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510(k) Data Aggregation
K Number
K123472Device Name
CIMVA UNIVERSAL
Manufacturer
Date Cleared
2013-03-05
(112 days)
Product Code
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
THERAPEUTIC MONITORING SYSTEMS (TMS), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CIMVA Universal is indicated for analyzing patterns of variation of physiological parameters (heart rate and respiratory rate) derived from the output of third party monitoring systems. CIMVA Universal is not designed for vital signs monitoring or self-monitoring of patients.
Device Description
The CIMVA Universal software is resident in a hospital server or other computer that is periodically connected to a repository of recorded data from third party physiological monitors. The current version of the software has four functions:
1. Allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories.
2. Allows the physician to choose the type of multi-organ variability analysis that he/she desires.
3. Calculates the selected measures of Variability.
4. Provides a physician-configurable report of the calculations
CIMVA Universal also allows the clinician to measure the degree to which multi-organ variability measures are altered in response to clinical events that are input by the user.
The calculations performed by CIMVA Universal are algorithms available in the public domain (as described in journal articles, etc.). None of the variability measures are proprietary to TMS. The results of these analyses could help physicians conduct research on the potential clinical utility of one or more of these variability measurements.
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