SYS*STIM 240

K113017 · Mettler Electronics Corp. · IPF · Jun 26, 2012 · Physical Medicine

Device Facts

• Record ID: K113017
• Device Name: SYS*STIM 240
• Applicant: Mettler Electronics Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 26, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms · Relaxation of muscle spasms · Prevention or retardation of disuse atrophy · Increase local blood circulation · Muscle re-education · Maintaining or increasing range of motion · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms · Symptomatic relief and management of chronic, intractable pain · Post-traumatic acute pain · Post-surgical acute pain Indications for DC (Direct Current) Mode · Relaxation of muscle spasm The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for: · Temporary increase in local blood circulation · Temporary relief of minor muscle and joint aches, pains and stiffness · Relaxation of muscles · Temporary relief of muscle spasms · Temporary relief of minor pain and stiffness associated with arthritis

Device Story

Sys*Stim 240 is a combination neuromuscular stimulator and low-level light therapy device. It delivers nine discrete electrical waveforms (Russian, Biphasic, HVPC, Interferential, Premodulated, Microcurrent, TENS, DC) and infrared light therapy via optional laser or cluster applicators. Clinicians operate the device in clinical settings, using a touch-sensitive interface and M Wheel navigation to select treatment protocols and monitor parameters. The device provides electrical stimulation to muscles and nerves or infrared energy to tissues. Outputs include electrical pulses for muscle/pain management and infrared light for circulation/pain relief. Safety features include automatic overload, over-current, and no-load trips, plus patient interrupt switches. Optional battery pack enables portable use. Output affects clinical decision-making by providing standardized protocols for pain management and muscle rehabilitation, potentially benefiting patients through reduced pain, improved muscle function, and increased range of motion.

Clinical Evidence

Bench testing only. No clinical data provided. Device compliance verified against electrical safety and performance standards including IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-2-10, IEC 60601-2-22 (laser), IEC 60825-1 (laser safety), and IEC 62471 (photobiological safety). Biocompatibility of electrodes confirmed via reference to previously cleared Mettler devices.

Technological Characteristics

ABS plastic housing. Microprocessor-controlled electrical stimulation and infrared light therapy. Waveforms: Russian, Biphasic, HVPC, Interferential, Premodulated, Microcurrent, TENS, DC. Laser diode (80 mW, 785 nm) or cluster (500 mW, 600/950 nm). Power: AC or 10.8V Li-ion battery. Connectivity: Standalone. Safety: Automatic overload/over-current/no-load trips, patient interrupt. Standards: ISO 14971, IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-2-10, IEC 60601-2-22, IEC 60825-1, IEC 62471.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, disuse atrophy prevention, local blood circulation increase, muscle re-education, range of motion maintenance, or post-surgical calf stimulation to prevent venous thrombosis. Also indicated for symptomatic relief of chronic intractable, post-traumatic, or post-surgical acute pain. Laser/cluster applicators indicated for temporary relief of minor muscle/joint aches, pain, stiffness, and arthritis-related pain.

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

• Chattanooga Group's Vectra Genisys 2channel electrotherapy system (K031077)
• Mettler Electronic Corp.'s Laser Sys*Stim 540 (K043586)

Reference Devices

• Sonicator Plus 992/994 (K984142)
• Sys*Stim 226 (K964028)
• Sys*Stim 294 (K984114)
• Sonicator Plus 930 (K013192)

Submission Summary (Full Text)

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K113017
PAGE 1 OF 5

JUN 2 6 2012

### 510(k) SUMMARY

### Mettler Sys*Stim 240, ME 240

Submitter's Name: Mettler Electronics Corp. Address: 1333 South Claudina Street Anaheim, CA 92805

> Telephone: [phone] x331 Fax: [phone]

Christina Cavuela Contact: QS/RA Manager

September 29, 2011 Date Prepared: Revised copy : March 27, 2012 Revised copy: May 23, 2012 Revised copy: June 25, 2012

#### Proposed Device Name:

a. TRADE NAME: Sys*Stim 240

b. CLASSIFICATION NAME: Powered Muscle Stimulator (890.5850), Transcutaneous Electrical Nerve Stimulator for pain relief (882.5890) and Infrared Lamp (890.5500) c. COMMON NAME: Combination Neuromuscular Stimulator

and Low Level Light Therapy device

#### Predicate Devices:

- a. TRADE NAME: Chattanooga Group's Vectra Genisys 2channel electrotherapy system
- b. 510(k) Number: (K031077)
- c. TRADE NAME: Mettler Electronic Corp.'s Laser Sys*Stim 540, infrared lamp, therapeutic heating device
- d. 510(k) Number: (K043586)

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#### Description of Proposed Device:

The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.

New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Clinicians can add full-featured light therapy capabilities to the Sys*Stim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the Sys*Stim 240.

Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.

The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.

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#### Proposed Device Intended Use Statement:

#### Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms

- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increase local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post surgical stimulation of calf muscles to prevent venous
- thrombosis

#### Additional Indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic, and TENS waveforms

- · Symptomatic relief and management of chronic, intractable pain
- · Post-traumatic acute pain
- · Post-surgical acute pain

#### Indications for DC (Direct Current) Mode

- · Relaxation of muscle spasm
#### The laser and cluster applicators of the Sys Stim 240 emit infrared energy for:

- Temporary increase in local blood circulation .
- Temporary relief of minor muscle and joint aches, pains and stiffness .
- Relaxation of muscles .
- Temporary relief of Muscle spasms .
- Temporary relief of minor pain and stiffness associated with arthritis

Biocompatibility Certification: Electrodes to be provided with this device are the same as those previously submitted since 1997 with Mettler Electronics Corp. devices: Sonicator Plus 992/994 (K984142); Sys*Stim 226 (K964028); Sys*Stim 294 (K984114); and Sonicator Plus 930 (K013192).

