AccessGUDID - DEVICE: Paige Prostate (00860007599118)

GUDID

Device Identifier (DI) Information

Brand Name: Paige Prostate
Version or Model: 1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PAIGE.AI, INC.

Primary DI Number: 00860007599118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081368558 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58721	Histology/cytology/microbiology image-analysis interpretive software IVD	An interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QPN	Software Algorithm Device To Assist Users In Digital Pathology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200080	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50574731-36b3-45e1-bd64-5204f3bef0bc
Public Version Date: November 18, 2021
Public Version Number: 1
DI Record Publish Date: November 10, 2021