(34 days)
Aesthetic body contouring.
The Vitruvian Aspirator is a pre-assembled device consisting of:
- . Housing: Powder Coated Steel
- . Vacuum Pump: Dual ½ hp dual voltage rocking piston motor with Maximum Suction flow rate of 125PSI, 6.4 cfm, 27.5in HG(711 mm of Hg)
- . Vacuum Meter Display: The device displays the vacuum levels digitally. The software does not control the unit in any way and does not accept any input.
- . Power Operations: 120/230 volt 50/60hz
- . Control: Pressure control valve located on the face of the device with rotary control knob with both LED numerical and Color Graphic LED display
- . Footswitch: Dual activated air powered
- IV Pole .
- . Filter: Bacterial filter having a pore size of 0.3 microns or less.
The provided document describes a 510(k) submission for the "Vitruvian Ultimate Aspirator." This product is a suction lipoplasty system, which is a medical device and not an AI/ML software device. Therefore, the questions related to AI/ML specific aspects like training data, inference, expert adjudication, etc., are not applicable.
Here's the information derived from the document regarding the acceptance criteria and performance testing for this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on compliance with recognized medical device standards and functional performance testing. The reported performance indicates compliance with these criteria.
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| IEC/EN 60601-1-2:2007/AC:2010 Clause 4.1 | Complies |
| IEC/EN 60601-1-2:2007/AC:2010 Clause 5 | Complies |
| IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 | All Requirements/Tests either Passed or were N/A |
| IEC 60601-1-6:2010 (Third Edition) | All Requirements/Tests either Passed or were N/A |
| IEC 62366:2007 (First Edition) | All Principles Evaluated either Passed or were N/A |
| Vitruvian Ultimate Aspirator Vacuum Display Calibration | All test results are within acceptable criteria range |
| Functional Equivalence to Predicate Device (Byron PSI-TEC Aspirator, K981215) in terms of: | |
| - Pump type (Two cylinder piston) | Same (Two cylinder piston) |
| - AC Power input (115-240V, 60-50Hz) | Similar (120V/230V, 50/60Hz) |
| - Maximum Vacuum (28 in of Hg) | Similar (27.5 in of Hg) |
| - Maximum flow rate (4.75 CFM) | Similar (6.4 CFM) |
| - Sound level (52 dB) | Similar (50 dB) |
| - Pressure control (Knob to control vacuum) | Same (Knob to control vacuum) |
| - Footswitch (Dual activated air powered) | Same (Dual activated air powered) |
| - Safety Features (Manual overflow valve in canister) | Same (Manual overflow valve in canister) |
| - Housing (Powder Coated Steel) | Same (Powder Coated Steel) |
| - IV Pole for Solutions | Same (Yes) |
| - Filter port | Same (Yes) |
| - Filter (0.3 Micron) | Same (0.3 Micron) |
| - Indication for Use | Same (Aesthetic body contouring) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for AI/ML. Instead, performance testing was conducted on the physical device itself. The provenance of this testing is indicated as the "Manufacturing Facility."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication.
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 is a physical medical device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional aspects, the "ground truth" or reference for performance is established by the specified industry standards (e.g., IEC 60601 series) and the functional specifications of the predicate device. For the vacuum display calibration, the "acceptable criteria range" serves as the ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML system requiring 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.