(298 days)
The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.
This FDA 510(k) summary for the MicroAire LipoTower System (K113128) does not describe a study to prove the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Sound Surgical Technologies LLC - SoundVaser System, K022051) by comparing technical characteristics, indications for use, and compliance with recognized standards.
Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC/standalone studies are not applicable or not provided in this type of regulatory document.
However, I can extract information related to the technical characteristics and standards compliance, which serve as a form of "acceptance criteria" for electro-mechanical medical devices like the MicroAire LipoTower System.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this type of device are primarily related to its technical specifications matching or being comparable to the predicate device, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.
Table of Acceptance Criteria (Technical/Compliance) and Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion / Standard | Predicate Device Performance (Sound Surgical Technologies, LLC (K022051)) | Proposed Device Performance (MicroAire LipoTower System) |
|---|---|---|---|
| Indications for Use | Fragmentation, emulsification, and aspiration of soft tissue in specified surgical specialties, and subcutaneous fatty tissues for aesthetic body contouring. | Stated for predicate | Same |
| Physical Characteristics | Size (H x W x D) | 89 x 46 x 43 cm | 106 x 56 x 69 cm (Different but within expected range for such systems) |
| Electrical Input | Input Power | 115 & 230 VAC, 50-60 Hz | 115 VAC, 50-60 Hz (Comparable in relevant power range) |
| Irrigation System | Type | Adjustable Flow | Same |
| Pump Type | Peristaltic | Same | |
| Flow Rate | (Not specified for predicate) | 50-600 ml/min | |
| Suction System | Vacuum | 24 in Hg | Adjustable up to 29 in Hg (Improved/higher capability) |
| Pump Type | (Not specified for predicate) | Rotary Vane | |
| Control Interface | Footswitch control | Yes | Yes |
| Collection Canisters | Capacity | 1250 ml | 1200 ml, 2000 ml (Similar/additional capacity options) |
| Biofilter | Presence | N/A (not specified for predicate) | Yes |
| Regulatory Status | Prescription Use | Yes | Yes |
| IEC Classification | Class I, Type | Class I, Type BF | Class I, Type B (Different type, but both standard classifications for medical electrical equipment) |
| Electrical Safety | IEC EN 60601-1 (General Requirements for Safety - 2nd Edition) | Compliant | Compliant |
| CAN/CSA C22.2 No. 601.1 (Medical Electrical Equipment, Part 1) | Compliant | Compliant | |
| UL 60601-1 (Medical Electrical Equipment, Part 1) | Compliant | Compliant | |
| EMC - Radiated Emissions | CISPR 11 for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant |
| EMC - Conducted Emissions | CISPR 11 for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant |
| EMC - Harmonics | IEC 61000-3-2 for IEC 60601-1-2 clause 36.201.3.1 | N/A (Predicate not specified) | **Not applicable (to devices whose voltage |
§ 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.