SONICATOR PLUS 930, MODEL ME 930 by METTLER ELECTRONICS CORP.

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)

Device Description

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

AI/ML Overview

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): <100 µA	<100 µA
Maximum Leakage Current (Electrodes): <100 µA	<100 µA
Compliance with UL 2601-1-UL, CSA C22.2 NO 601.1-M90, IEC60601-2-10, EN-55011 (CISPR-11), MDD 93/42/EEC, Annex II	Yes (for all listed standards)
Therapeutic Ultrasound
Frequency: 1.0 MHz ±5%	1.0 MHz ±5%
Frequency: 3.2 MHz ±5% (Predicate has 3.3 MHz ±5%)	3.2 MHz ±5% (Note: Slight difference from predicate's 3.3 MHz)
Modes: Continuous, Pulsed-20% duty cycle	Continuous, Pulsed-20% duty cycle
Pulse Repetition Rate: 100 Hz ±20%	100 Hz ±20%
Pulse Duration (20% duty cycle): 2 msec ±20%	2 msec ±20%, 20% duty cycle
Temporal Peak/average intensity ratio (20% duty cycle): 5:1 ±20%	5:1 ±20%, 20% duty cycle
Maximum intensity: 2.2 W/cm² with all applicators	2.2 W/cm²
Indication accuracy: ±20% (for any level above 10% of maximum)	±20% (for any level above 10% of maximum)
Timer Accuracy: ±0.5 minutes for times less than 5 minutes; ±10% for times from 5 to 10 minutes; ±1.0 minute for times greater than 10 minutes	±0.5 minutes for times less than 5 minutes; ±10% for times from 5 to 10 minutes; ±1.0 minute for times greater than 10 minutes
Compliance with IEC60601-2-5, FCC Part 15-B, FDA 21 CFR 1050.10, UL 2601-1-UL, CSA C22.2 NO 601.1-M90, EN-55011 (CISPR-11), MDD 93/42/EEC, Annex II	Yes (for all listed standards)

2. Sample size used for the test set and the data provenance:

Not Applicable. This document is a 510(k) premarket notification demonstrating substantial equivalence based on technical specifications, design, and indications for use. It does not describe a "test set" in the context of a clinical performance study with patient data. The "test set" here would refer to the physical device prototypes and their components undergoing engineering verification. Data provenance is internal engineering measurements and compliance testing, not clinical data from countries of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not relevant to this type of submission which relies on comparing technical specifications and intended use against a legally marketed predicate device. The "experts" involved would be the manufacturer's engineers and quality assurance personnel performing the measurements and verifying compliance with standards and internal specifications to demonstrate equivalence.

4. Adjudication method for the test set:

Not Applicable. There is no "adjudication method" in the context of resolving discrepancies in expert interpretations of clinical data. Testing typically involves objective measurements against predefined engineering tolerances and regulatory standards.

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:

Not Applicable. This document pre-dates and is unrelated to AI/ML device submissions, and therefore no MRMC studies or AI assistance effect sizes are discussed.

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

Not Applicable. This is a physical medical device (ultrasound and muscle stimulator). There is no "algorithm only" component in the context of an AI/software device. Its performance is the direct output of its physical and electrical functions.

7. The type of ground truth used:

The "ground truth" for this submission is implicitly the technical specifications and performance characteristics of the predicate device (Sonicator® Plus 992) and relevant industry standards (e.g., UL, CSA, IEC, FDA regulations). The proposed device (Sonicator® Plus 930) is compared against these established benchmarks to demonstrate substantial equivalence. This is not clinical pathology, expert consensus on patient data, or outcomes data.

8. The sample size for the training set:

Not Applicable. This device is hardware with firmware, not an AI/ML system that utilizes a "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant.

Summary of the Study (510(k) Premarket Notification):

The "study" presented here is a premarket notification (510(k)) submission to the FDA. The purpose of this submission is not to conduct a clinical trial or a performance study in the traditional sense, but rather to demonstrate substantial equivalence of the proposed device (Sonicator® Plus 930, Model ME 930) to a legally marketed predicate device (Sonicator® Plus 992, Model ME 992) under the provisions of the Federal Food, Drug, and Cosmetic Act.

The proof that the device meets "acceptance criteria" (defined by predicate device specifications and regulatory standards) is established through detailed technical comparison tables (Documents {2}, {6}, {7}, {12}, {13}, {14}, {15}) listing various physical, electrical, and performance characteristics. The manufacturer attests that the proposed device's specifications fall within acceptable ranges or are identical to the predicate device, thereby supporting its safety and effectiveness for the stated indications for use (Documents {1} and {18}). The FDA's review and resulting letter (Documents {16} and {17}) acknowledge this demonstration of substantial equivalence.

