DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM

K052340 · Alfa Tech Medical Systems, Ltd. · IMG · Dec 9, 2005 · Physical Medicine

Device Facts

• Record ID: K052340
• Device Name: DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
• Applicant: Alfa Tech Medical Systems, Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of 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 surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion

Device Story

DU857 is a two-channel physiotherapy system combining therapeutic ultrasound and neuromuscular stimulation in a cart-mounted console. Device inputs include user-defined settings via touch screen, keyboard, and soft knobs. Microprocessor-controlled electronics generate 1 and 3 MHz ultrasound and alternating current for muscle stimulation. Output is delivered via ultrasound applicators and muscle stimulator electrodes. Used in physiotherapy clinics by trained operators. System provides real-time feedback on operation mode and signal intensities. Output affects clinical decision-making by enabling heat/stretch therapy and muscle re-education. Benefits include pain management, spasm reduction, and prevention of atrophy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and non-clinical documentation.

Technological Characteristics

System console with microprocessor control; 1 and 3 MHz ultrasound; alternating current muscle stimulation. Aluminum chassis. Piezoelectric barium titanate transducer. IEC 60601-1, IEC 60601-2-5, IEC 60601-2-10 compliant. Touch screen interface with audio feedback. Two-channel output. AC line powered.

Indications for Use

Indicated for patients requiring physiotherapy treatment for pain relief, muscle spasm reduction, blood flow increase, range of motion improvement, neuromuscular stimulation, or prevention of disuse atrophy and post-surgical phlebo-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 930, Model ME 930 (K013192)

Submission Summary (Full Text)

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K052340

EXHIBIT 1

### DEC 9 2005

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

#### 1. Submitter's Identification:

Alfa Tech Medical Systems Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel

Date Summary Prepared: 8 August 2005

## Contact Persons:

Mr. Ilan Feferberg COO Alfa Tech Medical Systems, Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel [phone] Tel: + 972-3 5049039 Fax: E-mail: imft(@zahav.net.il

Mr. Yossi Ben David Alfa Tech QA Manager + 972-9 7711018 Tel: + 972-9 7711019 Fax: E-mail: [e-mail]

#### 2. Name of the Device:

- a. TRADE NAME: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System
- b. CLASSIFICATION NAME: Ultrasound and Muscle Stimulator
- 3. Common or Usual Name: Ultrasound Diathermy/Powered Muscle Stimulator

Page 1 of 6

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#### Predicate Devices Information: 4.

- . Mettler Electronics Corp., Sonicator Plus 930, Model ME 930 (K013192)
- ડ. Device Description: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
- · A system console including software and control electronics;
- · A control and display panel;

· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.

The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.

The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.

#### 6. Intended Use: (Same as those for predicate device)

## Therapeutic Ultrasound

- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Localized increase of 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 surgical pain
- 2. Temporary relaxation of muscle spasm
- 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- 4. Increase of blood flow in the treatment area
- 5. Prevention or retardation of disuse atrophy in post-injury type conditions
- 6. Muscle re-education
- 7. Maintaining or increasing range of motion

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#### Comparison to Predicate Devices: 7.

Comparison of technological characteristics to legally marketed predicate devices is given in the tables below:

