(318 days)
CoreLevée is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, toning and firming of buttocks and thighs.
CoreLevée is a non-invasive electromagnetic muscle stimulator that applies high-intensity electromagnetic field to the treatable body areas through two applicators. The coil enclosed in each applicator produces a magnetic field that induces electric currents within neuromuscular tissues. At its optimal level, these electric currents depolarize neuromuscular tissues causing effective muscle contraction.
CoreLevée consists of a Main Body, a software integrated color-touch LCD screen, two applicators, three applicator fixing belts, and a patient switch. The Main Body allows the proper operation of the entire system. The LCD screen works as a control panel and displays step-by-step guides through the entire therapy procedure. The therapeutic parameters such as treatment time, location, and stimulation frequency and intensity are easily set using the touch screen and the dial knob on the device. The micro-controller within the software continuously monitors the device system for its operation and functional normalcies. Two applicators can be used alone or together on top of clothing.
The device is a mobile standalone equipment with four wheels. The device housing protects the patient from electrical shock and mechanical injuries.
The provided document is a 510(k) summary for the CoreLevée device. It details the device's characteristics, indications for use, and a comparison to a predicate device (BTL 799-2). However, it does not contain a study that establishes acceptance criteria for clinical performance and demonstrates the device meets those criteria, nor does it provide a table of acceptance criteria and reported device performance in a clinical context.
The "Performance Data" section primarily focuses on:
- Biocompatibility: Stating it's not applicable as the device doesn't directly contact the skin.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Listing compliance with various IEC standards.
- Sterilization and Shelf-Life: Stating it's not sterile and is reusable with a 5-year expected service life.
- Software Validation and Verification Testing: Classifying the software as "moderate" level of concern and confirming validation.
- Performance Bench Testing: Confirming magnetic field intensity, oscilloscopic characterization, pulse repetition/duration, and theoretically derived induced current in tissues are within specifications and comparable to the predicate.
This document describes technical and safety performance, but not clinical acceptance criteria or a clinical study proving efficacy against such criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a predicate device, which often means showing similar technological characteristics and performance (including safety and, in some cases, limited clinical data if specifically required for a new question of safety/effectiveness). In this case, the manufacturer primarily relies on a comparison of technological characteristics and bench testing to demonstrate substantial equivalence, rather than a separate clinical study with predefined acceptance criteria for patient outcomes.
Therefore, I cannot provide the requested table of acceptance criteria and the study proving the device meets those criteria because the provided text does not contain this information. The document focuses on demonstrating substantial equivalence through technical specifications and bench testing, not clinical efficacy trials with specific acceptance metrics.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).