The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF). The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor. The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.

AI/ML Overview

The KOWA VX-20 is a retinal image shooting device. The provided text describes the performance testing conducted to ensure its safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO10940 (General Standard for Ophthalmic Instruments)	KOWA VX-20 met all requirements of the standard.
IEC60601-1 (Electrical Safety)	KOWA VX-20 met all requirements of the standard.
IEC60601-1-2 (Electromagnetic Compatibility)	KOWA VX-20 met all requirements of the standard.
ISO15004-2 (Optical Safety)	KOWA VX-20 met all requirements of Group 2 instrument in the standard.
FDA Guidance: "Guidance for the content of premarket submissions for software contained in medical devices, 2005" (Software Validity)	All functions are tested and confirmed good working to required items; software level of concern is moderate.
Biocompatibility Assessment (Material Safety)	Materials used were the same as other legally marketed devices in the US or evaluated under Material Safety Data Sheet (MSDS).
ISO14971:2007 (Risk Management)	The risk management of the device was deemed satisfactory.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a particular "test set" in terms of subject or image count for performance validation. Instead, the device's performance is demonstrated through adherence to various international and FDA standards, which typically involve testing the device itself rather than its performance on a dataset. The studies described are engineering and safety compliance tests, not clinical studies with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" here is compliance with technical standards, which is assessed through testing procedures defined by those standards, not through expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. Technical standard compliance is determined by test results against predefined limits, not by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. The submission focuses on device safety and technical performance, not on demonstrating improved human reader performance with the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The testing described for electrical safety, electromagnetic compatibility, optical safety, and software validation are assessments of the device's standalone performance against established technical and safety standards. There is no "algorithm only" performance reported in the context of an AI-powered diagnostic system, as this device's primary function is image acquisition.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on technical standards and regulations. This includes:

Specifications and requirements outlined in ISO10940, IEC60601-1, IEC60601-1-2, ISO15004-2.
FDA guidance for software validation.
Material safety data.
Risk management principles from ISO14971:2007.

8. The Sample Size for the Training Set

Not applicable. This device is an image acquisition device, not an AI model requiring a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned for this device.

Summary

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KI12330

FEB 1 6 2012

owa) Kowa Company. Ltd.

ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)3-3279-7646 FAX: +81-(0)3-3279-7621

510(k) Summary

Submitter information:

Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-3279-7646Fax: +81-3-3279-7621
Contact:	Hiroyuki Koide
Date summary prepared:	August 10, 2011
Device identification:Device trade name:Classification name:	KOWA VX-20Camera, Ophthalmic, AC-powered

Classification name:

System, Image Management, Ophthalmic HKI, NFJ

Identification of predicate devices:

Product code:

Kowa Company believes that this device is substantially equivalent to: KOWA VX-10α manufactured by Kowa, 510(k)# K091683, Canon CX-1 Retinal Camera manufactured by Canon, 510(k)# K092565.

Device description:

The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF).

The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor.

The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.

Intended use:

The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

Technical characteristics: Performance

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510(k) Notification

The KOWA VX-20 is tested in accordance with ISO10940. The KOWA VX-20 met all requirements of the standard.

Electrical safety

To guarantee Electrical safety, IEC60601-1 test was performed. The KOWA VX-20 met all requirements of the standard.

Electromagnetic compatibility

To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The KOWA VX-20 met all requirements of the standard.

Optical safety

To guarantee Optical safety, ISO15004-2 evaluation was performed. The KOWA VX-20 met all requirements of Group 2 instrument in the standard.

Software evaluation

To make sure Software validity of the KOWA VX-20 embedded softwares, evaluation based on FDA guidance, "Guidance for the content of premarket submissions for software contained in medical devices, 2005", was performed.

The levels of concern of these software items are moderate.

The validation of these software items is performed as a part of system function test. All functions are tested and confirmed good working to required items.

Biocompatibility

To guarantee biocompatibility, biocompatibility assessment was performed. The materials were used the same of the other legally marked devices in US or were evaluated under the Material Safety Data Sheet (MSDS).

Risk Management

The KOWA VX-20 was evaluated in accordance with ISO14971: 2007. The risk management of the device was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

Conclusion

KOWA VX-20 is equipped with the fundamental technology to the predicate devices for retinal image capturing and also delivers the equivalent level of safety. Therefore, it is concluded that there is no difference in the basic functions and safety between KOWA VX-20 and the predicate devices.

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510(k) Notification

Table A: Predicate Device Comparison
Device Name	KOWA VX-20	KOWA VX-10α	Canon CX-1 RetinalCameras
510(k) number	-	K091683	K092565
Indications for use	Same asKOWA VX-10α	The device is intended fortaking pictures of fundusimages with mydriatic orwithout mydriatic.	The device is intended to beused for taking digitalimages of retinal of humaneye with non-mydriatic andmydriatic.
Photography mode	Non-mydriatic,Mydriatic color,FA,Red free,FAF (optional)	Non-mydriaticMydriatic colorFA	COLORFLUO (FA)RED FREECOBALTFAF

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kowa Company, Ltd. c/o Mr. Hiroyuki Koide Section Manager, Regulatory Affairs Section 4-14 , Ninonbashihonco 3-Chrome Chuo-ku, Tokyo 103-8433 Japan

Re: K112330

Trade/Device Name: KOWA VX-20 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, NFJ Dated: January 19, 2012 Received: January 20, 2012

FEB 1 6 2012

Dear Mr. Koide:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Debra Falls

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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510(k) Notification

Indications for Use 4.0

KII2330 510(k) Number (if know):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

Over-The-Counter Use_ X Prescription Use_ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR

(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Mausha L. Burke nicholas

... Neurological and Ear, ﻻﺋﻦ: ﺍﻧﺘﻈﺎﺭ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻧﮩﯿﮟ ﺍﻭﺭ ﺍ

112330 . ., .; .; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Kowa Company Ltd., KOW.1 VX-20

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.