(266 days)
Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.
The Avinent Sterilization Cassettes are a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.
The provided text is related to the FDA 510(k) premarket notification for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The document details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.
However, the questions you've asked are typically relevant to studies evaluating the performance of AI/ML-driven medical devices (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details).
Since the Avinent Sterilization Cassettes are a physical medical device (sterilization trays), and not an AI/ML software or diagnostic tool, many of the requested data points (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, ground truth types related to expert consensus or pathology, etc.) do not apply to this type of submission.
The "studies" described are validation tests for the physical properties and functionality of the sterilization cassettes themselves (e.g., cleaning validation, steam sterilization validation, cycle life, cytotoxicity).
Let's adapt the answer based on the information available and the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Name of Testing | Purpose of Testing | Acceptance Criteria | Reported Device Performance / Results |
|---|---|---|---|
| Cleaning Validation | Validate the cleaning cycle in the instructions for use | No visible soil. Hemoglobin less than $2.2µg/cm²$. Protein level $≤6.4 µg/cm²$. MEM reactivity grade of 2 or less. | No visible soil. All acceptance criteria met ($ |
§ 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).