Clinical Evaluation Report for delivery set.docx
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Clinical Evaluation Report for delivery set.docx
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ClinicalEvaluationReportfordeliveryset
CLINICALEVALUATION
for
【MedicalFluidDeliverySetwithAccessories】
ModelTypes:
(ClassIIa,Sterile)
I.V.AdministrationSets
BloodTransfusionSets
EnteralExtensionSets
IrrigationTubingSets
ExtensionSets:
IE
InjectionPort:
IPN
Doc.Number:
CER-2013****
Revision:
A
Dateofreport:
2013****
Thisclinicalevaluationreportisevaluatedbybelowevaluator
Internalasqualification
Position:
QAEngineeringName:
Signature:
Internalasqualification
Position:
QAManagerName:
Signature:
Internalasqualification
Position:
GeneralManagerName:
Signature:
1.GeneralDetails
1)ProductName:
MedicalFluidDeliverySetwithaccessories
2)Manufacturer:
ABCCompany
*****************************,Taiwan,R.O.C.
TEL:
886-
FAX:
886-
E-mail:
2.Descriptionofthedeviceanditsintendedapplication
2.1.Descriptionofthedevice
ModelType
Description
IVAdministrationSet
Dripchamber,deliverytubing,rollerclamp,MLL
BloodTransfusionset
Dripchamber,deliverytubing,rollerclamp,stopcock,MLL
EnteralExtensionSet
FLL,deliverytubing,slideclamp,enteralconnector
IrrigationTubingSet
Spike,deliverytubing,rollerclamp,silicontubing,flushtube
Extensionsetandinjectport
Deliverytubing,clamp,FLL,MLL,T-Site
Thedeviceconsistsofaconventionalchamber,extensiontubing,clamp,standardfemaleluerconicalfitting,maleluerconicalfitting,andventedendcap.Theendcapcanberemovedforconnectingtoamaleluerfittingofadifferentdeviceforadministeringfluids.
Thenameandmaterialforeachcomponentislistedasfollows:
Item
ComponentName
Material/Tradename
1
Extensiontubing
PVC
2
RollerClamp
ABS
3
Femaleconicalfitting(FLL)
PVC
4
SidleClamp
HDPE
5
DripChamber
PE,ABS,PVC,ABS/Nylon
6
Maleconicalfitting(MLL)
PVC
7
LineFilter
Hydrophilicmembrane
8
CheckValve
PC
9
Endcap
LDPE
10
Unitpackagingpouch
Paper
2.2.IntendedApplication
ABCmedicalfluiddeliverysetsarethedevicesusedtoadministermedicalfluidfromacontainerintoapatient’svascularsystemorbodycavitiesthroughacathetersystemwhichmaycomposeofspikes,deliverytubing,flowregulator,filter,injectionsite,andadripchamber.
3.IntendedTherapeuticand/orDiagnosticIndicationsandClaims
3.1Intendedtherapeuticandindications
Onlyprovideauxiliary,notherapeuticefficacy.
3.2Intendedperformance
TheABCTMMedicalFluidDeliverySetisindicatedforuseininfusingmedicalornon-medicalfluidintobodysystem.Thedeviceisnon-invasivetohumanbody.
Accordingtoitsintendeduse,theABCTMMedicalFluidDeliverySetisnotanin-vivodevice,nor
doesitpossessadiagnosticortherapeuticfunction.Therearenomeasurableclinicaloutcomesinwhichthedeviceisindicatedtodeliverorachieve.
3.3Precautionsinusingthedevice
1)Thedeviceisspecifiedtobeusedbyprofessionalpersonslikedoctorsornursesintheclinicsorthehospitals.
2)Eachdeviceisinunitpackage.
3)EachunitproductissterilizedbyEtOandsingleuseonly.
3.3.1Surgicalcomplications
Thedevicewhichre-usedisdangerous,potentiallyinsymptomssuchasbacteria/microbialinfection.
3.3.2Adverseeffects
Noadversereactions.
3.3.3Warnings
1)TheproducttreatedwithEtOsterilizationcannotbeusewhenthepackagingisopenordamaged.
2)Iftheproductiscontaminatedbyamistakeoftheoperatorwhilecarryingouttheprocedures,itcannotbeused.
3)Alltheproductsaredisposableandnotintendedforre-use.
3.3.4Preservation&Handling
1)Theproductshouldbepreservedinadry.
2)Thesealedpackagingshouldnotbeeasilydamagedandtheidentificationtagwiththe
Lotno.shouldnotbeseparatedwhileinpreservation.
3)ThepackagingshouldbeopenABCediatelypriortosurgery,andtheuseoftheproductaftertheexpirationdateisprohibited.
4)ItshouldnotbeusedwhentheproducttreatedwithEtOsterilizationisre-sterilizedbytheuser.
3.3.5Caution
1)Sterilefluidpathwayinunopened,undamagedpackage.
2)Donotuseifprotectivecapsarenotinplace.
3)Asepticallyswabinjectionsiteperfacilitiesprotocol.
4)Singleuseonly.Donotre-sterilize.
5)Trainedmedicalpersonnelandphysicianonly.
4.Contextofevaluationandchoiceofclinicaldatatypes
Thefluiddeliverysetshavebeenwidelyusedforyearsandhavebeenconfirmeditsperformanceandsafetyinclinicalsettings.Thetypeofourproductshasmaturedinthemarket.Itisessentialmedicaldevicesoftheauxiliarytosupplierliquidflowduringsurgery.Thefunctionofthefluiddeliverysetsprovidesauxiliary,andithasnotherapeuticefficacy.
