Anesthesiology · De Novo · 2023
PMD-200
Medasense Biometrics Ltd.. Granted by FDA on 17 February 2023 under submission DEN210022, product code QVE (adjunctive pain measurement device for anesthesiology). What FDA's record says, in FDA's words.
Device record · DEN210022
- Device. PMD-200DEVICE
- Company. Medasense Biometrics Ltd.COMPANY
- Decision. 17 February 2023, De NovoDECISION
- Panel. AnesthesiologyPANEL
- Product code. QVE, Adjunctive Pain Measurement Device For AnesthesiologyCODE
- Regulation. 21 CFR 868.2200, 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.
The PMD-200 with the Nociception Level (NOL) Index is indicated for use in a clinical setting that requires assessment of changes in nociception levels in adult patients under general anesthesia receiving opioid or opioid-sparing analgesia as part of their care. The PMD-200 should be used as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the NOL index in conjunction with other available clinical and vital signs. De Novo Summary (DEN210022)
The product code's definition, from FDA's classification record. An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patients actual response to painful stimuli and is not intended to independently direct decision-making.
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
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QVE. 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.
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