Performance Testing: The Sys*Stim 240 has been certified for:

- ITS certification for ETL and C-ETL Listing .
- Compliance with EMC, EN 60601-1-2: 2001 and FCC's 47 CFR, . FCC Sub Part 18
- Compliance to IEC 60601-2-22: 2007 ●
- Compliance to IEC 60825-1: 2007 .
- Compliance to IEC 62471: 2006 ●
- Compliance to EN60601-2-10, (IEC 601-2-10) 2001

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# Comparison Table for Sys Sti 510K Submission

## Section 2

| 1. | 510 K # | K | K031077 |
|----|-------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------|
| 2. | Device Name | Sys*Stim 240 | Vectra Genisys |
| 3. | Manufacturer | Mettler Electronics | Encore Medical<br>(Chattanooga Group) |
| 4. | Power Source | AC line or optional battery pack 10.8 V<br>Lithium Ion | AC line or optional battery pack |
| | Line Current Isolation | Yes | Yes |
| | Patient Leakage Current (μΑ) | | |
| | Normal condition (ac) | 78 (Less than 100 μΑ) | Less than 100 μΑ |
| | Single fault condition (ac) | 78 (Less than 500 μΑ) | Less than 500 μΑ |
| 5. | Number Of Output Modes | 9 (one less output ) | 10 |
| 6. | Channel(s) | 2 Channel | 2 Channel |
| | Synchronous | 1 & 2 | 1 & 2 |
| | Reciprocal | 1 & 2 | 1 & 2 |
| | Other | Yes | Yes |
| 7. | Constant Current | Optional | Optional |
| | Constant Voltage | Optional | Optional |
| 8. | Software / Firmware /<br>Microprocessor Control | Yes | Yes |
| 9. | Automatic Overload Trip | Yes | Yes |
| | Automatic Over Current Trip | Yes | Warning only, Overcurrent |
| | 10. Automatic No Load Trip | Yes | Warning only, Bad electrode contact |
| | 11. Automatic Shut Off | Yes | Yes |
| | 12. Patient Override | Yes | Yes |
| | Control Method | Patient interrupt switch | Patient interrupt switch |
| | 13. Indicator Display | | |
| | On / Off Status | Yes | Yes |
| | Low Battery Indicator | Yes | Yes |
| | Voltage / Current Level | Yes | Yes |
| | 14. Timer Display: (Stimulator) | 0 - 60 minutes for stimulation<br>Auto based on dosage for light therapy | 0 - 60 minutes |
| | 15. Standards | | |
| | ISO 14971 : 2000 | Yes | Yes |
| | UL 60601-1 | Yes | Yes |
| | CSA C22.2 NO 601.1-M90 | Yes | Yes |
| | IEC/EN 60601-1 | Yes | Yes |
| | IEC/EN 60601-1-2 | Yes | Yes |
| | IEC/EN 60601-2-10 | Yes | Yes |
| | MDD 93/42/EEC, Annex II | Yes | Yes |
| | 16. Compliance with<br>21 CFR 898 | Yes | Yes |
| | 17. Weight (lbs.) | 4.5 lb / 5.50 lb with Battery (Lighter wt) | 7 |
| | 18. Dimensions (in.) H x W x L | 8 in (H) x 8 in (W) x 13 in (L) | 8.8 x 11.375 x 12.75 |
| | 19. Housing Materials &<br>Construction | ABS Plastic | ABS Plastic |

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## Explanation of Differences on the Comparison Table for the Sys*Stim® 240

:

| Item | Mettler | Chattanooga | Explanation |
|--------------------------------|------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. Number of output modes | 9 | 10 | Mettler does not have<br>Chattanooga's proprietary<br>VMS burst |
| 9. Automatic Over Current Trip | Yes | Warning only,<br>Overcurrent | On an error such as this one,<br>Mettler chooses to stop all<br>output in the interest of<br>patient safety. |
| 10. Automatic No Load Trip | Yes | Warning only,<br>Bad electrode<br>contact | Mettler chooses patient<br>safety, by requiring the<br>clinician to fix the contact<br>issue and then restart the<br>system, to assure there are<br>no excess outputs. |
| 17. Weight | 4.5 lbs. | 7 lbs. | Different design criteria, no<br>effect on function |
| 18. Dimensions | 8 x 8 x 13 | 8.8 x 11.375 x<br>12.75 | Different design criteria, no<br>effect on function |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

JUN 2 6 2012

Mettler Electronics Corporation % Ms. Christina Cayuela OS/RA Manager 1333 South Claudina Street Anaheim, California 92805

Re: K113017

Trade/Device Name: SYS*stim 240 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, ILY, GZJ, LIH Dated: May 26, 2012 Received: June 04, 2012

#### Dear Ms. Cayuela:

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.

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Page 2 - Ms. Christina Cayuela

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 of medical device-related adverse events) (21 CFR 803); 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.

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.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 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 yours,

Eunice Keith

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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### Indications for Use

510(k) Number (if known): K113017

Sys*Stim® 240, Model ME240 Device Name:

- 1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increase local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms
- · Symptomatic relief and management of chronic, intractable pain
- · Post-traumatic acute pain
- · Post-surgical acute pain

#### 3. Indications for DC (Direct Current) Mode

- Relaxation of muscle spasm
- 4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:
- · Temporary increase in local blood circulation
- · Temporary relief of minor muscle and joint aches, pains and stiffness
- · Relaxation of muscles
- · Temporary relief of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis

× Prescription Use

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Evaluation (ODE) Concurrent of CDRH Office of Device

KAYLA L. LYNCH
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

5 . 0(k) Number