RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053

K071113 · Restorative Therapies, Inc. · GZI · Jul 5, 2007 · Neurology

Device Facts

• Record ID: K071113
• Device Name: RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
• Applicant: Restorative Therapies, Inc.
• Product Code: GZI · Neurology
• Decision Date: Jul 5, 2007
• Decision: SESE
• Submission Type: Traditional
• 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 for rehabilitation. System components: motorized cycle ergometer, FES controller, stimulation cable, cutaneous electrodes, optional motorized arm crank, and pulse oximeter interface. Device operates by delivering 0-140mA charge-balanced stimulation to evoke muscle contractions or by using a motor for passive cycling. Users remain in their own seating (e.g., wheelchair). Controller runs custom software on a Pocket PC; interfaces with a remote database for therapy settings and session logs. Pulse oximeter interface displays/records pulse and SpO2 with alarming. Used in clinical or home settings; operated by patients or clinicians. Output allows active/passive cycling; helps maintain range of motion, increase circulation, and manage spasms. Database ensures patients start sessions with accurate, updated settings.

Clinical Evidence

Bench testing included review of user documentation, technical specification verification, and system performance testing. Pulse oximeter interface validated with four able-bodied individuals.

Technological Characteristics

FES cycle ergometer; mains powered. Controller: Pocket PC with custom software. Stimulator: 0-140mA charge-balanced. Motorized flywheel effect. Connectivity: remote database interface for therapy settings/logs. Optional motorized arm crank. Pulse oximeter interface. Seating: user-retained (e.g., wheelchair).

Indications for Use

Indicated for general rehabilitation in adults and children (ages 4-12 for pediatric version) to relax muscle spasms, prevent/retard disuse atrophy, increase local blood circulation, and maintain/increase 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-S (K060032)

Submission Summary (Full Text)

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K07///3

# RT300-S Summary of Safety and Effectiveness

JUL - 5 2007

(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]

Prepared on February 14th, 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-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:

RESTORATIVE THERAPIES, INC. product: "RT300-S", K060032, 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 ー SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090) ଧ
- a stimulation cable which connects the controller / stimulator to cutaneous ന electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part 4 number FA100015)
- an interface to a remote database for the storage and retrieval of therapy റ settings and the storage of therapy session logs
- an optional motorized arm crank (RTI part number PP102663) େ
- an interface to a pulse oximeter for the display and recording of pulse and 7 SpO2 levels and provision of alarming based on the data.

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This system allows a person with impaired lower extremity movement to undertake cycle 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:

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. | 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 motor to create<br>flywheel effect with<br>reduced weight and<br>space. | Uses motor to create<br>flywheel effect with<br>reduced weight and<br>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 without FES | No motorized arm crank |
| Pulse oximeter interface | Utilize pulse and SpO2 | No pulse oximeter |

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| I alle and the may of | data for display. | A STERNET A COLLECTION COLLECTION CONTRACT AND THE COLLECTION CONTRACT CONTRACT CARTER CONTRACT CARTER CONTRACT CONTRACT CARTER CONTRACT CARTER CONTRACT CARTER CONTRACT CARTE<br>interface provided |
|-----------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | recording and alarming | |

# (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 pulse oximeter interface | The RT300-S pulse oximeter interface<br>was validated with four able bodied<br>individuals. |

# 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 predicate 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 Union and in the U.S.A. The safety and effectiveness of the controller has been demonstrated over the development period of the RT300-S. The remote database enhances the safety and effectiveness of the system by ensuring that patients always commence a therapy session with their latest, accurate device settings.

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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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2007

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

RE: K071113

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 19, 2007 Received: April 20, 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

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Page 2 - Mr. Andrew Barriskill

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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Neil R. Ogden

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): K071113

Device Name: RT300-S and RT300-SP

Indications For 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.

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)

Neil R. Ogle

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________ 112