BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

K160378 · Brh Medical , Ltd. · IMI · Aug 25, 2017 · Physical Medicine

Device Facts

• Record ID: K160378
• Device Name: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
• Applicant: Brh Medical , Ltd.
• Product Code: IMI · Physical Medicine
• Decision Date: Aug 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation. 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

BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy; housed in a mobile cart. Device inputs include user-selected treatment parameters via a touch screen interface. System utilizes a microprocessor to control ultrasound (1 and 3 MHz) and electrical stimulation outputs. Output is delivered to the patient via control electrodes and a 4 cm2 piezoelectric transducer. Used in physical therapy clinics and hospitals by clinicians. The touch screen provides operational status and signal intensities; large knobs allow power adjustment. Output affects clinical decision-making by providing deep heat and muscle stimulation to address pain, spasm, and atrophy. Benefits include improved range of motion, muscle re-education, and prevention of post-surgical complications.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through testing against recognized standards: ANSI/AAMI ES60601-1, IEC 60601-2-5 (ultrasonic physiotherapy), IEC 60601-2-10 (nerve/muscle stimulators), ISO 14971 (risk management), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarms), IEC 60601-1-2 (EMC), and IEC 62304 (software development).

Technological Characteristics

System includes console, touch screen, and cart. Ultrasound: 1/3 MHz, piezoelectric (PZT807 crystal), 4 cm2 ERA, collimated beam, 303 stainless steel contact face. Electrical: 4-pole interferential, 4000 Hz carrier, 1-250 Hz beat frequency, regulated current output. Power: 90-264 VAC. Isolation: Transformer-based. Dimensions: 22x16.5x12 in. Weight: 22 lbs. Software: Microprocessor-controlled, locked. Sterilization: Not applicable (surface contact).

Indications for Use

Indicated for adult patients requiring therapeutic ultrasound for pain relief, muscle spasm reduction, localized blood flow increase, or joint range of motion improvement; and neuromuscular stimulation for chronic/acute pain relief, muscle spasm relaxation, prevention of post-surgical phlebo-thrombosis, blood flow increase, prevention of disuse atrophy, muscle re-education, and range of motion maintenance.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Predicate Devices

• Sonicator Plus 930 (K013192)
• The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System (K052340)

Submission Summary (Full Text)

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

August 25, 2017

BRH Medical Ltd. % Susan D. Goldstein-Falk Vice President - FDA Compliance mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021

Re: K160378

Trade/Device Name: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI, IPF, LIH, IMG Dated: July 27, 2017 Received: July 28, 2017

Dear Ms. Goldstein-Falk:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K160378

#### Device Name

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

#### Indications for Use (Describe)

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

TARGET POPULATION Adult patients

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for BRK Medical. The logo features the letters "BR" in gray, with the letter "K" stylized as a teal human figure with outstretched arms. Below the letters "BR" is the word "medical" in teal, written in a smaller, sans-serif font. The overall design is clean and modern, suggesting a company focused on health and well-being.

## K160378 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

General Information:

| Applicant: | BRH Medical Ltd. The Jerusalem Technological Gardens Building A, 1st Floor Jerusalem, 96951, Israel Tel: + 02-6483519 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | |
| CEO | Motti Oderberg Tel: ++ 972 (0)54-6772277 E-mail: [e-mail] |
| СТО | ILAN Feferberg Tel: ++972 (0)54-6678330 E-mail: [e-mail] |
| Date Prepared: | August 24, 2017 |
| Device Trade Name: | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) |
| Common or Usual Name: | Ultrasonic diathermy for Use in Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasonic Diathermy (21 CFR 890.5300) |
| Regulatory Class: | Class II |
| Product Code: | IMI |
| Common or Usual Name: | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasound and muscle stimulator (21 CFR 890.5860) |
| Regulatory Class: | Class II |
| Product Code: | IMG |

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Image /page/4/Picture/0 description: The image shows a logo for BRK medical. The letters "BR" are in gray, and the letter "K" is stylized in blue with a figure of a person with their arms raised above their head. The word "medical" is written in blue below the letters "BR".

Common or Usual Name: Classification Name: Regulatory Class: Product Code:

Common or Usual Name: Classification Name:

Regulatory Class: Product Code:

The Jerusalem Technological Garden Building A' Floor 1 Jerusalem -96591- Israel Tel ++972-2-6483519 Fax ++972-2-6483541

Stimulator, Muscle, Powered Powered muscle stimulator (21 CFR 890.5850) Class II IPF

Interferential Current Therapy Transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890) Class II LIH

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Image /page/5/Picture/0 description: The image contains a logo for BRK medical. The letters 'BR' are in gray, with 'K' in teal and a stick figure with arms raised incorporated into the 'K'. Below the letters is the word 'medical' in teal. The logo is simple and modern, using a clean font and a limited color palette.

| Primary Predicate Device: | Trade Name Sonicator® Plus 930<br>(Combination ultrasound and muscle stimulator) Mettler Electronic<br>Corp.<br>K013192 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate Device: | Trade Name The DU857 Dual Frequency Ultrasound Therapy<br>and Muscle Stimulator System<br>Alfa Tech Medical Systems Ltd.<br>K052340 |

### Device Description:

The BRH-A2 CUSEFS is comprised of the following main components:

- A system console including software and control electrodes; ●
- A control and display panel
- Specially designed cart
- User-friendly touch screen
- . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.

