(170 days)
TRC-50DX, TRC-NW300, TRC-NW7SF MARK III, TRC-NW8, TRC NW8F, TRC NW8F plus, TRC NW400, NW500, DC-3, DC-4, 3D OCT-1000, 3D OCT-2000, 3D OCT-1, 3D OCT-1(Type: Maestro2), DRI OCT Triton, CA-800, KR-800PA, Aladdin
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data management, processing, and remote operation, not AI/ML algorithms.
No
The device is a software program for collecting, storing, and managing ophthalmic imaging and diagnostic data; it does not directly treat or diagnose conditions.
No
The device is described as a software program for collecting, storing, and managing digital images, patient data, and clinical information, and for processing and displaying ophthalmic images. While it processes data from diagnostic devices (Topcon devices and 3D OCT-1 Maestro2), it does not directly perform diagnostic functions itself. It is a data management and viewing system that can provide quantitative comparison of measurements to a database, but it does not claim to make a diagnosis or provide diagnostic output directly from its own processing. The text specifically states it uses "the same algorithms and reference databases from the original data capture device," indicating its role is primarily data management and display rather than independent diagnostic analysis.
No
While the core function is software for data management and display, the device description explicitly mentions a "remote operation function" that allows users to control some image capture functions of a connected hardware device (3D OCT-1). This interaction with and control of hardware prevents it from being purely software-only.
Based on the provided information, it is unlikely that this device is 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The IMAGEnet6 Ophthalmic Data System is primarily a software program for managing and displaying ophthalmic images and data collected from Topcon devices. It processes and displays images and OCT data, and provides a quantitative comparison of posterior ocular measurements to a database of normal subjects.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The data it processes comes directly from imaging devices capturing information about the eye.
- Focus on Imaging and Data Management: The core functions described are image processing, data storage, management, and display, which are typical of medical imaging software, not IVDs.
- Comparison to a Database: While it uses a database for comparison, this is a comparison of measurements derived from images to a database of normal measurements, not an analysis of biological markers in a sample.
In summary, the IMAGEnet6 Ophthalmic Data System is a medical imaging software system that aids in the management and interpretation of ophthalmic images and data. It does not perform tests on biological samples, which is a defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.
It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
Product codes
NFJ
Device Description
IMAGEnet6 Ophthalmic Data System is a Web application that allows management of patient information, exam information and image information. It is installed on a server PC and operated via a web browser of a client PC.
When combined with 3D OCT-1 (type: Maestro2), IMAGEnet6 provides GUI for remote operation function. This function is an optional function which enables users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of 3D OCT-1 (Type:Maestro2) device via ethernet cable. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical coherence tomography data, digital images from Topcon devices (TRC-50DX, TRC-NW300, TRC-NW7SF MARK III, TRC-NW8, TRC NW8F, TRC NW8F plus, TRC NW400, NW500, DC-3, DC-4, 3D OCT-1000, 3D OCT-2000, 3D OCT-1, 3D OCT-1(Type: Maestro2), DRI OCT Triton, CA-800, KR-800PA, Aladdin)
Anatomical Site
posterior ocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Software verification and validation testing such as software system testing was performed for IMAGEnet6.
For the modified remote operation function, confirmed that image quality and diagnosability is the same with or without the remote operation function.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 01, 2024
Topcon Corporation % Lena Sattler President Orasi Consulting 226 1st Street Bonita Springs, Florida 34134
Re: K232828
IMAGEnet6 Ophthalmic Data System Trade/Device Name: Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: January 26, 2024 Received: January 26, 2024
Dear Lena Sattler:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to. 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-reportmedical-device-problems.
For comprehensive re11gulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Alexander Beylin -S 2024.03.01 14:35:46
Alexander Beylin -S -05'00'
for Elvin Ng
Assistant Director THT1A3: Retinal and Diagnostics Devices Team 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
2
Indications for Use
510(k) Number (if known) K232828
Device Name IMAGEnet6 Ophthalmic Data System
Indications for Use (Describe)
The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.
It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Topcon. The logo features a stylized, abstract symbol in blue, resembling two overlapping shapes that could be interpreted as stylized letter 'T's. Below the symbol, the word 'TOPCON' is printed in a bold, sans-serif font, also in black.