Summary

{0}------------------------------------------------

OCT 1 7 2001

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

Telephone: 714-533-2221

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:

{1}------------------------------------------------

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
1. Reduction of muscle spasm
1. Localized increase in blood flow
1. 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)
1. Temporary relaxation of muscle spasm (all waveforms)
1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
1. Increase of blood flow in the treatment area (all waveforms)
1. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
1. Muscle re-education (all waveforms)
1. Maintaining or increasing range of motion (all waveforms)

{2}------------------------------------------------

Comparison of Technological Characteristics Between Proposed and Predicate Devices:

510 K #Device NameManufacturer	K013192Sonicator Plus930MettlerElectronics	K984142Sonicator Plus992MettlerElectronics
Power Source	AC Line	AC Line
Number of outputmodes	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(mA)	0-65 ±10% mA RMS, max.,1 Kohm load, Interferentialmode0-50 ±10% mA RMS, max.,1 Kohm load, premodulatedmode	0-65 ±10% mA RMS, max.,1 Kohm load, Interferentialmode0-50 ±10% mA RMS, max.,1 Kohm load, premodulatedmode10-990 ±10 μA peak,1 Kohm load, microampmode
Max output voltage (V)	0-65 ±10% volts RMS, 1Kohm load, Interferentialmode0-50 ±10% volts RMSpremodulated mode	0-65 ±10% volts RMS, 1Kohm load, Interferentialmode0-50 ±10% volts RMSpremodulated mode1.0 ±10% volt peak, 1 Kohmload, microcurrent mode
Waveforms &Channels
All Channels	Premodulated	Premodulated
Channel 1 & 2	Interferential	Interferential
Channel 1	Combination Therapy andall others	High Volt and CombinationTherapy and all othersexcept microcurrent
Channel 2	All	Microcurrent and all othersexcept high volt
Output displays	Two simultaneously, amberchannel active indicators	Two simultaneously, amberchannel active indicators
Channel isolation	Yes	Yes
Line current isolation	Yes	Yes
Automatic overloadtrip	Yes	Yes
Automatic over currenttrip	Yes	Yes
Current/Voltage level	70 mA RMS, interferentialmode55 mA RMS, premodulatedmode	70 mA RMS, interferentialmode55 mA RMS, premodulatedmode110 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(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-M90	Yes	Yes
IEC60601-2-10	Yes	Yes
EN-55011 (CISPR-11)	Yes	Yes
MDD 93/42/EEC,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(D)	5 (H) x 14.5 (W) x 10 (D)
Housing materials	Aluminum chassis with anABS cover	Aluminum
Construction	Folded into a box shapeand seams welded &ground flush and a stylizedABS cover screwed ontometal box.	Stamped in a flat pattern,embossed, folded into a boxshape and seams welded &ground flush
II. Monophasic current
Type	N/A	Monophasic and biphasic,microcurrent
Shape		Square, (Microcurrent)
Net Charge		Positive or negative orneutral depending on thepolarity, microcurrent
Max phase rise time		Less than 1 μs
Max phase decay time		Less than 100 μs
Phase duration range		1-1000, ±10% ms,microcurrent mode
Interpulse interval		N/A, microcurrent mode
Frequency range		0.5 to 500 Hz, ±0.5 Hz or±5%, whichever is greater,microcurrent mode
Maximum currentdensity		49 μA/cm², microcurrentmode
III. Alternating Current
Type	Biphasic	Biphasic
Shape	Sinusoidal, (Interferential,Premodulated modes)	Sinusoidal, (Interferential,Premodulated modes)
Symmetry	Symmetrical	Symmetrical
	Balanced	Balanced
Net charge	Zero	Zero
method	Balanced Waveform	Balanced Waveform
Frequency range	4000-4250 Hz ±1%,(Interferential andPremodulated modes)	4000-4250 Hz ±1%,(Interferential andPremodulated modes)
Beat Frequency (pps)	1-250 ±2 Hz or 10%,whichever is greater	1-250 ±2 Hz or 10%,whichever is greater
Interference Pattern	Yes	Yes
Maximum CurrentDensity	3.52 mA/cm², interferential2.64 mA/cm², premodulated	3.52 mA/cm², interferential2.64 mA/cm², premodulated
Maximum PhaseCharge
(u Coulombs)500 OHMS(Interferential)	8.9	8.9
2K OHMS	7.0	7.0
10K OHMS	1.5	1.5
Formula	q=Ixt	q=Ixt
500 OHMS(Premodulated)	69.5	69.5
2K OHMS	4.7	4.7
10K OHMS	1.0	1.0
Formula	q=1xt	q=Ixt
500 OHMS(Microcurrent)	N/A	1000
2K OHMS	960	960
10K OHMS	610	610
Formula	q=1 x t	q=1 x t
Amplitude ModulationOptions
Reciprocal(Premodulated)	2-240 s ±10%	2-240 s ±10% or combinewith Surge for differentOn/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,50 s, 60 s or 1-240 s ±10% s

