The Non-Mydriatic Retinal Camera NW500 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.

Device Description

The Non-Mydriatic Retinal Camera NW500 is a non-mydriatic and slit-scanning ophthalmic camera intended to capture, display and store images of the retina and the surrounding adnexa (the fundus oculi) to aid in the diagnosis. It has automatic functions such as auto-alignment, auto-focus, auto-shoot and auto-small pupil functions which can be switched ON/OFF or automatic/manual operation. Eyes with pupil diameters of 2.0mm or more are photographable with NW500. The digital cameras incorporated in the main unit capture images of the retina and the surrounding adnexa (the fundus oculi), and the control panel (LCD touch panel) their associated information (such as patient/test/photography information). The captured images (static images) can also be displayed on a commercially available monitor of a personal computer (hereafter called “PC”) by using the capturing software, Ez Capture for NW500 which is one of the accessories of NW500. The captured images (static images) and their associated information (such as patient/test/photography information) can be exported to and stored in commercially available USB flash drives, PCs, servers (such as a DICOM server) and shared network folders as electric data, and they can be printed out from commercially available printers.

AI/ML Overview

The provided text describes the NON-MYDRIATIC RETINAL CAMERA NW500 (K221111), but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, especially not regarding AI/algorithm performance.

The document details the device's substantial equivalence to a predicate device (TRC-NW400 Non-Mydriatic Retinal Camera, K141481) based on its intended use, operation principle, and technological characteristics. It mentions that "Bench Testing" and "In-house test specification" were used to verify that the NW500 functions as intended and complies with consensus standards, but no specific performance metrics or acceptance criteria are listed for these tests.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria/Metric	Acceptance Criteria	Reported Device Performance	Notes
Resolving Power on Fundus - Color Image-Capturing			Same as predicate, presumed to meet predicate performance.
- Center	60 lp/mm or more (Predicate)	60 lp/mm or more	Direct comparison to predicate, indicating it meets or exceeds.
- Middle (r/2)	40 lp/mm or more (Predicate)	40 lp/mm or more	Direct comparison to predicate, indicating it meets or exceeds.
- Periphery (r)	25 lp/mm or more (Predicate)	25 lp/mm or more	Direct comparison to predicate, indicating it meets or exceeds.
Angular Field of View			Subject device has a slightly larger FOV.
- NW500 (Subject)	N/A	50°	The subject device extends beyond the predicate's capability.
- TRC-NW400 (Predicate)	N/A	45°/30°
Measuring Range for Dioptric Power	-33 D to +40 D	-33 D to +40 D	Same as predicate.
Operating Distance			Slightly different, but not stated if this required specific acceptance.
- NW500 (Subject)	N/A	35.5mm
- TRC-NW400 (Predicate)	N/A	34.8mm
Photographable Diameter of Pupil			Subject device can photograph smaller pupils.
- Normal (NW500)	N/A	φ2.5mm or more	Improved over predicate.
- Small Pupil (NW500)	N/A	φ2.0mm or more	Improved over predicate.
- Normal (TRC-NW400)	N/A	φ4.0mm or more
- Small Pupil (TRC-NW400)	N/A	φ3.3mm or more
Software Level of Concern	N/A	Moderate	Verified and validated as per FDA guidance.

Missing Information:

No specific acceptance criteria for image quality beyond resolving power is detailed. While standards like ISO 15004-1:2006 are listed, the specific metrics and thresholds used for acceptance are not provided.
The document explicitly states: "This section is not applicable because clinical data was not provided for this 510(k) submission." This means there was no clinical study to evaluate the device's image capture performance against specific diagnostic outcomes or expert interpretations. The approval is based on substantial equivalence to a predicate device, assuming similar performance characteristics due to similar technological aspects and bench testing.

Therefore, the following information cannot be provided from the given document:

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set/study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. The device is a camera, not an AI-assisted diagnostic tool described in this document.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The device is a camera. Software verification and validation were performed for the "Software of NW500," which was concluded to be a "Moderate Level of Concern," but this refers to the operational software of the camera, not an AI algorithm for diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study or ground truth establishment process is described.
8. The sample size for the training set: Not applicable, as no AI/algorithm training is described.
9. How the ground truth for the training set was established: Not applicable.

