FUTURA

K102524 · Dr. Oliver Wenker, M.D., M.B.A. · IMG · Nov 3, 2011 · Physical Medicine

Device Facts

• Record ID: K102524
• Device Name: FUTURA
• Applicant: Dr. Oliver Wenker, M.D., M.B.A.
• Product Code: IMG · Physical Medicine
• Decision Date: Nov 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

MUSCLE STIMULATOR INDICATIONS FOR USE: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. ULTRASOUND INDICATIONS FOR USE: Application of deep heat for: 1. Temporary relief of minor pain 2. Muscle spasm relief 3. Joint contracture relief Not for treatment of malignancies. Not for use on the face.

Device Story

Futura Pro is a 10-channel electronic muscle stimulator with a diathermic ultrasound attachment. Main control unit powers and manages stimulation and ultrasound. Stimulation: delivers transcutaneous electrical pulses via self-adhesive electrodes to skeletal muscles; controlled by microprocessor; features safe-start interlock circuits. Ultrasound: handheld applicator with piezoelectric transducer generates 1MHz deep heat; powered by main unit; uses acoustic coupling gel. Operator selects programs via screen interface; system displays intensity and treatment progress. Used in clinical settings under medical supervision. Benefits include precise electrode placement, independent channel control for varied waveforms, and graphical user interface for treatment guidance. Output leads feature LEDs for channel identification. System powered by internal 12V battery or external 12VDC supply.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, verification/validation reports, and adherence to recognized safety standards (BS EN 60601 series).

Technological Characteristics

10-channel muscle stimulator and 1MHz ultrasound applicator. Materials: self-adhesive electrodes (specified by manufacturer). Energy: 12V battery or 12VDC external supply. Connectivity: standalone console. Software: microprocessor-controlled, flash memory. Standards: BS EN 60601-1, 60601-2-10, 60601-2-5, 60601-1-2, 61000 series, 55022.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, or maintenance/increase of range of motion. Ultrasound indicated for temporary relief of minor pain, muscle spasm, and joint contracture. Contraindications: Malignancies, use on the face.

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

• Ultratone 20 (K926410)
• Ultrasonic Therapy Appliance (K050410)

Submission Summary (Full Text)

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K102524

# 510(k) Summary for Futura Pro (US Specification)

(This summary was revised on 21st October 2011)

#### Sponsor:

Olivier Wenker, MD, MBA The University of Texas MD Anderson Cancer Center 1400 Pressler Street, FCT 8.5050 Unit 1439 Houston, Texas 77030-3722 713-563-0936 C 832 443 1193 Email [e-mail]

#### Contact Person:

Courtland Imel Ceutical Laboratories, Inc. 2300 Valley View Lane, Suite 230 Farmers Branch, Texas 75234

Tel [phone] Fax [phone] Email [e-mail]

#### Device Details:

Proprietary name: Futura Pro (US Specification) Common/Usual name: Futura Pro Classification Name: Muscle Stimulator Ultrasound, and TENS (per 21 CFR 890.5860) Classification: II Product Code: IMG Regulation Number: CFR 890.5860 Panel: Physical Medicine Devices

#### Predicate Devices:

Device, Approval No.: Manufacturer, Ultratone Scientific Instruments Ltd, Ultratone 20, K926410 Hwang Sun Enterprise Co. Ltd, Ultrasonic Therapy Appliance, K050410

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K102524

#### Device Description

The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment.

The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin.

The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit.

Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted.

The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply.

Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately.

The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.

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# K102524

#### MUSCLE STIMULATOR

Intended Use:

1. Relaxation of muscle spasms

2. Prevention or retardation of disuse atrophy

3. Increasing local blood circulation

4. Muscle re-education

5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

6. Maintaining or increasing range of motion

These intended uses are similar to the predicate marketed device Ultratone 20 K926410.

#### ULTRASOUND

Intended Use:

Application of deep heat for:

1. Temporary relief of minor pain

2. Muscle spasm relief

3. Joint contracture relief

Not for treatment of malignancies.

Not for use on the face.

These intended uses are similar to the predicate marketed device HES® Ultrasonic Therapy Appliance K050410.