Pain Management

{3}------------------------------------------------

channel active indicators

{4}------------------------------------------------

62.5 µs (Interferential and

Premodulated)

118-125 us ±1%

118-125 ps ±1%

・

N/A

62.5 µs (Interferential and

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

{5}------------------------------------------------

{6}------------------------------------------------

AmplitudeModulation,Vector (Interferential)
Description	-50% amplitude modulationin anti phase	-50% amplitude modulationin anti phase
Modulation Period	8 s ± 1 s modulation period	8 s ± 1 s modulation period
Frequency ModulationOptions
Interferential orPremodulated	1-15 Hz ± 2 Hz or 10%whichever is greater	1-15 Hz ± 2 Hz or 10%whichever is greater
	80-150 Hz ± 2 Hz or 10%whichever is greater	80-150 Hz ± 2 Hz or 10%whichever is greater
	1-150 Hz ± 2 Hz or 10%whichever is greater	1-150 Hz ± 2 Hz or 10%whichever is greater
	xx-xx Hz ± 2 Hz or 10%whichever is greater, xx =any value from 1 to 250 Hz	xx-xx Hz ± 2 Hz or 10%whichever is greater, xx =any value from 1 to 250 Hz
Modulation Options
a) May be selectedindependently ortogether	Yes	Yes
b) Simultaneously foreach channel pair	Yes	Yes
c) Independentcontrols for eachchannel	Yes	Yes

