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510(k) Data Aggregation
K Number
K213423Device Name
T3 Platform software
Manufacturer
Etiometry. Inc.
Date Cleared
2023-01-06
(443 days)
Product Code
PLB, PPW
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Etiometry. Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- . To remotely consult regarding a patient's status, and
- To remotely review other standard or critical near real-time patient data in order to aid in . clinical decisions and deliver patient care in a timely manner.
The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:
- · Airway flow, volume, and pressure
- · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- · Bispectral index (BIS, signal quality index, suppression ratio)
- · Cardiac Index
- . Cardiac output
- Central venous pressure .
- . Cerebral perfusion pressure
- · End-tidal CO2
- · Heart rate
- · Heart rate variability
- Intracranial pressure .
- . Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2) .
- · Premature ventricular counted beats
- · Pulmonary artery pressure (systolic, diastolic, and mean)
- · Pulse pressure variation
- · Pulse Rate
- · Respiratory rate
- · Right atrium pressure
- · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
- · Umbilical arterial pressure (systolic, diastolic, and mean)
The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
Device Description
The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include:
- · Customizable display of physiologic parameters over entire patient stay
- Configurable annotation
- Web-based visualization that may be used on any standard browser
- Minimal IT footprint
- Software-only solution no new bedside hardware required
- Highly reliable and robust operation
- Auditable data storage
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