KOWA VX-10 A

K091683 · Kowa Co. , Ltd. · HKI · Jul 2, 2009 · Ophthalmic

Device Facts

• Record ID: K091683
• Device Name: KOWA VX-10 A
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.

Device Story

KOWA VX-10α is an ophthalmic camera for capturing fundus images. Device operates in mydriatic and non-mydriatic modes; utilizes halogen lamp for observation and xenon flash lamp for photography. Input consists of optical fundus data; output is 35mm film recording. Used in clinical settings by eye care professionals. Device is a simplified version of KOWA VX-10i; removes Indocyanine Green (ICG) angiography mode and Polaroid film recording capability. Lens coating modified; safety verified via ISO standards. Provides clinicians with high-resolution retinal images to assist in ocular health assessment and diagnosis.

Clinical Evidence

Bench testing only. Conformance to ISO 10940 (Ophthalmic instruments - Fundus cameras), ISO 15004-1 (General requirements), and ISO 15004-2 (Light hazard protection) demonstrated safety of the modified lens coating.

Technological Characteristics

Ophthalmic camera; 35mm film recording; halogen observation lamp (100W); xenon flash photography lamp (300WS). Magnification: 50°/30° (mydriatic), 45°/27° (non-mydriatic). Dioptric compensation: -32D to +35D. Working distance: 39mm. Weight: 35.5kg. Connectivity: Video camera output. Standards: ISO 10940, ISO 15004-1, ISO 15004-2.

Indications for Use

Indicated for patients requiring fundus imaging, with or without mydriasis, for diagnostic visualization of the retina.

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 VX-10i (K062021)

Submission Summary (Full Text)

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## -- СНУО КН. ТОКУО 193 8432 ИРА ਕ ਨ

K091683
4-14, NIHONBASHHONCHO 3-CHOME
CHUO-KU, TOKYO 103-8433 JAPAN

| Applicant: | Kowa Company, Ltd. |
|------------------------|---------------------------------|
| | 4-14, Nihonbashi-honcho 3-chome |
| | Chuo-ku, Tokyo 103-8433 Japan |
| Contact: | Akihiro Fujita |
| Date Summary Prepared: | May 15, 2009 |
| Device Trade Name: | KOWA VX-10α |
| Classification name: | Camera, Ophthalmic, AC-powered |
| Product code: | HKI |

Intended use:

イ

The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.

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## Comparison:

The KOWA VX-10i was chosen as the predicate device.

The KOWA VX-10a is a simplified version of the predicate device [KOWA VX-10i (k062021)] by removing the indocyanine green (ICG) angiography mode, removing the use of Polaroid film as a recording media, and changing the availability of the data card for writing patient information as an optional accessory. In addition the lens coating was changed.

In order to evaluate the effects of the change of lens coating for any optical hazards, the following tests were performed:

1. Test Report for ISO10940, 1998: Ophthalmic instruments - Fundus cameras

2. Test Report for ISO 15004-1, 2006: Ophthalmic instruments-Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments

3. Test report for ISO 15004-2:2007 Ophthalmic instruments-Fundamental requirements and test methods Part 2: Light hazard protection

The test results demonstrated that the KOWA VX-10α conforms to the above listed standards. which confirmed that the change in the lens coating did not raise any safety concerns. The test results are included in Appendix D.

A comparison of the KOWA VX-10a and the predicate device is shown below in Table B.

Table A. Predicate device

| Predicate Device | Manufacturer | 510(k) Number | Date Cleared |
|------------------|-------------------|---------------|--------------|
| KOWA VX-10i | KOWA Company Ltd. | K062021 | Nov. 1, 2006 |

Conclusion:

The KOWA VX-10a is equipped with the same fundamental technology features equivalent to the predicate devices, and also delivers the equivalent level safety and effectiveness. Therefore since there are no significant difference in the basic function, safety and effectiveness between the KOWA VX-10a and the predicate device, KOWA concludes that the KOWA VX-10a is substantially equivalent to the KOWA VX-10i (k062021).

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Table B. Comparison table

| | Proposed Device | Predicate Device |
|---------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | KOWA VX-10a | KOWA VX-10i (K062021) |
| Indications<br>For Use | Same | Take pictures of fundus images<br>with or without mydriatic. |
| Picture<br>magnifications | Mydriatic : 50°/ 30°<br>Non-mydriatic : 45°/ 27° | Mydriatic : 50°/ 30°<br>Non-mydriatic : 45°/ 27° |
| Photography mode | Non-mydriatic<br>Mydriatic color<br>Fluorescein angiography | Non-mydriatic<br>Mydriatic color<br>Fluorescein angiography<br>Indocyanine Green angiography |
| Working distance | Same | 39 mm |
| CCD camera for<br>observation | Same | Monochrome CCD |
| Record media | 35mm film | 35mm film<br>/ Polaroid film |
| Video camera<br>connect ability | Yes | Yes |
| Observation system | Same | Mydriatic : Finder<br>Non-mydriatic : LCD |
| Dioptric<br>compensation | Same | -32D ~ +35D |
| Focusing | Same | By aligning the split lines |
| Filter for FA | Present | Present |
| Filter for ICG | Not applicable | Present |
| Observation Light<br>Source | Same | Halogen lamp<br>100W |
| Photographing Light<br>Source | Same | Xenon flash lamp<br>300WS |
| Power consumption | Same | 180VA<br>1800VA (Instantaneous) |
| Dimension | Same | 400(W) x 520(D) x 752(H) mm |
| Weight | 35.5 kg<br>with power unit | 35.5 kg<br>with power unit |

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, Ltd. c/o Akihiro Fujita, General Manager Electronics and Optics Division 4-14. Nihonbashi-honcho 3-chrome Chuo-ku, Tokyo Japan 103-8433

JUL - 2 2009

Re: K091683

Trade/Device Name: Kowa VX-10a Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: May 15, 2009 Received: June 10, 2009

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 adulteration.

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

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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Kesia Alexander for

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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Indication for Use

510(k) Number (if known):

Device Name: KOWA VX-10α

Indication For Use:

The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.

V Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(División Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________