(13 days)
iPACS CARDIO™is intended for the manipulation, display, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
iPACS CARDIO™ is a software product that is added to the iPACS PRISMI™ device (K030751) and displays and manages various digital images and Cine objects in a Picture Archive and Communication System (PACS) environment and is intended to assist cardiology surgeons when doing preoperative planning and post-operative follow-up. iPACS CARDIO™ also includes various tools and can access additional tools within iPACS Prism.
The provided text is a 510(k) summary for the iPACS CARDIO™ device. It establishes substantial equivalence by comparing it to a predicate device (Sectra Angiography Package and Sectra Cardiology Package).
However, the document does not contain any information about acceptance criteria, efficacy studies, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or multi-reader multi-case studies.
The text primarily focuses on:
- Identification of the device: iPACS CARDIO™
- Submitter's Information: Real Time Image Inc.
- Trade Name, Common Name, and Classification: Picture Archiving Communications System, 892.2050 Device Classification: System, Image Processing.
- Predicate Device Information: Sectra Angiography Package and Sectra Cardiology Package (K034059).
- Device Description: Software added to iPACS PRISMI™ (K030751) for displaying and managing digital images and Cine objects in a PACS environment, intended to assist cardiology surgeons for pre-operative planning and post-operative follow-up. It includes various tools and can access additional tools within iPACS Prism.
- Indications for Use: Manipulation, display, and distribution of medical images, showing images from different modalities, and interfacing with storage and printing devices using DICOM or similar standards. Assists cardiology surgeons with pre-operative planning and post-operative follow-up. Typical users are trained professionals (e.g., orthopedic surgeons, physicians, radiologists).
- Technological Characteristics: Runs with iPACS Prism on Windows 2000 or XP, does not contact the patient, nor controls life-sustaining devices. A physician interprets images, allowing for human intervention.
- Conclusion: The submission contains adequate information to determine substantial equivalence to the predicate device. Manufacturing adheres to voluntary standards, and a hazard analysis classified potential hazards as "Minor."
- FDA Letter: A letter from the FDA acknowledging receipt and a determination of substantial equivalence.
Therefore, I cannot provide the requested information in the table or the detailed breakdown as the document does not contain data on acceptance criteria, device performance, study details, or ground truth establishment.
§ 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).