(175 days)
Not Found
No
The summary describes a data management and display system for ophthalmic images and data, without mentioning any AI or ML capabilities. The "comparison of posterior ocular measurements to a database of known normal subjects" is described as using the same algorithms and reference databases from the original data capture device, not as a function of the IMAGEnet 6 software itself, and does not inherently imply AI/ML.
No
The device is described as a software program that collects, stores, and manages digital images and data, without controlling or altering functions of medical devices. It is intended for processing and displaying ophthalmic images for diagnosis and comparison, not for directly treating a condition.
Yes
Explanation: The device is described as "intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information" and "The saved data can be displayed for diagnosis." It also states that "a failure or latent flaw in the software could lead to an erroneous diagnosis." These statements clearly indicate its role in diagnostics.
Yes
The device is explicitly described as a "software program" and a "Web application" that manages data and images from other medical devices without controlling their functions. The performance studies focus on software verification and validation, further supporting its software-only nature.
Based on the provided information, the IMAGEnet 6 Ophthalmic Data System is likely considered an IVD (In Vitro Diagnostic), although it doesn't directly analyze biological samples in the traditional sense of an IVD.
Here's why:
- Intended Use: The intended use explicitly states it's for "processing and displaying ophthalmic images and optical coherence tomography data" and 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 indicates it's used to provide information for diagnosis by analyzing data derived from the patient's body (the eye).
- Quantitative Tool for Comparison: The use of algorithms and reference databases for quantitative comparison to normal subjects is a key characteristic of many diagnostic tools, including those that analyze imaging data.
- Software as a Medical Device: The FDA considers software that processes and analyzes medical images for diagnostic purposes as a medical device. While not a traditional "in vitro" test of a biological sample, the analysis of imaging data derived from the body falls under the broader scope of diagnostic tools regulated by the FDA.
- Predicate Devices: The predicate devices listed (K132438 Topcon IMAGEnet 5 PC Software System and K161509 Topcon 3D OCT-1 Maestro) are also medical devices used in ophthalmic diagnosis. The IMAGEnet 6 is presented as an evolution or equivalent to these systems.
- Software Level of Concern: The software is classified as "moderate" level of concern because a failure could lead to an "erroneous diagnosis or delay in delivery of appropriate medical care." This further reinforces its role in the diagnostic process.
While it doesn't fit the classic definition of an IVD that analyzes blood, urine, etc., the FDA's regulatory framework for medical devices, particularly software used for diagnostic purposes based on patient data (like imaging), would likely classify this system as a type of diagnostic device. The term "IVD" is sometimes used more broadly in regulatory contexts to encompass devices that provide diagnostic information, even if they don't involve traditional in vitro analysis of biological samples.
Therefore, based on its intended use for processing and analyzing ophthalmic imaging data for diagnostic purposes, and its classification as a medical device with a moderate level of concern due to potential impact on diagnosis, it is highly probable that the IMAGEnet 6 Ophthalmic Data System is considered an IVD by regulatory bodies like the FDA.
N/A
Intended Use / Indications for Use
The IMAGEnet 6 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 without controlling or altering the functions and parameters of any medical devices or through computerized networks. It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet 6 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, OBO, HKI
Device Description
IMAGEnet 6 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.
IMAGEnet 6 Ophthalmic Data System receives information from Topcon ophthalmological medical devices and saves the information including the patient information. The saved data can be displayed for diagnosis. In addition, it can save patient information, exam information, and image information as digital data to a database. These data can also be exported as digital data.
IMAGEnet 6 Ophthalmic Data System does not control or alter the functions or parameters of any medical device. IMAGEnet 6 Ophthalmic Data System is used in cooperation with the capture software designated for each capture device to retrieve image data such as an OCT image or a fundus image. IMAGEnet 6 Ophthalmic Data System receives, displays, and saves the image data captured with the capture software.
It also allows to send/receive patient information and image information, etc. to/from an external system via communication conforming to the DICOM standard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ophthalmic images and optical coherence tomography data (OCT image or a fundus image)
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 was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could lead to an erroneous diagnosis or delay in delivery of appropriate medical care that would likely lead to a minor injury.
Additionally, the IMAGEnet 6 Ophthalmic Data System was tested to demonstrate that the measurement and analysis functions are equivalent to the predicate devices and been found equivalent to the predicate devices.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2017
Topcon Corporation % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K171370
Trade/Device Name: IMAGEnet 6 Ophthalmic Data System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ, OBO, HKI Dated: September 29, 2017 Received: October 2, 2017
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. 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.
