Triton System
GAUSS SURGICAL INC.The Triton System is a medical software application designed to assist surgical teams by estimating the amount of blood loss on used surgical sponges through image analysis. It runs on an iPad and uses validated hardware and software to calculate hemoglobin mass and blood volume, helping clinicians manage bleeding and surgical sponges more effectively during operations.
Intended Use
The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges.
Technology
The Triton System is a software program that captures images of used surgical sponges on an iPad to estimate hemoglobin mass and blood volume, using validated surgical sponges, hardware, software and accessory devices. It integrates image processing algorithms and user inputs to provide blood loss estimation and manage surgical sponge usage.
Performance
Performance testing included verification that the device performs as intended by comparing estimated hemoglobin mass and blood volume against scientifically valid alternative methods, under various conditions such as lighting and blood absorption levels. Human factors testing validated usability. Software verification and hazard analysis were completed. The system displays estimated cumulative error with each measurement. The device passed all verification tests showing equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/8/2016
5 months - 2
FDA Approval
8/5/2016
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