SONICATOR PLUS 930, MODEL ME 930

K013192 · Mettler Electronics Corp. · IMI · Oct 17, 2001 · Physical Medicine

Device Facts

• Record ID: K013192
• Device Name: SONICATOR PLUS 930, MODEL ME 930
• Applicant: Mettler Electronics Corp.
• Product Code: IMI · Physical Medicine
• Decision Date: Oct 17, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase in blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms) 2. Temporary relaxation of muscle spasm (all waveforms) 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms) 4. Increase of blood flow in the treatment area (all waveforms) 5. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms) 6. Muscle re-education (all waveforms) 7. Maintaining or increasing range of motion (all waveforms)

Device Story

Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. Device inputs include user-selected parameters via membrane panel and control knobs. It generates 1 and 3 MHz ultrasound and electrical stimulation waveforms (interferential, pre-modulated, medium frequency, symmetrical biphasic). Used in clinical settings by healthcare professionals. Output is delivered via interchangeable applicators and stimulation electrodes. LED displays provide real-time monitoring of treatment status and output levels. Device provides tactile and audio feedback. Clinical utility includes pain management, muscle relaxation, and rehabilitation. Benefits include non-invasive therapeutic intervention for musculoskeletal conditions and post-surgical recovery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Aluminum chassis with ABS cover. Ultrasound: 1.0/3.2 MHz, barium titanate transducer. Electrical stimulation: constant current, 2-channel, interferential/pre-modulated/medium frequency/biphasic waveforms. Connectivity: standalone. Standards: UL 2601-1, CSA C22.2 No 601.1-M90, IEC 60601-2-10, IEC 60601-2-5, EN-55011, 21 CFR 1050.10.

Indications for Use

Indicated for patients requiring pain relief, muscle spasm reduction, increased blood flow, or range of motion improvement via ultrasound or neuromuscular stimulation. Applicable for chronic intractable, acute post-traumatic, or post-surgical pain; prevention of post-surgical phlebo-thrombosis; prevention/retardation of disuse atrophy; and muscle re-education.

Regulatory Classification

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.

Predicate Devices

• Sonicator® Plus 992, Model ME 992 (K984142)

Submission Summary (Full Text)

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OCT 1 7 2001

Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805

> Telephone: [phone]

Robert E. Fleming Contact: Director of Operations

Date Prepared: October 1, 2001

#### Proposed Device Name:

- a. TRADE NAME: Sonicator® Plus 930, Model ME 930
- b. CLASSIFICATION NAME: Ultrasound and Muscle Stimulator
- c. COMMON NAME: Combination ultrasound and Muscle Stimulator

#### Predicate Device:

- a. TRADE NAME: Sonicator® Plus 992, Model ME 992
- b. 510(k) Number: K984142

#### Description of Proposed Device:

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.

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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

#### Proposed Device Intended Use Statement:

510(k) Number: K013192

Device Name: Sonicator® Plus 930, Model ME 930

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

#### Therapeutic Ultrasound

- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Localized increase in blood flow
- 4. Increase range of motion of contracted joints using heat and stretch techniques.

#### Neuromuscular Stimulation

- 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
- 2. Temporary relaxation of muscle spasm (all waveforms)
- 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
- 4. Increase of blood flow in the treatment area (all waveforms)
- 5. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
- 6. Muscle re-education (all waveforms)
- 7. Maintaining or increasing range of motion (all waveforms)

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Comparison of Technological Characteristics Between Proposed and Predicate Devices:

