FES CYCLE ERGOMETER, MODEL RT300-S

K050036 · Restorative Therapies, Inc. · GZI · Jun 27, 2005 · Neurology

Device Facts

• Record ID: K050036
• Device Name: FES CYCLE ERGOMETER, MODEL RT300-S
• Applicant: Restorative Therapies, Inc.
• Product Code: GZI · Neurology
• Decision Date: Jun 27, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RT300-S (adult version) and RT300-SP (pediatric version) 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-SP (pediatric version), is intended for population ages 4 to 12 years.

Device Story

RT300-S/SP is a Functional Electrical Stimulation (FES) cycle ergometer; system includes motorized cycle, FES controller, stimulation cable, and cutaneous electrodes. Device inputs: user-applied cutaneous electrodes; device outputs: electrical stimulation pulses to evoke muscle contractions and motorized cycling assistance. Used in clinical or rehabilitation settings; operated by clinicians or patients. Device transforms inputs via FES controller to provide active (FES-evoked) or passive (motor-driven) cycling. Enables patients with impaired lower extremity movement to perform cycling; assists in muscle spasm relaxation, atrophy prevention, blood circulation, and range of motion maintenance. Healthcare providers monitor system performance and patient progress; output directly facilitates physical therapy and rehabilitation exercises.

Clinical Evidence

Non-clinical testing included user documentation review, output characteristic measurement, and system performance verification. Clinical testing included operation verification on able-bodied subjects (confirming electrode-off detection and skin impedance handling) and ongoing clinical studies involving spinal cord injured subjects.

Technological Characteristics

Mains-powered FES cycle ergometer. Controller: Pocket PC-based with custom software. Stimulator: 0-140mA charge-balanced. Features motorized flywheel simulation and wheelchair-compatible seating. Connectivity: Not specified. Sterilization: Not applicable (cutaneous electrodes are typically provided sterile or non-sterile for patient use).

Indications for Use

Indicated for general rehabilitation in patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, and maintenance/increase of range of motion. Pediatric version (RT300-SP) indicated for ages 4 to 12.

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

• ERGYS (K841112)

Submission Summary (Full Text)

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K050036

## JUN 27 2005

# RT300-S 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 2363 Boston St Baltimore, MD 21224

Phone: [phone]

Prepared on June 24th 2005.

## (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-S, RT300-SP (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:

THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device

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

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

- a motorized cycle ergometer (RTI part number SA100047 for adults and ← SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090) ଧ
- a stimulation cable which connects the controller / stimulator to cutaneous ತಿ electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part ব number FA100015)

This system allows a person with impaired lower extremity movement to undertake cvcle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

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

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The RT300-S (adult version) and RT300-SP (pediatric version) 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-SP (pediatric version), is intended for population ages 4 to 12 years.

## (6) Technological Characteristics

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

| Technology | RT300-S | Predicate |
|----------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Power source (energy<br>used) | Mains power | Mains power |
| Controller | Based on Pocket PC<br>running custom software. | Uses custom controller<br>running custom software. |
| Stimulator (energy<br>delivered) | 0-140mA charge<br>balanced stimulator | 0-140mA charge<br>balanced stimulator |
| Flywheel | Uses motor to create<br>flywheel effect with<br>reduced weight and<br>space. | Uses heavy mechanical<br>flywheel. |
| Seating | Allows user to remain in<br>their own seating, e.g<br>wheelchair eliminating<br>the need for transfer. | Includes a dedicated<br>seating arrangement. |
| Passive cycling | Utilizes motor to provide<br>assistance during<br>passive cycling. | Requires manual<br>assistance to provide<br>power during passive<br>cycling. |

#### (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 | Confirm technical specifications for |

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| predicate device | 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 with able bodied subjects | The RT300-S was tested on able bodied<br>subjects to confirm correct operation of the<br>system including correct detection of<br>electrode off conditions with varying skin<br>impedances. |
| Testing with spinal cord injured<br>subjects | The RT300-S is being utilized in clinical<br>studies involving spinal cord injured subjects. |

## RTI concludes that:

The RT300-S has the same intended use as the predicate device.

The RT300-S 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 using a motor to simulate the oredicate device's mechanical flywheel and provide passive cycling assistance has been extensively demonstrated in particular by the ongoing clinical use of the motorized ergometer without the stimulation component both in the European Infotoneous in the U.S.A. The safety and effectiveness of the controller has been demonstrated over the development period of the RT300-S.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines beneath it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2005

Mr. Andrew Barriskill Restorative Therapies Incorporated 2263 Boston Street Baltimore, Maryland 21224

Re: K050036

Trade/Device Name: RT300-S and RT300-SP Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: April 26, 2005 Received: April 26, 2005

Dear Ms. Barriskill:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications forchered above and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to coninered prior to May 20, 1977) in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, uterefore, thanks of the Act include requirements for annual registration, listing of general condolo provisions of ractice, 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 your device is elaborired dontrols. 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 I least be advised that I Driv issuality over device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any 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 Of It Fart 6077, accems (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) This letter will anow you to oegin maneting of substantial equivalence of your device to a legally premarket notification: "The PDT intoclassification 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 If you desire specific acrite for your as [phone] . Also, please note the regulation entitled, Colliact the Office of Compuner as (21 t minication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Muriam C. Provost

Miriam C. Provost, Ph.D. Acting 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):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:

- a. Relaxation of muscle spasms
- b. Prevention or retardation of disuse atrophy
- c. Increasing local blood circulation
- d. Maintaining or increasing range of motion

The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

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

Page 1 of

Muriam C. Provost
(Division Signer or Designee)

(Division Sign-Off) Division of General, Restorative and New of General, Resto

510(k) Number_________________________________________________________________________________________________________________________________________________________________