(90 days)
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.
| Parameter/Indication | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Aesthetic Body Contouring (Dominant Flex) | Equivalent performance to predicate devices (Dominant 50 Lipo K063336 and HK Liposuction Aspirator Model AP-III K032802) in: | |
| Free air flow | Equivalent to predicates. | Demonstrated equivalent free air flow to predicate devices. |
| Vacuum build up | Equivalent to predicates. | Demonstrated equivalent vacuum build up to predicate devices. |
| Suctioning capacity (fluids with varying consistencies and cannulas) | Equivalent to predicates. | Demonstrated equivalent suctioning capacity of fluids with varying consistencies (sterile water, apple sauce, solidifier mix) and various cannulas to predicate devices. |
| Epicardial Ablation Probes (Basic and Dominant Flex) | Maintain vacuum at specified level when the pump is running. | Maintained vacuum at -600 mmHg ± 10% when the pump is running with the Estech Cobra Fusion Ablation System. |
| Cardiac Tissue Stabilizers (Basic and Dominant Flex) | Maintain vacuum at specified levels for a sustained period. | Maintained vacuum at settings of -250 or -400 mmHg for up to 8 hours with the Medtronic Octopus Evolution and Urchin Evo Positioners. |
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.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.