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The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use in hospitals and clinics.

Basic: The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.

Dominant Flex: The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.

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 l/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.

This document is an FDA 510(k) summary for the Medela Basic and Dominant Flex suction pumps. It states that no clinical testing was performed for this submission, as it relates primarily to re-phrased and slightly expanded indications for use. Therefore, the information typically found in acceptance criteria tables and study results for clinical performance is not present.

However, based on the provided document, here's what can be inferred and stated regarding the device and its compliance, specifically focusing on the non-clinical aspects and the lack of a clinical study for this 510(k):

Acceptance Criteria (Non-Clinical) and Reported Device Performance

Since this 510(k) is an administrative change to re-phrase and expand existing indications for use, and explicitly states "The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing," there isn't a table of clinical acceptance criteria and performance data as one would expect from a new device submission or a performance study.

Instead, the acceptance criteria for this specific submission relate to non-clinical performance and compliance with relevant standards. The document highlights:

Study Details (Focusing on the 510(k) submission, not a clinical study):

For this particular 510(k) submission (K170329), a traditional clinical study with patient data was not conducted. The basis for substantial equivalence relies on:

1. Predicate Device Equivalence: The Medela Basic and Dominant Flex were previously cleared under K150134. This submission re-phrases indications and adds "general suction" which is stated as being identical to the predicate device, Penumbra Aspiration Pump (K051758).
2. Non-Clinical Testing: Verification and Validation testing were performed to ensure that the labeling changes did not adversely affect the device's performance or compliance with safety standards.

Therefore, many of the typical questions for a clinical study are not applicable here.

1. Sample sizes used for the test set and the data provenance: Not applicable, as no new clinical test set was used for this 510(k) submission. Non-clinical testing (e.g., electrical safety, EMC) would involve testing units of the device, not patient data. The document implies prior testing for the original clearance (K150134) is still valid.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcomes. For non-clinical testing, expert judgement might be involved in reviewing test protocols and results, but it's not "ground truth" in the clinical sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 suction pump, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this specific submission, the "ground truth" for the device's performance is adherence to established engineering and safety standards, and functional verification that the re-phrased indications do not alter the physical operation or safety of the pump. The [K150134](https://510k.innolitics.com/search/K150134) submission, which initially cleared these devices, would have relied on previously established predicate device performance and non-clinical testing.
7. The sample size for the training set: Not applicable. This refers to machine learning algorithms, which is not what this device is.
8. How the ground truth for the training set was established: Not applicable.

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The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use during surgery.

The Basic Suction Pump is 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 Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes.

The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, 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 Dominant Flex Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes.

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 l/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 the Medela AG Basic and Dominant Flex Suction Pumps (K150134). The submission is a 510(k) for new Indications for Use, therefore, the study focuses on bench testing to demonstrate performance for these new indications, rather than a clinical study establishing new acceptance criteria for the entire device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a table format with corresponding reported performance for the entire device. Instead, it describes performance characteristics demonstrated through bench testing for the new indications.

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

• The document primarily describes bench testing, which typically involves a limited number of test units (samples) of the device itself rather than a large human subject test set.
• Sample size for the device under test: Not explicitly stated, but bench testing generally uses a small number of production or representative units.
• Data Provenance: The testing was conducted by Medela AG, likely at their facilities, indicating in-house (prospective) testing for the specific purpose of this 510(k) submission. No country of origin for test data is specified beyond the manufacturer's location (Switzerland).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• This information is not applicable as the studies are entirely non-clinical (bench testing). No human experts were involved in establishing "ground truth" for diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are entirely non-clinical (bench testing).

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 conducted. The submission focuses on non-clinical bench testing to demonstrate substantial equivalence for new indications.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable as the device is a physical suction pump, not an AI algorithm. The performance evaluation is inherently a standalone assessment of the device's physical capabilities.

7. The Type of Ground Truth Used

• The ground truth for the bench testing was based on objective measurements of physical parameters such as free air flow, vacuum build-up, suctioning capacity, and vacuum maintenance. This is a form of objective physical measurement rather than expert consensus, pathology, or outcomes data. Comparison was made against the specifications and performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a physical suction pump, not an AI algorithm that requires a training set.

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

• This information is not applicable as the device is a physical suction pump, not an AI algorithm.

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