KOWA VX-10

K043213 · Kowa Co. , Ltd. · HKI · Oct 6, 2005 · Ophthalmic

Device Facts

• Record ID: K043213
• Device Name: KOWA VX-10
• Applicant: Kowa Co. , Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Oct 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

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

Device Story

Kowa VX-10 is an ophthalmic fundus camera for capturing retinal images. It operates in two modes: non-mydriatic (using infrared light for observation and alignment via a built-in LCD monitor) and mydriatic (using visible light for manual alignment via an optical finder). A Xenon flash lamp provides illumination for image capture. The device supports multiple recording media, including 35mm film, Polaroid film, or video camera output by swapping the shooting unit. It features narrow and normal magnification modes, with the narrow mode allowing for detailed imaging of specific affected areas. Used in clinical settings by eye care professionals, the device assists in diagnosing and documenting retinal conditions. It also supports fluorescein angiographic (FA) imaging. The output consists of high-resolution fundus photographs, which clinicians use to evaluate retinal health and monitor disease progression, potentially improving diagnostic accuracy and patient management.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical comparison of optical specifications, imaging modes, and functional performance against legally marketed predicate devices.

Technological Characteristics

Ophthalmic camera; Xenon flash lamp (photographing); Halogen lamp (observation); Infrared light source (non-mydriatic observation); LCD monitor (non-mydriatic); Optical finder (mydriatic); Dioptric compensation range -32D to +35D; Supports 35mm film, Polaroid film, and video camera connectivity; Fluorescein angiography filter included.

Indications for Use

Indicated for capturing fundus images of the human eye in patients requiring either mydriatic or non-mydriatic 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

• Non-Mydriatic Retinal Camera, Model Cr6-45nm (K980246)
• KOWA PROFESSIONAL FUNDUS CAMERA MODEL FX-500 (K954780)

Submission Summary (Full Text)

{0}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, Ltd. % Richard N. Phillips, Ph.D. 1801 Rockville Pike Suite 300 Rockville, MD 20852

Re: K043213

Trade/Device Name: Kowa VX-10 i Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: September 27, 2005 Received: September 28, 2005

Dear Dr. Phillips:

This letter corrects our substantially equivalent letter of October 6, 2005.

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. Iisting 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.

OCT 2 5 2005

.. : : :

{1}------------------------------------------------

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

{2}------------------------------------------------

## Indications for Use

510(k) Number: K043213

Device Name: Kowa VX-10 Fundus Camera

Indications For Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR ·

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttyneu, DOED

Page 1 of 1

{3}------------------------------------------------

OCT & - 2005

K043213

### 9. Certification 9.1 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 |
| Date summary prepared: | Nov. 18, 2004 |
| Device identification: | |
| Device trade name: | KOWA VX-10 |

# Classification name: CAMERA, OPTHALMIC, AC-POWERED

I IK I

#### Intended use:

Product code:

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

#### Comparison:

As a substantial equivalent device, CANON Non-Mydriatic Retinal Camera, Model Cr6-45nm (referred to as CANON Cr6-45nm hereafter) and KOWA PROFESSIONAL FUNDUS CAMERA MODEL FX-500 (referred to as FX-500 hereafter) were selected.

KOWA VX-10 is a fundus image shooting device which delivers both functions of mydriatic and non-mydriatic, and is capable of shooting with 35mm film, Polaroid film or video camera by replacing the shooting unit in a similar to the predicate devices. The non-mydriatic function uses infrared light as does CANON Cr6-45nm, and alignment and focusing are made from the built-in monitor. A Xenon flash lamp is used for shooting. When mydriatic shooting function is used, visible light is used for observation, and alignment and focusing are made manually by looking into the finder as in FX-500. A Xenon flash lamp is used for shooting. Furthermore, like FX-500, it is capable of fluorescein angiographic fundus shooting.

{4}------------------------------------------------

KOWA VX-10 has two image shooting magnifications, narrow node and normal mode. The normal mode is same image shooting magnifications to the predicate devices. The narrow mode of image shooting magnifications is narrower than the predicate devices, and more detailed shooting of the affected area is possible.

KOWA VX-10 delivers safety equivalent to that of the predicate devices. A comparison among the functions of KOWA VX-10 and the predicate devices is provided in the comparison table.

#### Conclusion:

KOWA VX-10 is equipped with the fundamental technology features equivalent to the

| Predicate Device | Manufacturer | 510(k)No. | Date Cleared |
|----------------------------------------------------|--------------------|-----------|--------------|
| Non-Mydriatic Retinal<br>Camera, Model Cr6-45nm | CANON U.S.A., Inc. | K980246 | 05/06/1998 |
| KOWA PROFESSIONAL<br>FUNDUS CAMERA<br>MODEL FX-500 | Kowa Optimed, Inc. | K954780 | 12/01/1995 |

predicate devices, and also delivers the equivalent level of safety.

Thus it is concluded that there is no difference in the basic functions and safety between KOWA VX-10 and the predicate devices.

{5}------------------------------------------------

| | KOWA VX-10 | Non-Mydriatic Retinal<br>Camera, Model Cr6-<br>45nm | FX-500 |
|---------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------|
| Indications<br>For Use | Taking pictures of fundus<br>images with or without<br>mydriatic. | Taking pictures of retina of<br>human eye without<br>mydriatic. | Taking pictures of eye with<br>mydriatic. |
| Picture<br>magnifications | Mydriatic: 50° /25°<br>Non-mydriatic:45° /22° | Non-mydriatic: 45° /30° | Mydriatic: 50° /35° |
| Working distance | 39 mm | 45 mm | 38 mm |
| CCD camera for<br>observation | Same as the Cr6-45nm | Monochrome CCD | None |
| Record media | Same as the both | 35mm film<br>/ Polaroid film | 35mm film<br>/ Polaroid film |
| Video camera<br>connect ability | Same as the Cr6-45nm | Yes | No |
| Observation system | Mydriatic :<br>Same as the Fx-500<br>Non-mydriatic : LCD | CRT | Optical finder |
| Dioptric<br>compensation | -32D ~ +35D | -33D ~ +35D | -25D ~ +45D |
| Focusing | Same as the Cr6-45nm | By aligning the split lines | By focusing two oscillating<br>points |
| Filter for FA | Present | Not | Preset |
| Observation Light<br>Source | Same as the FX-500 | Halogen lamp<br>75W | Halogen lamp<br>50W |
| Photographing<br>Light Source | Same as the both | Xenon flash lamp<br>300WS | Xenon flash lamp<br>300WS |

:

Predicate device comparison table