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FDA于2020.12.11發(fā)布了關(guān)于簡(jiǎn)短(Abbreviated) 510(k)申請(qǐng)的相關(guān)產(chǎn)品指南，該指南是在遵守“基于安全有效性途徑”這一前提下編制提出的。在這個(gè)框架下,申請(qǐng)人若計(jì)劃使用安全有效性途徑提交一份關(guān)于非脊柱用金屬接骨螺釘及墊圈產(chǎn)品的510 (k)申請(qǐng)，可以選擇使用本指南中建議的性能指標(biāo)來(lái)證明與等同產(chǎn)品的實(shí)質(zhì)性等同，而不用比較兩者的其他更多性能參數(shù)。

該指南適用于非脊柱用金屬接骨螺釘及墊圈產(chǎn)品，屬第II類器械，對(duì)應(yīng)產(chǎn)品代碼分別為HWC和HTN。用于下頜、頜面、顱骨和眼眶骨折內(nèi)固定或用于脊柱的接骨螺釘或墊圈不在本指南適用范圍內(nèi)。用于縫合或弦狀結(jié)構(gòu)（如骨錨、韌帶聯(lián)合緊繩）作為植入系統(tǒng)一部分的產(chǎn)品也不在本指南適用范圍內(nèi)。各種型號(hào)的接骨螺釘(例如松質(zhì)骨螺釘、皮質(zhì)骨螺釘、空心螺釘、全螺紋螺釘、半螺紋螺釘)都在本指南適用范圍內(nèi)。組成該類產(chǎn)品的接骨螺釘和墊圈，其材料需為符合下列FDA認(rèn)可標(biāo)準(zhǔn)中的任意一種：

●ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

●ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

●ASTM F1295 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

●ASTM F67 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

●ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

●ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

●ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

需進(jìn)行的性能測(cè)試及標(biāo)準(zhǔn)如下：

力學(xué)測(cè)試

●扭轉(zhuǎn)強(qiáng)度

方法：ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

●轉(zhuǎn)動(dòng)扭矩

方法：ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws

●軸向拔出力

方法：建議使用Chapman等人在1996年所提出的方程進(jìn)行工程分析，以評(píng)估軸向拔出力。

使用以下公式計(jì)算理論拔出力：

滅菌(標(biāo)記為無(wú)菌的器械)和再處理(終端用戶滅菌)驗(yàn)證

●滅菌(標(biāo)記為無(wú)菌的器械)和再處理(終端用戶滅菌)

方法：FDA目前認(rèn)可的以下共識(shí)標(biāo)準(zhǔn)版本(如適用)：

●International Organization for Standardization (ISO) 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

●ISO 11135-1 Sterilization of health care products – Ethylene oxide- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

●ISO 11137-1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

●ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

●ISO 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes

生物相容性評(píng)價(jià)：

●生物相容性終點(diǎn)（由CDRH生物相容性指南確定）

方法：FDA目前認(rèn)可的生物相容性標(biāo)準(zhǔn)