The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.

Device Description

KOWA nonmyd series of camera consist of non-mydriatic fundus cameras with a digital image capture system, which does not require 35mm film or instant film. It maintains the same functionalities of the previous fundus cameras, and by capturing digital images it eliminates film development time, allowing the user to view images immediately.

The KOWA nonmyd series cameras are all fundamentally the same noting exception only to their output interfaces. Type D (KOWA nonmyd a-D) contains an internal CCD camera and exports data via USB interface. Type F (KOWA nonmyd 7) requires a CCD camera to be attached to the device and exports data by both memory card and via USB.

Application software for the KOWA nonmyd series contain a filing system, which can save, display, and manage the digital images.

For detailed observation, the KOWA nonmyd series have an optical variable power feature, which enables the viewer to select a picture angle. By selecting a picture angle it can achieve the same amount of image clarity as a conventional fundus camera.

In addition, the KOWA nonmyd series can be used even in cases where the pupil has not been completely dilated; in addition to the normal pupil diameter 4mm mode, there is also a small pupil diameter 3.7mm mode.

Similar to previous fundus cameras, the KOWA nonmyd series uses infrared light for illumination during alignment to provide a better patient experience. In addition, the devices are equipped with a highly sensitive CCD camera, and are therefore able to capture images at a much lower flash light intensity level than previous fundus cameras, further enhancing the patient experience.

AI/ML Overview

Here's an analysis of the provided text regarding the KOWA nonmyd series, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for KOWA nonmyd series

The KOWA nonmyd series (nonmyd 7 and nonmyd α-D) are non-mydriatic fundus cameras intended for retina image capturing. The device's acceptance criteria are implicitly defined by its substantial equivalence to the predicate device, the Nidek NM-1000, and its conformity to specific international standards.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative performance acceptance criteria (e.g., minimum image resolution, sensitivity, or specificity for a specific pathology). Instead, acceptance is demonstrated through substantial equivalence to a predicate device and conformity to relevant safety and performance standards.

The table below summarizes the key comparisons made between the KOWA nonmyd series and the predicate device, which inherently serve as the performance characteristics the new device aims to match or exceed.

Feature / Acceptance Criteria Category	Predicate Device (Nidek NM-1000) Performance	KOWA nonmyd series Performance (Type D and F)	Comparison / Implied Acceptance
Intended Use	Retina and anterior segment image capturing	Retina image capturing	Substantially Equivalent (retina)
Image Output Format	Nidek format, TIF	BMP, JPEG	Different, but still digital output. Acceptable.
Picture Angle	45 degrees	45 degrees/20 degrees	Equivalent (45 deg), KOWA also offers 20 deg. Acceptable.
Working Distance	43.3mm (from camera body to corner)	30mm	Different, but a functional attribute. Acceptable.
Working Distance Detection Method	Anterio (Observation), Fundus (Focusing)	Anterio (Observation), Fundus (Focusing)	Equivalent
Minimum Pupil Diameter	4mm	Normal: 4mm; Small: 3.7mm	Equivalent (4mm), KOWA also offers 3.7mm. Acceptable.
Observation CCD Camera	1/3 inch CCD Camera	1/3 inch CCD Camera	Equivalent
Photographing CCD Camera	1/2 inch CCD Camera, Digital Progressive Scan	Type D: 1/2 inch 2.1MP CCD; Type F: APS-C 6MP	Equivalent (Type D), Superior (Type F). Acceptable.
Observation Display (B/W)	6.4 inch LCD Monitor	5.6 inch LCD Monitor	Different size, but functional. Acceptable.
Photographing Display	6.4 inch LCD Monitor	Outer Monitor Use (Type D, F)	Different display method, but functional. Acceptable.
Dioptric Compensation	Total -32D to +40D	Total -33D to +40D	Substantially Equivalent
Focusing	Manual (motor driven), Split line focus	Split luminous bars coincidence	Different method, but functional. Acceptable.
Observation Light Source	Halogen lamp (Max 12V 50W) with IR filter	Halogen lamp (Max 12V 100W) with IR filter	Different wattage, but same type. Acceptable.
Photographing Light Source	Xenon flash (Max 25WS)	Xenon flash (Max 50WS)	Different wattage, but same type. Acceptable.
Internal Fixation Navigation	Manual lever	Fixed fixator selecting	Different method, but functional. Acceptable.
Switching Light Path	Beam Splitter	Same pathway, no beam split	Different design, but functional. Acceptable.
Observation Light Adjustment	Volume adjustment style	Volume adjustment style	Equivalent
Photographing Light Adjustment	Step adjustment style (8 steps)	Step adjustment style (5 steps)	Different number of steps, but functional. Acceptable.
Camera Stand Type	Tabletop; power source built-in	Tabletop; power source built-in	Equivalent
Horizontal Movement	Forward/Backward: 65mm; Left/Right: 106mm	Forward/Backward: 40mm; Left/Right: 100mm	Different ranges, but functional. Acceptable.
Vertical Movement (Camera Stand)	30mm	30mm	Equivalent
Shutter Release	Joystick upper button	Joystick upper button	Equivalent
Signal Outlet	USB, RGB Analog, NTSC Composite Video	Type D: USB; Type F: Flash memory card	Different options, but includes USB. Acceptable.
Vertical Movement (Chinrest)	65mm	60mm	Different range, but functional. Acceptable.
External Fixation Targets	Free-arm style (Option)	Free-arm style (Option)	Equivalent
Safety Requirements (IEC)	EN60601-1	IEC60601-1	Equivalent (different standard version/name)
EMC (IEC)	EN60601-1-2	IEC60601-1-2	Equivalent (different standard version/name)
Ophthalmic Instrument Req (ISO)	ISO15004	ISO15004	Equivalent
Dimensions	360mm(W) x 530mm(D) x 565mm(H)	Type F: 310x504x548mm; Type D: 310x504x462mm	Different, but functional. Acceptable.
Weight	26 kg	Type F: 21 kg; Type D: 21 kg	Different, but functional. Acceptable.