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K102524

# Technological Comparison - Summary Powered Muscle Stimulator Part Comparison with Predicate

| | Device of this 510(k) | Predicate Device |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | TO BE ASSIGNED | K926410 |
| Device Name | Futura Pro (USA Specification) | Ultratone 20 |
| Indications | • Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood circulation | • Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood circulation |
| | • Muscle re-education<br>• Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>• Maintaining or increasing range<br>of motion | • Muscle re-education<br>• Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>• Maintaining or increasing range<br>of motion |
| Power Source | | |
| Internal: | 12V battery. | 12V battery. |
| External: | 12V charger / adaptor | 15V Charger / adaptor |
| Number of Output<br>Modes | Two - Biphasic / Monophasic | Two - Biphasic / Monophasic |
| Number of Output<br>Channels | 10 channels | 10 channels |
| Channel Isolation | All outputs are fed via individual<br>output isolating transformers. | All outputs are fed via individual<br>output isolating transformers. |
| Software / Firmware<br>/ Microprocessor<br>Control | All functions are controllable by<br>the microprocessor. All software is<br>contained inside the unit in flash<br>memory. This is not accessible to<br>the operator. | All functions, except output<br>amplitude, are controlled by the<br>microprocessor. All software is<br>contained inside the unit in<br>EPROM. This is not accessible to<br>the operator. |
| Design | Console sending control signals to<br>a 10 channel electrical muscle<br>stimulation generator. The signal<br>is applied cutaneously via patient<br>connecting leads and self<br>adhesive stimulation electrodes. | Control console incorporating 10<br>channel electrical muscle<br>stimulation generator. The signal<br>is applied cutaneously via patient<br>connecting leads and stimulation<br>electrodes held in position with<br>straps. |
| Maximum RMS O/P<br>Current | $16.2 ormalfont{mA}_ ormalfont{rms} @ 500Ω$ | $15.5 ormalfont{mA}_ ormalfont{rms} @ 500Ω$ |
| Minimum electrode<br>size | 7.0 cm dia. (38.5 cm²) | 10.1 cm dia. (80.1 cm²) |
| Maximum Current<br>Density (RMS) | $0.421 ormalfont{mA/cm}^2 @ 500Ω$ | $0.194 ormalfont{mA/cm}^2 @ 500Ω$ |
| Maximum RMS<br>Power Density | $3.42 ormalfont{mW/cm}^2 @ 500Ω$ | $1.50 ormalfont{mW/cm}^2 @ 500Ω$ |

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Kl02524

# Ultrasound Part Comparison with Predicate

،

| | Device of this 510(k) | Predicate Device |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Ultrasound Applicator<br>Model No. UFPUA3 | Ultrasonic Therapy Appliance<br>Model No. HS 3008 |
| Manufacturer | Hwang Sun Enterprise Co. Ltd.<br>70955 No. 8, Keji 1st Rd., Annan<br>District, Tainan, Taiwan | Hwang Sun Enterprise Co. Ltd.<br>70955 No. 8, Keji 1st Rd., Annan<br>District, Tainan, Taiwan |
| 510(k) No. | TO BE ASSIGNED | K050410 |
| Indications | Application of deep heat for:<br>Temporary relief of minor pain<br>Muscle spasm relief<br>Joint contracture relief<br>Not for treatment of malignancies<br>Not for use on the face. | "generates deep heat within body<br>tissues for the treatment of<br>selected medical conditions such<br>as temporary relief of minor pain,<br>muscle spasms and joint<br>contractures, but not for the<br>treatment of malignancies." |
| Input Voltage | 24VDC | 24VDC |
| Timer auto off | Yes | Yes |
| Max. treatment<br>time | 15 min | 15 min |
| Frequency | 1000 KHz $ \u00b1 $ 5% | 1000 KHz $ \u00b1 $ 5% |
| Mode | Pulsed and mode where output is<br>switched on/off at 1 Hz. | Pulsed and mode where output is<br>switched on/off at 1 Hz. |
| Waveform type | Amplitude modulated | Amplitude modulated |
| Applicator size | Transducer diameter 46.5mm | Transducer diameter 46.5mm |
| Effective Radiating<br>Area | 15 cm² $ \u00b1 $ 10% | 15 cm² $ \u00b1 $ 10% |
| Temporal Max<br>Power | 0.97 W $ \u00b1 $ 10% | 0.97 W $ \u00b1 $ 10% |
| Temporal Max<br>Effective Intensity | 1.47 W/cm² $ \u00b1 $ 10% | 1.47 W/cm² $ \u00b1 $ 10% |
| Beam<br>nonconformity ratio | 6:1 | 6:1 |
| Design | Hand held device generating<br>ultrasonic frequency (1MHz) via<br>incorporated piezoelectric<br>transducer. Power is supplied<br>externally from the Futura Pro<br>console. | Hand held device generating<br>ultrasonic frequency (1MHz) via<br>incorporated piezoelectric<br>transducer. Power is supplied<br>externally from a separate power<br>adaptor. |

:

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#### Technological Differences between the Futura Pro (US Specification) and the predicates

K102524

The significant differences are:

The Futura Pro (US Specification) has a system where the electrode . connectors can be illuminated by the console, for identification of the electrodes. On a multi-channel powered muscle stimulator this aids channel identification.