510(k) SUMMARY TOPCON CORPORATION Traditional 510(k) for: IMAGEnet6 Ophthalmic Data System
GENERAL INFORMATION
Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan
Contact person:
Lena Sattler President, Orasi Consulting Phone: 440-554-3706 Email: lena@orasiconsulting.com
Date Prepared:
March 1, 2024
DEVICE INFORMATION
SUBJECT DEVICE:
| IMAGEnet6 Ophthalmic Data System | |
|---|---|
| Name of Device: | IMAGEnet6 Ophthalmic Data System |
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 892.2050 |
| Medical image management and processing system | |
| Product Code: | NFJ |
PREDICATE DEVICE:
IMAGEnet6 Ophthalmic Data System:
| Company | Topcon Corporation |
|---|---|
| Device | IMAGEnet6 Ophthalmic Data System |
| 510(k) No. | K171370 |
Classification Name: 21 C.F.R. § 892.2050
4
Image /page/4/Picture/1 description: The image shows the logo for TOPCON. The logo consists of a stylized blue symbol above the word "TOPCON" in a sans-serif font, also in blue. The symbol resembles two overlapping letter "N" shapes, creating a unique and recognizable mark for the company.
Medical image management and processing system
| Product Code: | NFJ |
|---|---|
| Subsequent Product | |
| Codes | HKI, OBO |
Brief Device Description
IMAGEnet6 Ophthalmic Data System
IMAGEnet6 Ophthalmic Data System is a Web application that allows management of patient information, exam information and image information. It is installed on a server PC and operated via a web browser of a client PC.
When combined with 3D OCT-1 (type: Maestro2), IMAGEnet6 provides GUI for remote operation function. This function is an optional function which enables users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of 3D OCT-1 (Type:Maestro2) device via ethernet cable. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.
Intended Use / Indications for Use
IMAGEnet6 Ophthalmic Data System
The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.
It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.
Performance Data
It has been verified that the subject device 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.
IMAGEnet6 Ophthalmic Data System
FDA-recognized, voluntary consensus standards
5
Image /page/5/Picture/1 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble the letter "N" or two curved brackets facing each other.
| IEC 62304:2015 | Medical device software - Software life cycle processes |
|---|---|
| NEMA PS 3.1 - 3.20 | |
| 2022d | Digital Imaging and Communications in Medicine |
| (DICOM) Set |
Software for IMAGEnet6 was concluded to be a Basic documentation level. Software verification and validation testing such as software system testing was performed for IMAGEnet6 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).
For the modified remote operation function, confirmed that image quality and diagnosability is the same with or without the remote operation function.
IMAGEnet6 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. IMAGEnet6 followed the recommendations in the FDA's Guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023).
Clinical Performance Data
This section is not applicable because clinical data was not required for this 510(k) submission.
Substantial Equivalence
The subject device is substantially equivalent to the predicate device because the intended use/indications for use, operation principle and technological characteristics of the subject device is substantially equivalent to those of the predicate device as shown in Table 1 below.
