(135 days)
The HS Surgical Kit Cases are indicated for the organization of surgical and/or prosthetic instruments during sterilization. storage, and transport. Use of this product facilitates the storage and organization of instruments during and after surgical procedures.
Neodent instrument kit cases are intended to allow sterilization of the medical devices included.
Neodent instrument kit cases must be wrapped in FDA-approved materials to maintain the sterility of the devices included.
The kits should be placed in an FDA-approved sterilization wrap for the indicated cycles and sterilized by moist heat (steam) using one of the following cycles:
Dynamic Air Removal (Pre-Vacuum): exposure at 132°C for 4 minutes, drying for 30 minutes.
Gravity displacement: exposure at 132°C for 15 minutes, drying for 50 minutes.
Neodent instrument kit cases are intended for sterilization of non-porous fillers.
The combined weight of the HS Surgical Kit case and associated instruments is 302.88 grams.
The weight of the empty case is approximately 214.85 grams. Neodent instrument kit cases should not 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 kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.
This is a medical device submission for the Neodent Implant System - Helix Short Surgical Kit Cases. The submission focuses on sterilization wrap containers (Class II, product code KCT).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manual Cleaning Validation: | |
| * Visual Inspection: No Visible Soil | Passed |
| * 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).