KIDScore D3 is an AI-enabled medical device from Vitrolife A/S that the U.S. FDA cleared through 510(k) K182798 on July 19, 2019. Its lead review panel is Obstetrics and Gynecology and its primary product code is PBH (Embryo Image Assessment System, Assisted Reproduction).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K182798 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Vitrolife A/S |
| Lead review panel | Obstetrics and Gynecology |
| Primary product code | PBH — Embryo Image Assessment System, Assisted Reproduction |
| Applicant (openFDA) | Vitrolife A/S |
| Applicant location | Viby J, DK |
| Device class | Class 2 |
| Regulation number | 21 CFR 884.6195 |
| 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. KIDScore D3 went through this pathway (K182798).
openFDA lists it as a Class 2 device under 21 CFR 884.6195. Class II devices are moderate risk and are subject to general and special controls.
Product code PBH covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. Vitrolife A/S has 1 AI-enabled device on the list, and the Obstetrics and Gynecology panel accounts for 5 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.