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 Description

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.

AI/ML Overview

The provided 510(k) summary for the SONICATOR® PLUS 920, Model ME 920, focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 940, Model ME 940) rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.

Therefore, much of the requested information regarding clinical study design, sample size, expert involvement, and ground truth establishment is not present in the provided document, as it is typical for a 510(k) submission based on substantial equivalence for this type of device. The acceptance criteria generally relate to meeting performance specifications similar to the predicate device and relevant industry standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the functional and physical specifications of the predicate device (Sonicator® Plus 940) and compliance with various international standards, as the proposed device claims substantial equivalence to it with minor differences. The reported device performance is presented as a direct comparison to the predicate device.

Acceptance Criteria (Implicitly based on Predicate and Standards)	Reported Device Performance (Sonicator® Plus 920)	Source of Criteria
General Characteristics:

Power Source: AC line | AC line | Predicate device, IEC/EN 60601-1
Isolation: Reinforced insulation | Reinforced insulation | Predicate device, IEC/EN 60601-1
Chassis Max Leakage Current: >50 µA under SFC | >50 µA under SFC | Predicate device, IEC/EN 60601-1
Electrodes Max Leakage Current: >50 µA under SFC (Predicate: >50 µA) | >100 µA under SFC | Predicate device, IEC/EN 60601-1 (Note: This is a deviation to consider)
Number of Output Modes: 8 | 8 | Predicate device
Channel(s): 4 (Predicate) | 2 | Predicate device (A primary difference)
Constant Current: Yes | Yes | Predicate device
Automatic Overload Trip: Yes | Yes | Predicate device
Automatic Over Current Trip: Yes | Yes | Predicate device
Automatic No Load Trip: Yes | Yes | Predicate device
Automatic Shut Off: Yes | Yes | Predicate device
Timer Display: 0 - 60 minutes | 0 - 60 minutes | Predicate device
Timer Accuracy: ± 3 % | ± 3 % | Predicate device
Maximum Treatment Time: 30 minutes | 30 minutes | Predicate device
Software/Firmware/Microprocessor Control: Yes | Yes | Predicate device
Electrical Stimulation Waveform Characteristics (Selected Examples): | |
EMS Max Output Voltage (500 Ω): 49 V (Predicate) | 50 V | Predicate device (Similar range)
TENS Max Output Current (500 Ω): 90 mA (Predicate) | 100 mA | Predicate device (Similar range)
Hi Volt Max Phase Charge (500 Ω): 48 µC | 48 µC | Predicate device
Microcurrent Max Output Current (10 kΩ): 0.750 mA | 0.74 mA | Predicate device (Similar range)
Therapeutic Ultrasound Specifications: | |
Frequency: 1 MHz and 3 MHz, ± 5 % | 1 MHz and 3 MHz, ± 5 % | Predicate device, FDA 21 CFR 1050.10
Modes: Continuous and Pulsed | Continuous and Pulsed | Predicate device
Pulse Repetition Rate: 100 Hz ± 10 % | 100 Hz ± 10 % | Predicate device
Pulse Duration: 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | 0.5, 1.0, 2.0, 3.0, 4.0 and 5 ms (± 10 %) | Predicate device
Maximum Output Power (ME 9201/9401): 12 W | 12 W for ME 9201 | Predicate device
Maximum Output Power (ME 9202/9402): 1.8 W | 1.8 W for ME 9202 | Predicate device
Maximum Intensity: 2 W/cm² (continuous), 3 W/cm² (pulsed) | 2 W/cm² (continuous), 3 W/cm² (pulsed) | Predicate device
Effective Radiating Area (5.5 cm² applicator): 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) | Predicate device
Effective Radiating Area (0.9 cm² applicator): 0.9 cm² (1 MHz) / 0.9 cm² (3 MHz) (Predicate) | 0.9 cm² (1 MHz) / 0.8 cm² (3 MHz) | Predicate device (Slight difference for 3MHz)
Maximum Beam Non-Uniformity Ratio (5.5 cm² applicable): 4.55:1 maximum (Predicate) | 4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum | Predicate device (Slight differences, but within acceptable range for equivalence according to submission)
Standards Compliance: | |
ISO 14971 : 2000 | Yes | Predicate device
UL 2601-1 | Yes | Predicate device
CSA C22.2 NO 601.1-M90 | Yes | Predicate device
IEC/EN 60601-1 | Yes | Predicate device
IEC/EN 60601-1-2 | Yes | Predicate device
IEC/EN 60601-2-10 (For stimulators) | Yes | Predicate device
IEC/EN 60601-2-5 (For ultrasonic therapy equipment) | Yes | Predicate device
MDD 93/42/EEC, Annex II | Yes | Predicate device
21 CFR 898 (for sunlamp products, potentially a typo or reference to 21 CFR 1050.10 for ultrasonics) | Yes | Predicate device (Acknowledged for ultrasonic standards 21 CFR 1050.10)