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name IMAGEnet 6 Ophthalmic Data System
Indications for Use (Describe)
The IMAGEnet 6 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 without controlling or altering the functions and parameters of any medical devices or through computerized networks. It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet 6 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 ) | |
|---|---|
| ☑ 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 IMAGEnet 6 Ophthalmic Data System
510(k) Owner
Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580 Japan Phone: (201) 599-5187 Facsimile: Contact Person: James Lorkowski, Regulatory Affairs Manager
Submission Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 (978) 207-1245 Phone:
Date Prepared: October 26, 2017
Trade Name of Device
IMAGEnet 6 Ophthalmic Data System
Common or Usual Name
Picture archiving and communication system
Classification Name
System, image management, ophthalmic 21 C.F.R. 892.2050 Class II Product Code: NFJ
Predicate Devices
Primary predicate: Topcon IMAGEnet 5 PC Software System (K132438) Secondary predicates: Topcon 3D OCT-1 Maestro (K161509)
Device Description
IMAGEnet 6 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.
4
IMAGEnet 6 Ophthalmic Data System receives information from Topcon ophthalmological medical devices and saves the information including the patient information. The saved data can be displayed for diagnosis. In addition, it can save patient information, exam information, and image information as digital data to a database. These data can also be exported as digital data.
IMAGEnet 6 Ophthalmic Data System does not control or alter the functions or parameters of any medical device. IMAGEnet 6 Ophthalmic Data System is used in cooperation with the capture software designated for each capture device to retrieve image data such as an OCT image or a fundus image. IMAGEnet 6 Ophthalmic Data System receives, displays, and saves the image data captured with the capture software.
It also allows to send/receive patient information and image information, etc. to/from an external system via communication conforming to the DICOM standard.
Intended Use / Indications for Use
The IMAGEnet 6 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 without controlling or altering the functions or parameters of any medical devices or through computerized networks. It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet 6 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.
Substantial Equivalence
Topcon's IMAGEnet 5 cleared in K132438 is the primary predicate for the IMAGEnet 6 Ophthalmic Data System. In addition to the functionality which is substantially equivalent to the IMAGEnet 5, IMAGEnet 6 Ophthalmic Data System has the OCT viewer function which retrieves saved OCT data (both fundus and tomographic images) and views the OCT images in both 2D and 3D formats. In order to demonstrate substantial equivalence of these features, the software from the Topcon 3D OCT-1 Maestro (K161509) is the secondary predicate device for IMAGEnet 6 Ophthalmic Data System.
5
The IMAGEnet 6 Ophthalmic Data System and the primary predicate device are both ophthalmic picture archiving and communications systems that collect, store, and manage digital images of the eye. The vast majority of product features are the same in the IMAGEnet 6 Ophthalmic Data System as in the IMAGEnet 5 including database, patient management, retrieval, display and operation, measurement, image tools, archive and backup, networking and security. image processing, import/export of images, and DICOM compliance, One difference between the IMAGEnet 6 Ophthalmic Data System and the primary predicate is that the IMAGEnet 6 Ophthalmic Data System can manage exam data including visual acuity and intraocular pressure data. This feature is not available in the IMAGEnet 5, however, this minor difference does not impact the safety or effectiveness of the device.
The IMAGEnet 6 Ophthalmic Data System has an additional feature which is substantially equivalent to the software of the secondary predicate device. The secondary predicate device is the Topcon 3D OCT-1 Maestro device which was cleared in K161509. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases as the cleared device which allows comparison of posterior ocular measurements to a database of known normal subjects. Both IMAGEnet 6 Ophthalmic Data System and cleared Topcon 3D OCT-1 Maestro device have similar software related functionality including: display, analysis, and access to the reference database for OCT data.
Therefore, the minor differences between the subject device and the predicate devices do not raise new questions of safety or effectiveness. The Topcon IMAGEnet 6 is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.
Performance Data
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could lead to an erroneous diagnosis or delay in delivery of appropriate medical care that would likely lead to a minor injury.
Additionally, the IMAGEnet 6 Ophthalmic Data System was tested to demonstrate that the measurement and analysis functions are equivalent to the predicate devices and been found equivalent to the predicate devices.
Conclusions
6
Topcon's IMAGEnet 6 Ophthalmic Data System is as safe and effective as the previously cleared IMAGEnet 5 (K132438). In addition to the functionality which is substantially equivalent to the IMAGEnet 5, IMAGEnet 6 Ophthalmic Data System has the OCT viewer function which retrieves saved OCT data (both fundus and tomographic images) and views the OCT images in both 2D and 3D formats. In order to demonstrate substantial equivalence of these features, the software from the Topcon 3D OCT-1 Maestro (K161509) is a secondary predicate device for IMAGEnet 6. IMAGEnet 6 Ophthalmic Data System has the same intended use and similar indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices and is therefore substantially equivalent.