Search Results

The Keyed Filler Bottle Adaptor is intended to be used to enable the bottle, in which the anaesthetic agent is supplied by the pharmaceutical company, to be connected to the keyed filler port of an anaesthetic vaporizer. The Keyed Filler Bottle Adaptor provides a flexible connection that allows the liquid agent to be filled into, and drained from, the vaporizer by gravity.

It is indicated for use with bottles of Halothane, Enflurane, Isoflurane and Sevoflurane that provide anaesthesia, via a vaporizer, to a patient connected to an anaesthetic machine.

The Keyed Filler Bottle Adaptor is an accessory to a restricted medical device and is intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The Keyed Filler Bottle Adaptor enables users to connect the bottle, in which the pharmaceutical company supplies specific liquid anaesthetic agents (Halothane, Enflurane, Isoflurane and Sevoflurane), to a compatible filling receptacle provided on an anaesthetic vaporizer, that is attached to an anaesthetic machine. Four versions of the adaptor are available, each one with a colour coded bottle connector and male adaptor (for connecting to the vaporizer). Each adaptor is specific to one of the anaesthetic agents named above and is considered to be an accessory to a vaporizer.

The provided text is a 510(k) summary for the Penlon Limited Keyed Filler Bottle Adaptor, which aims to demonstrate substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for AI/ML-based diagnostic devices.

Therefore, many of the requested categories of information are not applicable to this document. The document describes the device, its intended use, and claims substantial equivalence based on technological characteristics similar to the predicate device. It does not contain information about studies with specific acceptance criteria, sample sizes for test or training sets, expert adjudication methods, or MRMC comparative effectiveness studies.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary for this device focuses on demonstrating substantial equivalence to a predicate device (Southmedic, Inc. Vapofil Keyed Agent adaptor K945993) rather than presenting a study with specific performance metrics against pre-defined acceptance criteria. The claim is that "any minor differences do not make the Penlon Keyed Filler Bottle Adaptor any less safe and any less effective than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document as it doesn't describe a clinical or performance study with a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document as it doesn't describe a study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in this document. This type of study is typically conducted for diagnostic devices (especially those involving AI/ML) to assess reader performance with and without AI assistance, which is not relevant to a mechanical accessory like a keyed filler bottle adaptor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done and is not applicable to this device. This concept is relevant for AI/ML algorithms.

7. The Type of Ground Truth Used

This information is not provided as there is no study described that requires establishing ground truth. The device is a mechanical adaptor, and its performance is assessed through its mechanical characteristics and compatibility with other components, rather than against a "ground truth" in a clinical diagnostic sense.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a training set; this concept is relevant for AI/ML algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as there is no mention of a training set.

Ask a specific question about this device