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This is an example for the required design parameter information in a PMTA submission for one type of tobacco product Cigarette. 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 records for a device given SPDEVID of CIG01a.
Rows 3-5Show the tobacco product is a filtered, combusted type of cigarette.

Row Captions Debug Message

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di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB08DICIG01a1MANUFManufacturerJoes Cigs USA
2TOB08DICIG01a2TRADENAMTrade NameTreetop Methol King Size
3TOB08DICIG01a3DEVTYPEDevice TypeTobacco Product
4TOB08DICIG01a4TBPRDCATTobacco Product CategoryCigarette
5TOB08DICIG01a5TBPRSCATTobacco Product SubcategoryFiltered, Combusted
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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. The DU domain now contains information that was previously found in the Device Properties (DO) domain).  The domain now captures characteristics and properties of a device that do not change and can include characteristics and properties that can vary from subject to subject (not applicable here but added for reviewers comprehension). This is a findings domain and defines important characteristics of a device that the sponsor wishes to include in the submission but do not form part of the unique sponsor-defined identification of the device. Each property is identified using controlled terminology and is stored in DUTESTCD/DUTEST.

Rows 1-4:Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference.
Row 5:Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1
Row 6:Shows the characterizing flavor is menthol for this package of cigarettes.
Row 7:Shows the heat source is xxx.

du.xpt

du.xpt

RowSTUDYIDDOMAINSPDEVIDDUSEQDUTESTCDDUTESTDUCATDUSCATDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1TOB08DUCIG01a1PACKTYPPackage TypeCIGARETTEFILTERED, COMBUSTEDHARD PACK
HARD PACK

2TOB07DUCIG01a2PRDQUANProduct QuantityCIGARETTE FILTERED, COMBUSTED20CIGARETTE2020CIGARETTE
3TOB07DUCIG01a3LENGTHLengthCIGARETTEFILTERED, COMBUSTED86.0mm86.086.0mm
4TOB07DUCIG01a4DIAMETERDiameterCIGARETTEFILTERED, COMBUSTED26.0mm26.026.0mm
5TOB07DUCIG01a5VENTLTNVentilationCIGARETTEFILTERED, COMBUSTED10.0%10.010.0%
6TOB07DUCIG01a6CHARFLAVCharacterizing FlavorCIGARETTEFILTERED, COMBUSTEDMENTHOL



7TOB07DUCIG01a7HTSOURCEHeat SourceCIGARETTEFILTERED, COMBUSTED xxx



Dataset Debug Message

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This images shows the filtration zone where the ventilation occurs.

Question - is this helpful?  Will need permission.  This is from the second reference.



References:

  1. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/


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