2. Sample Size for Test Set and Data Provenance

The document does not describe a traditional clinical study with a "test set" of patient images or specific "data provenance" in the context of evaluating a diagnostic algorithm. This submission is for an ophthalmic camera, not an AI/ML diagnostic tool.

The "testing" mentioned refers to engineering and compliance testing against international standards rather than a clinical performance study with patient data. Therefore, the concepts of "sample size" and "data provenance" as typically applied to algorithmic performance evaluation are not applicable here.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. As noted above, this submission is for a medical device (fundus camera), not an AI diagnostic algorithm requiring expert ground truth for image interpretation.

4. Adjudication Method for Test Set

Not applicable. There is no "test set" in the context of image interpretation that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a fundus camera, a tool for image acquisition, not a diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance

Not applicable. The KOWA nonmyd series is a hardware device (fundus camera), not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. As this is a hardware device, "ground truth" in the context of diagnostic accuracy is not relevant to its regulatory submission. The "ground truth" for the device's performance is its ability to meet the technical specifications and safety standards.

8. Sample Size for the Training Set

Not applicable. The KOWA nonmyd series is a hardware device, not an AI/ML algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable. No training set is involved for this device.

Summary

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NOV 1 0 2005

510(k) Notification

K 053026

9. Certification 9.1 Summary for public disclosure

Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 Japan
Phone:	+81-3-3279-7329
Fax:	+81-3-3279-7541
Contact:	Satohiko Takanashi
e-mail address:	s-takana@kowa.co.jp
Date summary prepared:	January 11 , 2005
Device trade name:	KOWA nonmyd 7 (Type F)KOWA nonmyd a -D (Type D)
Classification name:	CAMERA, OPTHALMIC, AC-POWERED
Product code:	HKI

Intended use:

Device description:

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Application software for the KOWA nonmyd series contain a filing system, which can save, display, and manage the digital images.

Comparison:

The Nidek NM-1000 was chosen as a substantially equivalent device. The predicate device is a non-mydriatic fundus camera and it is equipped with a high resolution CCD camera so it does not require any film and can display images immediately after image capture. Also because it uses a highly sensitive CCD camera, the flash required for filming is reduced compared to conventional fundus cameras.

Similar to the predicate device, the KOWA nonmyd series cameras are equipped with a highly sensitive CCD so they do not require film and can display images immediately after image capture.

The KOWA nonmyd series, KOWA nonmyd 7 and KOWA nonmyd a-D, and the predicate device also share similar technical and safety characteristics. The result is show in the table below.

Performance testing:

KOWA nonmyd series, KOWA nonmyd 7 and KOWA nonmyd a-D, were tested to the following standards and conform to all specific requirements based on these standards. KOWA nonmyd series are equivalent to the predicate device.

Electrical safety

KOWA nonmyd series were tested in accordance with IEC60601-1: 1988. Amendment 1:1991 and Amendment 2: 1995, and met all requirements of standards.

Electromagnetic compatibility

KOWA nonmyd series were tested in accordance with IEC60601-1-2: 2001. and met all requirements of standard.

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Test requirements and test procedure for ophthalmic instruments

KOWA nonmyd series was tested in accordance with ISO15004: 1997, and met all requirements of the standard. Refer to Appendix B for details.

