SRT II MUSCLE STIMULATOR

K071677 · Therapeutic Innovations, Inc. · IPF · Jul 11, 2008 · Physical Medicine

Device Facts

• Record ID: K071677
• Device Name: SRT II MUSCLE STIMULATOR
• Applicant: Therapeutic Innovations, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

SRT II Muscle Stimulator is a 10-channel, 4-mode powered muscle stimulator housed in a portable case. Device inputs include user-selected operation modes and signal intensity settings via a control panel. System utilizes a microprocessor to generate alternating current for muscle stimulation, delivered through external electrodes and cables. Designed for clinical use, the device provides operators with visual feedback on signal intensities and modes. Output is electrical stimulation to target muscles; intended to assist in muscle re-education, spasm relaxation, and circulation improvement. Benefits include prevention of disuse atrophy and post-surgical thrombosis. Device operation is managed by healthcare professionals.

Clinical Evidence

No clinical data. Bench testing and non-clinical testing (electromagnetic emissions and immunity per CISPR 11, IEC 61000-3-2, IEC 61000-3-3, IEC 60601, and IEC 61000-4 series) were submitted to support substantial equivalence.

Technological Characteristics

Powered muscle stimulator; 10-channel, 4-mode output; microprocessor-controlled; portable console with display panel; uses external electrodes and cables. Complies with IEC 60601-1-2 for electromagnetic compatibility (emissions and immunity).

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance or increase of range of motion.

Regulatory Classification

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.

Predicate Devices

• Vectra 4C (K982317)

Submission Summary (Full Text)

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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

3. 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 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.

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

- 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 thrombosis
- 6. Maintaining or increasing range of motion

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# Non-Clinical Tests Submitted

| Emissions Test | Compliance | Guidance |
|----------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| RF Emissions<br>CISPR 11 | Group 1 | This Product only uses RF energy for its<br>internal functions. Therefore, its RF emissions are<br>low and are not likely to cause any interference in<br>nearby electronic equipment. |
| RF Emissions<br>CISPR 11 | Class B | This Product is suitable for use in establishments other than<br>domestic and those directly connected to public low-voltage<br>power supply networks |
| Harmonic<br>Emissions<br>IEC 61000-3-2 | N/A | |
| Voltage<br>Fluctuations/<br>Flicker Emissions<br>IEC 61000-3-3 | N/A | |

### Guidance and Manufacturer's Declaration-Electromagnetic Emissions

### Guidance and Manufacturer's Declaration - Electromagnetic Immunity

| Immunity<br>Test | IEC 60601<br>Test Level | Compliance Level | Guidance |
|---------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Electrostatic<br>Discharge<br>IEC 61000- 4-2 | $\pm$ 6 kV Contact<br>$\pm$ 8 kV Air | $\pm$ 6 kV Contact<br>$\pm$ 8 kV Air | relative humidity should be<br>at least 30%. |
| Radiated RF<br>IEC 61000-4-3 | 3 Vrms<br>3 Vrms | 80 MHz to 2.5 GHz<br>80 MHz to 2.5 GHz | Portable and mobile RF<br>communications<br>equipment should not be<br>used at close distances |
| Electrical<br>Fast Transient/<br>Burst<br>IEC 61000-4-4 | $\pm$ 2 kV on power<br>Supply Lines<br>$\pm$ 1 kV on<br>Input/Output Lines | $\pm$ 2 kV on Power<br>Supply Lines<br>$\pm$ 1 kV on<br>Input/Output Lines | Mains power quality should be that<br>of a typical commercial or hospital<br>environment |

## 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)

Mo

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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