Search Results

The Basic and Dominant Flex Suction Pumps are indicated for vacuum extraction, aspiration during flexible endoscopy and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside.

The Medela Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela Basic and Dominant Flex are user friendliness and simple cleaning.

Medela Basic and Dominant Flex cover the 4 main functions of

• Powerful and high suction capacity .
• Rapid vacuum build-up .
• Low vibrations and quiet .
• Design; smooth surface and easy to . use and clean

The Medela Basic provides a fixed airflow of 30 l/m and the Medela "Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 I/m.

All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located.

Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version.

A variety of reusable and disposable accessories are available for use with the Medela ` Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

The provided text describes a 510(k) summary for the Medela Basic and Dominant Flex Suction Pumps. It aims to demonstrate substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, the submission does not contain information typically found in a study designed to prove a device meets specific acceptance criteria using defined performance metrics, sample sizes, expert ground truth, or MRMC studies. Instead, it focuses on comparing the new device's technological characteristics and intended use to previously cleared predicate devices.

Here's a breakdown of why the requested information is largely absent or not directly applicable to this type of submission, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not presented in the context of a de novo study the device meets. The submission primarily compares the new device's specifications (flow, maximum vacuum) to predicate devices and asserts equivalence.

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

Not applicable. The submission does not describe a clinical study with a "test set" in the sense of patient data or samples used to evaluate device performance against clinical endpoints. The "non-clinical tests" mentioned (Risk Analysis, Software Validation, Electrical Safety, etc.) are engineering and regulatory compliance activities, not clinical performance studies on a specific dataset.

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

Not applicable. No multi-reader, multi-case study with ground truth established by experts is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a powered suction pump, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not applicable. There is no clinical study described that required a "ground truth" (e.g., pathology, outcomes data) to evaluate diagnostic or therapeutic accuracy. The closest concept is the "Bench Testing" which verified engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

Not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) submission which focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through a comparison of technological characteristics, intended use, and adherence to relevant voluntary standards. It explicitly states that no clinical testing was performed on the new device, and thus, does not detail studies designed to establish and meet specific performance acceptance criteria in the manner requested.

Ask a specific question about this device