PreClinical and Clinical Studies forNeurothrombectomy Devices.docx

PreClinical and Clinical Studies forNeurothrombectomy Devices.docx

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PreClinicalandClinicalStudiesforNeurothrombectomyDevices

GuidanceforIndustryandFDAStaff

Pre-ClinicalandClinicalStudies

forNeurothrombectomyDevices

Documentissuedon:

June18,2007

ForquestionsregardingthisdocumentcontactCarlosPeña,Ph.D.,M.S.,at（301）827-3340or

carlos.pena@cdrh.fda.govorNeilOgdenat（240）276-3600orneil.ogden@cdrh.fda.gov.

U.S.DepartmentofHealthandHumanServices

FoodandDrugAdministration

CenterforDevicesandRadiologicalHealth

GeneralSurgeryDevicesBranch

DivisionofGeneral,Restorative,andNeurologicalDevices

OfficeofDeviceEvaluationContainsNonbindingRecommendations

Preface

PublicComments

WrittencommentsandsuggestionsmaybesubmittedatanytimeforAgencyconsideration

totheDivisionofManagement,FoodandDrugAdministration,5630FishersLane,Room

1061,（HFA-305）,Rockville,MD,20852.Alternatively,electroniccommentsmaybe

submittedtohttp:

//www.fda.gov/dockets/ecomments.Whensubmittingcomments,please

refertotheexacttitleofthisguidancedocument.Commentsmaynotbeacteduponbythe

Agencyuntilthedocumentisnextrevisedorupdated.

AdditionalCopies

AdditionalcopiesareavailablefromtheInternetat:

http:

//www.fda.gov/cdrh/ode/guidance/1586.html.Youmayalsosendane-mailrequestto

dsmica@fda.hhs.govtoreceiveanelectroniccopyoftheguidanceorsendafaxrequestto

240-276-3151toreceiveahardcopy.Pleaseusethedocumentnumber（1586）toidentifythe

guidanceyouarerequesting.ContainsNonbindingRecommendations

TableofContents

1.INTRODUCTION............................................................................................................1

TheLeastBurdensomeApproach..........................................................................................2

2.REGULATORYPATHWAY.........................................................................................2

3.BIOCOMPATIBILITY...................................................................................................3

4.PRE-CLINICALEVALUATION..................................................................................3

A.TestProtocols.................................................................................................................3

B.TestMethodsandConditions........................................................................................3

C.ActualDeviceEvaluated................................................................................................3

D.StatisticalAnalysis.........................................................................................................3

5.BENCHTESTING..........................................................................................................4

6.ANIMALTESTING........................................................................................................4

A.Usability.........................................................................................................................4

B.Safety.............................................................................................................................4

C.Effectiveness..................................................................................................................5

7.CLINICALSTUDIES.....................................................................................................5

A.SubjectSelection............................................................................................................5

InclusionCriteria...............................................................................................................5

ExclusionCriteria..............................................................................................................6

OnsettoTreatmentwithNeurothrombectomyDevices....................................................6

MagnitudeoftheClotLoad:

Location,Size,andEtiology..............................................7

ControlGroups...................................................................................................................7

B.InitialAssessments.........................................................................................................7

Angiography......................................................................................................................7

ImagingAssessments.........................................................................................................8

NeurologicEvaluation.......................................................................................................8

C.Follow-UpAssessments.................................................................................................9

Angiography......................................................................................................................9

ImagingAssessments.........................................................................................................9

NeurologicEvaluation.......................................................................................................9

D.OutcomeMeasures.........................................................................................................9

SafetyEndpoints................................................................................................................9

EffectivenessEndpoints...................................................................................................10

8.MEASURESOFSUCCESS..........................................................................................11

9.ALTERNATIVESOURCESOFCLINICALINFORMATION..............................11ContainsNonbindingRecommendations

page1

GuidanceforIndustryandFDAStaff

Pre-ClinicalandClinicalStudiesfor

NeurothrombectomyDevices

ThisguidancerepresentstheFoodandDrugAdministration's（FDA's）currentthinkingon

thistopic.Itdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperateto

bindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiesthe

requirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternative

approach,contacttheFDAstaffresponsibleforimplementingthisguidance.Ifyoucannot

identifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthis

guidance.

