RT300-S AND RT300-SP FES CYCLE ERGOMETER

K072398 · Restorative Therapies, Inc. · GZI · Nov 21, 2007 · Neurology

Device Facts

• Record ID: K072398
• Device Name: RT300-S AND RT300-SP FES CYCLE ERGOMETER
• Applicant: Restorative Therapies, Inc.
• Product Code: GZI · Neurology
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RT300 adult and pediatric versions are intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion The RT300 pediatric version is intended for population ages 4 to 12 years.

Device Story

RT300 is a Functional Electrical Stimulation (FES) cycle ergometer for upper and lower extremity rehabilitation. System components include motorized leg/arm cycle ergometer, FES controller, stimulation cables, cutaneous electrodes, pulse oximeter interface, and remote database interface. Device operates by delivering FES to evoke muscle contractions (active cycling) or using motor power (passive cycling). Used in clinical or home settings; operated by patients or clinicians. Pulse oximeter provides real-time SpO2/pulse monitoring with alarms. Database stores therapy settings and session logs. Output allows clinicians to track progress and adjust stimulation parameters. Benefits include muscle spasm reduction, atrophy prevention, improved circulation, and range of motion maintenance.

Clinical Evidence

Clinical validation performed on five able-bodied individuals to confirm safety and effectiveness of upper extremity FES stimulation. No other clinical data provided. Non-clinical testing included review of predicate documentation, output characteristic measurements, and system performance verification.

Technological Characteristics

Mains-powered FES cycle ergometer. Controller based on Pocket PC running custom software. Stimulator delivers 0-140mA charge-balanced pulses via up to 12 cutaneous electrodes (6 channels). Features motorized leg/arm crank, flywheel effect, and pulse oximeter interface. Supports bilateral or unilateral stimulation. Connectivity includes interface to remote database for therapy logs/settings.

Indications for Use

Indicated for general rehabilitation in adults and pediatric patients (ages 4-12) requiring relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, and maintenance/increase of range of motion.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• RT300 (K071486)

Submission Summary (Full Text)

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K072398

# RT300 Summary of Safety and Effectiveness

(1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

Andrew Barriskill Restorative Therapies Inc 907 South Lakewood Ave Baltimore, MD 21224 Phone: [phone]

NOV 2 1 2007

Prepared on July 20th, 2007.

### (2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name:

Proprietary name: RT300 (FES cycle ergometer) Powered Muscle Stimulator Common name: Classification name:Powered Muscle Stimulator

## (3) Identification of the legally marketed device to which the submitter claims equivalence:

RESTORATIVE THERAPIES, INC. product: "RT300", K071486, a class 2 device

### (4) A description of the device that is the subject of the premarket notification submission.

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

- a motorized leg cycle ergometer (RTI part number SA100047 for adults and ー SA100044 for children)
- an optional motorized arm crank (RTI part number PP102663) വ
- an FES controller / stimulator (RTI part number SA100090) ന
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects র্ব the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels) 5
- an interface to a remote database for the storage and retrieval of therapy settings 6 and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 7 levels and provision of alarming based on the data

This system allows a person with impaired upper or lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked upper or lower extremity

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muscle contractions) and passively (utilizing power developed by the ergometer's motor).

# (5) Statement of the intended use of the device:

The RT300 adult and pediatric versions are intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Maintaining or increasing range of motion

The RT300 pediatric version is intended for population ages 4 to 12 years.

### (6) Technological Characteristics

The function of the RT300 is the same as the predicate device however there are certain technological similarities and differences as described below:

| Technology | RT300 | Predicate K071486 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Power source (energy<br>used) | Mains power | Mains power |
| Controller | Based on Pocket PC<br>running custom software. | Based on Pocket PC<br>running custom software. |
| Stimulator (energy<br>delivered) | 0-140mA charge<br>balanced stimulator | 0-140mA charge<br>balanced stimulator |
| Flywheel | Uses leg / arm crank<br>motor to create flywheel<br>effect with reduced<br>weight and space. | Uses leg / arm crank<br>motor to create flywheel<br>effect with reduced<br>weight and space. |
| Seating | Allows user to remain in<br>their own seating, e.g<br>wheelchair eliminating<br>the need for transfer. | Allows user to remain in<br>their own seating, e.g<br>wheelchair eliminating<br>the need for transfer. |
| Passive cycling | Utilizes motor to provide<br>assistance during<br>passive cycling. | Utilizes motor to provide<br>assistance during<br>passive cycling. |
| Database interface | Utilizes database<br>interface for storage and<br>retrieval of patient<br>therapy settings and<br>storage of session logs. | Utilizes database<br>interface for storage and<br>retrieval of patient<br>therapy settings and<br>storage of session logs. |
| Motorized arm crank | Allows active / passive<br>arm cycling with FES | Allows active / passive<br>arm cycling without FES |
| Pulse oximeter interface | Utilize pulse and SpO2<br>data for display,<br>recording and alarming | Utilize pulse and SpO2<br>data for display,<br>recording and alarming |
| Bilateral or Unilateral | Uses bilateral or | Uses bilateral or |

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| stimulation | unilateral stimulation | unilateral stimulation |
|-------------|------------------------|------------------------|
| | cables. | cables. |

# (b) Performance data

Non clinical testing to determine equivalence has been primarily composed of the following tests:

| Test or procedure | Description |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Review of user documentation for<br>predicate device | Ensure that equivalent functionality is<br>specified and implemented in the new<br>device. |
| Review of 510(k) submission for<br>predicate device | Confirm technical specifications for<br>completion of predicate details in<br>comparison tables |
| Output characteristic measurement of<br>new device | Confirm technical specifications for<br>completion of new device details in<br>comparison tables |
| Conduct of system testing | Conduct system testing to verify<br>performance to specification. |

| Clinical Test | Description |
|-----------------------------------------|----------------------------------------------------------------------------------------------|
| Testing the upper extremity stimulation | The RT300 upper extremity stimulation<br>was validated with five able bodied<br>individuals. |

# RTI concludes that:

The RT300 has the same intended use as the predicate device. The RT300 has the same output characteristics as the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness. The safety and effectiveness of providing both bilateral and unilateral electrical stimulation to the upper extremities has been demonstrated during validation testing.

In conclusion, RTI's clinical and non clinical testing has demonstrated that the RT300 is as safe and effective as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Restorative Therapies, Inc. % Mr. Andrew Barriskill CEO 907 South Lakewood Avenue Baltimore, Maryland 21224

NOV 2 1 2007

Re: K072398

Trade/Device Name: RT300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 21, 2007 Received: August 27, 2007

Dear Mr. Barriskill:

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. Andrew Barriskill

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 its toll-free number [phone] or [phone] or at its 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

510(k) Number (if known): K072398

Device Name: RT300

Indications For Use:

The RT300 adult and pediatric versions are intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Maintaining or increasing range of motion

The RT300 pediatric version is intended for population ages 4 to 12 years.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

Distion of General, Restorative. and Neurological Devi

510(k) Number

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