SONICATOR PLUS 920

K111482 · Mettler Electronics Corp. · IMG · Aug 25, 2011 · Physical Medicine

Device Facts

• Record ID: K111482
• Device Name: SONICATOR PLUS 920
• Applicant: Mettler Electronics Corp.
• Product Code: IMG · Physical Medicine
• Decision Date: Aug 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. Relief of pain, muscle spasms and joint contractures that may be associated with: · Adhesive capsulitis · Bursitis with slight calcification · Myositis · Soft tissue injuries · Shortened tendons due to past injuries and scar tissues 3. Relief of pain, muscle spasms and joint contractures resulting from: · Capsular tightness · Capsular tightening 4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain EMS, TENS, Hi Volt and Russian waveforms 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis DC (Direct Current) 1. Relaxation of muscle spasms

Device Story

Sonicator® Plus 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation; used in clinical settings by healthcare professionals. Device inputs include user-selected treatment parameters via membrane panel or touch-sensitive screen. It delivers 1 and 3 MHz ultrasound via dual-frequency applicators and various electrical stimulation waveforms (Interferential, Russian, EMS, High Volt, TENS, microcurrent, DC). Microprocessor-controlled system allows simultaneous use of two different waveforms. Output is delivered to patient via applicators or electrodes. Clinicians use preset or customized protocols to manage pain, muscle spasms, and joint contractures. Benefits include deep heat therapy, muscle re-education, and circulation improvement. Device features automatic overload, over-current, and no-load trips for safety.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through comparative bench testing of electrical and ultrasonic output specifications against the predicate device.

Technological Characteristics

Metal casing; microprocessor-controlled; 1 and 3 MHz ultrasound; electrical stimulation waveforms (Interferential, Russian, EMS, High Volt, TENS, microcurrent, DC). Standards: ISO 14971, UL 2601-1, CSA C22.2 No 601.1-M90, IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-2-5, IEC/EN 60601-2-10, 21 CFR 1050.10. Connectivity: Standalone AC line powered.

Indications for Use

Indicated for patients requiring therapeutic deep heat for sub-chronic/chronic conditions (pain, muscle spasms, joint contractures, adhesive capsulitis, bursitis, myositis, soft tissue injuries, scar tissue), symptomatic relief of chronic intractable/post-traumatic/post-surgical pain, muscle re-education, prevention of disuse atrophy, increased local blood circulation, maintenance of range of motion, and post-surgical calf muscle stimulation to prevent venous thrombosis.

Regulatory Classification

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.

Predicate Devices

• Sonicator® Plus 940, Model ME 940 (K071137)

Submission Summary (Full Text)

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K111482

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# 510(k) SUMMARY

# SONICATOR® PLUS 920, ME 920

Submitter's Name: Address:

Mettler Electronics Corp. 1333 South Claudina Street Anaheim, CA 92805

Telephone: Fax:

714-533-2221 X331 714-635-7539

Contact:

Christina Cayuela QS/RA Manager

Date Prepared: March 17, 2011

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AUG 2 5 2011

### Proposed Device Name:

a. TRADE NAME: Sonicator® Plus 920 , Model ME 920 b. CLASSIFICATION NAME: Ultrasound and muscle stimulator (Sec. 890.5860. Product Code IMG) c. COMMON NAME: Combination Ultrasound and Muscle Stimulator

### Predicate Device:

## TRADE NAME: Sonicator® Plus 940, Model ME 940 510(k) Number: K071137

### Description of Proposed Device:

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available.

The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option.

The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols.

The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

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## INDICATIONS FOR USE STATEMENT SONICATOR® PLUS 920, ME 920

510(k) Number: k111482

Device Name: Sonicator® Plus 920, Model ME 920

Proposed Device Indications for Use (same as those for predicate device):

### Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as;

- 1. Relief of pain, muscle spasms and joint contractures:
- 2. Relief of pain, muscle spasms and joint contractures that may be associated with:
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
- 3. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular tightening

### 4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms

- Symptomatic relief of chronic intractable pain 1.
- 2. Post-traumatic pain
- 3. Post-surgical pain

### EMS, TENS, Hi Volt and Russian waveforms

- 1. Relaxation of muscle spasms
- 2. Increase local blood circulation
- 3. Prevention or retardation of disuse atrophy
- 4. Muscle re-education
- ഗ് Maintaining or increasing range of motion
- Q. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

### DC (Direct Current)

- Relaxation of muscle spasms 1.

