(283 days)
Neodent Instrument Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 30-minute dry time (for GM Zygomatic Surgical Kit Case) or 20-minute dry time (for GM Helix LG Compact Surgical Kit Case)
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time (only for GM Helix LG Compact Surgical Kit Case)
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Zygomatic Surgical Kit Case and the instruments is 738.1 g. The weight of the empty kit case is 515 g.
The combined weight of the GM Helix LG Compact Kit Case and the instruments is 297.3 g. The weight of the empty kit case is 236 g.
Neodent Instrument Kit Cases should not to be stacked during sterilization.
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject devices include two (2) such kit cases. The lids are manufactured from injection molded polyphenylsulfone resin, the tray and base are manufactured from injection molded polysulfone resin. The designs include grommets and inserts of various geometries manufactured from molded silicone that retain the instruments within the tray and base. The subject device kit cases are provided nonsterile to the end-user.
The medical device in question is the Neodent Instrument Kit Cases, intended for use in sterilizing other medical devices by healthcare providers using moist heat (steam). The provided documentation details the acceptance criteria and the studies conducted to demonstrate its performance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manual Cleaning Validation | |
| Hemoglobin Test: - |
§ 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).