Cardiovascular · De Novo · 2021
Analytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.. Granted by FDA on 1 March 2021 under submission DEN200022, product code QNV (adjunctive hemodynamic indicator with decision point). What FDA's record says, in FDA's words.
Device record · DEN200022
- Device. Analytic for Hemodynamic Instability (AHI)DEVICE
- Company. Fifth Eye Inc.COMPANY
- Decision. 1 March 2021, De NovoDECISION
- Panel. CardiovascularPANEL
- Product code. QNV, Adjunctive Hemodynamic Indicator With Decision PointCODE
- Regulation. 21 CFR 870.2220, Class IIREG
- Source. FDA database entry · decision document (22 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
, including the importance of using AHI outputs as an adjunct to other parameters and patient information and not being used to solely direct therapy. Comprehension questions were used to address critical knowledge tasks or interactions that could not be evaluated through simulation. The results of the human factors validation study were analyzed to identify root causes of any difficulties or use errors observed during testing. Uncertainty regarding comprehension of the vital signs components termed signs of hemodynamic instability was addressed by prominently displaying this definition in the user interface. The results of the human factors validation study demonstrated that mitigations addressing use-related risk were effective. Human factors researchers conducted a root cause analysis to identify the root causes of each difficulty and use error that was validation study participants, a total of 960 critical performance (b) (4)observed. Across the and comprehension task interactions were attempted. Among these attempts, there was an (b) (4) (b) (4) (b) (4) overall success rate, difficulty rate ( observed difficulties), and (b) (4) use error rate observed use errors). The findings from the validation study demonstrate that (b) (4) the vast majority of simulated-use and comprehension tasks were completed without use error or difficulty.
The product code's definition, from FDA's classification record. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QNV, in Cardiovascular, from Fifth Eye Inc., or granted in 2021. The whole record is at FDA AI-enabled medical devices.
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