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

Device Description

The SRT II Muscle Stimulator 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 and cables.

The SRT II Device is a 4 mode, 10-channel unit for muscle stimulation housed in a portable case. The microprocessor controlled SRT II Device provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface.

The user friendly interface and its display provides operator information about operation mode and signal intensities.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "SRT II® Muscle Stimulator." This submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Criterion (Guidance)	Reported Device Performance (Compliance Level)
RF Emissions	CISPR 11 - Group 1	Group 1
RF Emissions	CISPR 11 - Class B	Class B
Electrostatic Discharge	IEC 61000-4-2: ± 6 kV Contact, ± 8 kV Air	± 6 kV Contact, ± 8 kV Air
Radiated RF	IEC 61000-4-3: 3 Vrms (80 MHz to 2.5 GHz)	3 Vrms (80 MHz to 2.5 GHz)
Electrical Fast Transient/Burst	IEC 61000-4-4: ± 2 kV on power supply lines, ± 1 kV on input/output lines	± 2 kV on Power Supply Lines, ± 1 kV on Input/Output Lines

Note: The document explicitly states "Harmonic Emissions IEC 61000-3-2" and "Voltage Fluctuations/Flicker Emissions IEC 61000-3-3" as N/A, meaning they were either not applicable or not tested for this device's conformity.

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

The submission states "Non-Clinical Tests Submitted" and details compliance with various IEC and CISPR standards for electromagnetic compatibility. These are bench tests and thus do not involve human subjects or clinical data in the traditional sense of a "test set." Therefore, there is no sample size for a test set and no data provenance (such as country of origin, retrospective/prospective). The tests were conducted in a laboratory setting to verify technical specifications.

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

Not Applicable. As this involved non-clinical bench testing for electromagnetic compatibility, there was no need for experts to establish ground truth on clinical data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., CISPR 11, IEC 61000-4-x).

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers or experts evaluating patient data. Since only non-clinical bench testing was performed, no adjudication method was employed.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Clinical Tests Submitted: None." Therefore, no MRMC comparative effectiveness study was done, and there is no reported effect size regarding human readers improving with or without AI assistance. This device is an electrical muscle stimulator, not an AI-driven diagnostic or therapeutic tool for which such a study would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. The SRT II Muscle Stimulator is a hardware device with embedded software for control. It is not an algorithm that performs a standalone diagnostic or therapeutic function without human intervention in the way an AI-driven image analysis tool would. Its performance is evaluated through its physical and electrical characteristics as per the non-clinical tests.

7. Type of Ground Truth Used

The "ground truth" for this submission is established by technical standards and specifications for electromagnetic compatibility and safety (e.g., CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4). The device's performance is compared against these predefined acceptable levels.

8. Sample Size for the Training Set

Not Applicable. This submission describes a hardware device, not a machine learning or AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As no training set was involved, no ground truth was established for it.

Summary

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510(K) SUMMARY

JUL 1 1 2008

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: K071677

1. Submitter's Identification: Therapeutic Innovations, 541 Buttermilk Pike, Suite 309, Crescent Springs, KY 41017
  Date Summary Prepared: June 6, 2008

Contact Persons: Bruce D. Rowe

2. Name of the Device:

TRADE NAME: SRT II® Muscle Stimulator a.
CLASSIFICATION NAME: Muscle Stimulator b.
C. PRODUCT CODE: IPF

Common or Usual Name: Powered Muscle Stimulator

4. Predicate Devices Information:

K982317, Vectra 4C, Chattanooga Group, Inc., Hixson, TN

5.Device Description: The SRT II Muscle Stimulator 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 and cables.

The user friendly interface and its display provides operator information about operation mode and signal intensities.

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

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 thrombosis
1. Maintaining or increasing range of motion

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Non-Clinical Tests Submitted

Emissions Test	Compliance	Guidance
RF EmissionsCISPR 11	Group 1	This Product only uses RF energy for itsinternal functions. Therefore, its RF emissions arelow and are not likely to cause any interference innearby electronic equipment.
RF EmissionsCISPR 11	Class B	This Product is suitable for use in establishments other thandomestic and those directly connected to public low-voltagepower supply networks
HarmonicEmissionsIEC 61000-3-2	N/A
VoltageFluctuations/Flicker EmissionsIEC 61000-3-3	N/A

Guidance and Manufacturer's Declaration-Electromagnetic Emissions

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

ImmunityTest	IEC 60601Test Level	Compliance Level	Guidance
ElectrostaticDischargeIEC 61000- 4-2	$\pm$ 6 kV Contact$\pm$ 8 kV Air	$\pm$ 6 kV Contact$\pm$ 8 kV Air	relative humidity should beat least 30%.
Radiated RFIEC 61000-4-3	3 Vrms3 Vrms	80 MHz to 2.5 GHz80 MHz to 2.5 GHz	Portable and mobile RFcommunicationsequipment should not beused at close distances
ElectricalFast Transient/BurstIEC 61000-4-4	$\pm$ 2 kV on powerSupply Lines$\pm$ 1 kV onInput/Output Lines	$\pm$ 2 kV on PowerSupply Lines$\pm$ 1 kV onInput/Output Lines	Mains power quality should be thatof a typical commercial or hospitalenvironment

Clinical Tests Submitted

None

Conclusion

The SRT II Muscle Stimulator has the same intended use and similar characteristics as the muscle stimulation predicate devices. 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 Therapeutic Innovations SRT II Muscle Stimulator is substantially equivalent to the muscle stimulation predicate devices.

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Indications for Use

Page 1 of 1

510(k) Number (if known): K071677

Device Name: SRT® II

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 post-surgical stimulation of calf muscles to prevent venous thrombosis; and

6 Maintaining or increasing range of motion.

Prescription Use X The Counter Use (Per 21 CFR 801 Subpart D) AND/OR Over-

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2n-Off Division of General, Restorative, and Neurological Devices

510(k) Number K071677

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Therapeutic Innovations, Inc. % Mr. Howard K. Mann Official Correspondent 8903 Spruce Mill Drive Yardley, Pennsylvania 19067

Re: K071677

Trade Name: SRT II Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: June 6, 2008 Received: June 9, 2008

.JUL 1 1 2008

Dear Mr. Mann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Howard K. Mann

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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

Enclosure .

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Indications for Use

Page 1

510(k) Number (if known): K071677

Device Name: SRT® II

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 post-surgical stimulation of calf muscles to prevent venous thrombosis; and

6 Maintaining or increasing range of motion.

Prescription Use X The Counter Use (Per 21 CFR 801 Subpart D) AND/OR Over-

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of/Device Evaluation (ODE)

D.H.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K071677

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).