K Number
K221111
Device Name
Non-Mydriatic Retinal Camera NW500
Manufacturer
Date Cleared
2022-08-29

(136 days)

Product Code
Regulation Number
886.1120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The description focuses on automated functions for image capture and handling, which are standard features in modern medical imaging devices and do not inherently indicate AI/ML. There is no mention of AI, ML, or related terms, nor is there any description of training or test data sets typically associated with AI/ML development.

No.
The device is solely for capturing images of the retina to aid in diagnosis, not for treating any condition.

Yes

The "Device Description" section states that the device is "intended to capture, display and store images of the retina and the surrounding adnexa (the fundus oculi) to aid in the diagnosis." This explicitly indicates a diagnostic purpose.

No

The device description clearly states it is a "Non-Mydriatic Retinal Camera NW500" and describes physical components like digital cameras, a control panel (LCD touch panel), and the ability to capture images using color and infrared light, indicating it is a hardware device with integrated software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Non-Mydriatic Retinal Camera NW500 is an imaging device that captures images of the retina and surrounding adnexa. It does not perform any tests on biological samples.
  • Intended Use: The intended use is to capture images and present data to an eye care professional to aid in diagnosis. This is a visual examination process, not an in vitro test.

Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.

N/A

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.

Product codes

HKI

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Color, Infrared light (IR)

Anatomical Site

retina and the surrounding adnexa (the fundus oculi)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

eye care professional

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)

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.

Bench Testing: In-house test specification.
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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141481

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.

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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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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 II
21 CFR 886.1120 (Ophthalmic camera)
Product Code:HKI

PREDICATE DEVICE:

CompanyTopcon Corporation
DeviceTRC-NW400 Non-Mydriatic Retinal Camera
510(k) No.K141481

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Brief 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.

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 15004-1:2006Ophthalmic instruments – Fundamental requirements
and test methods – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 10940:2009
ANSI Z80.36-2016American National Standard for Ophthalmics - Light
Hazard Protection for Ophthalmic Instruments (FDA-
recognized consensus standard)
ANSI AAMI ES60601-
1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2:2014Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance-Collateral standard: Electromagnetic
disturbances-Requirements and tests
IEC 60601-1-6: 2013Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 62366-1:2015Medical devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)]
ISO 10993-1:2018Biological evaluation of medical devices-Part 1:
Evaluation and testing within a risk management
process
ISO 10993-5:2009Biological evaluation of medical devices-Part 5:
Tests for in vitro cytotoxicity
ISO 10993-10:2010Biological evaluation of medical devices-Part 10:
Tests for irritation and skin sensitization
In-house test specification
Bench TestingIn-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 NumberNW500
(Subject device)TRC-NW400
(Predicate device)Substantial Equivalence
Discussion
Trade NameNON-MYDRIATIC RETINAL CAMERA NW500TRC-NW400
NON-MYDRIATIC RETINASame
510(k)
submitter/holderTOPCON CorporationTOPCON CorporationSame
510(k) NumberNAK141481N/A
Product codeHKIHKISame
Regulation No.886.1120886.1120Same
Product classIIIISame
Indications for UseThe 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.The TRC-NW400 intended for use in capturing images
of the retina and the anterior segment of
the eye and presenting the data to the eye care
professional, without use of a mydriatic.Substantially equivalent
Technological
Characteristics:
Device DesignNW500 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/photographyThe Topcon TRC-NW400 is a fundus camera designed
to observe, photograph and record the fundus oculi of a
patient's eye with or without the use of a mydriatic. The
TRC-NW400 does not come into contact with the
patient's eye and provides the fundus oculi image
information as an electronic image for later analysis.
The TRC-NW400 houses a color LCD monitor used for
observation and display of a photographed image and a
digital photography unit used for recording images. A
photographed image may be recorded on a personal
computer (hereinafter referred to as a PC), or on a
commercially available storage device (such as a flash
memory, a hard disk or a card reader/writer) connected
to the TRC-NW400. A photographed image may also be
printed on a commercially available digital printer
connected to the TRC-NW400 or PC.
Patient information may be input on the control panel of
the main unit or by using a commercially available data
input device (for example: a bar code reader or a
magnetic card reader) or PC.Substantially equivalent
The subject device (NW500)
and the predicate device
(TRC-NW400) have
equivalent technological
characteristics as ophthalmic
cameras to capture, display
and store images of the
fundus oculi, although they
have slight differences in
having or not the slit-
scanning movement and in
the photographable pupil
diameters, both of which do
not affect the intended use
nor the target population.
Also, the performance and
the safety of the subject
device (NW500) have been
verified by tests as described
in "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 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. | | Therefore, those slight
differences do not affect
safety and effectiveness as
an ophthalmic camera, and
the subject device (NW500)
is substantially equivalent to
the legally marketed
predicate device (TRC-NW400).

Substantially equivalent | | |
| | | | | | |
| Device
Specifications | Item | Device Specification | Item | Device Specification | |
| | Types of
image-
capturing | Color
Infrared light (IR) | Types of
image-
capturing | Color
Infrared light (IR) | |
| | Resolving
power on
fundus | Color image-capturing
● Center: 60 lp/mm or more
● Middle (r/2): 40 lp/mm or more
● Periphery (r): 25 lp/mm or more | Resolving
power on
fundus | Color image-capturing
● Center: 60 lp/mm or more
● Middle (r/2): 40 lp/mm or more
● Periphery (r): 25 lp/mm or more | |
| | Angular
Field of
View | 50° | Angular
Field of
View | 45°/30° | |
| | Measuring
range for
the
dioptric
power | -33 D to +40 D
When used without diopter correction
lens: -13D to +12D
When used with the minus diopter
correction lens: -33D to -12 D
When used with the plus diopter
correction lens: +11D to +40D | Measuring
range for
the
dioptric
power | -33 D to +40 D
When used without diopter
correction lens: -13D to +12D
When used with the minus diopter
correction lens: -33D to -12 D
When used with the plus diopter
correction lens: +11D to +40D | |
| | Operating
distance | 35.5mm | Operating
distance | 34.8mm | |
| | Photographable
diameter
of pupil | Normal: φ2.5mm or more
Small pupil: φ2.0mm or more | Photographable
diameter
of pupil | Normal: φ4.0mm or more
Small pupil: φ3.3mm or more | |
| | | | | | |
| Model Number | NW500
(Subject device) | | TRC-NW400
(Predicate device) | | Substantial Equivalence
Discussion |
| | Fixation
target | Internal fixation target
External fixation target | Fixation
target | Internal fixation target
External fixation target
Peripheral fixation target | |
| | Auxiliary
functions | Auto-alignment
Auto-focus
Auto-shoot
Auto-small pupil | Auxiliary
functions | Auto-alignment
Auto-focus
Auto-shoot
Auto small pupil diaphragm function
Blink detection function | |

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