Pathology · De Novo · 2021
Paige Prostate
Paige.AI. Granted by FDA on 21 September 2021 under submission DEN200080, product code QPN (software algorithm device to assist users in digital pathology). What FDA's record says, in FDA's words.
Device record · DEN200080
- Device. Paige ProstateDEVICE
- Company. Paige.AICOMPANY
- Decision. 21 September 2021, De NovoDECISION
- Panel. PathologyPANEL
- Product code. QPN, Software Algorithm Device To Assist Users In Digital PathologyCODE
- Regulation. 21 CFR 864.3750, Class IIREG
- Source. FDA database entry · decision document (25 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin- fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist. Paige Prostate is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized with Paige FullFocus WSI viewing software. Paige Prostate is an adjunctive computer-assisted methodology and its output should not be used as the primary diagnosis. Pathologists should only use Paige Prostate in conjunction with their complete standard of care evaluation of the slide image.
The product code's definition, from FDA's classification record. A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.
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.
- Modalities namedpathology slides
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QPN. 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.
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 QPN, in Pathology, or granted in 2021. 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.