| 510 K #<br>Device Name<br>Manufacturer | K013192<br>Sonicator Plus<br>930<br>Mettler<br>Electronics | K984142<br>Sonicator Plus<br>992<br>Mettler<br>Electronics |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC Line | AC Line |
| Number of output<br>modes | 4 | 6 |
| Channel(s) | 2 | 2 |
| Synchronous | 1 & 2 | 1 & 2 |
| Reciprocal | 1 & 2 | 1 & 2 |
| Other | Yes | Yes |
| Computerized | No | No |
| Software provided | N/A | N/A |
| Constant current | Yes | Yes |
| Constant voltage | No | No |
| Max output current<br>(mA) | 0-65 ±10% mA RMS, max.,<br>1 Kohm load, Interferential<br>mode<br>0-50 ±10% mA RMS, max.,<br>1 Kohm load, premodulated<br>mode | 0-65 ±10% mA RMS, max.,<br>1 Kohm load, Interferential<br>mode<br>0-50 ±10% mA RMS, max.,<br>1 Kohm load, premodulated<br>mode<br>10-990 ±10 μA peak,<br>1 Kohm load, microamp<br>mode |
| Max output voltage (V) | 0-65 ±10% volts RMS, 1<br>Kohm load, Interferential<br>mode<br>0-50 ±10% volts RMS<br>premodulated mode | 0-65 ±10% volts RMS, 1<br>Kohm load, Interferential<br>mode<br>0-50 ±10% volts RMS<br>premodulated mode<br>1.0 ±10% volt peak, 1 Kohm<br>load, microcurrent mode |
| Waveforms &<br>Channels | | |
| All Channels | Premodulated | Premodulated |
| Channel 1 & 2 | Interferential | Interferential |
| Channel 1 | Combination Therapy and<br>all others | High Volt and Combination<br>Therapy and all others<br>except microcurrent |
| Channel 2 | All | Microcurrent and all others<br>except high volt |
| Output displays | Two simultaneously, amber<br>channel active indicators | Two simultaneously, amber<br>channel active indicators |
| Channel isolation | Yes | Yes |
| Line current isolation | Yes | Yes |
| Automatic overload<br>trip | Yes | Yes |
| Automatic over current<br>trip | Yes | Yes |
| Current/Voltage level | 70 mA RMS, interferential<br>mode<br>55 mA RMS, premodulated<br>mode | 70 mA RMS, interferential<br>mode<br>55 mA RMS, premodulated<br>mode<br>110 mA peak, microcurrent |
| Automatic no load trip | Yes | Yes |
| Patient override | None | None |
| control method | On/Off or Hold | On/Off or Hold |
| Max leakage current<br>(μΑ) | | |
| Chassis | <100 | <100 |
| Electrodes | <100 | <100 |
| Indicator display | | |
| Unit functioning | Yes | Yes |
| Low battery indicator | N/A | N/A |
| Standards | | |
| UL 544 | No | No |
| UL 2601-1-UL | Yes | Yes |
| CUL | No | No |
| CSA C22.2 NO 601.1-<br>M90 | Yes | Yes |
| IEC60601-2-10 | Yes | Yes |
| EN-55011 (CISPR-11) | Yes | Yes |
| MDD 93/42/EEC,<br>Annex II | Yes | Yes |
| Timer settings | 1-60 minutes ±5% | 1-60 minutes ±5% |
| Automatic shut-off | Yes | Yes |
| Weight (lbs.) | 10 | 10 |
| Dimensions (in.) | | |
| H x W x L | 6 in (H) x 12 in (W) x 12 in<br>(D) | 5 (H) x 14.5 (W) x 10 (D) |
| Housing materials | Aluminum chassis with an<br>ABS cover | Aluminum |
| Construction | Folded into a box shape<br>and seams welded &<br>ground flush and a stylized<br>ABS cover screwed onto<br>metal box. | Stamped in a flat pattern,<br>embossed, folded into a box<br>shape and seams welded &<br>ground flush |
| II. Monophasic current | | |
| Type | N/A | Monophasic and biphasic,<br>microcurrent |
| Shape | | Square, (Microcurrent) |
| Net Charge | | Positive or negative or<br>neutral depending on the<br>polarity, microcurrent |
| Max phase rise time | | Less than 1 μs |
| Max phase decay time | | Less than 100 μs |
| Phase duration range | | 1-1000, ±10% ms,<br>microcurrent mode |
| Interpulse interval | | N/A, microcurrent mode |
| Frequency range | | 0.5 to 500 Hz, ±0.5 Hz or<br>±5%, whichever is greater,<br>microcurrent mode |
| Maximum current<br>density | | 49 μA/cm², microcurrent<br>mode |
| III. Alternating Current | | |
| Type | Biphasic | Biphasic |
| Shape | Sinusoidal, (Interferential,<br>Premodulated modes) | Sinusoidal, (Interferential,<br>Premodulated modes) |
| Symmetry | Symmetrical | Symmetrical |
| | Balanced | Balanced |
| Net charge | Zero | Zero |
| method | Balanced Waveform | Balanced Waveform |
| Frequency range | 4000-4250 Hz ±1%,<br>(Interferential and<br>Premodulated modes) | 4000-4250 Hz ±1%,<br>(Interferential and<br>Premodulated modes) |
| Beat Frequency (pps) | 1-250 ±2 Hz or 10%,<br>whichever is greater | 1-250 ±2 Hz or 10%,<br>whichever is greater |
| Interference Pattern | Yes | Yes |
| Maximum Current<br>Density | 3.52 mA/cm², interferential<br>2.64 mA/cm², premodulated | 3.52 mA/cm², interferential<br>2.64 mA/cm², premodulated |
| Maximum Phase<br>Charge | | |
| (u Coulombs)<br>500 OHMS<br>(Interferential) | 8.9 | 8.9 |
| 2K OHMS | 7.0 | 7.0 |
| 10K OHMS | 1.5 | 1.5 |
| Formula | q=Ixt | q=Ixt |
| 500 OHMS<br>(Premodulated) | 69.5 | 69.5 |
| 2K OHMS | 4.7 | 4.7 |
| 10K OHMS | 1.0 | 1.0 |
| Formula | q=1xt | q=Ixt |
| 500 OHMS<br>(Microcurrent) | N/A | 1000 |
| 2K OHMS | 960 | 960 |
| 10K OHMS | 610 | 610 |
| Formula | q=1 x t | q=1 x t |
| Amplitude Modulation<br>Options | | |
| Reciprocal<br>(Premodulated) | 2-240 s ±10% | 2-240 s ±10% or combine<br>with Surge for different<br>On/Off times |
| Surge (Premodulated) | | |
| Up Ramp | 3 s ± 0.5 s (all) | 3 s ± 0.5 s (all) |
| Down Ramp | 2 s ± 0.5 s (all) | 2 s ± 0.5 s (all) |
| Frequency | All Selectable Frequencies | All Selectable Frequencies |
| On Times | 5 s, 10 s | 10 s or 1-240 ±10% s |
| Off Times | 5 s, 10 s, 30 s or 50 s | 10 s, 20 s, 30 s, 40 s,<br>50 s, 60 s or 1-240 s ±10% s |

