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U.S. Department of Health and Human Services

Product Classification

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Device digital cervical cytology slide imaging system with artificial intelligence algorithm
Definition The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis.
Physical State System includes a digital imager and slide identification reader. Digital imager’s graphic, menu-driven interface may be accessed through a touch screen or connected computer. Slide images may be stored on a local or cloud server for review on an external computer using a dedicated software application. Includes an AI-based algorithm to identify objects of interest found on a digital image of the slide. System may be limited for use with specific Pap tests.
Technical Method Digitizes and presents whole slide image and objects of interest on a display monitor from cytology Pap test glass slide images using artificial intelligence (AI) based algorithms to detect and/or characterize cells and other entities of clinical interest/significance.
Target Area Cytologic slide preparations of human liquid-based cervical cytology (Pap test) specimens.
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodeQYV
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.3900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible