Search Results

Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices (natural aluminum color containers and lids) subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length

% Size Y211.10W % Size Y211.13W % Size Y211.15W

(% Max Load Wt. 12.5 Ibs

including basket & instruments)

Lumen Size min 1mm diameter

½ Size Y311.26W

(½ Size Max Load Wt. 9.25 Ibs including basket & instruments) Lumen size min 1mm diameter X 200mm length

½ Size Y311.10W

½ Size Y311.13W

½ Size Y311.15W

1/2 Size Y311.20W

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W

The devices are composed of anodized aluminum (this does not include colored anodized lids).

The provided document K112090 is a 510(k) Pre-market Notification for Sterilization Trays. It primarily discusses the substantial equivalence of the new Bahadir USA Sterilization Trays (including wide body versions) to their previously cleared predicate device (K102146).

This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. Instead, it outlines the device's intended use, materials, sterilization method, and dimensions, focusing on comparing these aspects to a predicate device to establish substantial equivalence for medical hardware.

Therefore, I cannot provide the requested information in a table or structured format as the submission does not pertain to AI/ML device performance or clinical studies of that nature.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The device described is a "STERILIZATION TRAY," which is a physical container used for sterilizing medical instruments. It is explicitly classified as "Sterilization Wraps, Trays, Containers Class 2 - KCT." This is a medical device hardware, not an AI/ML software device.
• Purpose of the Submission: The 510(k) submission's goal is to demonstrate "substantial equivalence" of the new sterilization trays to a previously cleared sterilization tray (predicate device K102146). This involves comparing features like materials, dimensions, intended use, and sterilization compatibility.
• Nature of the "Non-Clinical Tests Performed": The document states "The subject devices were subjected to sterility testing and performance testing." However, no details on acceptance criteria, specific test results (e.g., in a table), sample sizes, ground truth, expert involvement, or any form of multi-reader/multi-case (MRMC) study are provided within this summary for these tests. The statement is very high-level and does not offer the granular detail required for your request. It's safe to assume these "sterility and performance tests" would pertain to the effectiveness of the tray in allowing sterilization and maintaining sterility, not to an algorithm's diagnostic or predictive performance.

In summary, this 510(k) document is for a traditional medical device (sterilization trays) and does not describe acceptance criteria or a study related to an AI/ML device's performance, human reader improvement with AI, or standalone algorithm performance.

Ask a specific question about this device