(157 days)
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.
T-SHAPE 2 is also equipped with:
- Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
- -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).
Through the display, the light sources and RF energy can be fully deactivated or activated.
The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.
T-SHAPE 2 comprises a main console unit and several handpieces.
A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):
- -Large multipole handpiece with 6 diode laser and 6 RF plates;
- -Medium multipole handpiece with 4 diode laser and 4 RF plates;
- -Small multipole handpiece 4 RF plates and 1 red LED;
- -Thermal imaging camera;
- -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
- -Mesosphere handpiece with 45 motorized rotating spheres.
The provided text describes a medical device called T-SHAPE 2 and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria, quantitative performance metrics, or a study design with sample sizes, expert qualifications, or ground truth establishment.
The document states that "T-SHAPE 2 has been tested in accordance to consensus standard to demonstrate safety and Performance," and lists general performance data categories:
- Biocompatibility testing: Evaluated according to "biocompatibility flow chart for the selection of toxicity tests for 510(k)s."
- Safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60825-1, IEC 60601-1-2, and IEC TR 60601-4-2 standards.
- Software Verification and Validation Testing: Documentation provided per FDA guidance.
- Performance Bench Testing: "Evaluated to verify the skin tolerance, effect and cosmetic properties of a professional treatment through evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments."
Without quantitative performance data, it is not possible to create a table of acceptance criteria and reported device performance. Also, all other requested details regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are missing from the provided text.
The closest the document comes to performance metrics for the T-SHAPE 2 is under "Performance Bench Testing," which mentions "evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments" for "skin tolerance, effect and cosmetic properties" and safety mechanisms for RF heating. However, no specific metrics, targets, or results are provided.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.