#### Pain Management

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channel active indicators

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62.5 µs (Interferential and

62.5 µs (Interferential and

Premodulated)

Premodulated)

118-125 us ±1%

118-125 ps ±1%

・

N/A

62.5 µs (Interferential and

62.5 µs (Interferential and

Premodulated)

Premodulated)

118-125 µs ±1 %

118-125 µs ±1%

N/A

Max phase rise time

Max phase decay time

Phase duration range

interferential

premodulated

Interphase interval

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:

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| Amplitude<br>Modulation,<br>Vector (Interferential) | | |
|-----------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Description | -50% amplitude modulation<br>in anti phase | -50% amplitude modulation<br>in anti phase |
| Modulation Period | 8 s ± 1 s modulation period | 8 s ± 1 s modulation period |
| Frequency Modulation<br>Options | | |
| Interferential or<br>Premodulated | 1-15 Hz ± 2 Hz or 10%<br>whichever is greater | 1-15 Hz ± 2 Hz or 10%<br>whichever is greater |
| | 80-150 Hz ± 2 Hz or 10%<br>whichever is greater | 80-150 Hz ± 2 Hz or 10%<br>whichever is greater |
| | 1-150 Hz ± 2 Hz or 10%<br>whichever is greater | 1-150 Hz ± 2 Hz or 10%<br>whichever is greater |
| | xx-xx Hz ± 2 Hz or 10%<br>whichever is greater, xx =<br>any value from 1 to 250 Hz | xx-xx Hz ± 2 Hz or 10%<br>whichever is greater, xx =<br>any value from 1 to 250 Hz |
| Modulation Options | | |
| a) May be selected<br>independently or<br>together | Yes | Yes |
| b) Simultaneously for<br>each channel pair | Yes | Yes |
| c) Independent<br>controls for each<br>channel | Yes | Yes |

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Comparison of Technological Characteristics Between Proposed and Predicate Devices (continued):