| Model
Number | Subject Device
IMAGEnet6 (ver2.52.1) | Predicate device
IMAGEnet6 (ver1.52) | Substantial
Equivalence
Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ophthalmic Data System
IMAGEnet6 | Ophthalmic Data System
IMAGEnet6 | N/A |
| 510(k)
submitter | TOPCON Corporation | TOPCON Corporation | Same |
| 510(k)
Number | K232828 | K171370 | N/A |
| Product code | NFJ | NFJ | Same |
| Regulation No. | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product class | II | II | Same |
| Intended
purpose | The IMAGEnet6 Ophthalmic Data
System is a software program that is
intended for use in the collection,
storage and management of digital
images, patient data, diagnostic data | The IMAGEnet6 Ophthalmic Data
System is a software program that is
intended for use in the collection,
storage and management of digital
images, patient data, diagnostic data | Different
Deleted the
following sentence
due to addition of
remote operation |
| Model
Number | Subject Device
IMAGEnet6 (ver2.52.1) | Predicate device
IMAGEnet6 (ver1.52) | Substantial
Equivalence
Discussion |
| | and clinical information from Topcon
devices. | and clinical information from
TOPCON devices without
controlling or altering the functions
or parameters of any medical
devices or through computerized
networks. | function:
without controlling
or altering the
functions or
parameters of any
medical devices or
through |
| | It is intended for processing and
displaying ophthalmic images and
optical coherence tomography data. | It is intended for processing and
displaying ophthalmic images and
optical coherence tomography data. | computerized
networks. |
| | The IMAGEnet6 Ophthalmic Data
System uses the same algorithms and
reference databases from the original
data capture device as a quantitative
tool for the comparison of posterior
ocular measurements to a database of
known normal subjects. | The IMAGEnet6 Ophthalmic Data
System uses the same algorithms
and reference databases from the
original data capture device as a
quantitative tool for the comparison
of posterior ocular measurements to a
database of known normal
subjects. | This difference does
not affect the SE
discussion because
comparison testing
confirmed that
image quality and
diagnosability is the
same with or without
the remote operation
function. |
| Connectable
devices | TRC-50DX, TRC-NW300, TRC-
NW7SF MARK III
TRC-NW8, TRC NW8F,
TRC NW8F plus, TRC NW400,
NW500 | TRC-50DX, TRC-NW300, TRC-
NW7SF MARK III
TRC-NW8, TRC NW8F,
TRC NW8F plus, TRC NW400, | Different
The following
device connections
have been added:
3D OCT-1(Type:
Maestro2), DRI |
| | DC-3, DC-4
3D OCT-1000, 3D OCT-2000,
3D OCT-1
3D OCT-1(Type: Maestro2), DRI
OCT Triton,
CA-800, KR-800PA, Aladdin, | DC-3, DC-4
3D OCT-1000, 3D OCT-2000,
3D OCT-1 | OCT Triton, CA-
800, KR-800PA,
Aladdin, NW500
This difference does
not affect the SE
discussion because
the intended purpose
to collection, storage |
| | | | and management of
digital images,
patient data,
diagnostic data and
clinical information
from Topcon devices
does not change
from the predicate
device even
connectable device |
| Model
Number | Subject Device
IMAGEnet6 (ver2.52.1) | Predicate device
IMAGEnet6 (ver1.52) | Substantial
Equivalence
Discussion |
| Database | YES | YES | Same |
| Patient
management | YES | YES | Same |
| Acquisition | YES | YES | Same |
| Archive
and
Backup | YES | YES | Same |
| DVD / CD-R
for archiving | YES | YES | Same |
| Image
processing | YES | YES | Same |
| Import/Export
images
DICOM | YES | YES | Same |
| Interacts with
OTS
PC
installed
software
of
Maestro2 | YES | NO | Different
IMAGEnet6
now
interacts with the
OTS PC installed
software
of
Maestro2.
This difference does
not affect the SE
discussion
because
the intended purpose
to collection, storage
and management of
digital
images,
patient
data,
diagnostic data and
clinical information
from Topcon devices
does
not
change
from the predicate
device
even
connectable
device
is added.
For the modified
remote
operation
function,
comparison
testing
confirmed
that
image quality and
diagnosability is the
same with or without |
TABLE 1: SUBSTANTIAL EQUIVALENCE: IMAGENET6
6
Image /page/6/Picture/1 description: The image shows the logo for Topcon. The logo consists of the word "TOPCON" in black, block letters, with a stylized blue symbol above it. The symbol appears to be two overlapping, rounded shapes, possibly representing the letter "N" or a stylized eye.
7
Image /page/7/Picture/1 description: The image shows the logo for TOPCON. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol resembles two overlapping, curved shapes with a horizontal white line running through the middle.
8
Image /page/8/Picture/0 description: The image contains the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in a bold, sans-serif font. The symbol appears to be two overlapping shapes with a horizontal line through the middle.
| Model
Number | Subject Device
IMAGEnet6 (ver2.52.1) | Predicate device
IMAGEnet6 (ver1.52) | Substantial
Equivalence
Discussion |
|-----------------|-----------------------------------------|-----------------------------------------|------------------------------------------|
| | | | function. |
Conclusions
Topcon's IMAGEnet 6 Ophthalmic Data System (version 2.52.1) is as safe and effective as the previously cleared IMAGEnet 6 (version 1.52), K171370.