Table 1. Comparison of general characteristics to legally marketed predicate

| Item for comparison | Description | | Comments |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Claimed device | Predicate device | |
| 510K # | Pending FDA 510(k) approval | K013192 | |
| Device Name | DU857 Dual Frequency<br>Ultrasound Therapy and<br>Muscle Stimulator System | Sonicator Plus 930 | |
| Manufacturer | AlfaTech Medical Systems<br>Ltd. | Mettler Electronics | |
| Intended use | Therapeutic Ultrasound and<br>Neuromuscular Stimulation | Therapeutic Ultrasound and<br>Neuromuscular Stimulation | |
| Target population | Patients who need<br>physiotherapy treatment | Patients who need<br>physiotherapy treatment | |
| Design | The concept is to combine<br>two kinds of physiotherapy<br>units in one device | The concept is to combine<br>two kinds of physiotherapy<br>units in one device | |
| Materials | Metal enclosure | Metal enclosure | |
| Performance | Use friendly interface, easy to<br>operate | Use friendly interface, easy to<br>operate | |
| Sterility | Sterilization is not used | Sterilization is not used | |
| Biocompatability | Yes | Yes | |
| Mechanical Safety | Compliant with mechanical<br>safety requirements of IEC<br>60601-1, IEC 60601-2-5, IEC<br>60601-2-10 safety standards | Compliant with mechanical<br>safety requirements of<br>UL2601-1, CSA C22.2 NO<br>601.1-M90, IEC 60601-2-5,<br>IEC 60601-2-10 safety<br>standards | Mechanical safety<br>requirements of IEC60601-1<br>and UL2601-1 are the same<br>except additional<br>requirements of UL2601-1<br>cl.55 for polymeric covers.<br>These requirements are not<br>applicable for DU857 System<br>because such materials are<br>not used. |
| Chemical Safety | No chemical hazards | No chemical hazards | |
| Human Factors | For analysis see Risk<br>Management file | | |
| Energy delivered | The delivered energy is<br>limited according to<br>requirements of collateral IEC<br>60601-2-5, IEC 60601-2-10<br>safety standards | The delivered energy is<br>limited according to<br>requirements of collateral IEC<br>60601-2-5, IEC 60601-2-10<br>safety standards | The maximum DU857<br>intensities in ultrasound and<br>electrotherapy treatment are<br>less than used in Sonicator<br>Plus 930, see table 2 |
| Compatibility with<br>environment and other<br>devices | The system is used inside<br>buildings. Interaction with<br>other devices is not<br>performed | The system is used inside<br>buildings. Interaction with<br>other devices is not<br>performed | |
| Used at: (hospital,<br>home, ambulances) | Physiotherapy clinics | Physiotherapy clinics | |
| Standards met | IEC 60601-1, IEC 60601-2-5,<br>IEC 60601-2-10 | UL2601-1, CSA C22.2 NO<br>601.1-M90, IEC 60601-2-5,<br>IEC 60601-2-10 | |
| Electrical Safety | IEC 60601-1, IEC 60601-2-5,<br>IEC 60601-2-10 | UL2601-1, CSA C22.2 NO<br>601.1-M90, IEC 60601-2-5,<br>IEC 60601-2-10 | |
| Thermal Safety | IEC 60601-1, IEC 60601-2-5,<br>IEC 60601-2-10 | UL2601-1, CSA C22.2 NO<br>601.1-M90, IEC 60601-2-5,<br>IEC 60601-2-10 | |
| Radiation Safety | N/A | N/A | |
| Item for comparison | Claimed device | Predicate device | |
| 510K # | | K013192 | |
| Device Name | DU857 Dual Frequency Ultrasound<br>Therapy and Muscle Stimulator System | Sonicator Plus 930 | |
| Manufacturer | AlfaTech Medical Systems Ltd. | Mettler Electronics | |
| Power Source | AC line | AC line | |
| Input: | 90-132VAC, 50-60Hz,4A; 207-264VAC,<br>50Hz, 2A | 90-240VAC, 50-60Hz, 2.3A Nom | |
| Classification | Protective Class I Equipment | Protective Class I Equipment | |
| Year 2000 Compliant | Yes | Yes | |
| Weight (lbs) | 165 | 10 | |
| Dimensions (in.) HxW xL | 67 in (H) x 26 in (W) x 35 in (D) | 6 in (H) x 12 in (W) x 12 in (D) | |
| Housing materials | Aluminum chassis | Aluminum chassis with ABS cover | |
| Construction | Folded into a specially designed cart | Folded into a box shape and seams<br>welded & ground flush and a stylized ABS<br>cover screwed onto metal box | |
| Operating temperature | +50°F to +86°F<br>+10°C to +30°C | +50°F to +104°F<br>+10°C to +40°C | |
| Humidity | Operating, 30% to 75% Relative Humidity<br>at 86°F<br>Nonoperating, 20 to 80% Relative<br>Humidity, noncondensing | Operating, 30% to 75% Relative Humidity<br>at 104°F<br>Nonoperating, 5 to 95% Relative<br>Humidity, noncondensing | |
| Storage temperature | 32°F to 113°F<br>0°C to 45°C | -40°F to 167°F<br>-40°C to 75°C | |
| Timer Accuracy | $\pm$ 5 seconds for all times range | $\pm$ 0.5 minutes for times less than 5 minutes<br>$\pm$ 10% for times from 5 to 10 minutes<br>$\pm$ 1.0 minute for times greater than 10<br>minutes | |
| Maximum Treatment Time | 30 minutes - ultrasound or combination<br>therapy<br>30 minutes - electrical stimulation | 30 minutes - ultrasound or combination<br>therapy<br>60 minutes - electrical stimulation | |
| Treatment Timer | Treatment time counts down to zero when<br>a time is set, or up to 30 minutes when no<br>time is set. The digital timer indicates the<br>remaining or elapsed treatment time<br>during the "Hold" period. | Treatment time counts down to zero when<br>a time is set, or up to 60 or 30 minutes<br>when no time is set. The digital timer<br>indicates the remaining or elapsed<br>treatment time during the "Hold" period. | |
| Item for comparison | Neuromuscular Stimulation | | |
| 510K # | | K013192 | |
| Standards | | | |
| UL544 | No | No | |
| UL2601-1-UL | No | Yes | |
| CUL | No | No | |
| CSA C22.2 NO 601.1-<br>M90 | No | Yes | |
| IEC 60601-1 | Yes | No | |
| IEC 60601-2-10 | Yes | Yes | |
| FCC Part 15-B | Yes | Yes | |
| EN-55011 (CISPR-11) | Yes | Yes | |
| FDA, 21 CFR 1050.10 | Yes | Yes | |
| MDD 93/42EEC, Annex II | Yes | Yes | |
| Timer settings | 1-30 minutes $\pm$ 1% | 1-60 minutes $\pm$ 5% | |
| Automatic Shut Off | Yes | Yes | |
| Number of output modes | 1 | 3 | |
| Channel(s) | 2 | 2 | |
| Synchronous | 1&2 | 1&2 | |
| Reciprocal | No | Yes | |
| Other | No | Yes | |
| Computerized Software<br>Provided | Yes | N/A | |

