# K152258: T3 Software

- Pathway: 510(k) (Traditional)
- Applicant: Etiometry, Inc.
- Decided: Mar 31, 2016 after 233 days
- Product code: PLB (Multivariate Vital Signs Index)
- 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: 8 generations back to K962603 (1997). 51 ancestors in all.
16 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)
- K142732: T3 Software, Etiometry, Inc. (2015) Summary page 5.
- K151715: T3 Software, Etiometry, Inc. (2015). Cleared while this submission was under review Summary page 5.
- K081140: Visensia, Obs Medical (2008) Summary page 5.
- K110953: Visensia, Visensia with Alert, Obs Medical (2011) Summary page 5.

## Most influential descendants
- K163065: T3 Software (2017), 15 descendants of its own
- K190273: T3 Platform software (2019), 14 descendants of its own
- K202306: T3 Platform software (2020), 13 descendants of its own
- K213230: T3 Platform Software (2022), 12 descendants of its own
- K222463: EchoGo Heart Failure (2022), 7 descendants of its own

## Indications for use
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 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. T3 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. T3 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) It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The 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. WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

Source page: https://510kreport.com/device/K152258
Methodology: https://510kreport.com/methodology