# K202306: T3 Platform software

- Pathway: 510(k) (Traditional)
- Applicant: Etiometry, Inc.
- Decided: Nov 25, 2020 after 103 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962603 (1997). 54 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190273: T3 Platform software, Etiometry, Inc. (2019) Summary page 6.

## Most influential descendants
- K213230: T3 Platform Software (2022), 12 descendants of its own
- K222463: EchoGo Heart Failure (2022), 7 descendants of its own
- K240860: EchoGo Amyloidosis (1.0) (2024), 2 descendants of its own
- K223578: T3 Platform software (2023), 2 descendants of its own
- K213423: T3 Platform software (2023), 2 descendants of its own

## Indications for use
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 utilize this information 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. T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module. The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide. IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The 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. IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 5.0 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. WARNINGS: Do not use the T3 Platform software as an active patient monitoring system. Do not use the T3 Platform software to replace any part of the hospital's device monitoring. Do not rely on the T3 Platform software as the sole source of patient status information. Do not use the IVCO2 Index as a substitute for arterial blood gases.

Source page: https://510kreport.com/device/K202306
Methodology: https://510kreport.com/methodology