(321 days)
No
The description focuses on the optical and mechanical functions of a fundus camera, with no mention of AI or ML for image analysis or processing.
No.
The device is described as an image shooting device for fundus images, and its intended use is for taking pictures. It does not mention any therapeutic function.
Yes.
The device takes images of the fundus. Capturing images for later interpretation is a component of diagnosis.
No
The device description clearly describes a hardware device (fundus image shooting device) with physical components like a Xenon flash lamp, built-in monitor, and finder, and the ability to use different film types. It does not indicate it is solely software.
Based on the provided information, the Kowa VX-10 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Kowa VX-10 is a fundus camera used to take images of the inside of the eye (fundus). It directly interacts with the patient's body to capture images, rather than analyzing a sample taken from the body.
- The intended use is for taking pictures of fundus images. This is a diagnostic imaging procedure, not an in vitro test.
- The device description details the imaging technology and how it captures images of the fundus. It does not mention any analysis of biological samples.
Therefore, the Kowa VX-10 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Kowa VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
Product codes
HKI
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.
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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 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
9. Certification 9.1 Summary for public disclosure
Submitter information:
| Applicant: | Kowa Company, Ltd.
4-14, Nihonbashi-honcho 3-Chome
Chuo-ku, Tokyo, 103-8433 Japan
Phone: +81-3-3279-7329
Fax: +81-3-3279-7541 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | |||
| Camera, Model Cr6-45nm | CANON U.S.A., Inc. | K980246 | 05/06/1998 |
| KOWA PROFESSIONAL | |||
| FUNDUS CAMERA | |||
| 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
Camera, Model Cr6-
45nm | FX-500 |
|---------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------|
| Indications
For Use | Taking pictures of fundus
images with or without
mydriatic. | Taking pictures of retina of
human eye without
mydriatic. | Taking pictures of eye with
mydriatic. |
| Picture
magnifications | Mydriatic: 50° /25°
Non-mydriatic:45° /22° | Non-mydriatic: 45° /30° | Mydriatic: 50° /35° |
| Working distance | 39 mm | 45 mm | 38 mm |
| CCD camera for
observation | Same as the Cr6-45nm | Monochrome CCD | None |
| Record media | Same as the both | 35mm film
/ Polaroid film | 35mm film
/ Polaroid film |
| Video camera
connect ability | Same as the Cr6-45nm | Yes | No |
| Observation system | Mydriatic :
Same as the Fx-500
Non-mydriatic : LCD | CRT | Optical finder |
| Dioptric
compensation | -32D ~ +35D | -33D ~ +35D | -25D ~ +45D |
| Focusing | Same as the Cr6-45nm | By aligning the split lines | By focusing two oscillating
points |
| Filter for FA | Present | Not | Preset |
| Observation Light
Source | Same as the FX-500 | Halogen lamp
75W | Halogen lamp
50W |
| Photographing
Light Source | Same as the both | Xenon flash lamp
300WS | Xenon flash lamp
300WS |
:
Predicate device comparison table