Non-Mydriatic Retinal Camera NW500

K221111 · Topcon Corporation · HKI · Aug 29, 2022 · Ophthalmic

Device Facts

• Record ID: K221111
• Device Name: Non-Mydriatic Retinal Camera NW500
• Applicant: Topcon Corporation
• Product Code: HKI · Ophthalmic
• Decision Date: Aug 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

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 Story

Non-mydriatic, slit-scanning ophthalmic camera; captures, displays, and stores retinal and adnexa images. Features auto-alignment, auto-focus, auto-shoot, and auto-small pupil functions; manual or automatic operation. Used in clinical settings by eye care professionals. Input: optical retinal data. Output: static digital images displayed on integrated LCD touch panel or external PC monitor via 'Ez Capture for NW500' software. Data exportable to USB, servers (DICOM), or network folders. Aids diagnosis by providing high-resolution fundus images without pupil dilation, improving patient comfort and workflow efficiency.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and performance evaluations against FDA-recognized consensus standards (ISO 15004-1, ISO 10940, ANSI Z80.36, IEC 60601 series, ISO 10993 series).

Technological Characteristics

Non-mydriatic, slit-scanning ophthalmic camera. Captures color and infrared images. Resolving power: 60 lp/mm (center), 40 lp/mm (middle), 25 lp/mm (periphery). Angular field of view: 50°. Dioptric range: -33D to +40D. Connectivity: USB, DICOM server, network folders. Software: Moderate Level of Concern. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for capturing and displaying retinal images for eye care professionals to aid in diagnosis, without mydriatic use. Suitable for patients with pupil diameters of 2.0mm or more.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• TRC-NW400 Non-Mydriatic Retinal Camera (K141481)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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:[phone]

# Date Prepared:

August 29, 2022

# DEVICE INFORMATION SUBJECT DEVICE(S):

| Name of Device: | NON-MYDRIATIC RETINAL CAMERA NW50 |
|----------------------|-------------------------------------------------|
| Classification Name: | Class II<br>21 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

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 15004-1:2006 | Ophthalmic instruments – Fundamental requirements<br>and test methods – Part 1: General requirements<br>applicable to all ophthalmic instruments |
| ISO 10940:2009<br>ANSI Z80.36-2016 | American National Standard for Ophthalmics - Light<br>Hazard Protection for Ophthalmic Instruments (FDA-<br>recognized consensus standard) |
| ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance-Collateral standard: Electromagnetic<br>disturbances-Requirements and tests |
| IEC 60601-1-6: 2013 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Usability |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability<br>engineering to medical devices [Including<br>CORRIGENDUM 1 (2016)] |
| ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1:<br>Evaluation and testing within a risk management<br>process |
| ISO 10993-5:2009 | Biological evaluation of medical devices-Part 5:<br>Tests for in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices-Part 10:<br>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<br>(Subject device) | TRC-NW400<br>(Predicate device) | Substantial Equivalence<br>Discussion |
| Trade Name | NON-MYDRIATIC RETINAL CAMERA NW500 | TRC-NW400<br>NON-MYDRIATIC RETINA | Same |
| 510(k)<br>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 for<br>use in capturing images of the retina and presenting the<br>data to the eye care professional, without the use of a<br>mydriatic. | The TRC-NW400 intended for use in capturing images<br>of the retina and the anterior segment of<br>the eye and presenting the data to the eye care<br>professional, without use of a mydriatic. | Substantially equivalent |
| Technological<br>Characteristics:<br>Device Design | NW500 is a non-mydriatic and slit-scanning ophthalmic<br>camera intended to capture, display and store images of<br>the retina and the surrounding adnexa (the fundus oculi) to<br>aid in the diagnosis. It has automatic functions such as<br>auto-alignment, auto-focus, auto-shoot and auto-small<br>pupil functions which can be switched ON/OFF or<br>automatic/manual operation. Eyes with pupil diameters of<br>2.0mm or more are photographable with NW500.<br>The digital cameras incorporated in the main unit capture<br>images of the retina and the surrounding adnexa (the<br>fundus oculi), and the control panel (LCD touch panel)their associated information (such as<br>patient/test/photography information). The captured<br>images (static images) can also be displayed on a<br>commercially available monitor of a personal computer<br>(hereafter called “PC”) by using the capturing software, Ez<br>Capture for NW500 which is one of the accessories of<br>NW500. The captured images (static images) and their<br>associated information (such as patient/test/photography | The Topcon TRC-NW400 is a fundus camera designed<br>to observe, photograph and record the fundus oculi of a<br>patient's eye with or without the use of a mydriatic. The<br>TRC-NW400 does not come into contact with the<br>patient's eye and provides the fundus oculi image<br>information as an electronic image for later analysis.<br>The TRC-NW400 houses a color LCD monitor used for<br>observation and display of a photographed image and a<br>digital photography unit used for recording images. A<br>photographed image may be recorded on a personal<br>computer (hereinafter referred to as a PC), or on a<br>commercially available storage device (such as a flash<br>memory, a hard disk or a card reader/writer) connected<br>to the TRC-NW400. A photographed image may also be<br>printed on a commercially available digital printer<br>connected to the TRC-NW400 or PC.<br>Patient information may be input on the control panel of<br>the main unit or by using a commercially available data<br>input device (for example: a bar code reader or a<br>magnetic card reader) or PC. | Substantially equivalent<br>The subject device (NW500)<br>and the predicate device<br>(TRC-NW400) have<br>equivalent technological<br>characteristics as ophthalmic<br>cameras to capture, display<br>and store images of the<br>fundus oculi, although they<br>have slight differences in<br>having or not the slit-<br>scanning movement and in<br>the photographable pupil<br>diameters, both of which do<br>not affect the intended use<br>nor the target population.<br>Also, the performance and<br>the safety of the subject<br>device (NW500) have been<br>verified by tests as described<br>in "Performance Data"<br>above |