2. Sample Size Used for the Test Set and Data Provenance

This is a premarket notification (510(k)) for substantial equivalence for a medical device (an electrotherapy and ultrasound combination unit), not a clinical trial of a diagnostic or AI-driven device. Therefore, there is no "test set" in the sense of a patient cohort evaluated for diagnostic or AI performance.

The "testing" mentioned typically involves internal engineering verification and validation (V&V) to ensure the device meets its design specifications and complies with relevant safety and performance standards. This V&V data is generally proprietary and summarized in the 510(k) submission, not provided in detail here.

Sample size for test set: Not applicable in the context of a clinical test set for diagnostic performance. Performance is evaluated against engineering specifications and comparison to the predicate device.
Data provenance: Not applicable. The data is internal engineering test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for this type of 510(k) submission. There is no "ground truth" derived from expert review of cases, as this is not a diagnostic device or an AI application with human-in-the-loop performance evaluation. The "truth" is established by adherence to design specifications and compliance with standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device. Adjudication methods like "2+1" are used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome for a test case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is not an AI-driven device or a diagnostic imaging system that would involve human readers and AI assistance for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical therapy unit, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This is not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance evaluation would be its conformance to specified electrical and ultrasonic output parameters as measured by calibrated equipment, and verification against design requirements and safety standards. The primary "ground truth" supporting its marketing is its substantial equivalence to the predicate device which has a history of safe and effective use.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable. As it's not an AI/ML model, there is no training set or associated ground truth.

In Summary:

The provided 510(k) summary demonstrates compliance by comparing the proposed device's technical specifications and intended uses to those of a legally marketed predicate device (Sonicator® Plus 940). The acceptance criteria are largely implicit in demonstrating that the Sonicator® Plus 920 performs as intended and is as safe and effective as the predicate device by meeting similar engineering specifications and conforming to recognized electrical and medical device safety standards (e.g., IEC/EN 60601 series, ISO 14971, FDA 21 CFR 1050.10).

The study that "proves" the device meets acceptance criteria, in this context, is the technical comparison report (the "Comparison of Technological Characteristics" tables in the document) and documentation of compliance with various international standards. This type of submission relies on the established safety and effectiveness of the predicate device. Differences are highlighted (e.g., 2 channels vs. 4 channels, minor variations in output parameters or applicator ERAs), and the manufacturer's responsibility is to demonstrate that these differences do not raise new questions of safety or effectiveness.

Summary

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K111482

ા હાંડ

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 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:
1. 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
1. 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.
1. Post-traumatic pain
1. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1. Relaxation of muscle spasms
1. Increase local blood circulation
1. Prevention or retardation of disuse atrophy
1. 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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K111482 4 of 15

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 CurrentIsolation	Reinforced insulation	Reinforced insulation
	Max Leakage Current(µA)
	Chassis	>50 under SFC	> 50 under SFC
	Electrodes	>50 under SFC	>100 under SFC
5.	Number Of OutputModes	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 / YesMicroprocessorControl		Yes
9.	Automatic OverloadTrip	Yes	Yes
	Automatic OverCurrent Trip	Yes	Yes
10.	Automatic No LoadTrip	Yes	Yes
11.	Automatic Shut Off	Yes	Yes
12.	Patient OverrideControl Method	NoOn/Off, Hold or Stop	NoOn/Off, Hold or Stop
13.	Indicator Display
	On / Off Status	Yes	Yes
	Voltage/CurrentLevel	Yes	Yes
	Low BatteryIndicator	N/A	N/A
14.	Timer Display:	0 - 60 minutes	0 - 60 minutes
15.	StandardsISO 14971 : 2000	Yes	Yes
	UL 2601-1	Yes	Yes
	CSA C22.2 NO601.1-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,Annex II	Yes	Yes
16.	Compliance with21 CFR 898	Yes	Yes
17.	Weight (lbs.)	11	11
18.	Dimensions (in.) Hxwx L	4.9 x 13.6 x x 10.5	4.9 x 13.6 x x 10.5
19.	Housing Materials &Construction	Metal Casing	Metal Casing

デ

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Neuromuscular Stimulation, section 3