{7}------------------------------------------------

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

Neuromuscular Stimulation

510 K #Device Name	K013912Sonicator Plus930	K984142Sonicator Plus992
Manufacturer	MettlerElectronics	MettlerElectronics
Power Source	AC Line	AC Line
Number Of OutputModes	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(mA)	0-65 ±10% mA RMS, max.,1 Kohm load, Interferentialmode	0-65 ±10% mA RMS, max.,1 Kohm load, Interferentialmode
	0-50 ±10% mA RMS, max.,1 Kohm load, premodulatedand medium frequencymodes	0-50 ±10% mA RMS, max.,1 Kohm load, premodulatedand medium frequencymodes
		0-99 ±10% mA peak, max.,1 Kohm load, biphasic mode
		0-2500 ±10% mA peak,max., 1 Kohm, high voltmode
		10-990 ±10 µA peak, 1Kohm load, microamp mode
Max Output Voltage (V)	0-65 ±10% volts RMS, 1Kohm load, Interferentialmode	0-65 ±10% volts RMS, 1Kohm load, Interferentialmode
	0-50 ±10% volts RMSpremodulated mode andmedium frequency modes	0-50 ±10% volts RMSpremodulated mode andmedium frequency modes
		99 ±10% volts peak, 1Kohm load, biphasic mode
		0-500 ±10% volts peak, 1Kohm load, high volt mode
		1.0 ±10% volt peak, 1 Kohmload, microcurrent mode
Waveforms &Channels
All Channels	Premodulated, MediumFrequency	Premodulated, MediumFrequency, Biphasic
Channel 1 & 2	Interferential	Interferential
Channel 1	Combination Therapy andall others	High Volt and CombinationTherapy and all othersexcept microcurrent
Channel 2	All	Microcurrent and all othersexcept high volt
Output Displays	Two simultaneously, amberchannel active indicators	Two simultaneously, amberchannel active Indicators
Channel Isolation	Yes	Yes
Line Current Isolation	Yes	Yes
Automatic OverloadTrip	Yes	Yes
Automatic OverCurrent Trip	Yes	Yes
Current/Voltage Level	70 mA RMS, interferentialmode55 mA RMS, premodulatedand medium frequencymodes	70 mA RMS, interferentialmode55 mA RMS, premodulatedand medium frequencymodes110 mA peak, biphasicN/A, high volt andmicrocurrent modes
Automatic No LoadTrip	Yes	Yes
Patient Override	None	None
Control Method	On/Off or Hold	On/Off or Hold
Max Leakage Current(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-M90	Yes	Yes
IEC60601-2-10	Yes	Yes
EN-55011 (CISPR-11)	Yes	Yes
MDD 93/42/EEC,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(D)	5 (H) x 14.5 (W) x 10 (D)
Housing Materials	Aluminum chassis with anABS cover	Aluminum
Construction	Folded into a box shape and Stamped in a flat pattern,seams welded & groundflush and a stylized ABScover screwed onto metalbox.	embossed and folded into abox shape and seamswelded & ground flush
II. Monophasic Current	N/A
Type		Monophasic, high volt
		Monophasic and biphasic,microcurrent
Shape		Twin spikes, (high volt)
		Square, (Microcurrent)
Net Charge		Positive or Negativedepending on the polarity,high volt
		Positive or negative orneutral depending on thepolarity, 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%amplitude, high volt mode
Interpulse Interval		1-1000, ±10% ms,microcurrent mode75 µs, ±25 µs at 50%amplitude, high volt
		N/A, microcurrent mode
Frequency Range		1-120 Hz, ±1 Hz or ±5%,whichever is greater, highvolt mode
		0.5 to 500 Hz, ±0.5 Hz or±5%, whichever is greater,microcurrent mode
Maximum CurrentDensity		0.088 mA/cm², high voltmode
		49 µA/cm², microcurrentmode
III. Alternating Current
Type	Biphasic	Biphasic
Shape	Sinusoidal, (Interferential, Premodulated and Medium Frequency)	Sinusoidal, (Interferential, Premodulated and Medium Frequency)Square, (Biphasic)
Symmetry	SymmetricalBalanced	SymmetricalBalanced
Net Charge	Zero	Zero
Method	Balanced Waveform	Balanced Waveform
Max Phase Rise Time	62.5 µs (Interferential and Premodulated)100 µs (Medium Frequency)	62.5 µs (Interferential and Premodulated)100 µs (Medium Frequency)
Max Phase Decay Time	62.5 µs (Interferential and Premodulated)100 µs (Medium Frequency)	62.5 µs (Interferential and Premodulated)100 µs (Medium Frequency)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)2500 Hz ±2% (Medium Frequency mode)	4000-4250 Hz ±1%, (Interferential and Premodulated modes)2500 Hz ±2% (Medium Frequency mode)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 CurrentDensity	3.52 mA/cm², interferential2.64 mA/cm², premodulatedand medium frequency	3.52 mA/cm², interferential2.64 mA/cm², premodulatedand medium frequency0.176 mA/cm², biphasic
Maximum PhaseCharge(u Coulombs)
500 OHMS(Interferential)	8.9	8.9
2K OHMS	7.0	7.0
10K OHMS	1.5	1.5
Formula	q=Ixt	q = Ixt
500 OHMS(Premodulated)	69.5	69.5
2K OHMS	4.7	4.7
10K OHMS	1.0	1.0
Formula	q=Ixt	q=Ixt
500 OHMS (MediumFrequency)	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
Formula		q=1 x t

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

500 OHMS

N/A

1000

· ·· ·

(Microcurrent)

{12}------------------------------------------------

2K OHMS	960
10K OHMS	610
Formula	q=1 x t
Amplitude ModulationOptions
Reciprocal(Premodulated,Biphasic, MediumFrequency)	2-240 s ±10%	2-240 s ±10% or combinewith Surge for differentOn/Off times
Surge (Premodulated,Biphasic, MediumFrequency, High Volt)
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	5s, 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,50 s, 60 s or 1-240 s ±10%
AmplitudeModulation.Vector (Interferential)
Description	-50% amplitude modulationin anti phase	-50% amplitude modulationin anti phase
Modulation Period	8 s ± 1 s modulation period	8 s ± 1 s modulation period
Frequency ModulationOptions
Interferential orPremodulated	1-15 Hz ± 2 Hz or 10%whichever is greater	1-15 Hz ± 2 Hz or 10%whichever is greater
	80-150 Hz ± 2 Hz or 10%whichever is greater	80-150 Hz ± 2 Hz or 10%whichever is greater
	1-150 Hz ± 2 Hz or 10%whichever is greater	1-150 Hz ± 2 Hz or 10%whichever is greater
	xx-xx Hz ± 2 Hz or 10%whichever is greater, xx =any value from 1 to 250 Hz	xx -- xx Hz ± 2 Hz or 10%whichever is greater, xx =any value from 1 to 250 Hz

