(120 days)
The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,
INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical Cassettes:
-
INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm
-
INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment.
To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
The Anthogyr Surgical Cassettes are designed to organize, steam sterilize, and protect dental surgical instruments. They are intended for healthcare providers and must be enclosed in an FDA-cleared steam sterilizable pouch.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection (after cleaning): No Visible Soil | Passed |
| Hemoglobin Test (after cleaning): |
§ 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).