Summary

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August 29, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Topcon Corporation % Maureen O'Connell President OConnell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180

Re: K221111

Trade/Device Name: Non-Mydriatic Retinal Camera NW500 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: July 15, 2022 Received: July 18, 2022

Dear Maureen O'Connell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K221111

Device Name

NON-MYDRIATIC RETINAL CAMERA NW500

Indications for Use (Describe)

The Non-Mydriatic Retinal Camera NW500 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

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510(k) SUMMARY TOPCON CORPORATION NON-MYDRIATIC RETINAL CAMERA NW500

GENERAL INFORMATION

Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan

Contact person:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone:978-207-1245

Date Prepared:

August 29, 2022

DEVICE INFORMATION SUBJECT DEVICE(S):

Name of Device:	NON-MYDRIATIC RETINAL CAMERA NW50
Classification Name:	Class II21 CFR 886.1120 (Ophthalmic camera)
Product Code:	HKI

PREDICATE DEVICE:

Company	Topcon Corporation
Device	TRC-NW400 Non-Mydriatic Retinal Camera
510(k) No.	K141481

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Brief Device Description

Intended Use / Indications for Use

The Non-Mydriatic Retinal Camera NW500 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.

Performance Data

It has been verified that NW500 functions as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device.

FDA-recognized, voluntary consensus standards
ISO 15004-1:2006	Ophthalmic instruments – Fundamental requirementsand test methods – Part 1: General requirementsapplicable to all ophthalmic instruments
ISO 10940:2009ANSI Z80.36-2016	American National Standard for Ophthalmics - LightHazard Protection for Ophthalmic Instruments (FDA-recognized consensus standard)
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance-Collateral standard: Electromagneticdisturbances-Requirements and tests
IEC 60601-1-6: 2013	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability
IEC 62366-1:2015	Medical devices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)]
ISO 10993-1:2018	Biological evaluation of medical devices-Part 1:Evaluation and testing within a risk managementprocess
ISO 10993-5:2009	Biological evaluation of medical devices-Part 5:Tests for in vitro cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices-Part 10:Tests for irritation and skin sensitization
In-house test specification
Bench Testing	In-house test specification

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Software of NW500 was concluded to be a Moderate Level of Concern. Software verification and validation testing were performed, and documentation is provided as recommended by the FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued on May 11, 2005).

Clinical Performance Data

This section is not applicable because clinical data was not provided for this 510(k) submission.

Substantial Equivalence

The subject device, NW500 is substantially equivalent to the predicate device because the intended use/indications for use, operation principle and technological characteristics of NW500 is substantially equivalent to those of the predicate device as shown in Table 1.

Also, it has been confirmed by bench tests that slight differences of NW500 compared to the predicate device do not affect the safety and effectiveness as an ophthalmic camera.