{13}------------------------------------------------

Modulation Options
a) May be selectedindependently ortogether	Yes	Yes
b) Simultaneously foreach channel pair	Yes	Yes
c) Independentcontrols for eachchannel	Yes	Yes

Therapeutic Ultrasound

510 K #	K013192	K984142
Device Name	Sonicator® Plus930	Sonicator Plus992
Manufacturer	MettlerElectronics	MettlerElectronics
Power Source	AC Line	AC Line
Standards
UL 544	No	No
UL 2601-1-UL	Yes	Yes
CUL	No	No
CSA C22.2 NO 601.1-M90	Yes	Yes
IEC60601-2-5	Yes	Yes
FCC Part 15-B	Yes	Yes
EN-55011 (CISPR-11)	Yes	Yes
FDA, 21 CFR 1050.10	Yes	Yes
MDD 93/42/EEC,Annex II	Yes	Yes
Timer Accuracy:	±0.5 minutes for times lessthan 5 minutes±10% for times from 5 to 10minutes±1.0 minute for times graterthat 10 minutes	±0.5 minutes for times lessthan 5 minutes±10% for times from 5 to 10minutes±1.0 minute for times graterthat 10 minutes
Maximum TreatmentTime:	30 minutes-ultrasound orcombination therapy	30 minutes-ultrasound orcombination therapy

Ultrasonic GeneratorSpecifications
Frequency	1.0 MHz ±5%	1.0 MHz ±5%
	3.2 MHz ±5%	3.2 MHz ±5%
		3.3 MHz ±5%Continuous
Modes	ContinuousPulsed-20% duty cycle	Pulsed-20% duty cyclePulsed-50% duty cycle
Pulse Repetition Rate	100 Hz ±20%	100 Hz ±20%
Pulse Duration	2 msec ±20%, 20% dutycycle	2 msec ±20%, 20% dutycycle5 msec ±20%, 50% dutycycle
Temporal Peak/average intensity ratio	5:1 ±20%, 20% duty cycle	5:1 ±20%, 20% duty cycle2:1 ±20%, 50% duty cycle
Maximum outputpower	11 W with a 5 cm2applicator, (ME 7513)	22 W with a 10 cm2applicator, (ME 7310)11 W with a 5 cm2applicator, (ME 7513)2.2 W with a 1 cm2applicator (ME 7331)
Maximum intensity	2.2 W/cm2	2.2 W/cm2 with allapplicators
Indication accuracy	±20% (for any level above10% of maximum)	±20% (for any level above10% of maximum)
Ultrasonic ApplicatorSpecifications
Piezoelectric discs	The output transducerutilizes a barium titanatedisc with a specially coatedface.	The output transducerutilizes a barium titanatedisc with a specially coatedface.
Applicator PartNumber
ME 7310	N/A
Frequency		1 MHz ±5%
Effective RadiatingArea		10 cm2±10%

ME 7331	N/A
Frequency		3.3 MHz ±5%
Effective RadiatingArea		1 cm2±10%

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ME 7513 1 or 3.2 MHz ±5% Frequency 5 cm²±10% Effective Radiating Area

1 or 3.2 MHz ±5% 5 cm²±10%

Maximum Beam Non-6:1 Uniformity Ratio

6:1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/16/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing or feather shapes.

Public Health Service

OCT 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert E. Fleming Director of Operations Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805

Re: K013192 Trade/Device Name: Sonicator® Plus 930, Model ME 930 Regulation Number: 890.5300, 890.5850, 882.5890 Regulation Name: Ultrasonic diathermy Powered muscle stimulator Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: IMI, IPF, GZJ, LIH Dated: September 21, 2001 Received: September 25, 2001

Dear Mr. Fleming:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Mr. Robert E. Fleming

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Mark N Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT SONICATOR PLUS 930, ME 930

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
1. Reduction of muscle spasm
1. Localized increase in blood flow
1. 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)
1. Temporary relaxation of muscle spasm (all waveforms)
1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
1. Increase of blood flow in the treatment area (all waveforms)
1. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
1. Muscle re-education (all waveforms)
1. Maintaining or increasing range of motion (all waveforms)

Mark N Melkeren

(Division Sign-Off) (Division Sign-On), Restorative Division ological Devices KO13192

510(k) Number_

Regulation Number and Section

§ 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.