#### E

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| Model Number | NW500<br>(Subject device) | TRC-NW400<br>(Predicate device) | Substantial Equivalence Discussion | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | information) can be exported to and stored in<br>commercially available USB flash drives, PCs, servers<br>(such as a DICOM server) and shared network folders as<br>electric data, and they can be printed out from<br>commercially available printers. | | Therefore, those slight<br>differences do not affect<br>safety and effectiveness as<br>an ophthalmic camera, and<br>the subject device (NW500)<br>is substantially equivalent to<br>the legally marketed<br>predicate device (TRC-NW400).<br><br>Substantially equivalent | | |
| | | | | | |
| Device<br>Specifications | Item | Device Specification | Item | Device Specification | |
| | Types of<br>image-<br>capturing | Color<br>Infrared light (IR) | Types of<br>image-<br>capturing | Color<br>Infrared light (IR) | |
| | Resolving<br>power on<br>fundus | Color image-capturing<br>● Center: 60 lp/mm or more<br>● Middle (r/2): 40 lp/mm or more<br>● Periphery (r): 25 lp/mm or more | Resolving<br>power on<br>fundus | Color image-capturing<br>● Center: 60 lp/mm or more<br>● Middle (r/2): 40 lp/mm or more<br>● Periphery (r): 25 lp/mm or more | |
| | Angular<br>Field of<br>View | 50° | Angular<br>Field of<br>View | 45°/30° | |
| | Measuring<br>range for<br>the<br>dioptric<br>power | -33 D to +40 D<br>When used without diopter correction<br>lens: -13D to +12D<br>When used with the minus diopter<br>correction lens: -33D to -12 D<br>When used with the plus diopter<br>correction lens: +11D to +40D | Measuring<br>range for<br>the<br>dioptric<br>power | -33 D to +40 D<br>When used without diopter<br>correction lens: -13D to +12D<br>When used with the minus diopter<br>correction lens: -33D to -12 D<br>When used with the plus diopter<br>correction lens: +11D to +40D | |
| | Operating<br>distance | 35.5mm | Operating<br>distance | 34.8mm | |
| | Photographable<br>diameter<br>of pupil | Normal: φ2.5mm or more<br>Small pupil: φ2.0mm or more | Photographable<br>diameter<br>of pupil | Normal: φ4.0mm or more<br>Small pupil: φ3.3mm or more | |
| | | | | | |
| Model Number | NW500<br>(Subject device) | | TRC-NW400<br>(Predicate device) | | Substantial Equivalence<br>Discussion |
| | Fixation<br>target | Internal fixation target<br>External fixation target | Fixation<br>target | Internal fixation target<br>External fixation target<br>Peripheral fixation target | |
| | Auxiliary<br>functions | Auto-alignment<br>Auto-focus<br>Auto-shoot<br>Auto-small pupil | Auxiliary<br>functions | Auto-alignment<br>Auto-focus<br>Auto-shoot<br>Auto small pupil diaphragm function<br>Blink detection function | |

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