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# Comparison of Technological Characteristics Between Proposed and Predicate Devices:

| Section 2 | | | |
|-----------|--------------------------------------------------------|----------------------------|----------------------------|
| 1. | 510 K # | K071137 | K |
| 2. | Device Name | Sonicator® Plus 940 | Sonicator® Plus 920 |
| 3. | Manufacturer | Mettler Electronics | Mettler Electronics |
| 4. | Power Source | AC line | AC line |
| | Line Current<br>Isolation | Reinforced insulation | Reinforced insulation |
| | Max Leakage Current<br>(µA) | | |
| | Chassis | >50 under SFC | > 50 under SFC |
| | Electrodes | >50 under SFC | >100 under SFC |
| 5. | Number Of Output<br>Modes | 8 | 8 |
| 6. | Channel(s) | 4 | 2 |
| | Synchronous | 1 & 2 or 3 & 4 | 1 & 2 |
| | Reciprocal | 1 & 2 or 3 & 4 | 1 & 2 |
| | Other | Yes | Yes |
| 7. | Constant Current | Yes | Yes |
| | Constant Voltage | No | No |
| 8. | Software / Firmware / Yes<br>Microprocessor<br>Control | | Yes |
| 9. | Automatic Overload<br>Trip | Yes | Yes |
| | Automatic Over<br>Current Trip | Yes | Yes |
| 10. | Automatic No Load<br>Trip | Yes | Yes |
| 11. | Automatic Shut Off | Yes | Yes |
| 12. | Patient Override<br>Control Method | No<br>On/Off, Hold or Stop | No<br>On/Off, Hold or Stop |
| 13. | Indicator Display | | |
| | On / Off Status | Yes | Yes |
| | Voltage/Current<br>Level | Yes | Yes |
| | Low Battery<br>Indicator | N/A | N/A |
| 14. | Timer Display: | 0 - 60 minutes | 0 - 60 minutes |
| 15. | Standards<br>ISO 14971 : 2000 | Yes | Yes |
| | UL 2601-1 | Yes | Yes |
| | CSA C22.2 NO<br>601.1-M90 | Yes | Yes |
| | IEC/EN 60601-1 | Yes | Yes |
| | IEC/EN 60601-1-2 | Yes | Yes |
| | IEC/EN 60601-2-10 | Yes | Yes |
| | MDD 93/42/EEC,<br>Annex II | Yes | Yes |
| 16. | Compliance with<br>21 CFR 898 | Yes | Yes |
| 17. | Weight (lbs.) | 11 | 11 |
| 18. | Dimensions (in.) Hxw<br>x L | 4.9 x 13.6 x x 10.5 | 4.9 x 13.6 x x 10.5 |
| 19. | Housing Materials &<br>Construction | Metal Casing | Metal Casing |

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# Neuromuscular Stimulation, section 3