EachunitproductofthefluiddeliverysetissterilizedbyEtOandsingleuseonly.Thefluiddeliveryset'spackageisconsideredasprimarykeyfactorsforproduct’ssafety.Sterilityguaranteedunlessunitpackageisopenedordamaged.Inordertoprovetheperformanceandsafetyofthefluiddeliverysetsproductshelflife,physicaltests(suchastensilestrengthtest,clampingtest,airleakagetestandpathpatency)andpackageconformity(suchassealpeelstrengthanddyepenetrationtest)andsterilitytestareconducted.Manymanufacturershavebeenproduceofthesimilarproductsinthemarket.Inordertocomparethefunctionandperformance,wecollectinformationofthesimilarproductonthemarketandcompareit.
5.SummaryoftheClinicalDataandAppraisal
1)Thepredicatedevicesidentifiedarea)NiproScalpVeinSet(K),manufacturedbyNisshoCorporation,andb)SURFLOWingedInfusionSet(K),manufacturedbyTerumo,Inc.Bothdeviceshavebeenonthemarketforclinicalapplicationsformanyyearswithnoknownadverseevents.Intermsofdesignandmaterial,bothdevicesarebuiltwithconventionalstainlesssteelneedle,needlehub,extensiontubing,femaleconical(luer)fittingwithanendcap.Theendcapcanberemovedtoallowforconnectionofthefemaleluerfittingtoadevicecontainingamaleluerfittingforsamplingoradministeringfluid.ThefollowinggivesacomparisonchartfortheABCMedicalFluidDeliverySetversusthetwopredicatedevices.
Elementsof
Comparison
ABCMedicalFluid
DeliverySet
Nipro
K
SURFLOK
Reference
Standard
Intendeduse(s)
Samplingorinfusionfluid
Same
Same
Needlelength
N/A
Same
Same
Needlegauge
N/A
Same
Same
Extensiontubing/conical
fittingbondingstrength
>15N
Same
Same
ISO8536-4
Clampingefficacy
Withstand10psigwaterpressurefor30sec.
Same
Same
ISO8536-4
Waterpressureresistance
Withstand10psigwaterpressurefor30sec.
Same
Same
ISO8536-4
Leakagefromdevice
Noairleakageat10psigfor
30sec.
Same
Same
ISO8536-4
Biocompatibilityofmaterial
“limitedexposure,indirectbloodpath,externalcommunicatingdevice”
Same
Same
ISO10993-1
Plasticcomponents
PP,HDPE,PVC,LDPE,ABS,PC
Same
Same
Labeling
801requirements.ENISO15223
CouncilDirective
2007/42/EC
-
-
Theproductsoffluiddeliverysetareclaimedtobesubstantialequivalenttoothermarketedproducts,withthesameintendeduseandsimilarproductdesign.
6.DataAnalysis
6.1Performance
ABCfluiddeliverysethasbeencomparedtothetwoproductsonmarket.Itisconductedwithotherproductshavingthesameusingconditions,operatingprinciple,andpropertiesasoursinordertovalidateequivalentperformancefulfillmentwhenappliedtoclinicaluse.
Inordertoprovetheperformanceofthefluiddeliverysetsinproductshelflife,physical
tests(suchastensilestrengthtest,clampingtest,airleakagetestandpathpatency)
areconducted.Thefunctionaltestresultsaresummarizedasfollows:
ModelType
Tensile
strength
Clamping
Airleakage
Pathpatency
IVAdministrationSet
Pass
Pass
Pass
Pass
BloodTransfusionset
Pass
Pass
Pass
Pass
EnteralExtensionSet
Pass
Pass
Pass
Pass
IrrigationTubingSet
Pass
Pass
Pass
Pass
Extensionsetandinjectport
Pass
Pass
Pass
Pass
*32pcssamplesarepreparedforeachtest.
*Acceptancecriteria:
1)Tensilestrength-5lbf
2)Clamping-10psi/30sec
3)Airleakage-10psi/30sec
4)Pathpatency-10psi/30sec
Thetestresultsshowthatthefluiddeliverysetscanprovidetheperformancenormally.
6.2Safety
TheABCfluiddeliverysetisalreadyapprovedforplacingonthemarketbyTaiwanDOH.HospitalsofTaiwanhavebeenusingABCfluiddeliverysetfrom2003andwedon'treceiveanyincidentorharmcasesfromthemofthepastyear.
Inordertoprovethesafetyofthefluiddeliverysetsinproductshelflife,packageconformity(suchassealpeelstrengthanddyepenetrationtest)andsterilitytestare
conducted.Thetestresultsaresummarizedasfollows:
ModelType
Sealpeelstrength
Dyepenetration
Sterility
IVAdministrationSet
Pass
Pass
Pass
BloodTransfusionset
Pass
Pass
Pass
EnteralExtensionSet
Pass
Pass
Pass
IrrigationTubingSet
Pass
Pass
Pass
Extensionsetandinjectport
Pass
Pass
Pass
*10pcssamplesarepreparedforeachtest.
*Acceptancecriteria:
1)Sealpeelstrength-1lbf
2)Dyepenetration-Nopenetration
3)Sterility-Negative(Nogrowth)
Thetestresultsshowthatsterilityguaranteedunlessunitpackageisopenedordamaged.Itdemonstratesthefluiddeliverysetsaresafetyinnormallystate.
6.3ProductLiteratureandInstructionsforUse
6.3.1ProductLiterature
Thedevicesusedtoadministermedicalfluidfromacontainerintoapatient’svascular
systemorbodyca
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