Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
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:

Temporary relief of minor pain
Muscle spasm relief
Joint contracture relief
Not for treatment of malignancies. Not for use on the face.

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.

AI/ML Overview

The provided 510(k) summary for the Futura Pro (US Specification) does not contain specific acceptance criteria with corresponding performance metrics from a dedicated study. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a formal table of acceptance criteria with measured device performance. Instead, it relies on a comparison with predicate devices and compliance with international standards. The "performance" is implicitly demonstrated by the device's technical specifications falling within acceptable ranges or being comparable to the predicates, as well as by meeting safety standards.

The document highlights some differences where the Futura Pro (US Specification) exceeds the predicate in certain aspects (e.g., current density, which is still "well within accepted levels," and power density), and improvements in user interface and control. These are presented as benefits rather than failures to meet specific quantified criteria.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) related to clinical efficacy is mentioned. The submission states, "No clinical tests were performed." Non-clinical tests were for compliance with standards.

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

Since no clinical tests were performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study was done. The submission explicitly states, "No clinical tests were performed."

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

The Futura Pro is a physical medical device (muscle stimulator and ultrasound), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop does not directly apply in this context. The operational performance of the device itself (e.g., electrical outputs, ultrasound parameters) was likely assessed during non-clinical testing to ensure it met design specifications and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was compliance with established national and international safety and performance standards (e.g., BS EN 60601 series, BS EN 55022, BS EN 61000 series). The device's technical specifications and outputs were measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve an AI algorithm that would require 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 algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets "acceptance criteria" (understood here as regulatory requirements for substantial equivalence and safety) is primarily a non-clinical testing and comparison study.

Non-Clinical Tests:
- Purpose: To demonstrate that the Futura Pro (US Specification) performs as intended and conforms to the specified safety and performance standards.
- Methods: Comparison of outputs (electrical stimulation and ultrasound parameters) with predicate devices and independent testing against a comprehensive list of European (BS EN) and international standards for medical electrical equipment, including general safety, particular requirements for stimulators and ultrasonic physiotherapy equipment, and electromagnetic compatibility (EMC).
- Key Findings (as reported): "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." The device also successfully passed all listed BS EN standards.
- Data Provenance: Testing carried out by the manufacturer (Ultratone Scientific Instruments) and independent laboratories (implicitly, for certification to BS EN standards). Location of these labs is not specified.
- Design: This was a series of engineering and performance verification tests rather than a clinical study.
Substantial Equivalence Argument:
- The submission argues that the Futura Pro is substantially equivalent to legally marketed predicate devices (Ultratone 20, K926410, and Ultrasonic Therapy Appliance, K050410).
- This is supported by detailed technological comparisons in tables for both the muscle stimulator and ultrasound parts, highlighting similarities in intended use, power source (with minor variations), number of output modes/channels, channel isolation, software control, design, frequency, mode, waveform type, applicator size, effective radiating area, temporal max power, temporal max effective intensity, and beam nonconformity ratio.
- Differences are acknowledged and explained as not raising new safety or effectiveness issues, often being presented as benefits (e.g., illuminated connectors, self-adhesive electrodes that result in higher but acceptable current density, graphical display, sophisticated control circuitry, integrated power for ultrasound).

In essence, the "study" for this device was a combination of engineering design validation, verification testing against recognized standards, and a comprehensive comparison of technical characteristics to already cleared predicate devices, all performed in a non-clinical setting. No human subjects were involved.

Summary

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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 wenker@ispub.com

Contact Person:

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

Tel 972-241-8374 Fax 972-241-0619 Email cimel@ceuticallabs.com

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.