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## Table 2. Comparison of technological characteristics to legally marketed predicate

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:

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| Constant Current | No | Yes | | | |
|-----------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--|-----|--|
| Constant Voltage | No | No | | | |
| Max Output Current (mA) | 0-36±10% mA RMS, max.,<br>1Kohm load, Muscle Stimulator mode | 0-65±10% mA RMS, max.,<br>1Kohm load, Muscle Stimulator mode | | | |
| | N/A | 0-50±10% mA RMS, max.,<br>1Kohm load, premodulated and medium<br>frequency modes | | | |
| | N/A | 0-99±10% mA peak, max.,<br>1Kohm load, biphasic mode | | | |
| | N/A | 0-2500±10% mA peak, max.,<br>1Kohm load, high volt mode | | | |
| | N/A | 10-990±10 μA peak,<br>1Kohm load, microamp mode | | | |
| Max output Voltage (V) | 0-36±30% volts RMS,<br>1Kohm load, Muscle Stimulator mode | 0-65±10% volts RMS,<br>1Kohm load, Muscle Stimulator mode | | | |
| | N/A | 0-50±10% volts RMS,<br>1Kohm load, premodulated and medium<br>frequency modes | | | |
| | N/A | 99±10% volts peak,<br>1Kohm load, biphasic mode | | | |
| | N/A | 0-500±10% volts peak,<br>1Kohm load, high volt mode | | | |
| | N/A | 1.0±10% volt peak,<br>1Kohm load, microamp mode | | | |
| Frequency range | 4800-5050 Hz ±1%(Interferential mode) | 4000-4250 Hz ±1%(Interferential and<br>Premodulated modes)<br>2500 Hz ±2%(Medium frequency mode) | | | |
| Electrodes | ME2221 | ME2221 | | | |
| Waveforms & Channels | | | | | |
| All Channels | Interferential | Premodulated, Medium Frequency,<br>Biphasic | | | |
| Channel 1 & 2 | Muscle Stimulator | Muscle Stimulator | | | |
| Channel 1 | Muscle Stimulator | Combination Therapy and all others | | | |
| Channel 2 | Muscle Stimulator | All | | | |
| Output Displays | Two simultaneously, amber channel<br>active indicators | Two simultaneously, amber channel<br>active indicators | | | |
| Channel Isolation | Yes | Yes | | | |
| Line Current Isolation | Yes | Yes | | | |
| Automatic Overload Trip | Yes | Yes | | | |
| Current/Voltage level | 50 mA RMS, Muscle Stimulator mode<br>N/A | 70 mA RMS, Muscle Stimulator mode<br>55 mA RMS, premodulated and medium<br>frequency mode | | | |
| Automatic No Load Trip | Yes | Yes | | | |
| Patient Override | None | None | | | |
| Control Method | On/Off | 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 | | | |
| Therapeutic Ultrasound | | | | | |
| 510K # | | K013192 | | | |
| Standards | | | | | |
| UL544 | No | No | | | |
| UL2601-1-UL | No | Yes | | | |

