(233 days)
Aesthetic Body Contouring
The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.
The provided FDA 510(k) summary for the Vitruvian Liposaber pertains to a suction lipoplasty system, which is a physical device used for aesthetic body contouring. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and comparison of technical specifications, rather than clinical studies involving human patients or AI performance metrics.
Therefore, the requested information regarding AI acceptance criteria, specific study designs (MRMC, standalone), human reader performance improvement, multi-expert ground truth establishment, training and test set sample sizes for AI, and adjudication methods is not applicable to this device and its 510(k) submission.
The document explicitly states: "No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non-clinical testing details in this submission support the substantial equivalence of the device." This confirms that the approval is based on equivalence to existing, commonly understood devices, not on novel AI performance.
Below is a summary of the acceptance criteria and device performance as demonstrated in this 510(k) in the context of the device's technical specifications and non-clinical testing.
Acceptance Criteria and Reported Device Performance (Non-Clinical) for Vitruvian Liposaber™
The Vitruvian Liposaber™ is a physical medical device (suction lipoplasty system). Its acceptance criteria and performance are demonstrated through comparison to a predicate device and non-clinical testing, as opposed to AI performance metrics.
1. Table of Acceptance Criteria (as implied by comparison to predicate and non-clinical testing) and the Reported Device Performance:
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Subject Device: Vitruvian Liposaber™) |
|---|---|
| Intended Use Equivalence: Aesthetic Body Contouring | Aesthetic Body Contouring (Same as Predicate) |
| User Equivalence: Trained and experienced healthcare professionals | Healthcare professionals completely familiar with use of the device (Same as Predicate) |
| Mechanism of Action Equivalence: Electronic control system designed to reciprocate a cannula in lipoplasty applications. | Electronic control system designed to reciprocate a cannula in lipoplasty applications. (Same as Predicate) |
| Electrical Safety Compliance: Meet IEC 60601-1 standards | Complies with IEC 60601-1:2005 and IEC60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Electromagnetic Compatibility (EMC) Compliance: Meet IEC 60601-1-2 standards | Complies with IEC 60601-1-2:2014+A1:2020 (Meets/Updates to applicable standards) |
| Biocompatibility: Intended use compatible materials | Considered biocompatible per ISO 10993-1 |
| Software Verification and Validation: Per IEC 62304/FDA Software Guidance | Verification and validation per IEC 62304/FDA Software Guidance |
| System Functionality - Stroke Rate/RPM Display Accuracy: Accurate display of speed. | Stroke Rate/RPM Display Calibration Validation: Pass |
| System Functionality - Stroke Distance Validation: Cannula reciprocation within specified range. | Stroke Distance Validation: Pass (2.90 mm +/- 0.3mm) (Similar to Predicate 2.8mm ±0.4mm) |
| System Functionality - Dynamic and Static Load Performance: Ability to perform under expected loads. | Dynamic and Static Load Validation: Pass |
| System Functionality - Surface Temperature during Operation: Patient contacting surface temperature within safe limits. | ** |
§ 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.