#### Neuromuscular Stimulation

| 510 K #<br>Device Name | K013912<br>Sonicator Plus<br>930 | K984142<br>Sonicator Plus<br>992 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Mettler<br>Electronics | Mettler<br>Electronics |
| Power Source | AC Line | AC Line |
| Number Of Output<br>Modes | 3 | 6 |
| Channel(S) | 2 | 2 |
| Synchronous | 1 & 2 | 1 & 2 |
| Reciprocal | 1 & 2 | 1 & 2 |
| Other | Yes | Yes |
| Computerized | No | No |
| Software Provided | N/A | N/A |
| Constant Current | Yes | Yes |
| Constant Voltage | No | No |
| Max Output Current<br>(mA) | 0-65 ±10% mA RMS, max.,<br>1 Kohm load, Interferential<br>mode | 0-65 ±10% mA RMS, max.,<br>1 Kohm load, Interferential<br>mode |
| | 0-50 ±10% mA RMS, max.,<br>1 Kohm load, premodulated<br>and medium frequency<br>modes | 0-50 ±10% mA RMS, max.,<br>1 Kohm load, premodulated<br>and medium frequency<br>modes |
| | | 0-99 ±10% mA peak, max.,<br>1 Kohm load, biphasic mode |
| | | 0-2500 ±10% mA peak,<br>max., 1 Kohm, high volt<br>mode |
| | | 10-990 ±10 µA peak, 1<br>Kohm load, microamp mode |
| Max Output Voltage (V) | 0-65 ±10% volts RMS, 1<br>Kohm load, Interferential<br>mode | 0-65 ±10% volts RMS, 1<br>Kohm load, Interferential<br>mode |
| | 0-50 ±10% volts RMS<br>premodulated mode and<br>medium frequency modes | 0-50 ±10% volts RMS<br>premodulated mode and<br>medium frequency modes |
| | | 99 ±10% volts peak, 1<br>Kohm load, biphasic mode |
| | | 0-500 ±10% volts peak, 1<br>Kohm load, high volt mode |
| | | 1.0 ±10% volt peak, 1 Kohm<br>load, microcurrent mode |
| Waveforms &<br>Channels | | |
| All Channels | Premodulated, Medium<br>Frequency | Premodulated, Medium<br>Frequency, Biphasic |
| Channel 1 & 2 | Interferential | Interferential |
| Channel 1 | Combination Therapy and<br>all others | High Volt and Combination<br>Therapy and all others<br>except microcurrent |
| Channel 2 | All | Microcurrent and all others<br>except high volt |
| Output Displays | Two simultaneously, amber<br>channel active indicators | Two simultaneously, amber<br>channel active Indicators |
| Channel Isolation | Yes | Yes |
| Line Current Isolation | Yes | Yes |
| Automatic Overload<br>Trip | Yes | Yes |
| Automatic Over<br>Current Trip | Yes | Yes |
| Current/Voltage Level | 70 mA RMS, interferential<br>mode<br>55 mA RMS, premodulated<br>and medium frequency<br>modes | 70 mA RMS, interferential<br>mode<br>55 mA RMS, premodulated<br>and medium frequency<br>modes<br>110 mA peak, biphasic<br>N/A, high volt and<br>microcurrent modes |
| Automatic No Load<br>Trip | Yes | Yes |
| Patient Override | None | None |
| Control Method | On/Off or Hold | On/Off or Hold |
| Max Leakage Current<br>(μΑ) | | |
| Chassis | <100 | <100 |
| Electrodes | <100 | <100 |
| Indicator Display | | |
| Unit Functioning | Yes | Yes |
| Low Battery Indicator | N/A | N/A |
| Standards | | |
| UL 544 | No | No |
| UL 2601-1-UL | Yes | Yes |
| CUL | No | No |
| CSA C22.2 NO 601.1-<br>M90 | Yes | Yes |
| IEC60601-2-10 | Yes | Yes |
| EN-55011 (CISPR-11) | Yes | Yes |
| MDD 93/42/EEC,<br>Annex II | Yes | Yes |
| Timer Settings | 1-60 minutes ±5% | 1-60 minutes ±5% |
| Automatic Shut Off | Yes | Yes |
| Weight (lbs.) | 9 | 10 |
| DIMENSIONS (in.) | | |
| H x W x L | 6 in (H) x 12 in (W) x 12 in<br>(D) | 5 (H) x 14.5 (W) x 10 (D) |
| Housing Materials | Aluminum chassis with an<br>ABS cover | Aluminum |
