Who is the manufacturer of IMAGEnet6 Ophthalmic Data System?

Topcon Corporation filed the 510(k) submission for IMAGEnet6 Ophthalmic Data System (K232828).

What is the FDA product code for IMAGEnet6 Ophthalmic Data System?

NFJ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for IMAGEnet6 Ophthalmic Data System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IMAGEnet6 Ophthalmic Data System?

IMAGEnet6 Ophthalmic Data System (K171370).

Who can help prepare an FDA 510(k) submission like IMAGEnet6 Ophthalmic Data System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMAGEnet6 Ophthalmic Data System

K232828 · Topcon Corporation · NFJ · Mar 1, 2024 · Radiology

Device Facts

Record ID	K232828
Device Name	IMAGEnet6 Ophthalmic Data System
Applicant	Topcon Corporation
Product Code	NFJ · Radiology
Decision Date	Mar 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

IMAGEnet6 is a web-based ophthalmic data management software installed on a server PC and accessed via client web browsers. It collects, stores, and manages digital images, patient data, and clinical information from various Topcon ophthalmic devices. The system processes and displays ophthalmic images and OCT data. It includes a remote operation function for the 3D OCT-1 (Maestro2) device, allowing users to control image capture via a connected PC or tablet within social distancing range. The software utilizes the same algorithms and reference databases as the original data capture devices to perform quantitative comparisons of posterior ocular measurements against normative databases. Healthcare providers use the displayed data and quantitative outputs to assist in clinical decision-making and patient management. The device benefits patients by facilitating efficient data management and standardized ocular measurements.

Clinical Evidence

No clinical data was required for this 510(k) submission. Substantial equivalence was supported by bench testing, including software verification and validation, and performance testing of the remote operation function to ensure image quality and diagnosability remained equivalent to the predicate.

Technological Characteristics

Web-based software application; server-client architecture; operates via web browser. Connectivity via Ethernet. Complies with IEC 62304:2015 (software life cycle) and NEMA PS 3.1-3.20 (DICOM). Cybersecurity controls implemented per FDA guidance. Software version 2.52.1.

Indications for Use

Indicated for the collection, storage, management, processing, and display of ophthalmic images and optical coherence tomography (OCT) data in patients undergoing ophthalmic examination. Used as a quantitative tool for comparing posterior ocular measurements to a database of known normal subjects.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

IMAGEnet6 Ophthalmic Data System (K171370)

Related Devices

K171370 — IMAGEnet 6 Ophthalmic Data System · Topcon Corporation · Nov 1, 2017
K132438 — IMAGENET 5 PC SOFTWARE SYSTEM · Topcon Medical Systems, Inc. · Oct 17, 2013
K093313 — SYNERGY · Topcon Medical Systems, Inc. · Dec 2, 2009
K132667 — SYNERGY ODM · Topcon Medical Systems, Inc. · Oct 9, 2013
K082364 — IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR · Topcon Corp. · Sep 30, 2008

Submission Summary (Full Text)

{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) #### 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." {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.