RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

K090750 · Restorative Therapies, Inc. · GZI · Aug 5, 2009 · Neurology

Device Facts

• Record ID: K090750
• Device Name: RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
• Applicant: Restorative Therapies, Inc.
• Product Code: GZI · Neurology
• Decision Date: Aug 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RT300 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 is for prescription use only. The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

Device Story

RT300 is a Functional Electrical Stimulation (FES) cycle ergometer for upper/lower extremity rehabilitation. System includes motorized leg cycle ergometer, optional motorized arm crank, FES controller with 6-channel stimulator, up to 5 additional wireless single-channel stimulators, stimulation cables, cutaneous electrodes, and optional Stimwear garment. Device interfaces with remote database for therapy settings/logs and pulse oximeter for SpO2/pulse monitoring with alarms. Operated by clinician or patient in clinical/home settings. Device provides active (FES-evoked muscle contraction) or passive (motor-driven) cycling. Controller manages stimulation parameters; wireless stimulators allow standalone use. Data output assists clinicians in tracking therapy progress and adjusting settings. Benefits include improved muscle function, circulation, and range of motion for patients with impaired movement.

Clinical Evidence

Validation testing conducted on able-bodied individuals. RT300 with 5 additional RT50 stimulation channels validated with 5 subjects. RT50 in standalone mode validated with 5 subjects. Stimwear garment validated on 1 subject. Testing included abdominal and erector spinae muscle stimulation. No clinical data on patient populations provided.

Technological Characteristics

System comprises motorized cycle ergometer, FES controller, and wireless stimulators. Controller based on Pocket PC running custom software. Stimulator delivers 0-140mA charge-balanced stimulation. Connectivity includes wireless stimulation channels, database interface, and pulse oximeter interface. Power via mains and rechargeable batteries. Stimwear garment uses integrated electrodes.

Indications for Use

Indicated for general rehabilitation in patients requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, or maintenance/increase of range of motion. Pediatric version for ages 4-12; Stimwear garment for ages 12 and above.

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 (K072398)
• ERGYS (K841112)
• REHASTIM & REHAMOVE (K073237)

Submission Summary (Full Text)

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K690750

AUG 0 5 2009

### 510(k) Summary

Note: Changes from K072398 RT300 Summary of Safety and Effectiveness are shown in italics.

### 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]

Prepared on June 22nd 2009.

(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) Common name: Powered Muscle Stimulator Classification name: External functional neuromuscular stimulator

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

RESTORATIVE THERAPIES, INC. product: "RT300", K072398, a class 2 device

THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to Stimwear only.

HASOMED GMBH product: "REHASTIM & REHAMOVE", K073237, a class 2 device. Relates to stand alone stimulator use only.

(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) 2

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- ന an FES controller with built in 6 channel stimulator (RTI part number SA100090)
- up to 5 additional wireless single channel stimulators (RTI part number 4 FA106897)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which ട് connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation ଚି channels)
- an interface to a remote database for the storage and retrieval of therapy 7 settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and ക SpO2 levels and provision of alarming based on the data
- ക a stimwear garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)

This system allows a person with impaired upper or lower extremity movement to undertake cvcle ergometry both actively (utilizing FES evoked upper or 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 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 is for prescription use only.