1.Introduction

ThisguidancedocumentdescribesFDA’srecommendationsforpre-clinicalandclinicalstudies

thatinvolveneurothrombectomydevicesconductedtosupportpremarketsubmissionsfor

neurothrombectomydevicesindicatedforischemicstroke.Aneurothrombectomydeviceis

intendedtoretrieveordestroybloodclotsinthecerebralneurovasculaturebymechanical（i.e.,

snareorsuction）,laser,ultrasoundtechnologies,orcombinationoftechnologies.

Thisguidancedocumentdoesnotdescribeallelementsrequiredforpremarketnotification

（510（k））submissions,investigationaldeviceexemption（IDE）,orpremarketapproval（PMA）

applications.ThisguidancedocumentsupplementsotherFDApublicationson510（k）

submissions,IDE,andPMAapplicationsandisnotareplacementforthesedocuments.

PremarketNotification-510（k）Information

Forgeneralinformationon510（k）,referto21CFR807.87,theguidanceentitledFormatfor

TraditionalandAbbreviated510（k）s

1

and“PremarketNotification510（k）”inthe（Center

forDevicesandRadiologicalHealth）CDRHDeviceAdviceat

http:

//www.fda.gov/cdrh/devadvice/314.html.

InvestigationalDeviceExemptionInformation

ForgeneralIDEinformation,referto21CFRPart812ortothe“IntroductionIDE

Overview,”athttp:

//www.fda.gov/cdrh/devadvice/ide/index.shtml.

PremarketApprovalApplication（PMA）Information

ForgeneralinformationaboutPMAapplications,referto21CFR814or“Application

Methods,”athttp:

//www.fda.gov/cdrh/devadvice/pma/app_methods.html.

1

http:

//www.fda.gov/cdrh/ode/guidance/1567.htmlContainsNonbindingRecommendations

page2

FDA’sguidancedocuments,includingthisguidancedocument,donotestablishlegally

enforceableresponsibilities.Instead,guidancedocumentsdescribetheAgency’scurrent

thinkingonatopicandshouldbeviewedonlyasrecommendations,unlessspecificregulatoryor

statutoryrequirementsarecited.TheuseofthewordshouldinAgencyguidancedocuments

meansthatsomethingissuggestedorrecommended,butnotrequired.

TheLeastBurdensomeApproach

Theissuesidentifiedinthisguidancedocumentrepresentthosethatwebelieveneedtobe

addressedbeforeyourdevicecanbemarketed.Indevelopingtheguidance,wecarefully

consideredtherelevantstatutorycriteriaforAgencydecision-making.Wealsoconsidered

theburdenthatmaybeincurredinyourattempttofollowtheguidanceandaddresstheissues

wehaveidentified.Webelievethatwehaveconsideredtheleastburdensomeapproachto

resolvingtheissuespresentedintheguidancedocument.If,however,youbelievethatthere

isalessburdensomewaytoaddresstheissues,youshouldfollowtheproceduresoutlinedin

the“ASuggestedApproachtoResolvingLeastBurdensomeIssues”document.Itis

availableonourCenterwebpageat:

http:

//www.fda.gov/cdrh/modact/leastburdensome.html.

2.RegulatoryPathway

Theregulatorypathway,i.e.,premarketnotificationsubmission（510（k））,denovoclassification,

orpremarketapprovalapplication（PMA）,foraneurothrombectomydevicedependsonthe

identificationofanappropriatepredicatedevice,thetechnologyofthedevice,anditsindications

foruse.Mechanicalneurothrombectomydevicesindicatedforretrievalofclotsinpatientswit