The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.

There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.

The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.

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Image /page/6/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, with the "R" slightly overlapping the "B". To the right of the letters is a stylized figure of a person in teal. The word "medical" is in teal below the letters "BR".

## Indications for Use:

The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation

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

#### TARGET POPULATION

Adult patients

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Image /page/7/Picture/0 description: The image contains the logo for BRK medical. The logo has the letters "BR" in gray, with the letter "K" in teal. The "K" is stylized to look like a person with their arms raised. Below the letters is the word "medical" in teal.

## Substantial Equivalence Comparison of Subject Device to Predicate Devices

| Parameter | BRH-A2 Combined Ultrasound<br>and Electric Field Stimulation<br>(CUSEFS) K160378 | Primary Predicate<br>Sonicator Plus 930<br>K013192 | Secondary Predicate<br>DU857 K052340 |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BRH-A2 Combined Ultrasound and<br>Electric Field Stimulation (CUSEFS) | Sonicator Plus 930 | DU857 |
| 510(k) number | K160378 | K013192 | K052340 |
| Classification<br>Name | Ultrasonic Diathermy for Use in<br>Applying Therapeutic Deep Heat,<br>Stimulator, Ultrasound And<br>Muscle, For Use In Applying<br>Therapeutic Deep Heat,<br>Stimulator, Muscle, Powered and<br>Interferential Current Therapy | Ultrasonic Diathermy,<br>Powered Muscle<br>Stimulator, Transcutaneous<br>Electrical Nerve Stimulator<br>for Pain relief and<br>Interferential Current<br>Therapy. | Ultrasound and Muscle<br>Stimulator |
| Model Number | BRH-A2 | ME930 | DU857 |
| Product Code | IMI, IMG, IPF, LIH | IMI, GZJ, IPF, LIH | IMI, IMG, IPF, LIH |
| Manufacturer | BRH Medical Ltd. | Mettler Electronics | Alfa Tech Medical<br>Systems Ltd |
| Indications for<br>use | Therapeutic Ultrasound:<br>1. Pain relief<br>2. Reduction of muscle<br>spasm<br>3. Localized increase of<br>blood flow<br>4. Increase range of motion<br>of contracted joints using<br>heat and stretch<br>techniques.<br><br>Neuromuscular Stimulation<br>1. Symptomatic relief of<br>chronic intractable pain,<br>acute post traumatic pain<br>or acute surgical pain<br>2. Temporary relaxation of<br>muscle spasm<br>3. Prevention of post-<br>surgical phlebo-<br>thrombosis through<br>immediate stimulation of<br>calf muscles<br>Increase of blood flow in<br>4. | Therapeutic Ultrasound:<br>1. Pain relief<br>2. Reduction of<br>muscle spasm<br>3. Localized increase<br>of blood flow<br>4. Increase range of<br>motion of<br>contracted joints<br>using heat and<br>stretch<br>techniques.<br><br>Neuromuscular Stimulation<br>1. Symptomatic relief<br>of chronic<br>intractable pain,<br>acute post<br>traumatic pain or<br>acute surgical pain<br>(Interferential and<br>Pre-modulated<br>waveforms)<br>2. Temporary | Therapeutic Ultrasound:<br>1. Pain relief<br>2. Reduction of<br>muscle spasm<br>3. Localized<br>increase of<br>blood flow<br>4. Increase range<br>of motion of<br>contracted<br>joints using<br>heat and<br>stretch<br>techniques.<br><br>Neuromuscular<br>Stimulation<br>1. Symptomatic<br>relief of chronic<br>intractable<br>pain, acute<br>post traumatic<br>pain or acute<br>surgical pain |
| | the treatment area.<br>5. Prevention or retardation<br>of disuse atrophy in post-<br>injury type conditions<br>6. Muscle re-education<br>7. Maintaining or increasing<br>range of motion<br><br>TARGET POPULATION | relaxation of<br>muscle spasm(all<br>waveforms)<br>3. Prevention of<br>post-surgical<br>phlebo-thrombosis<br>through<br>immediate<br>stimulation of calf<br>muscles(all<br>waveforms)<br>4. Increase of blood<br>flow in the<br>treatment area(all<br>waveforms)<br>5. Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions(all<br>waveforms)<br>6. Muscle re-<br>education(all<br>waveforms)<br>7. Maintaining or<br>increasing range of<br>motion(all<br>waveforms) | 2. Temporary<br>relaxation of<br>muscle spasm<br>3. Prevention of<br>post-surgical<br>phlebo-<br>thrombosis<br>through<br>immediate<br>stimulation of<br>calf muscles<br>4. Increase of<br>blood flow in<br>the treatment<br>area.<br>5. Prevention or<br>retardation of<br>disuse atrophy<br>in post-injury<br>type conditions<br>6. Muscle re-<br>education<br>7. Maintaining or<br>increasing<br>range of<br>motion |
