(267 days)
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
The BTL Elite is a shortwave diathermy system intended for the therapeutic application of deep heating. The control unit consists of the control system and the electronic system. The control system contains the main microprocessor and software for control of the entire equipment; the electronic system contains the complete electronics for electromagnetic field generation. The device is operated via a 5.7 inch color touch screen and graphic user interface that allows for maximum operator comfort. A large control knob is provided to increase and decrease output power. A neon check light is provided to verify that radiofrequency energy is being transmitted between the capacitive applicators. If such energy is transmitted, the indicator illuminates. If the initial energy is set too low, the check light will not illuminate. The check light is not designed for the use with inductive applicators. For therapeutic procedures, various capacitive and inductive applicators are available. Applicators of various size are available to accommodate different size treatment areas. Applicators are connected to the rear of the main unit using the connector cable and are affixed to the adjustable arm. With the capacitive field method, the treated body part is located in the highfrequency electric field between two insulated electrodes. The body and the applicators together form a capacitor. The transformation of electromagnetic energy into heat occurs in tissues of low blood circulation. Thus, the major amount of heat is generated in areas near the surface. While contact application causes intensive warming of superficial tissues, contactless application causes deeper warming. The inductive field method produces high-frequency electric currents within the body tissue by means of induction. These currents increase with increasing electric conductivity of the corresponding tissue region. The danger of excessive heating of the outer layers of tissue is therefore significantly reduced. Individual treatment parameters can be manually set and adjusted by the operator. All treatment parameters can be set and saved as a reference for future therapy sessions. The BTL Elite control unit continuously monitors the output of the system for safe operation. In addition, output can be terminated at any time during a treatment session by the patient pulling the safety switch. If the therapy is stopped by pulling the safety switch, the applicator immediately stops emitting electromagnetic energy and the unit switches to a pause mode. Patient safety is assured through a number of ways including proper maintenance of the system, operator training, and adherence to the general safety precautions and instructions provided in the user manual.
The provided document is a 510(k) summary for the BTL Elite Shortwave Diathermy device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain any performance study data, acceptance criteria, or information about how the device meets any specific criteria beyond establishing substantial equivalence to existing devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such information is not present in the provided text.
Specifically, the document states under "Performance Data": "The review of the technical characteristics, indications for use, and verification and validation information provided in the 510(k) Premarket Notification demonstrates that the BTL Elite system is substantially equivalent to its predicate devices." This implies that the 'study' conducted was a comparison to predicate devices, and the 'acceptance criteria' were met by demonstrating this substantial equivalence, rather than through a dedicated performance study with quantitative metrics reported here.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.