(110 days)
Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle spasm
- Localized increase of 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 surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Muscle re-education
- Maintaining or increasing range of motion
Therapeutic Massager:
- Relieves muscle spasms
- Provides temporary relief of minor muscle aches and pains
- Temporarily improves local blood circulation
- Temporarily reduces the appearance of cellulite
The TNN-DU810 Non-Invasive Subdermal Therapy System is comprised of the following main components:
A system console including software and control electrodes;
A control and display panel: .
Device accessories including muscle stimulator electrodes (ME2221, Mettler Corp., K#013192) and cables, ultrasound transducers (applicators) (ME7513, Mettler Corp.) acoustic gel (Sonigel, Mettler Corp), and cables. The electrodes. ultrasound transducers and acoustic gel have all been cleared under the Mettler Electronics Corp. 510(k). Also included is a Dermosonic vacuum treatment roller head, cleared under the Dermosonic device. K024307.
The TNN-DU810 device has dual frequencies ultrasound therapy, muscle stimulator systems and therapeutic vacuum massager.
The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The system consists of the Alfatech DU857 device (K#052340) and the Dermosonic Therapeutic Vacuum Applicator, a component cleared in the Dermosonic K#024307 ..
The frequency Ultrasound Therapy, Muscle Stimulator System is identical to the DU857. It is important to note that there is no electric connection between the ultrasound therapy, muscle stimulator system and the therapeutic vacuum massager.
Each of the two components of the system (ultrasound plus neuromuscular stimulation) and the therapeutic massager function independently and have no connection between them.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TNN-DU810 Non-Invasive Subdermal Therapy System:
Summary of Device Performance and Acceptance Criteria:
The provided document is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically demonstrated by showing substantial equivalence to a legally marketed predicate device, rather than explicit quantitative performance metrics against pre-defined thresholds. The device aims to achieve similar functionality and safety as the predicate devices.
The "acceptance criteria" can be inferred from the comparison table (Table 1) and the overall conclusion of substantial equivalence. The device is 'accepted' if it can demonstrate equivalent characteristics and performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item for Comparison | Acceptance Criteria (Predicate Device) | Reported Device Performance (TNN-DU810) |
|---|---|---|
| Intended Use | Therapeutic vacuum Massager and Ultrasonic Diathermy, including: temporarily improvement local blood circulation and temporarily reduction the appearance of cellulite. | Therapeutic vacuum Massager, Ultrasonic Diathermy and neuromuscular stimulation, including: temporarily improvement local blood circulation and temporarily reduction the appearance of cellulite. (Note: Added neuromuscular stimulation to intended use compared to Predicate 2) |
| Design | 1 model, 1 ultrasound applicators, 3 vacuum treatment roller head | 1 model, 2 ultrasound applicators, 4 conductive electrodes, 1 vacuum treatment roller head |
| Specifications | Not specified | Ground current leakage |
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator 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 applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles 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 ultrasound and muscle stimulator 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 ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.