导读：今天我们就来介绍于2024年11月21日发布的《骨科非脊柱金属骨螺钉和垫圈-基于安全和性能途径的性能标准》。
目前FDA510（k）提交方式有三种：传统、特殊以及简略型，“基于安全和性能途径”（ThesafetyandPerformanceBasedPathway）是简略型510（k）的一种可选途径，适用于某些广为人知、且易于理解的器械类型。制造商通过证明申报器械符合FDA确定的性能标准，以证明该器械与已合法上市的器械一样安全有效。
范围
从监管范围：受21CFR888.3040和21CFR888.3030监管，产品代码为WHC、HTN、NDG的II类非脊柱金属骨螺钉和垫圈。
从预期用途：骨螺钉用于骨科非脊柱骨折固定、截骨或小关节融合或关节固定，垫圈仅用于与骨螺钉配合使用，以帮助分散螺钉头/骨界面的负荷。此外，用于下颌、颌面、颅骨和眼眶骨折固定等其他部位的，或与缝合线等装置一起使用骨螺钉或垫圈均不属于本指南的范围。
从器械设计特征：骨螺钉设计多种多样，但符合以下FDA认可的共识标准，则属于本指南的范围：
?ASTMF136StandardSpecificationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)
?ASTMF1472StandardSpecificationforWroughtTitanium-6Aluminum-4VanadiumAlloyforSurgicalImplantApplications(UNSR56400)
?ASTMF1295StandardSpecificationforWroughtTitanium-6Aluminum-7NiobiumAlloyforSurgicalImplantApplications(UNSR56700)
?ASTMF67StandardSpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)
?ASTMF138StandardSpecificationforWrought18Chromium-14Nickel2.5MolybdenumStainlessSteelBarandWireforSurgicalImplants(UNSS31673)
?ASTMF139StandardSpecificationforWrought18Chromium-14Nickel2.5MolybdenumStainlessSteelSheetandStripforSurgicalImplants(UNSS31673)
?ASTMF1537StandardSpecificationforWroughtCobalt-28Chromium-6MolybdenumAlloysforSurgicalImplants(UNSR31537,UNSR31538,andUNSR31539)
测试性能标准
机械台架测试：应按照FDA目前认可的ASTMF543版本StandardSpecificationandTestMethodsforMetallicMedicalBoneScrew进行，并对代表最坏情况的最终螺钉设计版本进行所有测试，且阐述如何确定最坏情况设计的理由。此外，还应使用工程分析的方法，通过扭转强度测试、驱动扭矩测试以及轴向拉伸强度测试来评估骨螺钉的轴向拉伸强度，具体验收标准可结合本指南及ASTMF543指南。
灭菌（标记为无菌的器械）和再处理（终端用户灭菌）验证测试：应证明器械及其特定仪器的清洁度和无菌度，或清洁和灭菌能力达到10-6的无菌保证水平。制造商应向FDA提交包装（无菌屏障系统）及其如何保持器械无菌的说明、包装测试方法的说明（但不包括包装测试数据）。测试方法应按照FDA目前认可的下列共识标准版本，包括但不限于：
?InternationalOrganizationforStandardization(ISO)17665Sterilizationofhealthcareproducts–Moistheat-Requirementsforthedevelopment,validation,androutinecontrolofasterilizationprocessformedicaldevices
?ISO11135Sterilizationofhealthcareproducts–Ethyleneoxide-Requirementsfordevelopment,validation,androutinecontrolofasterilizationprocessformedicaldevices
?ISO11137-1Sterilizationofhealthcareproducts-Radiation-Part1:Requirementsfordevelopment,validation,androutinecontrolofasterilizationprocessformedicaldevices
?ISO11137-2Sterilizationofhealthcareproducts-Radiation-Part2:Establishingthesterilizationdose
?ISO11137-3Sterilizationofhealthcareproducts-Radiation-Part3:Guidanceondosimetricaspectsofdevelopment,validationandroutinecontrol
?ISO/TS11137-4Sterilizationofhealthcareproducts-Radiation-Part4:Guidanceonprocesscontrol
?ISO13004Sterilizationofhealthcareproducts-Radiation-Substantiationofselectedsterilizationdose:MethodVDmaxSD
?ISO11607-1Packagingforterminallysterilizedmedicaldevices–Part1:Requirementsformaterials,sterilebarriersystemsandpackagingsystems
?ISO11607-2Packagingforterminallysterilizedmedicaldevices–Part2:Validationrequirementsforforming,sealingandassemblyprocesses
?ASTMF88/F88MStandardTestMethodforSealStrengthofFlexibleBarrierMaterials
?ASTMF3039StandardTestMethodforDetectingLeaksinNonporousPackagingorFlexibleBarrierMaterialsbyDyePenetration
?ASTMF2096StandardTestMethodforDetectingGrossLeaksinPackagingbyInternalPressurization(BubbleTest)
?ISO20857Sterilizationofhealthcareproducts—Dryheat—Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
参考资料：
1.OrthopedicNon-SpinalMetallicBoneScrewsandWashers–PerformanceCriteriaforSafetyandPerformanceBasedPathway
2.SafetyandPerformanceBasedPathway-GuidanceforIndustryandFoodandDrugAdministration