2/8

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K102524

MUSCLE STIMULATOR

Intended Use:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
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:

Temporary relief of minor pain
Muscle spasm relief
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• Prevention or retardation ofdisuse atrophy• Increasing local blood circulation	• Relaxation of muscle spasms• Prevention or retardation ofdisuse atrophy• Increasing local blood circulation
	• Muscle re-education• Immediate postsurgicalstimulation of calf muscles toprevent venous thrombosis• Maintaining or increasing rangeof motion	• Muscle re-education• Immediate postsurgicalstimulation of calf muscles toprevent venous thrombosis• Maintaining or increasing rangeof motion
Power Source
Internal:	12V battery.	12V battery.
External:	12V charger / adaptor	15V Charger / adaptor
Number of OutputModes	Two - Biphasic / Monophasic	Two - Biphasic / Monophasic
Number of OutputChannels	10 channels	10 channels
Channel Isolation	All outputs are fed via individualoutput isolating transformers.	All outputs are fed via individualoutput isolating transformers.
Software / Firmware/ MicroprocessorControl	All functions are controllable bythe microprocessor. All software iscontained inside the unit in flashmemory. This is not accessible tothe operator.	All functions, except outputamplitude, are controlled by themicroprocessor. All software iscontained inside the unit inEPROM. This is not accessible tothe operator.
Design	Console sending control signals toa 10 channel electrical musclestimulation generator. The signalis applied cutaneously via patientconnecting leads and selfadhesive stimulation electrodes.	Control console incorporating 10channel electrical musclestimulation generator. The signalis applied cutaneously via patientconnecting leads and stimulationelectrodes held in position withstraps.
Maximum RMS O/PCurrent	$16.2 ormalfont{mA}_ ormalfont{rms} @ 500Ω$	$15.5 ormalfont{mA}_ ormalfont{rms} @ 500Ω$
Minimum electrodesize	7.0 cm dia. (38.5 cm²)	10.1 cm dia. (80.1 cm²)
Maximum CurrentDensity (RMS)	$0.421 ormalfont{mA/cm}^2 @ 500Ω$	$0.194 ormalfont{mA/cm}^2 @ 500Ω$
Maximum RMSPower Density	$3.42 ormalfont{mW/cm}^2 @ 500Ω$	$1.50 ormalfont{mW/cm}^2 @ 500Ω$

પ્પાર

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Kl02524

Ultrasound Part Comparison with Predicate

	Device of this 510(k)	Predicate Device
Device Name	Ultrasound ApplicatorModel No. UFPUA3	Ultrasonic Therapy ApplianceModel No. HS 3008
Manufacturer	Hwang Sun Enterprise Co. Ltd.70955 No. 8, Keji 1st Rd., AnnanDistrict, Tainan, Taiwan	Hwang Sun Enterprise Co. Ltd.70955 No. 8, Keji 1st Rd., AnnanDistrict, Tainan, Taiwan
510(k) No.	TO BE ASSIGNED	K050410
Indications	Application of deep heat for:Temporary relief of minor painMuscle spasm reliefJoint contracture reliefNot for treatment of malignanciesNot for use on the face.	"generates deep heat within bodytissues for the treatment ofselected medical conditions suchas temporary relief of minor pain,muscle spasms and jointcontractures, but not for thetreatment of malignancies."
Input Voltage	24VDC	24VDC
Timer auto off	Yes	Yes
Max. treatmenttime	15 min	15 min
Frequency	1000 KHz $ \u00b1 $ 5%	1000 KHz $ \u00b1 $ 5%
Mode	Pulsed and mode where output isswitched on/off at 1 Hz.	Pulsed and mode where output isswitched on/off at 1 Hz.
Waveform type	Amplitude modulated	Amplitude modulated
Applicator size	Transducer diameter 46.5mm	Transducer diameter 46.5mm
Effective RadiatingArea	15 cm² $ \u00b1 $ 10%	15 cm² $ \u00b1 $ 10%
Temporal MaxPower	0.97 W $ \u00b1 $ 10%	0.97 W $ \u00b1 $ 10%
Temporal MaxEffective Intensity	1.47 W/cm² $ \u00b1 $ 10%	1.47 W/cm² $ \u00b1 $ 10%
Beamnonconformity ratio	6:1	6:1
Design	Hand held device generatingultrasonic frequency (1MHz) viaincorporated piezoelectrictransducer. Power is suppliedexternally from the Futura Proconsole.	Hand held device generatingultrasonic frequency (1MHz) viaincorporated piezoelectrictransducer. Power is suppliedexternally from a separate poweradaptor.

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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 (800) 638-2041 or (301) 796-7100 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
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
1. 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
1. Muscle spasm relief
1. 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

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.