(53 days)
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.
Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.
Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.
The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.
The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.
Sterility:
Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.
This K042943 submission for the NOUVAG AG Vacuson 40 and Vacuson 60 is a 510(k) premarket notification. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on a comprehensive de novo validation study with specific acceptance criteria and detailed performance reporting.
Based on the provided information, here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for a 510(k) submission of this nature. 510(k)s for devices like powered suction pumps often rely on demonstrating adherence to recognized standards and direct comparison of functional specifications to a legally marketed predicate device.
The brief summary of nonclinical tests states: "The Vacuson 40 and Vacuson 60 have been designed and tested to applicable safety standards. The Vacuson 40 and Vacuson 60 do not raise any new issues of safety, effectiveness, or performance of the product." This indicates an implicit acceptance criterion of meeting applicable safety standards and performing similarly to the predicate without introducing new risks.
Key Performance Specifications (from Device Description):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maximum Suction Flow Rate: | |
| Vacuson 40 | 40 litres/min |
| Vacuson 60 | 60 litres/min |
| Sterility: | Sterility by user up to 134°C for suction tube, suction jars with jar lids. |
| Operational Mechanism: | Continuously regulatable suction by a valve, monitored through a manometer. |
| Safety Features: | At least one suction jar with overflow safety device, bacterial filter. |
2. Sample Size Used for the Test Set and Data Provenance
Not specified. This type of detail is not typically included in a 510(k) summary for a powered suction pump where testing is more focused on engineering specifications and adherence to standards rather than a clinical "test set" in the context of diagnostic accuracy. The testing would primarily involve laboratory measurements of flow rates, pressure, and safety features.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a device like a powered suction pump would be its engineering specifications and performance against industry standards, not expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of a test set requiring adjudication in the context of this device and submission type.
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
Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm. Performance would be assessed in terms of its mechanical function (suction power, flow rate) in a standalone manner, separate from human operation, to meet its specifications.
7. The Type of Ground Truth Used
The ground truth used for this type of device would be its engineering specifications and performance against recognized industry standards. This includes:
- Measurement of maximum suction flow rate.
- Verification of overflow safety device functionality.
- Confirmation of bacterial filter efficacy (if applicable to the device, or specified for the filter itself).
- Temperature resistance for sterilization.
- Compliance with electrical safety and electromagnetic compatibility (EMC) standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
In summary:
This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368) by showing similar intended use, technological characteristics, and adherence to applicable safety standards. The information provided is typical for a summary of a traditional medical device's premarket notification, where the "study" is often a series of engineering tests and comparisons rather than a clinical trial with acceptance criteria defined by diagnostic accuracy metrics.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.