(136 days)
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)
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
1
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)
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:
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 |
and test methods – Part 1: General requirements | |
applicable to all ophthalmic instruments | |
ISO 10940:2009 | |
ANSI Z80.36-2016 | American 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)2012 | Medical electrical equipment - Part 1: General |
requirements for basic safety and essential | |
performance | |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General |
requirements for basic safety and essential | |
performance-Collateral standard: Electromagnetic | |
disturbances-Requirements and tests | |
IEC 60601-1-6: 2013 | Medical electrical equipment - Part 1-6: General |
requirements for basic safety and essential | |
performance - Collateral standard: Usability | |
IEC 62366-1:2015 | Medical devices - Part 1: Application of usability |
engineering to medical devices [Including | |
CORRIGENDUM 1 (2016)] | |
ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1: |
Evaluation and testing within a risk management | |
process | |
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 Equivalence | ||
Discussion | |||
Trade Name | NON-MYDRIATIC RETINAL CAMERA NW500 | TRC-NW400 | |
NON-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 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 Design | 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 | The 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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