(18 days)
Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used for the treatment of many conditions such as:
- Relieving pain.
- Reducing muscle spasm.
- Increasing range of motion of contracted joints using heat and stretch techniques.
- Increasing blood flow to tissues in the treatment area.
The AutoTherm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice. The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the AutoTherm 390. The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting cables for the condenser and inductive coil applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.
The provided documentation for the AUTO*THERM 390, MODEL ME 390 (K042554) does not include a study describing the acceptance criteria or a study proving the device meets said criteria.
The information primarily consists of:
- 510(k) Summary Statement: Details the device name, predicate device, a description of the proposed device, and its intended use.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence to a predicate device.
- Indications for Use Statement: Reiterates the intended uses of the device.
There is no mention of:
- Specific acceptance criteria (performance metrics, thresholds).
- A study design or execution.
- Sample sizes (test, training, or validation sets).
- Data provenance.
- Expert involvement or adjudication for ground truth.
- Comparative effectiveness studies (MRMC).
- Standalone performance studies.
- Ground truth methodologies.
The clearance of this device (K042554) was based on substantial equivalence to a predicate device (Auto*Therm 395, Model 395) as stated in the FDA clearance letter ("determined the device is substantially equivalent... to legally marketed predicate devices"). In substantial equivalence pathways, it is common for manufacturers to demonstrate that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, rather than conducting new clinical performance studies with pre-defined acceptance criteria, especially for well-established technologies like shortwave diathermy.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.