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510(k) Data Aggregation
K Number
K250078Device Name
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
Manufacturer
Mindset Medical, Inc.
Date Cleared
2025-05-30
(137 days)
Product Code
QME
Regulation Number
870.2785Why did this record match?
Applicant Name (Manufacturer) :
Mindset Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse and respiration rate of adult patients in home use, hospitals, clinics, and long-term care settings.
The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.
Informed Vital Core is not intended to independently direct therapy.
Device Description
The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) and respiration rate (RR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR and RR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR. Additionally, this system utilizes software for optical camera-based measurement of respiration rate. The non-contact, periodic, spot measurement of respiration rate is taken when the subject is at rest based on shoulder movement.
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K Number
K241633Device Name
Informed Vital Core Application (IVC App)
Manufacturer
Mindset Medical, Inc.
Date Cleared
2024-11-18
(165 days)
Product Code
QME
Regulation Number
870.2785Why did this record match?
Applicant Name (Manufacturer) :
Mindset Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use, hospitals, clinics, and long-term care settings.
The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.
Informed Vital Core is not intended to independently direct therapy.
Device Description
The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.
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