(166 days)
eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.
This document is an FDA 510(k) clearance letter for a Picture Archiving and Communications System (PACS) software application called eUnity. It primarily focuses on the regulatory aspects of the device, declaring it substantially equivalent to a predicate device.
Crucially, this document does not contain information about the acceptance criteria and the study that proves the device meets those criteria, as typically required for AI/ML-driven medical devices.
The product, eUnity, is described as a software application that displays medical image data, performs operations related to transfer, storage, display, and measurement of image data, and allows for image manipulations. This description indicates it is a standard PACS viewer, not an AI/ML diagnostic or assistive device that would undergo rigorous performance testing against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document does not discuss:
- Acceptance Criteria Table: No performance metrics or thresholds are mentioned.
- Study Details: No studies demonstrating performance against specific criteria are described.
- Sample Size: No information on test or training set sizes.
- Data Provenance: No details on the origin of data used for testing or training.
- Experts/Ground Truth: No mention of experts, ground truth establishment, or adjudication.
- MRMC Studies: No comparative effectiveness studies with human readers.
- Standalone Performance: No standalone performance metrics for an algorithm.
- Ground Truth Type: Not applicable, as this is a PACS viewer, not a diagnostic algorithm.
- Training Set Details: Not applicable.
The FDA's review for this device (a PACS viewer) likely focused on its ability to accurately display images, handle data, and ensure basic functionality equivalent to existing devices, rather than on the diagnostic performance of an AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
Client Outlook Inc. % Ms. Christie Eby Director of Operations and Quality 103 Bauer Place, Suite #3 Waterloo, Ontario, N2L6B5 CANADA
Re: K161515
Trade/Device Name: eUnity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2016 Received: October 18, 2016
Dear Ms. Eby:
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. 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.
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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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.
Michael O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
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Indications for Use
510(k) Number (if known) K161515
Device Name eUnity
Indications for Use (Describe)
eUnity is a software application that displays medical image data and associated clinical reports. eUnity performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
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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§ 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).