(73 days)
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No
The summary describes software for image collection, storage, and management, with no mention of AI, ML, or advanced image processing techniques typically associated with AI/ML.
No
The device is described as software for collecting, storing, and managing digital images and data, which is an administrative or data management function. There is no mention of treating or diagnosing a disease or condition.
Yes
The "Intended Use" section states that the software is for "collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon imaging devices." The inclusion of "diagnostic data" implies that the device handles information that contributes to diagnosis.
Yes
The summary explicitly states the device is a "software program" and its function is the collection, storage, and management of data from imaging devices, not the imaging devices themselves.
Based on the provided information, it is unlikely that the IMAGEnet 5 PC Software System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as the "collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon imaging devices." This focuses on data handling and management, not on performing tests on biological samples or providing diagnostic information derived from those samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing results that are used to diagnose, monitor, or treat a disease or condition based on the analysis of biological samples.
- Performing any kind of in vitro test.
The software appears to be a system for managing data generated by other imaging devices, which are likely medical devices themselves, but not necessarily IVDs.
In summary, the provided information strongly suggests that the IMAGEnet 5 PC Software System is a medical device for data management related to imaging, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMAGEnet 5 PC Software 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 imaging devices through a direct connection with Topcon instruments or through computerized networks.
Product codes
NFJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 17, 2013
Topcon Medical Systems, Inc % Ms. Maureen O`Connell President O Connell Regulatory Consultants. Inc. 5 Timber Lane North Reading, MA 01864
Re: K132438
Trade/Device Name: IMAGEnet 5 PC Software System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications Systems Regulatory Class: Class II Product Code: NFJ Dated: August 2, 2013 Received: August 5, 2013
Dear Ms. 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. Iisting 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.
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Page 2 - Ms. Maureen O'Connell
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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,
Kesia Y. Alexander -S
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 Statement
510(k) Number (if known): K 132 4 38
IMAGEnet 5 PC Software System Device Name:
Indications for Use:
The IMAGEnet 5 PC Software 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 imaging devices through a direct connection with Topcon instruments or through computerized networks.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marsha L. Burke Nicholas -S 2013.10.07 14:35:10 -04'00'
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