(76 days)
The Plug System S Plus is intended for mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
The Plug System S Plus is a vaporizer mounting adapter that will allow Dräger Vapor 19.1 vaporizers to be mounted on Selectatec Series Mounted Manifolds.
The provided text describes a medical device called the "Plug System S Plus," which is a vaporizer mounting adapter. The document focuses on demonstrating that this device is substantially equivalent to existing devices, primarily the Ohmeda Tec 5 Continuous Flow Vaporizer (Tec 5), to obtain FDA clearance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format as one might expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is described through comparison and adherence to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Mounting Dräger Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds. | The Plug System S Plus is specifically designed for this purpose. The device's description and intended use directly address this. |
| Interlock Mechanism Functionality: Prevent more than one vaporizer being ON at a time when used on Selectatec Manifolds. | The Plug System S Plus, when used with the Vapor 19.1, incorporates an interlock mechanism that prevents more than one vaporizer from being ON at a time. This mechanism functions on the same principle as the predicate Tec 5 vaporizer, using extension rods, and is described as having the "same intended use and principal of operation." |
| Bypass Functionality (Vapor 19 with Plug System S Plus): Internally bypass gas flow when mounted on a Selectatec manifold, similar to a Vapor 19 on a North American Dräger anesthesia machine. | With the Plug System S Plus mounted, the manifold port valves are continually open, and the bypass function is internal to the Vapor 19 vaporizer, matching the bypass route of a Vapor 19 on a North American Dräger anesthesia machine. |
| Compliance with ASTM Standard F 1161-88: Adherence to relevant safety and performance standards for anesthesia vaporizers. | Qualification included testing to demonstrate compliance with ASTM Standard F 1161-88. |
| Compatibility with Ohmeda Anesthesia Machines: Effects of mounting on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. | Qualification included testing for the effects of mounting the device on representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. |
| Safety: Device operates without introducing new or increased risks. | The entire submission aims to demonstrate that the modifications (addition of the Plug System S Plus) do not alter the fundamental safety or effectiveness of the Vapor 19.1, especially in comparison to the cleared predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a dataset for an AI model. The "testing" referred to is for hardware qualification.
- Sample Size for Testing: Not explicitly stated numerically (e.g., number of units tested). It mentions "testing to demonstrate compliance" and "testing for the effects of mounting the device on representative Ohmeda anesthesia machines." The term "representative" implies a selection, but no specific count is given.
- Data Provenance: The testing appears to have been conducted by the manufacturer, Drägerwerk AG (Germany) or North American Dräger (USA), as part of their qualification process. It is an internal prospective testing related to device development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable to this document. The device is a mechanical adapter, not a diagnostic tool requiring expert interpretation of results. "Ground truth" in this context would be engineering specifications and functional performance. The "experts" involved would be the engineers and technicians performing the qualification tests. Their specific number and detailed qualifications are not provided, but it's assumed they are qualified personnel for device testing.
4. Adjudication Method for the Test Set
This is not applicable. There's no interpretive task that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and compliance with engineering specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This device is a mechanical adapter. It is not an AI-based system, nor does its function involve human interpretation of cases or data. Therefore, an MRMC study and effect size in human reader improvement with AI are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a mechanical component. There is no algorithm or AI component involved, standalone or otherwise.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is based on:
- Engineering Specifications: The design parameters and functional requirements of the Plug System S Plus.
- Predicate Device Performance: The known and accepted performance characteristics of the Dräger-Vapor® 19.1 and the Ohmeda Tec 5 Continuous Flow Vaporizer. This includes their interlock mechanisms and vaporizer bypass functions.
- Industry Standards: Compliance with ASTM Standard F 1161-88.
- Functional Testing: Demonstrating that the device performs its intended function (mounting, interlock, bypass) correctly on representative machines.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and established medical device standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).