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The Airbrush™ Liposculptor System is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The Airbrush TM Liposculptor System consists of a handheld pneumatic reciprocating hand-piece, multiple detachable and interchangeable cannulas, and the power control console (Intellimotion™ Controller) and connection cables, The Airbrush™ Liposculptor System uses external air sources which the user may choose among those readily available within a hospital or clinical environment. The pneumatic hand-piece reciprocates the inner of the two attached cannulas through an infinitely adjustable stoke length of 0-10 cm at an infinitely adjustable rate of 0-300 strokes per minute. The hand-piece is powered and controlled by the Intellimotion™ Power Control Console. Reciprocation of the interchangeable inner cannulas is effected by means of a releasable coupling to a carriage riding on a dual acting magnetic cylinder. The knob on the side allows the surgeon to adjust with his/her index finger the stroke length from 0 to 10 cm. When turned to 0, the stroke knob turns reciprocation "off" and positions and locks the inner cannula at the forward most position for cannula changing. removal or manual liposuction The trigger on the bottom, when depressed, serves to adjust the rate of reciprocation from 0-300 cpm. When released or when the instrument is set down, a spring elevates the trigger so that reciprocation is turned "off" and the inner cannula is positioned and locked at the forward most position for cannula changing, removal or manual liposuction. The slide latch at the front of the trigger allows the trigger to be locked in a depressed position when in the posterior position and the trigger to be opened for cannula changing or removal when placed in the anterior position. Standard suction connecting tubing is used to connect the barb at the base of the inner cannula to a conventional aspiration unit. The inlet valves at either end of the dual acting magnetic cylinder are alternately pressurized and vented by connection to air lines entering the multi-plug at the rear of the instrument. A transducer in the housing provides instantaneous feedback information as to the motion and location of the cylinder carriage at all times. The interchangeable cannula pairs are essentially blunt-tipped hollow concentric tubes of either stainless steel or plastic. The internal diameter ranges from 2mm to 8mm and the overall length external to the instrument varies from 14 to 33 cm length. In each case one or more smaller oval apertures on the inner cannula remain aligned with a longer slot on the outer cannula during each stroke. The surgeon may vary the rate and stroke of the reciprocating action while he is actively performing liposuction. Should the surgeon set either the rate or length of stroke to zero, reciprocation is turned "off" and the device functions as a manual aspiration device. The reciprocating action of the Airbrush™ Liposuction simulates the manual hand motion of the surgeon. At the same time, the powered cannula minimizes surgical effort by reducing the amount of necessary hand motion. The Airbrush ™ Liposuction System has a built-in safety feature which precludes the device being activated when cannulas are being changed or in the event hard tissue is encountered. Since inner cannula motion is by means of a magnetic linkage only, if significant resistance is encountered to inner cannula motion, the magnetic linkage will be reversibly uncoupled. Sterility of the multiple use Airbrush ™ Liposculptor hand-piece (reusable) and connection cables (reusable) is achieved through Steam Sterilization, the disposable suction cannula and connection cables are sterilized using Gamma Radiation or Ethylene Oxide Sterilization.

The provided text is a 510(k) premarket notification for the Airbrush™ Liposculptor System, which is a medical device. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not applicable to this type of regulatory submission.

The 510(k) submission primarily describes:

• Device Name: Airbrush™ Liposculptor System
• Intended Use: Removal of soft tissue and fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring.
• Device Description: Consists of a handheld pneumatic reciprocating hand-piece, detachable/interchangeable cannulas, and a power control console (Intellimotion™ Controller) with connection cables. It uses external air sources.
• Mechanism of Action: The pneumatic hand-piece reciprocates the inner of two attached cannulas with adjustable stroke length (0-10 cm) and rate (0-300 strokes per minute). This action simulates manual hand motion while reducing surgical effort.
• Safety Feature: A built-in safety feature uncouples the magnetic linkage if significant resistance is encountered, preventing activation when cannulas are being changed or hard tissue is encountered.
• Sterilization: Reusable components are steam sterilized; disposable cannulas and cables are sterilized using Gamma Radiation or Ethylene Oxide.
• Software: Controls reciprocation rate, stroke, and cushioning based on surgeon input and transducer feedback.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a performance study under acceptance criteria.

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