(397 days)
The Nobel Biocare Kit Boxes are used in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices between surgical uses. The Nobel Biocare Kit Boxes are not intended on their own to maintain sterility, it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap. Sterilization validations for the worst-case Kit Box included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The Kit Boxes were validated for a maximum load of 469 grams including kit box and instruments.
The Kit Boxes are a module-based kit system that can be organized in different ways according to the user's needs. A Module is composed by a Kit Box and an inserted Kit Plate. The Module can be used as a cleaning and sterilization container. Additionally, it is used for presentation and storage of products. These products are sold as standalone articles (Drills, Screw Taps, Depth Gauge, Implant Drivers, Torque Wrench etc.) and are available in a variety of combinations for different implant systems.
The Modules are intended for storing, organizing and sterilizing the instruments used during implant/prosthetic/retrieval treatment with Nobel Biocare implants.
The Module have 2 different sizes: The Main Module, and the Sub-Module.
Main Module: The Main Module measures 170 mm x 145 mm x 57 mm in size and consists of a Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
Sub-Module: The Sub-Module (smaller Module) measures 170 mm x 57 mm and consists of Kit Box and a Kit Plate to be inserted. The Kit Box consists of a base with support (stand) and a removable transparent plastic lid. The base is made of silicone over molded on a grey or red plastic base. The inserted Kit Plate snaps into the base of the Kit Box and consists of a pattern of silicone Grommets and tool holders for instruments.
The provided document is a 510(k) premarket notification for a medical device (Kit Boxes) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria for a diagnostic or AI-driven system.
The document does not contain the information requested in points 1-9 regarding acceptance criteria and study details for a device's performance, especially in the context of an AI/diagnostic system. The "performance data" section (Section VII) refers to sterilization validation, shelf-life, and biocompatibility testing, which are relevant for a sterilization device but not for a diagnostic or AI product.
Therefore, I cannot extract the requested information from this document. The document describes a medical device used for organizing, sterilizing, transporting, and storing other medical devices, and the review is for its substantial equivalence to similar existing products, not for its performance in a clinical diagnostic or AI-assisted context.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).