Risk management

KOWA nonmyd series were evaluated in accordance with ISO14971: 2000. The risk management of the devices was deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

Conclusion:

The KOWA nonmyd series is equipped with the same fundamental technology as the predicate device and maintains the same level of safety performance. Therefore it has been concluded that there are no significant differences in the technical characteristics and safety between KOWA nonmyd series and the predicate device.

Table A: Predicate device

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Nidek Non-MydriaticFundus CameraModel NM-1000	Nidek Incorporated	K014274	Apr. 17, 2002

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			Table B: Predicate Device Comparison
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	KOWA nonmyd series: Non-mydriaticfundus camera, type D and F	Nidek Non-mydriatic Fundus CameraModel NM-1000
Intended use	The KOWA nonmyd series, non-mydriatic fundus cameras areintended for use with retina imagecapturing.	The Nidek NM-1000 is an ophthalmic camerathat is intended for use in capturing images ofthe retina and the anterior segment of the eye.
Saved Image Format	BMP, JPEG	Nidek format, TIF
Picture angle	45degree/20degree	45degree
Working distance	30mm	43.3mm (from camera body to corner)
Working distancedetection method	Anterio (Observation)Fundus (Focusing on blight spots)	Anterio (Observation)Fundus (Focusing on blight spots)
Minimum diameterof pupil	Normal pupil mode: 4mmSmall pupil mode: 3.7mm	4mm
CCD camera forobservation	1/3 inch CCD Camera	1/3 inch CCD Camera
CCD camera forPhotographing	Type D:1/2inch 2.1mega pixel CCD CameraDigital Progressive Scan (built-in)Type F:APS-C size 6mega pixel CCD CameraDigital Progressive Scan(K9L-BM39 used as Digital camera)	1/2inch CCD CameraDigital Progressive Scan (built-in)
Observation Display(B/W)	5.6 inch LCD Monitor	6.4 inch LCD Monitor
Photographing Display	Type D, F: Outer Monitor Use	6.4 inch LCD Monitor
Dioptric compensation	Total -33D to +40D	Total -32D to +40D
Focusing	Split luminous bars coincidence	Manual (motor driven)Split line focus on the retina (-10 to +14D)

	KOWA nonmyd series: Non-mydriatic funduscamera, Type D and F	Nidek Non-mydriatic Fundus CameraModel NM-1000
Observation LightSource	Halogen lamp (Max 12V 100W)with infrared filter	Halogen lamp (Max 12V 50W)with infrared filter
Photographing LightSource	Xenon flash (Max 50WS)	Xenon flash (Max. 25WS)
Internal FixationNavigation	Fixed fixator selecting	Manual lever
Switching light path ofobservation &photographing	Same pathway, no beam split	Beam Splitter
Observation lightadjustment	Volume adjustment style	Volume adjustment style
Photographing lightadjustment	Step adjustment style (5 steps)	Step adjustment style (8 steps)
Camera stand (Base)
Type	Tabletop; power source built-in	Tabletop; power source built-in
Horizontal Movement	Forward/Backward: 40mmLeftward/Rightward: 100mm	Forward/Backward: 65mmLeftward/Rightward: 106mm
Vertical Movement	30mm	30mm
Shutter Release	Joystick upper button	Joystick upper button
Signal outlet	Type D: USBType F: Flash memory card	USB, RGB Analog, NTSC Composite Video
Chinrest
Vertical Movement ofchinrest	60mm	65mm
External FixationTargets	Free-arm style (Option)	Free-arm style (Option)
Compliance with safety standards
Safety requirements	IEC60601-1	EN60601-1
EMC	IEC60601-1-2	EN60601-1-2
Ophthalmic instrumentrequirements	ISO15004	ISO15004
Dimensions
Size	Type F: 310mm(W) x 504mm(D) x 548mm(H)Type D: 310mm(W) x 504mm(D) x 462mm(H)	360mm(W) x 530mm(D) x 565mm(H)
Weight	Type F: 21 kg with the digital cameraType D: 21 kg	26 kg

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Table C: Predicate Device Comparison

KOW i nomnyd " and KOWA nomnyd a D. Kowa Company, I id.

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Image /page/5/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

NOV 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Company, Ltd. c/o Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Rd. Newton, CT 06470

Re: K053026

Trade/Device Name: Kowa nonmyd 7 (type F) & nonmyd α-D (type D) Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 25, 2005 Received: October 27, 2005

Dear Mr. Borsai:

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 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.

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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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510(k) Notification

Indications for Use

510(k) Number (if know): KD5

Device Name: KOWA nonmyd 7 and KOWA nonmyd a-D

Indications for Use:

Joenette R. Been

Division of Ophthalmic Ear Nose and Throat Dev

510(k) Number

Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.