(112 days)
The Medela® Dominant 50 Lipo is intended to be used for aesthetic body contouring.
The Medela® Dominant 50 Lipo Suction Pump is identical to original and approved Medela Dominant 50 Secretion Aspirators (K021368), which is all based on the wellproven Medela piston-cylinder system.
The Medela® Dominant 50 Lipo suction pump is an AC powered aspirator and incorporates in its housing an AC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a membrane vacuum requlator, a safety device of polysulfone with an overflow protection device and connection tubing, an electric cord and an instruction manual.
The standard mobile version includes a mobile stand with fitting rails 10 x 25 mm, 4 antistatic castors, two with locking device and an integrated ON/OFF foot switch. The Medela® Dominant 50 Lipo also comes in rack versions i.e. without handle and cable holder for storage/operation in racks with reduced space.
This notification for the Medela® Dominant 50 Lipo Suction Pump is for labeling change and to include additional indications. There have been no modifications or design changes to the currently cleared and marketed Medela® Dominant 50, 510(k) No. K021368.
The Medela® Dominant 50 Lipo Suction Pump is a further innovative development of Medela's well-proven piston/cylinder system. The drive power is transferred to the piston/cylinder modules. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.
The Medela® Dominant 50 Lipo suction pump has a suction capacity of 50 liters per minute and a maximum vacuum up to -90 kPa (-675 mmHg). The pump is marked "high vacuum - high flow".
A variety of reusable and disposable accessories are available. A variety of cannuals for various liposuction procedures and aesthetic body contouring are also available.
The Medela® Dominant 50 Lipo Suction Pump's acceptance criteria and the study proving its compliance are laid out below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No "new aspects regarding safety and effectiveness" due to modifications. (Implied acceptance criteria based on decision-making process for device changes.) | The device is "identical in construction and performance to the legally marketed device as submitted under FDA File Number K021368." The "only modification relates to a more differentiated trade name - Medela® Dominant 50 Lipo instead of Medela® Dominant 50 only (Lipo reflects the intended use)." |
| Substantial Equivalence to Predicate Device | Concluded to be "substantially equivalent, reliable, safe and effective for the intended use" to the Medela® Dominant 50 Secretion Aspirators (K021368) and other listed predicate devices (HK Liposuction Aspirator, Vacusat®). |
| Adherence to FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" | The modification (trade name and additional indications) "does not affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process)." |
| Specific Performance Metrics (for a powered suction pump) | Suction capacity of 50 liters per minute. Maximum vacuum up to -90 kPa (-675 mmHg). Marked "high vacuum - high flow." (These are performance characteristics of the identical predicate device, not new test results for this 510(k) submission). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes a 510(k) summary for a substantial equivalence determination, not a clinical study with a distinct test set of patient data.
- Sample Size: Not applicable. This submission relies on the existing clearance of an identical device and asserts that no new performance testing data from a "test set" is required because there are no technical changes affecting safety or effectiveness.
- Data Provenance: Not applicable in the context of a new test set. The submission refers to the predicate device's existing clearance (K021368), which implies that any performance data from that previous clearance would be considered "retrospective" in relation to this administrative update. The document itself does not detail the provenance of the data that supported the original K021368 clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described above, there was no new "test set" of data requiring expert evaluation for ground truth establishment. The substantial equivalence determination is based on the technical characteristics of the device and comparison to legally marketed predicates.
4. Adjudication Method for the Test Set
Not applicable. No new test set requiring adjudication was used.
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 for lipoplasty and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical medical device (suction pump), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, the Medela® Dominant 50 Secretion Aspirator (K021368), and its adherence to relevant performance specifications (e.g., suction capacity, maximum vacuum). The claim is that the proposed device is identical in all relevant aspects to this predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.