. The stimulation pulses are applied using disposable self adhesive electrodes rather than conductive rubber electrodes held in place with elastic straps. The self adhesion helps to prevent inadvertent movement of the electrodes during treatment and is considered to be a benefit. The specified electrodes for the Futura Pro (US Specification) are smaller to allow more precision when applying them. It does make the applied current density greater. This is considered acceptable as the resultant current density is well within accepted levels

The Futura Pro (US Specification) has a screen capable of displaying . graphics. This can immediately present relevant information to assist the user in the operation of the device in text and graphical form. The instructions and set up sequence are shown on the display and this assists the operator to carry out the treatment without making errors. This is considered to be a risk lowering benefit with no adverse effect when considered with the predicate.

The Futura Pro (US Specification) has a more sophisticated control . circuitry and software in the powered muscle stimulator to allow groups of output channels to operate independently of the others. This has the advantage of being able to apply different stimulation waveforms to different treatment points. The overall power applied to the patient is limited in the hardware exactly as it is in the predicate by the saturation of each output transformer.

The Futura Pro (US Specification) provides the hand held ultrasound . diathermy device with power. This is taken from the internal low voltage source within the Futura Pro (US Specification) and there are means to stop the ultrasound operation via the console in addition to the control on the hand set. These are considered to be benefits over and above the predicate.

There are no adverse effects from these differences.

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K102524

# Non-clinical tests

Comparisons of the outputs for the Futura Pro (US Specification) and the predicates show similar results that are suitable for transcutaneous electrical muscle stimulation and the application of deep heat using ultrasound.

In addition to the validation and verification reports submitted in this premarket notification, independent testing has been carried out to demonstrate the device conforms to the following standards:

- BS EN 60601-1:2006 Medical electrical equipment. General . requirements for basic safety and essential performance.
- . BS EN 60601-2-10:2001 - Medical electrical equipment. Particular requirements for the safety of nerve and muscle stimulators
- BS EN 60601-2-5:2001 Medical electrical equipment. Particular . requirements for safety. Particular requirements for the safety of ultrasonic physiotherapy equipment
- BS EN 55022:2006+A1:2007 Information technology equipment. Radio . disturbance characteristics. Limits and methods of measurement
- BS EN 61000-4-5:2006 Electromagnetic compatibility (EMC). Testing . and measurement techniques. Surge immunity test
- . BS EN 61000-4-6:2009 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Immunity to conducted disturbances, induced by radio-frequency fields
- . BS EN 61000-4-11:2004 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Voltage dips, short interruptions and voltage variations immunity tests
- . BS EN 60601-1-2:2007 -- Immunity standard for medical equipment
- BS EN 61000-4-2:1995 ESD Requirements .
- BS EN 61000-4-3:2006+A1:2008 Radiated susceptibility requirement .

The manufacturer, Ultratone Scientific Instruments, adheres to recognized and established industry practice for medical devices and all devices are subject to final performance testing.

# Clinical tests

No clinical tests were performed.

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K102524

### Technological Characteristics and Substantial Equivalence Conclusions

Ultratone Scientific Instruments Ltd believes that, based on verification. validations, and safety and performance testing results, the Futura Pro (US Specification) is substantially equivalent to other legally marketed devices and to the standard procedures cited above without raising new safety and/or effectiveness issues. Moreover, any differences in their technological characteristics that do exist would not have a significant effect on the safety or effectiveness of the device.

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

NOV - 3 2011

Dr. Olivier Wenker, M.D., M.B.A. % Mr. Courtland Imel 2300 Valley View Lane, Suite 230 Farmers Branch, Texas 75234

Re: K102524

Trade Name: Futura Pro (US Specification) Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle Stimulator Regulatory Class: Class II Product Code: IMG Dated: October 10, 2011 Received: October 13, 2011

Dear Mr. Imel:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Courtland Imel

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. Page 2 - Courtland Imel

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/CDRH/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.fdagov/MedicalDevices/Safety/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

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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# 3. Indications for Use Statement

510(k) Number: K102524

Futura Pro (US Specification) Device Name:

# MUSCLE STIMULATOR

#### INDICATIONS FOR USE:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 6. Maintaining or increasing range of motion

Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

## ULTRASOUND

#### INDICATIONS FOR USE:

Application of deep heat for:

- 1. Temporary relief of minor pain
- 2. Muscle spasm relief
- 3. Joint contracture relief

Not for treatment of malignancies. Not for use on the face.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use XX
(Part 21 CFR 801 Subpart D) say NOT
Over-The-Counter Use *_*_
(21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K102524