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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Kowa VX-10 Fundus Camera. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with defined endpoints.

Therefore, the document does not contain the following information:

A table of acceptance criteria and reported device performance based on a dedicated study.
Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for such a test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Results from a standalone (algorithm only) performance study.
The type of ground truth used to establish performance metrics (e.g., pathology, outcomes data).
Sample size for a training set or how ground truth for a training set was established.

Instead, the document focuses on comparing the Kowa VX-10's features, indications for use, and technical specifications to two predicate devices: the CANON Non-Mydriatic Retinal Camera, Model Cr6-45nm, and the KOWA PROFESSIONAL FUNDUS CAMERA MODEL FX-500.

The "study" that proves the Kowa VX-10 meets acceptance criteria, in the context of a 510(k) submission, is a comparison study demonstrating substantial equivalence to predicate devices.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) but rather a comparison of technical specifications and features against predicate devices. The "reported device performance" is essentially that its features and functions are equivalent or superior to the predicates.

Feature / Criteria	Kowa VX-10 (Reported Performance)	Non-Mydriatic Retinal Camera, Model Cr6-45nm (Predicate 1)	Kowa Professional Fundus Camera Model FX-500 (Predicate 2)
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)	Monochrome CCD	None
Record Media	Same as both (35mm film / Polaroid film)	35mm film / Polaroid film	35mm film / Polaroid film
Video camera connect ability	Same as the Cr6-45nm (Yes)	Yes	No
Observation System	Mydriatic: Same as the Fx-500 (Optical finder)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 aligning the split lines	By focusing two oscillating points
Filter for FA	Present	Not present	Present
Observation Light Source	Same as the FX-500 (Halogen lamp 50W)	Halogen lamp 75W	Halogen lamp 50W
Photographing Light Source	Same as both (Xenon flash lamp 300WS)	Xenon flash lamp 300WS	Xenon flash lamp 300WS
Safety	Equivalent to that of the predicate devices.	Demonstrated safety as a cleared device	Demonstrated safety as a cleared device
Fundamental Technology	Equivalent to the predicate devices.	Fundamental technology for an ophthalmic camera	Fundamental technology for an ophthalmic camera
Basic Functions	No difference in basic functions compared to predicate devices.	Capable of non-mydriatic fundus imaging	Capable of mydriatic and fluorescein angiographic fundus imaging
Additional Functionality	"narrow mode" for more detailed shooting. (Narrower than predicates)	Standard image shooting magnifications	Standard image shooting magnifications

2. Sample size used for the test set and the data provenance:

Not Applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to pre-existing devices based on features, specifications, and intended use, rather than a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a fundus camera, which is an imaging acquisition device, not an AI-powered diagnostic tool requiring MRMC studies for human reader improvement.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

No. This device is a hardware imaging device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, which the Kowa VX-10 is aiming to be substantially equivalent to.

8. The sample size for the training set:

Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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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

.. : : :

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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 (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

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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

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OCT & - 2005

K043213

9. Certification 9.1 Summary for public disclosure

Submitter information:

Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-3279-7329Fax: +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.

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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 RetinalCamera, Model Cr6-45nm	CANON U.S.A., Inc.	K980246	05/06/1998
KOWA PROFESSIONALFUNDUS CAMERAMODEL 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.

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	KOWA VX-10	Non-Mydriatic RetinalCamera, Model Cr6-45nm	FX-500
IndicationsFor Use	Taking pictures of fundusimages with or withoutmydriatic.	Taking pictures of retina ofhuman eye withoutmydriatic.	Taking pictures of eye withmydriatic.
Picturemagnifications	Mydriatic: 50° /25°Non-mydriatic:45° /22°	Non-mydriatic: 45° /30°	Mydriatic: 50° /35°
Working distance	39 mm	45 mm	38 mm
CCD camera forobservation	Same as the Cr6-45nm	Monochrome CCD	None
Record media	Same as the both	35mm film/ Polaroid film	35mm film/ Polaroid film
Video cameraconnect ability	Same as the Cr6-45nm	Yes	No
Observation system	Mydriatic :Same as the Fx-500Non-mydriatic : LCD	CRT	Optical finder
Dioptriccompensation	-32D ~ +35D	-33D ~ +35D	-25D ~ +45D
Focusing	Same as the Cr6-45nm	By aligning the split lines	By focusing two oscillatingpoints
Filter for FA	Present	Not	Preset
Observation LightSource	Same as the FX-500	Halogen lamp75W	Halogen lamp50W
PhotographingLight Source	Same as the both	Xenon flash lamp300WS	Xenon flash lamp300WS

Predicate device comparison table

Regulation Number and Section

§ 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.