This is an example for the required design parameter information in a PMTA submission for one type of tobacco product Electronic Nicotine Delivery Systems (ENDS). There are many more and various types of tobacco products, and their parameters can be found in the in the PMTA Final Rule. The applicant submitting for PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results for all these parameters.
Device Identifiers (DI) is a study reference dataset that provides a mechanism for uniquely identifying a device. The primary purpose of this dataset is to provide a list of the devices used in a study and to provide identifying information for each device, such as device type, manufacturer, model name, etc., as applicable. All identifying information is grouped by the Sponsor Device Identifier (SPDEVID), a consistent variable, that is available for use in other domains where data pertaining to the device may be found.
Rows 1-5:
Show the identifying information for an Electronic Nicotine Delivery System (ENDS), a composite device.
Rows 6-8:
Show the Heating Element component of the ENDS.
Rows 9-11:
Show the Battery component of the ENDS.
Rows 12-14:
Show the Power Delivery Unit (PDU) component of the ENDS.
di.xpt
di.xpt
Row
STUDYID
DOMAIN
SPDEVID
DISEQ
DIPARMCD
DIPARM
DIVAL
1
TOB08
DI
CIG01a
1
MANUF
Manufacturer
Joes Cigs USA
2
TOB08
DI
CIG01a
2
TRADENAM
Trade Name
Treetop Methol King Size
3
TOB08
DI
CIG01a
3
DEVTYPE
Device Type
Tobacco Product
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Device-In-Use (DU) domain represents properties of the device as used.
Rows 1-5:
Show the device settings for the Electronic Nicotine Delivery System (ENDS), the composite device, SPDEVID ENDS25. The DUGRPID variable groups together the settings for the ENDS device.
Rows 6-14:
Show the device settings for the Heating Element device, SPDEVID HEATELM01. The DUGRPID of 2 was used to group the settings together for the Heating Element device.
Rows 15-28:
Show the device settings for the Battery, SPDEVID BATT003. The DUGRPID of 3 was used to group the settings together for the Battery device.
Rows 29-38:
Show the device settings for the Power Delivery Unit (PDU), SPDEVID PDU06. The DUGRPID of 4 was used to group the settings together for the PDU device.
$titleHtml
du.xpt
Row
STUDYID
DOMAIN
SPDEVID
DUSEQ
DUGRPID
DUTESTCD
DUTEST
DUCAT
DUSCAT
DUORRES
DUORRESU
DUSTRESC
DUSTRESN
DUSTRESU
1
TOB08
DU
CIG01a
1
Package Type
CIGARETTE
FILTERED, COMBUSTED
HARD
PACK
HARD
PACK
2
TOB07
DU
CIG01a
2
Product Quantity
CIGARETTE
FILTERED, COMBUSTED
20
CIGARETTE
20
20
CIGARETTE
3
TOB07
DU
CIG01a
3
LENGTH
Length
CIGARETTE
FILTERED, COMBUSTED
86.0
mm
86.0
86.0
mm
4
TOB07
DU
CIG01a
4
DIAMETER
Diameter
CIGARETTE
FILTERED, COMBUSTED
26.0
mm
26.0
26.0
mm
5
TOB07
DU
CIG01a
5
Ventilation
CIGARETTE
FILTERED, COMBUSTED
10.0
%
10.0
10.0
%
6
TOB07
DU
CIG01a
6
Characterizing Flavor
CIGARETTE
FILTERED, COMBUSTED
MENTHOL
7
TOB07
DU
CIG01a
7
Heat Source
CIGARETTE
FILTERED, COMBUSTED
xxx
8
Dataset Debug Messages
There are four leading, trailing, or non-breaking spaces in the dataset.
There seem to be multiple domains (DU, <br/>) present in the dataset.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The RELDEV dataset is used to record the relationships between the ENDS device and it's components.
Row 1:
Shows the composite ENDS device. The PARENT variable is null and LEVEL is 1 because this device is the top-level device, not the component of any other device.
Rows 2-5:
Show the components used with the Electronic Nicotine Delivery Systems (ENDS) device identified in row 1. PARENT=ENDS25 and LEVEL=2 to indicate these are components of that device.