The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

### (6) Technological Characteristics

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

| Technology | RT300 | Predicate K072398 | Predicate K841112 | Predicate K073237 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Power source (energy used) | Mains power and rechargeable battery for RT50 stimulators | Mains power | N/A | N/A |
| Controller | Based on Pocket PC | Based on Pocket PC | N/A | N/A |
| Technology | RT300 | Predicate<br>K072398 | Predicate<br>K841112 | Predicate<br>K073237 |
| | running custom<br>software. | running<br>custom<br>software. | | |
| Stimulator<br>(energy<br>delivered) | Built in AC<br>mains powered<br>0-140mA 6<br>channel charge<br>balanced<br>stimulator. | Built in AC<br>mains<br>powered 0-<br>140mA 6<br>channel<br>charge<br>balanced<br>stimulator. | N/A | N/A |
| Additional<br>stimulation<br>channels | Up to 5<br>additional<br>wireless<br>battery<br>powered<br>stimulation<br>channels<br>delivering 0-<br>140mA charge<br>balanced<br>stimulation. | Additional<br>stimulation<br>channels not<br>available. | N/A | N/A |
| Stand alone<br>stimulation<br>mode | Wireless<br>battery<br>powered<br>stimulation<br>channels may<br>be used in<br>stand alone<br>mode with out<br>the cycle<br>ergometer. | Stand alone<br>mode not<br>available. | N/A | Stimulator<br>"can be used<br>as a portable<br>or stationary<br>device for<br>training and<br>rehabilitation<br>applications" |
| Stimwear<br>garment | Stimwear<br>garment<br>incorporating<br>electrodes<br>available for<br>low extremity<br>cycling, ages<br>12 and above. | Stimwear<br>garment not<br>available. | Available<br>stimwear<br>garment<br>incorporating<br>electrodes. | N/A |
| Muscles<br>available for<br>stimulation | Quadriceps,<br>hamstrings,<br>gluteals,<br>gastroc, anterior | Quadriceps,<br>hamstrings,<br>gluteals,<br>gastroc | N/A | N/A |
| Technology | RT300 | Predicate<br>K072398 | Predicate<br>K841112 | Predicate<br>K073237 |
| | tibialis, shoulder,<br>biceps, triceps,<br>anterior,<br>posterior and<br>middle deltoid,<br>wrist, grasp,<br>abdominals,<br>erector spinae. | anterior<br>tibialis,<br>shoulder,<br>biceps,<br>triceps,<br>anterior,<br>posterior and<br>middle<br>deltoid, wrist,<br>grasp | N/A | N/A |
| Flywheel | Uses leg / arm<br>crank motor to<br>create flywheel<br>effect with<br>reduced weight<br>and space. | Uses leg /<br>arm crank<br>motor to<br>create<br>flywheel<br>effect with<br>reduced<br>weight and<br>space. | N/A | N/A |
| Seating | Allows user to<br>remain in their<br>own seating, e.g<br>wheelchair<br>eliminating the<br>need for<br>transfer. | Allows user<br>to remain in<br>their own<br>seating, e.g<br>wheelchair<br>eliminating<br>the need for<br>transfer. | N/A | N/A |
| Passive cycling | Utilizes motor to<br>provide<br>assistance<br>during passive<br>cycling. | Utilizes<br>motor to<br>provide<br>assistance<br>during<br>passive<br>cycling. | N/A | N/A |
| Database<br>interface | Utilizes<br>database<br>interface for<br>storage and<br>retrieval of<br>patient therapy<br>settings and<br>storage of<br>session logs. | Utilizes<br>database<br>interface for<br>storage and<br>retrieval of<br>patient<br>therapy<br>settings and<br>storage of<br>session logs. | N/A | N/A |
| Technology | RT300 | Predicate<br>K072398 | Predicate<br>K841112 | Predicate<br>K073237 |
| Motorized arm<br>crank | Allows active /<br>passive arm<br>cycling with FES | Allows active<br>/ passive<br>arm cycling<br>with FES | N/A | N/A |
| Pulse oximeter<br>interface | Utilize pulse and<br>SpO2 data for<br>display,<br>recording and<br>alarming | Utilize pulse<br>and SpO2<br>data for<br>display,<br>recording<br>and alarming | N/A | N/A |
| Bilateral or<br>Unilateral<br>stimulation | Uses bilateral or<br>unilateral<br>stimulation<br>cables. | Uses<br>bilateral or<br>unilateral<br>stimulation<br>cables. | N/A | N/A |

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Table 1 Device technology comparison

## (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 RT50 stimulation | The RT300 with 5 additional RT50<br>stimulation channels was validated with<br>five able bodied individuals.<br>The RT50 in standalone mode was<br>validated with five able bodied<br>individuals. |

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| Clinical Test | Description |
|-----------------------------------|------------------------------------------------------------------------------------------------|
| Testing additional muscle groups. | The RT50 clinical testing included<br>testing of abdominal and erector spinae<br>stimulation . |
| Testing the Stimwear garment | The RT300 with the Stimwear garment<br>was validated on one able bodied<br>individual. |

### 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 up to 5 additional channels of electrical stimulation utilizing the RT50 to the upper and lower extremities, erector spinae and abdominal muscle groups has been demonstrated during validation testing. The safety and effectiveness of utilizing Stimwear and carbon electrodes 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 devices.

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Image /page/6/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three thick, curved lines forming the body and wings.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Restorative Therapies, Inc % Andrew Barriskill CEO 907 South Lakewood Ave Baltimore, MD 21224

AUG 0 5 2009

Re: K090750

Trade Name: RT300 Functional Electrical Stimulation (FES) Cycle Ergometer Regulation Number: 21 CFR §882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: July 15, 2009 Received: July 16, 2009

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 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); medical device reporting of medical devicerelated 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.

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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours,

Rua U. Thm, mo
Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

### 510(k) Number: K090750

# Device Name: RT300 Functional Electrical Stimulation (FES) cycle ergometer

Indications For Use:

Prescription Use

The RT300 (adult and 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 is for prescription use only.

X

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

The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above. .

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices | Page 1 of 1 |
| 510(k) Number | K090750 |

AND/OR

Over-The-Counter Use