FDA于2020.12.11发布了关于简短(Abbreviated) 510(k)申请的相关产品指南，该指南是在遵守“基于安全有效性途径”这一前提下编制提出的。在这个框架下,申请人若计划使用安全有效性途径提交一份关于脊柱钢板系统产品的510 (k)申请，可以选择使用本指南中建议的性能指标来证明与等同产品的实质性等同，而不用比较两者的其他更多性能参数。

　　该指南适用于颈椎前路或胸腰椎前/侧路脊柱钢板系统产品，属第II类器械，对应产品代码为KWQ。用于脊柱后路或枕骨的钢板系统不在适用范围内。组成该类产品的钢板和配套螺钉，其材料需为符合下列FDA认可标准中的任意一种：

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

　　●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)

　　需进行的性能测试及标准如下：

　　力学测试

　　●ASTM F1717 -静态压缩弯曲

　　方法：ASTM F1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

　　●ASTM F1717 -静态扭转

　　方法：ASTM F1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

　　●ASTM F1717 -动态压缩弯曲疲劳试验

　　方法：ASTM F1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

　　灭菌(标记为无菌的器械)和再处理(终端用户灭菌)验证

　　●灭菌(标记为无菌的器械)和再处理(终端用户灭菌)

　　方法：FDA目前认可的以下共识标准版本(如适用)：

　　●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

　　生物相容性评价：

　　●生物相容性终点(由CDRH生物相容性指南确定)

　　方法：FDA目前认可的生物相容性标准

　　奥咨达医疗是一家全球医疗器械3C产业服务平台，提供医疗器械注册、医疗器械临床、医疗器械CDMO、医疗器械CRO、医疗器械FDA等服务，欢迎咨询。