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Table 1: Substantial Equivalence
Model Number	NW500(Subject device)	TRC-NW400(Predicate device)	Substantial EquivalenceDiscussion
Trade Name	NON-MYDRIATIC RETINAL CAMERA NW500	TRC-NW400NON-MYDRIATIC RETINA	Same
510(k)submitter/holder	TOPCON Corporation	TOPCON Corporation	Same
510(k) Number	NA	K141481	N/A
Product code	HKI	HKI	Same
Regulation No.	886.1120	886.1120	Same
Product class	II	II	Same
Indications for Use	The Non-Mydriatic Retinal Camera NW500 intended foruse in capturing images of the retina and presenting thedata to the eye care professional, without the use of amydriatic.	The TRC-NW400 intended for use in capturing imagesof the retina and the anterior segment ofthe eye and presenting the data to the eye careprofessional, without use of a mydriatic.	Substantially equivalent
TechnologicalCharacteristics:Device Design	NW500 is a non-mydriatic and slit-scanning ophthalmiccamera intended to capture, display and store images ofthe retina and the surrounding adnexa (the fundus oculi) toaid in the diagnosis. It has automatic functions such asauto-alignment, auto-focus, auto-shoot and auto-smallpupil functions which can be switched ON/OFF orautomatic/manual operation. Eyes with pupil diameters of2.0mm or more are photographable with NW500.The digital cameras incorporated in the main unit captureimages of the retina and the surrounding adnexa (thefundus oculi), and the control panel (LCD touch panel)their associated information (such aspatient/test/photography information). The capturedimages (static images) can also be displayed on acommercially available monitor of a personal computer(hereafter called “PC”) by using the capturing software, EzCapture for NW500 which is one of the accessories ofNW500. The captured images (static images) and theirassociated information (such as patient/test/photography	The Topcon TRC-NW400 is a fundus camera designedto observe, photograph and record the fundus oculi of apatient's eye with or without the use of a mydriatic. TheTRC-NW400 does not come into contact with thepatient's eye and provides the fundus oculi imageinformation as an electronic image for later analysis.The TRC-NW400 houses a color LCD monitor used forobservation and display of a photographed image and adigital photography unit used for recording images. Aphotographed image may be recorded on a personalcomputer (hereinafter referred to as a PC), or on acommercially available storage device (such as a flashmemory, a hard disk or a card reader/writer) connectedto the TRC-NW400. A photographed image may also beprinted on a commercially available digital printerconnected to the TRC-NW400 or PC.Patient information may be input on the control panel ofthe main unit or by using a commercially available datainput device (for example: a bar code reader or amagnetic card reader) or PC.	Substantially equivalentThe subject device (NW500)and the predicate device(TRC-NW400) haveequivalent technologicalcharacteristics as ophthalmiccameras to capture, displayand store images of thefundus oculi, although theyhave slight differences inhaving or not the slit-scanning movement and inthe photographable pupildiameters, both of which donot affect the intended usenor the target population.Also, the performance andthe safety of the subjectdevice (NW500) have beenverified by tests as describedin "Performance Data"above

E

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Model Number	NW500(Subject device)	TRC-NW400(Predicate device)	Substantial Equivalence Discussion
	information) can be exported to and stored incommercially available USB flash drives, PCs, servers(such as a DICOM server) and shared network folders aselectric data, and they can be printed out fromcommercially available printers.		Therefore, those slightdifferences do not affectsafety and effectiveness asan ophthalmic camera, andthe subject device (NW500)is substantially equivalent tothe legally marketedpredicate device (TRC-NW400).Substantially equivalent

DeviceSpecifications	Item	Device Specification	Item	Device Specification
	Types ofimage-capturing	ColorInfrared light (IR)	Types ofimage-capturing	ColorInfrared light (IR)
	Resolvingpower onfundus	Color image-capturing● Center: 60 lp/mm or more● Middle (r/2): 40 lp/mm or more● Periphery (r): 25 lp/mm or more	Resolvingpower onfundus	Color image-capturing● Center: 60 lp/mm or more● Middle (r/2): 40 lp/mm or more● Periphery (r): 25 lp/mm or more
	AngularField ofView	50°	AngularField ofView	45°/30°
	Measuringrange forthedioptricpower	-33 D to +40 DWhen used without diopter correctionlens: -13D to +12DWhen used with the minus dioptercorrection lens: -33D to -12 DWhen used with the plus dioptercorrection lens: +11D to +40D	Measuringrange forthedioptricpower	-33 D to +40 DWhen used without dioptercorrection lens: -13D to +12DWhen used with the minus dioptercorrection lens: -33D to -12 DWhen used with the plus dioptercorrection lens: +11D to +40D
	Operatingdistance	35.5mm	Operatingdistance	34.8mm
	Photographablediameterof pupil	Normal: φ2.5mm or moreSmall pupil: φ2.0mm or more	Photographablediameterof pupil	Normal: φ4.0mm or moreSmall pupil: φ3.3mm or more

Model Number	NW500(Subject device)		TRC-NW400(Predicate device)		Substantial EquivalenceDiscussion
	Fixationtarget	Internal fixation targetExternal fixation target	Fixationtarget	Internal fixation targetExternal fixation targetPeripheral fixation target
	Auxiliaryfunctions	Auto-alignmentAuto-focusAuto-shootAuto-small pupil	Auxiliaryfunctions	Auto-alignmentAuto-focusAuto-shootAuto small pupil diaphragm functionBlink detection function

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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.