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510 K #Device NameManufacturer ·	K071137Sonicator® Plus 940Mettler Electronics	KSonicator® Plus 920Mettler 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)±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(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,Premodulated	1 - 250 Hz	1 - 250 Hz
MultiphasicWaveforms
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(µC)
500 Q
EMS	12.7	15.9
TENS	80	60
Hi Volt	48	48
Russian	12.7	15.9
Maximum CurrentDensity
(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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KII148Z 7 of 15

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K111482

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K111482 9 of 15

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,Premodulated	Biphasic	Biphasic
TENS	Biphasic	Biphasic
Microcurrent	Biphasic and pulsed monophasic	Biphasic and pulsed monophasic
Shape
Interferential, 4-pole	Sinusidal	Sinusidal
Interferential, 2-pole,Premodulated	Sinusidal	Sinusidal
TENS	Square	Square
Microcurrent	Square	Square
Max Output Voltage (V)±20%
500 Ω
Interferential, 4-pole	48	50
Interferential, 2-pole,Premodulated	49	50
TENS	46	50
Microcurrent	0.38	0.37
2 kΩ
Interferential, 4-pole	110	115
Interferential, 2-pole,Premodulated	115	110
TENS	100	115
Microcurrent	1.55	1.5
10 KΩ
Interferential, 4-pole	120	120
Interferential. 2-pole,Premodulated	120	115
TENS	105	125
Microcurrent	7.5	7.4
Max Output Current(mA) ±20%
500 Ω
Interferential, 4-pole	96	100
Interferential, 2-pole,Premodulated	98	100
TENS	90	100
Microcurrent	0.760	0.74
2 kΩ
Interferential, 4-pole	55	58
Interferential, 2-pole,Premodulated	57	55
TENS	50	58
Microcurrent	0.780	0.75
10 kΩ
Interferential, 4-pole	12	12
Interferential, 2-pole,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,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,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,Premodulated	1 - 250 Hz	1 - 250 Hz
MultiphasicWaveforms............
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,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(uC)
500 Ω
Interferential, 4-pole	12.7	15.9
Interferential, 2-pole,Premodulated	12.7	15.9
TENS	60	60
Microcurrent	75	75
Maximum CurrentDensity
(mA/cm², 500 Ω)
Interferential, 4-pole	3.50*	3.45
Interferential, 2-pole,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,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,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
Microcurrent	N/A	N/A
c. Burst duration (ms)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	N/A
TENS	70	70
Microcurrent	N/A	N/A
d. Duty Cycle (b x c)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	N/A
TENS	3.6 - 77.8 %	3.6 - 77.8 %
Microcurrent	N/A	N/A
On Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	N/A
TENS	1 - 30	1 - 30
Microcurrent	N/A	N/A
Off Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	N/A
TENS	1 - 99	1 - 99
Microcurrent	N/A	N/A

