatibility

KOWA nonmyd series were tested in accordance with IEC60601-1-2: 2001. and met all requirements of standard.

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Test requirements and test procedure for ophthalmic instruments

KOWA nonmyd series was tested in accordance with ISO15004: 1997, and met all requirements of the standard. Refer to Appendix B for details.

### Risk management

KOWA nonmyd series were evaluated in accordance with ISO14971: 2000. The risk management of the devices was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

# Conclusion:

The KOWA nonmyd series 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 technical characteristics and safety between KOWA nonmyd series and the predicate device.

# Table A: Predicate device

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-------------------------------------------------------|--------------------|------------|---------------|
| Nidek Non-Mydriatic<br>Fundus Camera<br>Model NM-1000 | Nidek Incorporated | K014274 | Apr. 17, 2002 |

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:

| | | | Table B: Predicate Device Comparison |
|--|--|--|--------------------------------------|
|--|--|--|--------------------------------------|

:

| | KOWA nonmyd series: Non-mydriatic<br>fundus camera, type D and F | Nidek Non-mydriatic Fundus Camera<br>Model NM-1000 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The KOWA nonmyd series, non-<br>mydriatic fundus cameras are<br>intended for use with retina image<br>capturing. | The Nidek NM-1000 is an ophthalmic camera<br>that is intended for use in capturing images of<br>the retina and the anterior segment of the eye. |
| Saved Image Format | BMP, JPEG | Nidek format, TIF |
| Picture angle | 45degree/20degree | 45degree |
| Working distance | 30mm | 43.3mm (from camera body to corner) |
| Working distance<br>detection method | Anterio (Observation)<br>Fundus (Focusing on blight spots) | Anterio (Observation)<br>Fundus (Focusing on blight spots) |
| Minimum diameter<br>of pupil | Normal pupil mode: 4mm<br>Small pupil mode: 3.7mm | 4mm |
| CCD camera for<br>observation | 1/3 inch CCD Camera | 1/3 inch CCD Camera |
| CCD camera for<br>Photographing | Type D:<br>1/2inch 2.1mega pixel CCD Camera<br>Digital Progressive Scan (built-in)<br>Type F:<br>APS-C size 6mega pixel CCD Camera<br>Digital Progressive Scan<br>(K9L-BM39 used as Digital camera) | 1/2inch CCD Camera<br>Digital Progressive Scan (built-in) |
| Observation Display<br>(B/W) | 5.6 inch LCD Monitor | 6.4 inch LCD Monitor |
| Photographing Display | Type D, F: Outer Monitor Use | 6.4 inch LCD Monitor |
| Dioptric compensation | Total -33D to +40D | Total -32D to +40D |
| Focusing | Split luminous bars coincidence | Manual (motor driven)<br>Split line focus on the retina (-10 to +14D) |
| | | |
| | KOWA nonmyd series: Non-mydriatic fundus<br>camera, Type D and F | Nidek Non-mydriatic Fundus Camera<br>Model NM-1000 |
| Observation Light<br>Source | Halogen lamp (Max 12V 100W)<br>with infrared filter | Halogen lamp (Max 12V 50W)<br>with infrared filter |
| Photographing Light<br>Source | Xenon flash (Max 50WS) | Xenon flash (Max. 25WS) |
| Internal Fixation<br>Navigation | Fixed fixator selecting | Manual lever |
| Switching light path of<br>observation &<br>photographing | Same pathway, no beam split | Beam Splitter |
| Observation light<br>adjustment | Volume adjustment style | Volume adjustment style |
| Photographing light<br>adjustment | Step adjustment style (5 steps) | Step adjustment style (8 steps) |
| Camera stand (Base) | | |
| Type | Tabletop; power source built-in | Tabletop; power source built-in |
| Horizontal Movement | Forward/Backward: 40mm<br>Leftward/Rightward: 100mm | Forward/Backward: 65mm<br>Leftward/Rightward: 106mm |
| Vertical Movement | 30mm | 30mm |
| Shutter Release | Joystick upper button | Joystick upper button |
| Signal outlet | Type D: USB<br>Type F: Flash memory card | USB, RGB Analog, NTSC Composite Video |
| Chinrest | | |
| Vertical Movement of<br>chinrest | 60mm | 65mm |
| External Fixation<br>Targets | Free-arm style (Option) | Free-arm style (Option) |
| Compliance with safety standards | | |
| Safety requirements | IEC60601-1 | EN60601-1 |
| EMC | IEC60601-1-2 | EN60601-1-2 |
| Ophthalmic instrument<br>requirements | ISO15004 | ISO15004 |
| Dimensions | | |
| Size | Type F: 310mm(W) x 504mm(D) x 548mm(H)<br>Type D: 310mm(W) x 504mm(D) x 462mm(H) | 360mm(W) x 530mm(D) x 565mm(H) |
| Weight | Type F: 21 kg with the digital camera<br>Type D: 21 kg | 26 kg |

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# Table C: Predicate Device Comparison

KOW i nomnyd " and KOWA nomnyd a D. Kowa Company, I id.

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Image /page/5/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

NOV 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, Ltd. c/o Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Rd. Newton, CT 06470

Re: K053026

Trade/Device Name: Kowa nonmyd 7 (type F) & nonmyd α-D (type D) Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 25, 2005 Received: October 27, 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

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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510(k) Notification

Indications for Use

510(k) Number (if know): KD5

Device Name: KOWA nonmyd 7 and KOWA nonmyd a-D

Indications for Use:

The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.

Joenette R. Been

Division of Ophthalmic Ear Nose and Throat Dev

510(k) Number

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)