Search Results

The Mini ONE® Enteral Extension Set is intended for use as an extension set for the Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible enteral feeding devices. The extension set is for administering feeding, medications, and decompression to compatible devices.

The AMT Mini ONE® Enteral Extension Set is intended for use with the AMT Mini ONE® Gastrostomy Button, the AMT G-Jet Gastric-Jejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible feeding devices. The overall functionality and manufacturing methods remain similar to our original clearance of the Mini ONE Feeding Set in 510(K) K971757. The device materials and manufacturing methods were also recently cleared for use in our G-Jet Gastric-Jejunal Feeding Tube 510(K) Submissions K110804 and K123716. The main difference between our original Mini ONE Feeding Set Clearance (K971757) and this submission is the inclusion of new end connectors that are designed to the ISO/IEC 80369 series.
The extension set consists of several different assembled components and materials that make up the device. Each extension set consists of several common components: A Mini ONE® connector that is able to connect to a compatible enteral feeding tube, flexible tubing, a pinch clamp to block the tubing, and ENfit enteral connector(s) to connect to a compatible feeding bag or syringe.
There are two types of Mini ONE® connectors that are used for the extension set. The first type is a straight through connector that is used for bolus or gravity feedings/administration of medication. The second type of connector is a right angle connector that better directs the tubing around the patient for longer feedings/administration of medication. Both connectors are identical in material and in design along the connecting portion that fits with a compatible enteral device. The Mini ONE® connectors are also compatible with Kimberly Clark Mic-Key® Gastrostomy and enteral devices. Mic-Key® compatibility was cleared through the 510(K) process in K971757, K110804, and K123716.
The flexible tubing used with each device comes in two different diameters and several different lengths. The two diameter options are provided to accommodate different types of feeds and medications to the patient. The tubing may be provided as straight tubing or in a coiled configuration. The different lengths are supplied to provide different options for patient orientation and maneuvering and include lengths of 2-24" lengths. Each tubing length also has a pinch clamp included to allow the user to close off the tubing while not in use.
The enteral connectors in this submission are provided in two different configurations with the extension sets. The first configuration is a single ENFit connector assembled directly onto the tubing. The single port connection is typically used for bolus or gravity use. The second configuration is a Y-Port connection with two ENFit connections, each with a separate plug. The two port connection allows the user to administer medication and feed through the device at the same time.
The Mini ONE® Enteral Extension Set is provided non-sterile for single user use only. It is made from DEHP and Latex free materials. The Mini ONE® Enteral Extension Set is provided in a number of configurations providing different Mini ONE® adapter designs, lengths of tubing, diameters of tubing, and number of ENFit connectors. Description of each difference in design configurations is listed below:
Feeding Set Configurations: Type of Mini ONE® Connector: Straight (bolus/gravity) or right angle (continuous/pump) Number of ENFit connectors: One or Two Tubing Diameter: 0.218" or 0.165" Tubing Length: 2-24" Part Number Scheme: 8-XXXX (where XXXX signifies tubing length, number of ENFit connectors, MiniONE® Connector Type, and tubing diameter)

The provided text is a 510(k) summary for a medical device called the "AMT Mini ONE® Enteral Extension Set." It describes the device, its intended use, and comparative analysis with a predicate device to establish substantial equivalence for regulatory clearance. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or performance study. Instead, it refers to standard bench testing and a human factors study for a physical medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these concepts are not applicable to the content provided.

Ask a specific question about this device