Obstetrics and Gynecology · 510(k) · 2019
KIDScore D3
Vitrolife A/S. Cleared by FDA on 19 July 2019 under submission K182798, product code PBH (embryo image assessment system, assisted reproduction). What FDA's record says, in FDA's words.
Device record · K182798
- Device. KIDScore D3DEVICE
- Company. Vitrolife A/S (DK)COMPANY
- Decision. 19 July 2019, 510(k), substantially equivalent (traditional review); received 2 October 2018DECISION
- Panel. Obstetrics and GynecologyPANEL
- Product code. PBH, Embryo Image Assessment System, Assisted ReproductionCODE
- Regulation. 21 CFR 884.6195, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
The product code's definition, from FDA's classification record. The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PBH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
21 June 2019 · Malfunction · EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR · SMITHS MEDICAL ASD, INC. · report 3012307300-2019-03611
INFORMATION WAS RECEIVED THAT A THE "POCKET" ON A SMITHS MEDICAL EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR "IS NOT CLOSED. NOT STERILIZED". NO ADVERSE EFFECTS WERE REPORTED.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PBH, in Obstetrics and Gynecology, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.