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510(k) Data Aggregation
K Number
K221179Device Name
SomnoMetry
Manufacturer
Neumetry Medical Inc
Date Cleared
2022-09-21
(149 days)
Product Code
OLZ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Neumetry Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SomnoMetry is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. SomnoMetry is a software-only medical device to be used to analyze physiological signals and automatically score sleep study results, including the staging of sleep, AHI, and detection of sleepdisordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. All automatically scored events are subject to verification by a qualified clinician.
Device Description
The SomnoMetry is an Artificial Intelligent/Machine Learning (AI/ML)-enabled Software as a Medical Device (SaMD) that automatically scores sleep study results by analyzing polysomnography (PSG) signals recorded during sleep studies. It is intended to be used under the supervision of a clinician in clinical environments to aid in the diagnosis of sleep and respiratory related sleep disorders.
All scored events that are analyzed, displayed, and summarized can be manually marked or edited by a qualified clinician during review and verification.
SomnoMetry consists of:
- A web Application Programing Interface (API) to allow authenticated users to upload . PSG files to SomnoMetry Platform
- A database to store the input, intermedium output, final output, and associated data ●
- A database API to access the database and store/retrieve the output ●
- A dashboard to display, retrieve, manage, edit, verify, and summarize the output
- An AI/ML Engine using AI/ML algorithms/approaches to analyze PSG data ●
- A reporting API to generate sleep reports
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