Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
SFH · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.3755
Classification
FDA Product Code
SFH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.3755
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.