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| 510 K #<br>Device Name<br>Manufacturer · | K071137<br>Sonicator® Plus 940<br>Mettler Electronics | K<br>Sonicator® Plus 920<br>Mettler Electronics |
|------------------------------------------|-------------------------------------------------------|-------------------------------------------------|
| Waveform | | |
| EMS | Biphasic | Biphasic |
| TENS | Biphasic | Biphasic |
| Hi Volt | Pulsed Monophasic and Biphasic | Pulsed Monophasic and Biphasic |
| Russian | Biphasic | Biphasic |
| Shape | | |
| EMS | Sinusidal | Sinusidal |
| TENS | Square | Square |
| Hi Volt | Twin spike | Twin spike |
| Russian | Gated Sinusoidal | Gated Sinusoidal |
| Max Output Voltage (V)<br>±20% | | |
| 500 Ω | | |
| EMS | 49 | 50 |
| TENS | 46 | 50 |
| Hi Volt | 146 | 155 |
| Russian | 50 | 50 |
| 2 kΩ | | |
| EMS | 115 | 115 |
| TENS | 100 | 110 |
| Hi Volt | 155 | 170 |
| Russian | 110 | 110 |
| 10 kΩ | | |
| EMS | 120 | 120 |
| TENS | 105 | 115 |
| Hi Volt | 190 | 220 |
| Russian | 120 | 120 |
| Max Output Current<br>(mA) ±20% | | |
| 500 Ω | | |
| EMS | 98 | 100 |
| TENS | 90 | 100 |
| Hi Volt | 292 | 310 |
| Russian | 100 | 100 |
| 2 kΩ | | |
| EMS | 57 | 58 |
| TENS | 50 | 55 |
| Hi Volt | 78 | 85 |
| Russian | 55 | 55 |
| 10 kΩ | | |
| EMS | 12 | 12 |
| TENS | 10.5 | 12 |
| Hi Volt | 19 | 22 |
| Russian | 12 | 12 |
| Pulse Width Range | | |
| EMS | 500, 250, 200 µs | 500, 250, 200 µs |
| TENS | 100 - 600 µs | 100 - 600 µs |
| Hi Volt | 10 - 80 µs | 10 - 80 µs |
| Russian | 400 µs | 400 µs |
| Frequency (Hz) | | |
| EMS | 2 kHz, 4 kHz, 5 kHz | 2 kHz, 4 kHz, 5 kHz |
| | | |
| TENS | 0.5 - 250 Hz | 0.5 - 250 Hz |
| Hi Volt | 0.5 - 200 Hz | 0.5 - 200 Hz |
| Russian | 2.5 kHz | 2.5 kHz |
| Beat Frequency (Hz) | | |
| Interferential, 2-pole,<br>Premodulated | 1 - 250 Hz | 1 - 250 Hz |
| Multiphasic<br>Waveforms | | |
| Symmetrical Phases? | | |
| EMS | Yes | Yes |
| TENS | Yes | Yes |
| Hi Volt | Yes | Yes |
| Russian | Yes | Yes |
| Phase Duration | | |
| EMS | 250, 125, 100 us | 250, 125, 100 µs |
| TENS | 50 - 300 us | 50 - 300 µs |
| Hi Volt | 10 - 80 us | 10 - 80 µs |
| Russian | 200 us | 200 us |
| Net Charge | Zero | Zero |
| Symmetry | Symmetric | Symmetric |
| Method | Balanced | Balanced |
| Maximum Phase Charge<br>(µC) | | |
| 500 Q | | |
| EMS | 12.7 | 15.9 |
| TENS | 80 | 60 |
| Hi Volt | 48 | 48 |
| Russian | 12.7 | 15.9 |
| Maximum Current<br>Density | | |
| (mA/cm2, 500 Ω) | | |
| EMS | 2.96* | 2.46 |
| TENS | 1.91* | 1.97 |
| Hi Volt | 1.87* | 2.32 |
| Russian | 3.50* | 3.45 |
| Maximum Power Density | | |
| (W/cm², 500 Ω) | | |
| EMS | 0.089 | 0.062 |
| TENS | 0.037 | 0.039 |
| | | |
| Hi Volt | 0.035 | 0.054 |
| Russian | 0.121 | 0.121 |
| Burst Mode | | |
| a. Pulses per burst | | |
| EMS | N/A | N/A |
| TENS | 7 | 7 |
| Hi Volt | 7 | 7 |
| Russian | N/A | N/A |
| b. Bursts per second | | |
| EMS | N/A | N/A |
| TENS | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 |
| Hi Volt | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 |
| Russian | 0 - 100 | 0 - 100 |
| c. Burst duration (ms) | | |
| EMS | N/A | N/A |
| TENS | 70 | 70 |
| Hi Volt | 120 | 120 |
| Russian | 2, 4, 6......20 | 2, 4, 6......20 |
| d. Duty Cycle (b x c) | | |
| EMS | N/A | N/A |
| TENS | 3.6 - 77.8 % | 3.6 - 77.8 % |
| Hi Volt | 6.3 % to 85.7 % | 6.3 % to 85.7 % |
| Russian | 10, 20, 30, ........100% | 10, 20, 30, ........100% |
| On Time (ms) | | |
| EMS | 1 - 99 | 1 - 99 |
| TENS | 1 - 30 | 1 - 30 |
| Hi Volt | 1 - 30 | 1 - 30 |
| Russian | 1 - 30 | 1 - 30 |
| Off Time (s) | | |
| EMS | 1 - 99 | 1 - 99 |
| TENS | 1 - 99 | 1 - 99 |
| Hi Volt | 1 - 99 | 1 - 99 |
| Russian | 1 - 99 | 1 - 99 |

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# Pain Management, Section 3