| | Adult patients | | |
| Design and<br>Appearance | Image: BRH MEDICAL device | Image: Device with buttons and screen | |
| Size (HxWxD) | 22 x 16.5 x 12 in | 6 x 12 x 12 in | 67 X 26 X 35 in |
| Weight | 22 pounds | 10 pounds | 165 pounds |
| Design | The concept is to combine two<br>kinds of therapeutic methods in a | The concept is to combine<br>two kinds of therapeutic | The concept is to<br>combine two kinds of |
| | compact unit. | methods in one device | therapeutic methods in one device |
| Overall design<br>difference | Separate touch screen controls<br>both ultrasound & neuromuscular<br>stimulation | A membrane panel and a<br>touch screen to set up<br>treatments | A membrane panel and<br>a touch screen to set up<br>treatments |
| Materials | Metal enclosure | Metal enclosure | Metal enclosure |
| Housing<br>materials | Folded into a box shape and<br>seams welded & ground flush and<br>a stylized ABS cover screwed onto<br>metal box | Folded into a box shape<br>and seams welded &<br>ground flush and a stylized<br>ABS cover screwed onto<br>metal box | Aluminum chassis |
| Performance | Use friendly interface, easy to<br>operate | Use friendly interface, easy<br>to operate | Use friendly interface,<br>easy to operate |
| Target<br>population | Adult patients | Patients who need<br>Therapeutic Ultrasound and<br>or Electrotherapy<br>treatments | Patients who need<br>physiotherapy<br>treatment |
| Environment(s)<br>of use | Physical therapy clinics; hospitals | Physical therapy clinics;<br>hospitals | Physical therapy clinics;<br>hospitals |
| BASIC UNIT CHARACTERISTICS | | | |
| Power source | AC Line | AC Line | AC Line |
| Power input | 90-264 VAC, 50-60 Hz | 90-240VAC, 50-60Hz | 90-132VAC, 50-60Hz,4A;<br>207-264VAC, 50Hz, 2A |
| Method Line<br>current isolation | Yes<br>Isolation transformer | Yes | Yes |
| Operating<br>temperature | +50°F to +104°F | +50°F to +104°F | +50°F to +86°F |
| Humidity | Operating, 30% to 75% RH (not<br>condensed)<br>Storage, 20% to 80% RH (not<br>condensed) | Operating, 30% to 75%<br>Relative Humidity (RH) at<br>104°F<br>Storage, 5% to 95% RH (not<br>condensed) | Operating, 30% to 75%<br>Relative Humidity at<br>86°F<br>Non operating, 20 to<br>80% Relative Humidity,<br>noncondensing |
| Storage<br>temperature | 40°F to 167°F | 40°F to 167°F | 32°F to 113°F<br>0°C to 45°C |
| Indicator display | Yes | Yes | Yes |
| On/off status | | | |
| Treatment<br>timer | Treatment time counts down to<br>zero when time is set | Treatment time counts<br>down to zero when time is<br>set | Treatment time counts<br>down to zero when a<br>time is set, or up to 30<br>minutes when no time is<br>set. The digital timer<br>indicates the remaining<br>or elapsed treatment<br>time during the "Hold" |
| Timer Accuracy | | | |
| | ± 0.5 seconds for all times range | ±0.5 minutes for times less<br>than 5 minutes<br>tl 0% for times from 5 to 10<br>minutes<br>±1.0 minute for times<br>greater than 10 minutes | ± 5 seconds for all times<br>range |
| Number of channels | 2 | 2 | 2 |
| Software control | Yes | Yes | Yes |
| Automatic overload trip | Yes | Yes | Yes |
| Insulation | BF | BF | BF |
| Patient override control | Yes | Yes | Yes |
| Maximum Treatment Time | 30 minutes - ultrasound therapy<br>30 minutes - neuromuscular<br>stimulation | 30 minutes - ultrasound<br>therapy<br>60 minutes -<br>neuromuscular stimulation | 30 minutes - ultrasound<br>therapy<br>30 minutes - neuro<br>muscular stimulation |
| Treatment Timer | Treatment time counts down to<br>zero when time is set, or up to 30<br>minutes when no time is set. The<br>digital timer indicates the<br>remaining or elapsed treatment<br>time during the 'Hold' period. | Treatment time counts<br>down to zero when time is<br>set, or up to 60 or 30<br>minutes when no time is<br>set. The digital timer<br>indicates the remaining or<br>elapsed treatment time<br>during the 'Hold' period | Treatment time counts<br>down to zero when time<br>is set, or up to 60 or 30<br>minutes when no time is<br>set. The digital timer<br>indicates the remaining<br>or elapsed treatment<br>time during the 'Hold'<br>period |
| Power Indicator | Yes | Yes | Yes |
| Operational Indicator | Yes | Yes…