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510(k) Data Aggregation
K Number
K172329Device Name
Patient Status Engine
Manufacturer
Isansys Lifecare Ltd
Date Cleared
2018-04-23
(264 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
Isansys Lifecare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information.
The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.
Device Description
The Patient Status Engine (PSE2) is a wireless data collection system that monitors physiological data and consists of the following components / subsystems and optional third party devices as listed below:
Components and Subsystems:
Patient Gateway (Samsung Tablet) – Manufactured by Samsung
Patient Gateway Software – Manufactured by Isansys Lifecare Ltd
Lifetouch Blue Sensor – Manufactured by Isansys Lifecare Ltd
Lifetemp Sensor– Manufactured by Isansys Lifecare Ltd
Lifeguard Server Software – Manufactured by Isansys Lifecare Ltd
Additional third party Accessories:
Pulse Oximeter 3150– Manufactured by Nonin
Blood Pressure Monitor UA767– Manufactured by A&D Medical
Skintact ECG Electrodes – Manufactured by Leonhard Lang
Ambu White Sensors – Manufactured by Ambu Inc.
At the subsystem level the Patient Gateway, Lifetouch Blue Sensor and Lifetemp Sensor are collectively identified as the Patient Digitisation Engine (PDE2). The inclusion of the Lifeguard Server completes the Patient Status Engine (PSE2).
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