(22 days)
Proposed Device Indications For Use (same as those for predicate device):
Therapeutic Ultrasound
- Pain relief
- Reduction of muscle spasm
- Localized increase in blood flow
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
- Temporary relaxation of muscle spasm (all waveforms)
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
- Increase of blood flow in the treatment area (all waveforms)
- Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
- Muscle re-education (all waveforms)
- Maintaining or increasing range of motion (all waveforms)
The Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 930 provides pre-modulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 930 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The two-channel Sonicator Plus 930 allows the clinician to utilize up to two different waveforms using two channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option.
The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine. The new Treatment Status Indicator shows the operator which stimulation waveform has been chosen for treatment. The status display moves when treatment output is active.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. Two LED output displays allow the clinician to monitor two channels simultaneously for two channel combination treatment protocols. These also allow the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 930 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms
The provided text is a 510(k) premarket notification for a medical device, the Sonicator® Plus 930. This document focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 992) rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or AI/software validation study would.
Therefore, the requested information components related to an AI/software study (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this document. This document details technical specifications and indications for use to show equivalence, not performance against specific clinical endpoints or diagnostic accuracy.
However, I can extract the "acceptance criteria" in the context of device specifications and the "reported device performance" as presented in the comparison tables. It's important to understand that these are design specifications and measured characteristics rather than statistical performance metrics from a user study.
Here's an interpretation based on the provided text, focusing on the nearest equivalents for "acceptance criteria" and "reported device performance":
Acceptance Criteria and Reported Device Performance for Sonicator® Plus 930
The "acceptance criteria" for the Sonicator® Plus 930, as presented in this 510(k) submission, are primarily defined by its technical specifications and performance characteristics being substantially equivalent to the predicate device, Sonicator® Plus 992. The "reported device performance" are the stated specifications and measured values for the Sonicator® Plus 930.
1. Table of Acceptance Criteria and Reported Device Performance
As this document is a comparison for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device's specifications meet or are comparable to those of the predicate device for safe and effective use. The "reported device performance" for the proposed device (Sonicator® Plus 930) is directly stated in the tables.
Below are selected examples of technical characteristics from the provided comparison tables, representing key "acceptance criteria" (predicate values) and "reported device performance" (proposed device values). A comprehensive table would include all parameters listed in documents {2}, {6}, {7}, {12}, {13}, {14}, and {15}.
| Characteristic / Acceptance Criteria (Predicate Device K984142) | Reported Device Performance (Proposed Device K013192) |
|---|---|
| Neuromuscular Stimulation | |
| Max output current (Interferential mode): 0-65 ±10% mA RMS, max., 1 Kohm load | 0-65 ±10% mA RMS, max., 1 Kohm load, Interferential mode |
| Max output current (Premodulated mode): 0-50 ±10% mA RMS, max., 1 Kohm load | 0-50 ±10% mA RMS, max., 1 Kohm load, premodulated and medium frequency modes |
| Max output voltage (Interferential mode): 0-65 ±10% volts RMS, 1 Kohm load | 0-65 ±10% volts RMS, 1 Kohm load, Interferential mode |
| Max output voltage (Premodulated mode): 0-50 ±10% volts RMS | 0-50 ±10% volts RMS premodulated mode and medium frequency modes |
| Frequency range (Interferential & Premodulated modes): 4000-4250 Hz ±1% | 4000-4250 Hz ±1%, (Interferential and Premodulated modes) |
| Beat Frequency (pps): 1-250 ±2 Hz or 10%, whichever is greater | 1-250 ±2 Hz or 10%, whichever is greater |
| Timer Settings: 1-60 minutes ±5% | 1-60 minutes ±5% |
| Maximum Leakage Current (Chassis): |
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.