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510(k) Data Aggregation
K Number
K220117Device Name
ARC Intensive Care Information System (ARC System)
Manufacturer
Date Cleared
2023-06-06
(508 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Ordinatrum Solutions
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiology and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring.
The ARC System software is intended to be used by healthcare professionals for the following purposes:
- · To remotely consult, regarding a patient's status
- · To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care
- · To create and manage Patient Prioritization Rules
- · To access Patient Prioritization information
WARNING:
- Rx Only.
- · Do not use the ARC System as an active patient monitoring.
- · Do not use the ARC System to replace any part of the hospital's device monitoring.
- · Do not rely on the ARC System software as the sole source of patient status information.
Device Description
The ARC ICU Information System is intended to provide the Intensive Care Unit (ICU) with clinical decision support, workflow management, interoperability and device connectivity. The system receives near real-time data from medical devices in the ICU and presents them on a single dashboard to provide secondary clinical decision support. Patient vitals from ventilators, monitors, pumps, smart beds, IoT sensors etc. are connected to the ARC Box. From the ARC Box, data is propagated through the ARC software, and displayed on a central monitoring system, the ARC DS. The data is available on remote monitoring devices, such as a mobile device or physician tablet. The ARC System is composed of a physical hardware component (ARC Box), which interfaces with the ICU medical devices, and the ARC System Software components.
Decision support algorithms, treatment protocols and applications used within ARC System do not come with a predefined procedure or standard. A skilled health care professional can use ARC System to create and define a healthcare workflow dynamically on the basis of an individual hospital, clinic or physician. ARC ICIS is a Web-based and Cloud Ready system that is built on IoMT and BigData technologies. It is intended to provide reliable and secure access to patient information.
ARC Box is a vendor-neutral connectivity solution that retrieves patient data from different device makers and transfers this data, via serial ports and/or ethernet ports, to a central dashboard. It is built on IoT for secure and quick communication between medical devices while gathering rich data. It temporarily stores data in the event of unexpected circumstances such as power outage or server failure and transfers saved data to ARC ICIS to be visualized for Clinical Decision Support.
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