Pulse Oximetry
Regulatory Tests
Co-oximeter Validation Blood tests
(Regulatory Accuracy – Clinical Trial):
Hypoxia compared to
Arterial
Co-oximetry
[ISO 9919]
Human Desaturation Study: Steady state accuracy testing during
saturation plateaus over the specified
range
(usually 70-100% SaO2)
in increments of 1-2% (Co-ox data point each 1-2% over the range
tested).
This is the
Validation Submission Clinical Trial which is the required test
for FDA submission – it is
an Accuracy
Validation Blood Study. We will analyze the data and
provide a report from this study that
you can
submit directly to the FDA.
It meets (and exceeds) the ISO 9919 Pulse Oximetry
Standard and
also the FDA
Reviewer Guidance Document.
This test is
usually done as the last step in product Validation and is
submitted to the FDA. It is a human
hypoxia study
that compares the test pulse oximeter and or sensor to
simultaneous blood samples that
are analyzed
on a Bench Co-oximeter.
[FOR A MORE IN-DEPTH DESCRIPTION OF THIS TEST CLICK HERE]
Motion Accuracy Validation: Hypoxia compared
to Arterial Co-oximetry [ISO9919]
Human
Desaturation Study during motion conditions:
Steady state accuracy testing with motion during
saturation plateaus over the specified range.
Low
Perfusion Accuracy Validation: Hypoxia compared to
Arterial Co-oximetry [ISO 9919]
Human Desaturation Study during low perfusion levels (low signal
modulation):
As measured by
Perfusion Index during saturation plateaus.
Neonatal Accuracy:
Hospital Data
Collection compared to Arterial Co-oximetry [FDA Guidance]
Data collection in on
hospitalized infants: Steady state saturation plateus.
Form-Fit-Function:
Intended Population evaluation [FDA Guidance]
Data collection in hospitalized
patients
and non-hospitalized
subjects:
Evaluate
sensor application in
the
intended
population and ability to obtain clinically usable readings (not
accuracy
verification).
Pulse Rate Accuracy: NEED TEXT HERE
