(294 days)
The SCIZER delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue(SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.
The SCIZER is specifically indicated for non-invasive waist circumference reduction.
The Subject Device consists of 2 handpieces, a control unit, a Touch LCD monitor, power supply unit for irradiation and for setting parameters after the main power and key switch is turned on.
HIFU energy is irradiated based on a linear scanning method through the handpiece depending on irradiation energy that is set in advance by the user. The Cartridge D13 used with the Subject Device focuses the HIFU energy from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. The Cartridge can treat a region of tissue up to 46mm long and 46mm wide. The Cartridge can apply a maximum of 24 lines at a time. As a result, tissue temperature rises over 56°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in the destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.
Immediately before the procedure, purified water was applied to the treatment area to promote the desired energy transmission of the ultrasound transducer. To minimize the pain from the thermal HIFU procedure, the cooling level was used through the GUI. It is recommended to use an ultrasound imaging system to visualize the sub-dermal regions of interest before treatment. It allows the physician to compile a precise view of the target treatment area.
The provided text describes the clinical study conducted for the SCIZER (SC1-M410) device to demonstrate its safety and effectiveness for non-invasive waist circumference reduction. This is a 510(k) submission, meaning the focus is on substantial equivalence to a predicate device, LipoSonix® system model 2.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary efficacy outcome serves as the key acceptance criterion.
| Acceptance Criteria (Primary Efficacy Outcome) | Reported Device Performance |
|---|---|
| Waist circumference reduction above 2.45 cm after two sets of treatments/procedures. | All three analysis sets (FAS, PPS, IAS) revealed a statistically significant difference in the waist circumference between the 8th week (and 16th week) and prior to the 1st procedure, compared to the reference value of 2.45cm (δ). The null hypothesis (D |
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.