:

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| CUL | No | No |
|------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| CSA C22.2 NO 601.1-<br>M90 | No | Yes |
| IEC 60601-1 | Yes | No |
| IEC 60601-2-5 | Yes | Yes |
| FCC Part 15-B | Yes | Yes |
| EN-55011 (CISPR-11) | Yes | Yes |
| FDA, 21 CFR 1050.10 | Yes | Yes |
| MDD 93/42EEC, Annex II | Yes | Yes |
| Ultrasonic Generator<br>Specifications | | |
| Frequency | $1 MHz±5%$ | $1 MHz±5%$ |
| | $3 MHz±5%$ | $3 MHz±5%$ |
| Modes | Continuous | Continuous |
| | | Pulsed - 20% duty cycle |
| | | Pulsed - 50% duty cycle |
| Pulse Repetition Rate | Not applicable | $100 Hz±20%$ |
| Pulse Duration | Not applicable | 2 msec±20%, 20% duty cycle |
| Temporal Peak/average<br>intensity ratio | Not applicable | 5:1±20%, 20% duty cycle |
| | | 2:1±20%, 50% duty cycle |
| Maximum Output Power | 7.5 W with a $5 cm^2$ applicator, (ME 7513) | 11 W with a $5 cm^2$ applicator, (ME 7513) |
| Maximum Intensity | $1.5 W/cm^2$ | $2.2 W/cm^2$ |
| Indication Accuracy | ±20% (for any level above 10% of<br>maximum) | ±20% (for any level above 10% of<br>maximum) |
| Ultrasonic Applicator<br>Specifications | | |
| Piezoelectric Disks | The output transducer utilizes a barium<br>titanate disc with a specially coated face | The output transducer utilizes a barium<br>titanate disc with a specially coated face |
| Applicator Part Number | ME7513 | ME7513 |
| Frequency | 1 or 3 MHz±5% | 1 or 3.2 MHz±5% |
| Effective Radiating Area | $5 cm^2±10%$ | $5 cm^2±10%$ |
| Maximum Beam Non-Uniformity Ratio | 6:1 | 6:1 |

#### 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Not applicable

#### 9. Discussion of Clinical Tests Performed: Not applicable

#### 10. Conclusions:

The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System has the same intended use and similar characteristics as the predicate device, the Sonicator Plus ® 930, Model ME 930 device. Moreover, bench testing and non-clinical testing documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Alfa Tech Medical Systems Ltd. DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

Alfa Tech Medical Systems, Ltd. c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K052340

Trade/Device Name: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System Regulation Number: 21 CFR 890.529 Regulation Name: Ultrasound and Muscle Stimulator Regulatory Class: II Product Codes: IMG, IMI, IPF, LIH Dated: November 22, 2005 Received: November 23, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your soctor s retty production is substantially equivalent (for the indications for relerenced above and nave decemined are devices marketed in interstate commence use stated in the encrosure/ to regally manistal Device Amendments, or to devices that provision in May 26, 1770, the onacthern with the provisions of the Federal Food, Drug, and Cosmetic flave been reclassified in accordance the me me market approval application (PMA). You may, Act (Act) that do not require approvate of the general controls provisions of the Act. The general therefore, market the device, sabject or anual registration, listing of devices, good controls provisions of the necessed prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see acorrols. Existing major regulations affecting your device can be may be subject to such additional controls. "Line 11, 2008. 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 FICA 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 CEP Box 907). Federal statutes and regulations administration and listing (21 CFR Part 807); the Act 3 requirements, morading, earling practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket noutheation: "The PDF Intentig sification 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), please If you ucate specific advice 10. Jour 2019 276-0120. Also, please note the regulation entitled, Colliact the Office of Ochphanes as (210) fication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, general information on your respension its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Exhibit B

Page 1 of 1

510(k) Number (if known): K052340

# Device Name: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System

## Indications For Use:

. ...

Therapeutic Ultrasound:

- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Localized increase of 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 surgical pain
- 2. Temporary relaxation of muscle spasm
- 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- 4. Increase of blood flow in the treatment area.
- 5. Prevention or retardation of disuse atrophy in post-injury type conditions
- 6. Muscle re-education
- 7. Maintaining or increasing range of motion

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

2

(Division of the of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

**510(k) Number** K052340