(223 days)
Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.
When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.
The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:
- Temperature: 270°F/132°C
- Exposure time: 4 minutes.
- Drying time: 20 minutes.
- The cassettes are not to be stacked during sterilization.
KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.
Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.
Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.
The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.
The provided text describes the "Microdent Sterilization Cassette" and its performance data. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Cycle Validation | Sterility assurance level (SAL) of ≤ 10⁻⁶ | Pass |
| Drying Validation | No visible moisture | Pass |
| Cleaning (Manual Pre-Cleaning and Automated Cleaning) | No visible soil. | |
| Protein: |
§ 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).