Considerations For Testing
Usually, the US FDA requires that at least 200 data points from in vivo accuracy testing are included in an application for device approval. The FDA has specified that 200 data points are necessary for each oximeter and probe type combination. Of course, multiple combinations of probes and oximeters can be studied simultaneously on each subject. Probes on any body area have been studied in our laboratory including ears, bridge of nose, forehead, back, chest, and toes. We do not recommend placing probes on the thumb.
For the approval of neonatal pulse oximeters, the FDA may also require data from neonates/infants obtained in the clinic or hospital. Desaturation testing of neonatal probes is done in adults (we recommend smaller fingers). Clinical data for pulse oximetry accuracy can be obtained at UCSF in neonates who require cardiac surgery, in a protocol under the direction of Dr. Greg Stratmann. Contact Dr. Bickler for more information.
The FDA has also stated that testing in human subjects must include individuals of both genders and of a range of skin pigmentation.
We believe this information to be accurate, but cannot make guarantees concerning the details of current FDA guidelines. The manufacturer is responsible for determining what FDA requirements are applicable to the devices they are testing.
Manufacturers are encouraged to arrive in San Francisco the day before testing to set up equipment and make sure that data acquisition systems are working properly.
The costs of performing the study, paying the subjects, developing the computer facility and program, plotting the individual responses, and of personnel salaries require that we obtain payment for these studies as shown on the accompanying table. These tests are also used to support the physiology research of this laboratory.
The manufacturer is charged an amount determined by the number of subjects, the number of blood samples per subject, and the number of oximeters (as shown by the cost table on the next page) plus the facility fee and UCSF overheads.
The costs are determined as the sum of the following:
#subjects x $550
+#blood samples x $15
+#recorded oximeters x $350
+#unrecorded oximeters x $200
+7.5% Anesthesia Department Fee
+33% UCSF Indirect Costs
Example: A manufacturer wishes to do a study with 10 subjects, with 22 samples from each subject. The manufacturer has 6 oximeters that he wishes us to record and analyze and 2 additional oximeters that he does not wish us to record. The total charge for this scenario is computed as detailed below:
Sponsor: Beautiful Pulse Oximeters, Ltd.
Period: 11/20/08-12/19/08 (Study dates: 11/20 & 11/21)
Title: Accuracy of pulse oximeters with profound hypoxia
Study No. PHYS01
All amounts are in US Dollars
$6,600 --12 subjects
$4,500 --25 samples
$2,100 --6 oximeters, recorded, or unrecorded ≤4
$400 --2 oximeters, unrecorded >4
$1,249 --ABL90 Equipment Fee
$1,032 --7.5% Anesthesia Department Fee
$5,208 --33% UCSF Indirect Costs
$21,089 --TOTAL COSTS
+30% If creation of methemoglobin or carboxyhemoglobin is required
+25% If arterial CO2 is controlled to particular targets
+25% If low perfusion or motion testing is required
+25% If a special subject population is required (i.e. all very darkly pigmented subjects.)
+15% If additional staff members are required for study conduct
+15% If the manufacturer is not present for the study, or additional procedures added (such as + hypoxia runs)
-15% If study data is shared with manufacturer (i.e. subject gas exchange data).
If additional data beyond co-oximeter and/or pulse oximeter readouts.
CANCELLATION POLICY: Please be aware that a 50% cancellation charge is applied to studies cancelled within 2 weeks of the study date; 20% will be charged if cancellation is not made within three weeks. A contract for each study must be in place prior to the start of the study, ideally 30 days prior. When reserving your study dates, please keep in mind it takes some time to execute, review and approve a contract, so our business office requests the process begin 60 days prior to study start. In some instances, particularly with new companies or companies from overseas locations, we may require a partial payment for the study in advance. No extra charge is made for dual recording of oximeters by both manufacturers and us. There is no extra charge for motion controlled testing if the manufacturer is required to bring their own motion device.
Because the cost of resources for a day of testing are mostly fixed, we require a minimum of 6 subjects per day for our standard pulse oximeter test. For a our more specialized tests that take longer, the minimum number of subject per day is more flexible.