| Construction | Folded into a box shape and Stamped in a flat pattern,<br>seams welded & ground<br>flush and a stylized ABS<br>cover screwed onto metal<br>box. | embossed and folded into a<br>box shape and seams<br>welded & ground flush |
| II. Monophasic Current | N/A | |
| Type | | Monophasic, high volt |
| | | Monophasic and biphasic,<br>microcurrent |
| Shape | | Twin spikes, (high volt) |
| | | Square, (Microcurrent) |
| Net Charge | | Positive or Negative<br>depending on the polarity,<br>high volt |
| | | Positive or negative or<br>neutral depending on the<br>polarity, Microcurrent |
| Max Phase Rise Time | | Less than 1 µs |
| Max Phase Decay Time | | Less than 100 µs |
| Phase Duration Range | | 10 µs, ±5 µs at 50%<br>amplitude, high volt mode |
| Interpulse Interval | | 1-1000, ±10% ms,<br>microcurrent mode<br>75 µs, ±25 µs at 50%<br>amplitude, high volt |
| | | N/A, microcurrent mode |
| Frequency Range | | 1-120 Hz, ±1 Hz or ±5%,<br>whichever is greater, high<br>volt mode |
| | | 0.5 to 500 Hz, ±0.5 Hz or<br>±5%, whichever is greater,<br>microcurrent mode |
| Maximum Current<br>Density | | 0.088 mA/cm², high volt<br>mode |
| | | 49 µA/cm², microcurrent<br>mode |
| III. Alternating Current | | |
| Type | Biphasic | Biphasic |
| Shape | Sinusoidal, (Interferential, Premodulated and Medium Frequency) | Sinusoidal, (Interferential, Premodulated and Medium Frequency)<br>Square, (Biphasic) |
| Symmetry | Symmetrical<br>Balanced | Symmetrical<br>Balanced |
| Net Charge | Zero | Zero |
| Method | Balanced Waveform | Balanced Waveform |
| Max Phase Rise Time | 62.5 µs (Interferential and Premodulated)<br>100 µs (Medium Frequency) | 62.5 µs (Interferential and Premodulated)<br>100 µs (Medium Frequency) |
| Max Phase Decay Time | 62.5 µs (Interferential and Premodulated)<br>100 µs (Medium Frequency) | 62.5 µs (Interferential and Premodulated)<br>100 µs (Medium Frequency)<br>Less than 10 µs (Biphasic) |
| Phase Duration Range | | |
| Interferential | 118-125 µs ±1% | 118-125 µs ±1% |
| Premodulated | 118-125 µs ±1% | 118-125 µs ±1% |
| Medium Frequency | 200 ±2% µs | 200 ±2% µs |
| Biphasic | N/A | 50-300 ±10% µs |
| Interphase Interval | N/A | N/A |
| Frequency Range | 4000-4250 Hz ±1%, (Interferential and Premodulated modes)<br>2500 Hz ±2% (Medium Frequency mode) | 4000-4250 Hz ±1%, (Interferential and Premodulated modes)<br>2500 Hz ±2% (Medium Frequency mode)<br>1-120 ±1 Hz or ±5% whichever is greater, (Biphasic mode) |
| Beat Frequency (pps) | 1-250 ±2 Hz or 10%, whichever is greater | 1-250 ±2 Hz or 10%, whichever is greater |
| Burst Mode | Yes (Medium Frequency—10 ms On/Off, 50 Hz) | Yes (Medium Frequency—10 ms On/Off, 50 Hz) |
| Maximum Current<br>Density | 3.52 mA/cm², interferential<br>2.64 mA/cm², premodulated<br>and medium frequency | 3.52 mA/cm², interferential<br>2.64 mA/cm², premodulated<br>and medium frequency<br>0.176 mA/cm², biphasic |
| Maximum Phase<br>Charge<br>(u Coulombs) | | |
| 500 OHMS<br>(Interferential) | 8.9 | 8.9 |
| 2K OHMS | 7.0 | 7.0 |
| 10K OHMS | 1.5 | 1.5 |
| Formula | q=Ixt | q = Ixt |
| 500 OHMS<br>(Premodulated) | 69.5 | 69.5 |
| 2K OHMS | 4.7 | 4.7 |
| 10K OHMS | 1.0 | 1.0 |
| Formula | q=Ixt | q=Ixt |
| 500 OHMS (Medium<br>Frequency) | 16.0 | 16.0 |
| 2K OHMS | 11.4 | 11.4 |
| 10K OHMS | 2.5 | 2.5 |
| Formula | q=Ixt | q=Ixt |
| 500 OHMS (Biphasic) | N/A | 29.8 |
| 2K OHMS | | 27.9 |
| 10K OHMS | | 6.1 |
| FORMULA | | q=Ixt |
| 500 OHMS (High Volt) | N/A | 14.9 |
| 2K OHMS | | 3.9 |
| 10K OHMS | | 0.8…