SERVICESwww.18jjj

NOV18ZUO8510(k)SummaryAsrequiredbySection807.
92(c)~owne~sNae:AvalonLaboratories,LLC~~Address~~2610E.
HomesteadPlaceRanchoDominguez,CA90220USA310761-8660ax:~~~~~310761-8665ContactPerson:LeeWirth/DirectorofQualityAssuranceandRegulatoryAffairsrummarPrepared:July3,2008tiameofdevice:VascularAccessKitTrde/ProprietarName:-AvalonEliteVascularAccessKit[lassificationName:21CFR870.
1310-Dilator~rductCode:OREubstantiallyEquivalent:K070749EstechPercutaneousInsertionDilatorKitescription:VascularAccessKit-containingdilators,guidewire,scalpel,introducerneedle,andsyringe.
ttendedUse:Intendedforsingleusebytrainedphysiciantoassistinvesselcannulation.
omparisontoPredicate:-SimilarintermsofdIesign(physicalcharacteristics),materials,content,intendeduse,performancecharacteristics,packaging,andsterilization.
uJpportingData:ValidationTestingwasusedtoestablishtheperformancecharacteristicsoftheVascularAccessKitasfollows:LBiocompatibility'PackagingIntegrity*TransportationIntegrity*SterilizationValidationFunctionalTestinglponclusions:~~Theresultsofthesevalidationtestsdemonstratethekitisassafeandeffectiveasthelegallym-arketedpredicatedevice.
DEPARTMENTOFHEALTH&HUMANSERVICESPublicHealthServiceFoodandDrugAdministration9200CorporateBoulevardRockvilleMD20850NOV182008AvalonLaboratories,LLCc/oMr.
LeeWirthDirector,QA/RA2610E.
HomesteadPlaceRanchoDominquez,CA90220Re:K081940Trade/DeviceName:AvalonEliteVascularAccessKitRegulationNumber:21CFR870.
1310RegulationName:VesseldilatorforpercutaneouscatheterizationRegulatoryClass:ClassIIProductCode:DREDated:September23,2008Received:September26,2008DearMr.
Wirth:WehavereviewedyourSection510(k)premarketnotificationofintenttomarketthedevicereferencedaboveandhavedeterminedthedeviceissubstantiallyequivalent(fortheindicationsforusestatedintheenclosure)tolegallymarketedpredicatedevicesmarketedininterstatecommercepriortoMay28,1976,theenactmentdateoftheMedicalDeviceAmendments,ortodevicesthathavebeenreclassifiedinaccordancewiththeprovisionsoftheFederalFood,Drug,andCosmeticAct(Act)thatdonotrequireapprovalofapremarketapprovalapplication(PMA).
Youmay,therefore,marketthedevice,subjecttothegeneralcontrolsprovisionsoftheAct.
ThegeneralcontrolsprovisionsoftheActincluderequirementsforannualregistration,listingofdevices,goodmanufacturingpractice,labeling,andprohibitionsagainstmisbrandingandadulteration.
Ifyourdeviceisclassified(seeabove)intoeitherclassII(SpecialControls)orclassIII(PMA),itmaybesubjecttosuchadditionalcontrols.
ExistingmajorregulationsaffectingyourdevicecanbefoundintheCodeofFederalRegulations,Title21,Parts800to898.
Inaddition,FDAmaypublishfurtherannouncementsconcerningyourdeviceintheFederalRegister.
PleasebeadvisedthatFDA'sissuanceofasubstantialequivalencedeterminationdoesnotmeanthatFDAhasmadeadeterminationthatyourdevicecomplieswithotherrequirementsoftheActoranyFederalstatutesandregulationsadministeredbyotherFederalagencies.
YoumustcomplywithalltheAct'srequirements,including,butnotlimitedto:registrationandlisting(21CFRPart807);labeling(21CFRPart801);goodmanufacturingpracticerequirementsassetforthinthequalityPage2-Mr.
LeeWirthsystems(QS)regulation(21CFRPart820);andifapplicable,theelectronicproductradiationcontrolprovisions(Sections531-542oftheAct);21CFR1000-1050.
ThisletterwillallowyoutobeginmarketingyourdeviceasdescribedinyourSection510(k)premarketnotification.
TheFDAfindingofsubstantialequivalenceofyourdevicetoalegallymarketedpredicatedeviceresultsinaclassificationforyourdeviceandthus,permitsyourdevicetoproceedtothemarket.
Ifyoudesirespecificadviceforyourdeviceonourlabelingregulation(21CFRPart801),pleasecontacttheCenterforDevicesandRadiologicalHealth's(CDRH's)OfficeofComplifanceat(240)276-0120.
Also,pleasenotetheregulationentitled,"Misbrandingbyreferencetopremarketnotification"(21CFRPart807.
97).
Forquestionsregardingpostmarketsurveillance,pleasecontactCDRH'sOfficeofSurveillanceandBiometrics'(OSB's)DivisionofPostmarketSurveillanceat240-276-3474.
Forquestionsregardingthereportingofdeviceadverseevents(MedicalDeviceReporting(MDR)),pleasecontacttheDivisionofSurveillanceSystemsat240-276-3464.
YoumayobtainothergeneralinformationonyourresponsibilitiesundertheActfromtheDivisionofSmallManufacturers,InternationalandConsumerAssistanceatitstoll-freenumber(800)638-2041or(240)276-3150oratitsInternetaddresshttp://www.
fda.
gov/cdrh/industry/support/index.
html.
Sincelyyo.
.
.
s.
Bran.
Zuckerman,M.
D.
DireorDivisionofCardiovascularDevicesOfficeofDeviceEvaluationCenterforDevicesandRadiologicalHealthEnclosureIndicationsforUse510(k)Number(ifknown):IPrescriptionUseAND/OROver-The-CounterUse(Part21CFR801SubpartD)(21CFR801SubpartC)(PLEASEDONOTWRITEBELOWTHISLINE-CONTINUEONANOTHERPAGEIFNEEDED)ConcurrenceofCDRH,OfficeofDeviceEvaluation(ODE)(Divso0~ign-OffDivisionCardiov,'Page1of510(kjumberwrjjj