Triton System is an AI-enabled medical device from GAUSS SURGICAL INC. that the U.S. FDA cleared through 510(k) K160338 on August 5, 2016. Its lead review panel is General Hospital and its primary product code is PBZ (Image Processing Device For Estimation Of External Blood Loss).
See also all FDA AI clearances in 2016.
Key facts
| Submission number | K160338 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | GAUSS SURGICAL INC. |
| Lead review panel | General Hospital |
| Primary product code | PBZ — Image Processing Device For Estimation Of External Blood Loss |
| Applicant (openFDA) | Gauss Surgical, Inc., |
| Applicant location | Los Altos, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 880.2750 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Triton System went through this pathway (K160338).
openFDA lists it as a Class 2 device under 21 CFR 880.2750. Class II devices are moderate risk and are subject to general and special controls.
Product code PBZ covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. GAUSS SURGICAL INC. has 1 AI-enabled device on the list, and the General Hospital panel accounts for 6 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.