510 K #Device NameManufacturer	K071137Sonicator® Plus 940Mettler Electronics	KSonicator® Plus 920Mettler Electronics
Waveform
Continuous DC	DC	DC
Shape
Continuous DC	DC	DC
Max Output Voltage (V)±20%
500 Ω
Continuous DC	10.2	10.5
2 kΩ
Continuous DC	28	26
10 kΩ
Continuous DC	34	31
Max Output Current(mA) ±20%
500 Ω
Continuous DC	20	21
2 kΩ
Continuous DC	14	13
10 kΩ
Continuous DC	3.4**	3.1
Maximum CurrentDensity
(mA/cm², 500 Ω)
Continuous DC	0.99	0.99
Maximum Power Density
(W/cm², 500 Ω)
Continuous DC	0.0079	0.0098
On Time (s)
Continuous DC	Controlled by probe	Controlled by probe
Off Time (s)
Continuous DC	Controlled by probe	Controlled by probe
510 K #	K071137	K
Device Name	Sonicator® Plus 940	Sonicator® Plus 920
Manufacturer	Mettler Electronics	Mettler Electronics
Power Source	AC Line	AC Line
Standards
ISO 14971 : 2000	Yes	Yes
UL 2601-1	Yes	Yes
CSA C22.2 NO 601.1- M90	Yes	Yes
IEC/EN 60601-1	Yes	Yes
IEC/EN 60601-1-2	Yes	Yes
IEC/EN 60601-2-5	Yes	Yes
FDA, 21 CFR 1050.10	Yes	Yes
MDD 93/42/EEC,Annex II	Yes	Yes
Timer Accuracy:	$\pm$ 3 %	$\pm$ 3 %
Maximum TreatmentTime:	30 minutes	30 minutes
Ultrasonic Generator Specifications
Frequency	1 MHz and 3 MHz, $\pm$ 5 %	1 MHz and 3 MHz, $\pm$ 5 %
Modes	Continuous and Pulsed	Continuous and Pulsed
Pulse Repetition Rate	100 Hz $\pm$ 10 %	100 Hz $\pm$ 10 %
Pulse Duration	0.5, 1.0, 2.0. 3.0, 4.0 and 5 ms ( $\pm$ 10%)	0.5, 1.0, 2.0. 3.0, 4.0 and 5 ms ( $\pm$ 10%)
Temporal Peak/average intensityratio	2:1 $\pm$ 20 % at 50 % Duty Cycle2.5 :1 $\pm$ 20 % at 40 % Duty Cycle3.3:1 $\pm$ 20 % at 30 % Duty Cycle5:1 $\pm$ 20 % at 20 % Duty Cycle10:1 $\pm$ 20 % at 10 % Duty Cycle20:1 $\pm$ 20 % at 5 % Duty Cycle	2:1 $\pm$ 20 % at 50 % Duty Cycle2.5 :1 $\pm$ 20 % at 40 % Duty Cycle3.3:1 $\pm$ 20 % at 30 % Duty Cycle5:1 $\pm$ 20 % at 20 % Duty Cycle10:1 $\pm$ 20 % at 10 % Duty Cycle20:1 $\pm$ 20 % at 5 % Duty Cycle
Maximum outputpower	12 W for ME 94011.8 W for ME 9402	12 W for ME 92011.8 W for ME 9202
Maximum intensity	2 W/cm² for continuous mode3 W/cm² for pulsed mode	2 W/cm² for continuous mode3 W/cm² for pulsed mode

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Muscle Spasm, section 3

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Therapeutic Ultrasound

and the comments of the comments of the comments of the comments of the contraction of the contraction of the contribution of the contribution of the contribution of the cont

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Indication accuracy

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± 20 %

Ultrasonic Applicator Specifications

Piezoelectric discs	Ultrasound transducer attached to ametal surface and patient contactthrough the metal	Ultrasound transducer attached to ametal surface and patient contactthrough the metal
Applicator Part	ME 9401	ME 9201

Frequency	1 MHz and 3 MHz ±5%
Effective RadiatingArea	5.5 cm² (1 MHz) / 6.0 cm² (3 MHz)
Maximum BeamNon-Uniformity Ratio	4.55 : 1 maximum

1 MHz and 3 MHz ±5% 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz)

4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum

Applicator PartNumber	ME 9402	ME 9202
Frequency	1 MHz and 3 MHz ±5%	1 MHz and 3 MHz ±5%
Effective RadiatingArea	0.9 cm² (1MHz) / 0.9 cm² (3 MHz)	0.9 cm² (1MHz) / 0.8 cm² (3 MHz)
Maximum BeamNon-Uniformity Ratio	4.68 : 1 maximum	4.7:1 maximum
Other Applicators	None	None
Frequency	N/A	N/A
Effective RadiatingArea	N/A	N/A
Maximum BeamNon-Uniformity Ratio	N/A	N/A

Values shown are current correct values for ME940 device and reported in mA/cm² to match the same mAcm2 nomenclature reported for ME920 device (values appearing in original K071137 submission were in Alcm2)

** Value shown is correct value for ME940 device (value appearing in original K071137 submission was erroneously reported as 17 mA, much higher than the actual correct lower value of 3.4 mA shown above)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mettler Electronics Corporation % Ms. Christina Cayuela OS/RA Manager 1333 South Claudina Street Anaheim, CA 92805

AUG 25 2011

Re: K111482

Trade/Device Name: Sonicator Plus 920, Model ME 920 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: II Product Code: IMG, GZJ, GZJ, GZI and IPF Dated: July 20, 2011 Received: July 26, 2011

Dear Ms. Cayuela:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Christina Cayuela

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eune S. Keitt

-Sr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1 b

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K111482

Device Name:

Sonicator® Plus 920, ME 920

Indications for Use:

Therapeutic Ultrasound

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

1. Relief of pain, muscle spasms and joint contractures:
1. 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
1. 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
1. Post-traumatic pain
1. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1.Relaxation of muscle spasms

1. Increase local blood circulation
Prevention or retardation of disuse atrophy 3.
1. Muscle re-education
ર. Maintaining or increasing range of motion
1. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current)

Relaxation of muscle spasms

veforms

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111482

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

(

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.