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| 510 K # | K071137 | K |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sonicator® Plus 940 | Sonicator® Plus 920 |
| Manufacturer | Mettler Electronics | Mettler Electronics |
| Waveform | | |
| Interferential, 4-pole | Biphasic | Biphasic |
| Interferential, 2-pole,<br>Premodulated | Biphasic | Biphasic |
| TENS | Biphasic | Biphasic |
| Microcurrent | Biphasic and pulsed monophasic | Biphasic and pulsed monophasic |
| Shape | | |
| Interferential, 4-pole | Sinusidal | Sinusidal |
| Interferential, 2-pole,<br>Premodulated | Sinusidal | Sinusidal |
| TENS | Square | Square |
| Microcurrent | Square | Square |
| Max Output Voltage (V)<br>±20% | | |
| 500 Ω | | |
| Interferential, 4-pole | 48 | 50 |
| Interferential, 2-pole,<br>Premodulated | 49 | 50 |
| TENS | 46 | 50 |
| Microcurrent | 0.38 | 0.37 |
| 2 kΩ | | |
| Interferential, 4-pole | 110 | 115 |
| Interferential, 2-pole,<br>Premodulated | 115 | 110 |
| TENS | 100 | 115 |
| Microcurrent | 1.55 | 1.5 |
| 10 KΩ | | |
| Interferential, 4-pole | 120 | 120 |
| Interferential. 2-pole,<br>Premodulated | 120 | 115 |
| TENS | 105 | 125 |
| Microcurrent | 7.5 | 7.4 |
| Max Output Current<br>(mA) ±20% | | |
| 500 Ω | | |
| Interferential, 4-pole | 96 | 100 |
| Interferential, 2-pole,<br>Premodulated | 98 | 100 |
| TENS | 90 | 100 |
| Microcurrent | 0.760 | 0.74 |
| 2 kΩ | | |
| Interferential, 4-pole | 55 | 58 |
| Interferential, 2-pole,<br>Premodulated | 57 | 55 |
| TENS | 50 | 58 |
| Microcurrent | 0.780 | 0.75 |
| 10 kΩ | | |
| Interferential, 4-pole | 12 | 12 |
| Interferential, 2-pole,<br>Premodulated | 12 | 12 |
| TENS | 10.5 | 13 |
| Microcurrent | 0.750 | 0.74 |
| Pulse Width Range | | |
| Interferential, 4-pole | 500, 250, 200 μs | 500, 250, 200 μs |
| Interferential, 2-pole,<br>Premodulated | 500, 250, 200 μs | 500, 250, 200 μs |
| TENS | 100 - 600 μs | 100 - 600 μs |
| Microcurrent | 1.25 ms - 1.67 s | 1.25 ms - 1.67 s |
| Frequency (Hz) | | |
| Interferential, 4-pole | 2 kHz, 4 kHz, 5 kHz | 2 kHz, 4 kHz, 5 kHz |
| Interferential, 2-pole,<br>Premodulated | 2 kHz, 4 kHz, 5 kHz | 2 kHz, 4 kHz, 5 kHz |
| TENS | 0.5 - 250 Hz | 0.5 - 250 Hz |
| Microcurrent | 0.3 - 400 Hz | 0.3 - 400 Hz |
| Beat Frequency (Hz) | | |
| Interferential, 4-pole | 1 - 250 Hz | 1 - 250 Hz |
| Interferential, 2-pole,<br>Premodulated | 1 - 250 Hz | 1 - 250 Hz |
| Multiphasic<br>Waveforms............ | | |
| Symmetrical Phases? | | |
| Interferential, 4-pole | Yes | Yes |
| Interferential, 2-pole, | Yes | Yes |
| Premodulated | | |
| TENS | Yes | Yes |
| Microcurrent | Yes | Yes |
| Phase Duration | | |
| Interferential, 4-pole | 250, 125, 100 μs | 250, 125, 100 μs |
| Interferential, 2-pole,<br>Premodulated | 250, 125, 100 μs | 250, 125, 100 μs |
| TENS | 50 - 300 μs | 50 - 300 μs |
| Microcurrent | 1.25 ms - 1.67 s | 1.25 ms - 1.67 s |
| Net Charge | Zero | Zero |
| Symmetry | Symmetric | Symmetric |
| Method | Balanced | Balanced |
| Maximum Phase Charge<br>(uC) | | |
| 500 Ω | | |
| Interferential, 4-pole | 12.7 | 15.9 |
| Interferential, 2-pole,<br>Premodulated | 12.7 | 15.9 |
| TENS | 60 | 60 |
| Microcurrent | 75 | 75 |
| Maximum Current<br>Density | | |
| (mA/cm², 500 Ω) | | |
| Interferential, 4-pole | 3.50* | 3.45 |
| Interferential, 2-pole,<br>Premodulated | 2.96* | 2.46 |
| TENS | 1.91* | 1.97 |
| Microcurrent | 0.026* | 0.026 |
| Maximum Power Density | | |
| (W/cm², 500 Ω) | | |
| Interferential, 4-pole | 0.121 | 0.121 |
| Interferential, 2-pole,<br>Premodulated | 0.089 | 0.062 |
| TENS | 0.037 | 0.039 |
| Microcurrent | 0.000007 | 0.000007 |
| Burst Mode | | |
| a. Pulses per burst | | |
| Interferential, 4-pole | N/A | N/A |
| Interferential, 2-pole, | N/A | N/A |
| | | |
| Premodulated | | |
| TENS | 7 | 7 |
| Microcurrent | N/A | N/A |
| b. Bursts per second | | |
| Interferential, 4-pole | N/A | N/A |
| Interferential, 2-pole,<br>Premodulated | N/A | N/A |
| TENS | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7…