TRIO 300

K990787 · Ito Co., Ltd. · IPF · Oct 20, 1999 · Physical Medicine

Device Facts

• Record ID: K990787
• Device Name: TRIO 300
• Applicant: Ito Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Story

Trio 300 is a portable, battery-powered, dual-channel electrical stimulator; provides four stimulation modes: TENS, EMS, microcurrent, and programmable. Device uses surface electrodes to deliver electrical pulses to patient; controlled via LED/LCD screen interface with SELECT, SET, and arrow keys for parameter adjustment. Operates on battery or AC adapter. Used in clinical or home settings under physician direction. Healthcare providers use device to manage pain and support physical therapy goals; output affects clinical decision-making by providing non-pharmacological pain relief and muscle rehabilitation. Benefits include reduced pain, improved muscle function, and prevention of venous thrombosis.

Clinical Evidence

No clinical data. Bench testing only. Device compliance verified against electrical safety standards EN-60601 and electromagnetic compatibility standard EN 60601-1-2. Design qualification testing confirmed device met design specifications.

Technological Characteristics

Portable, battery-powered electronic pulse generator; microprocessor-based with digital and analog circuits. Features dual-channel output and LCD user interface. Supplied with surface electrodes (2"x2" and 2"x3.5"). Energy source: battery or AC adapter. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (TENS/Microcurrent modes) or muscle spasm relaxation, prevention/retardation of disuse atrophy, muscle re-education, increased local blood circulation, maintenance/increase of range of motion, and post-surgical calf muscle stimulation to prevent venous thrombosis (EMS mode).

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

• Acutron Mentor Model 961 (K981976)
• Bio-Medical Research Model NT2000 Stimulator (K972244)

Submission Summary (Full Text)

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/K550787

## 510(k) Summary

# Trio 300 Multi-Mode Electical Stimulator

Common/Classification Name: 21 CFR 882.5890, 21 CFR 890.5850

lto Co., Ltd. 3-3-3 Toyotama-Minami Nerima-ku, Tokyo 176-8605 JAPAN

Contact: H. Okada , Prepared: March 8, 1999

### LEGALLY MARKETED PREDICATE DEVICES A.

The Trio 300 Multi-Mode Electrical Stimulator is a device that combines four types of electrical stimulation in one device. It has a TENS mode, an electrical muscle stimulation mode, a microcurrent mode, and a general programmable mode. Since it appears that this particular combination of modes has not been present to date in any single device, it is necessary to claim substantial equivalence to more one predicate device. The TENS, microcurrent, and than programmable modes of the Trio 300 Multi-Mode Electrical Stimulator are substantially equivalent to the corresponding modes of the Acutron Mentor Model 961 (K981976). The electrical muscle stimulation (EMS), TENS, and programmable modes of the Trio 300 Multi-Mode Electrical Stimulator are substantially equivalent to the Bio-Medical Research Model NT2000 Stimulator (K972244).

#### B. DEVICE DESCRIPTION

The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation.

The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.

The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the

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SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.

#### C. INTENDED USE

The TENS mode of the Trio 300 is indicated for the symptomatic relief of chronic intractable pain. It is also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle reeducation, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

#### D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Trio 300 Multi-Mode Electrical Stimulator is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices. The Trio 300 Multi-Mode Electrical Stimulator has the same technological characteristics as the predicate devices. This premarket notification will describe the characteristics of the Trio 300 Multi-Mode Electrical Stimulator in sufficient detail to assure substantial equivalence except for a few of the characteristics where performance testing was carried out (e.g., electrical safety).

#### E. TECHNOLOGICAL CHARACTERISTICS

The Trio 300 and one of the predicate devices all portable, batterypowered, electronic pulse generator devices with surface electrodes. The Trio 300 and both predicate devices are microprocessor-based and employ digital and analog circuits to produce the specified waveforms and levels. All employ an LCD screen as the user interface.

The electrodes that will be supplied with the Trio 300 Multi-Mode Electrical Stimulator are manufactured in the U.S. by Axelgaard Manufacturing Company and are currently marketed products (K970426). Two sizes are available, 2″ by 2″ and 2″ by 3.5″.

#### F. TESTING

Testing was carried out to assure compliance with recognized electrical safety standards. Ito has certified compliance with the EN-60601 standard for electrical safety. Testing to UL 2601 is in progress.

TUV has issued an Attestation of Conformity for the Trio 300 in regard

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to the EN 60601-1-2 standard for electromagnetic compatibility.

The design qualification testing demonstrated that the Trio 300 met its design specifications.

#### G. CONCLUSION

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1999

T. Whit Athey, Ph.D. Senior Consultant Representing ITO Co., Ltd. C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K990787 Re: Trade Name: Trio 300 Multi-Mode Electrical Stimulator Regulatory Class: II Product Codes: IPF, GZJ Dated: July 21, 1999 Received: July 21, 1999

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,

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Page 2 - T. Whit Athey, Ph.D.

through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Calvin M. Hite, Ph.D.

Witten, M. Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Dcoello

ivision oNGeneral Restorative Devic 510(k) Number