RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

K060032 · Restorative Therapies, Inc. · GZI · Mar 10, 2006 · Neurology

Device Facts

• Record ID: K060032
• Device Name: RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
• Applicant: Restorative Therapies, Inc.
• Product Code: GZI · Neurology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Special
• 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: - Relaxation of muscle spasms 1. - Prevention or retardation of disuse atrophy 2. - Increasing local blood circulation ತ - Maintaining or increasing range of motion র্য 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; inputs include user-applied cutaneous electrodes for muscle stimulation and motor-driven cycling. System transforms inputs via FES controller to evoke lower extremity muscle contractions or provide passive motor-assisted cycling. Used in clinical settings; operated by clinicians or patients. Features remote database interface for therapy setting storage/retrieval and session logs. Output allows healthcare providers to monitor therapy progress; facilitates rehabilitation by maintaining muscle function and circulation. Benefits patients with impaired lower extremity movement by enabling active/passive exercise without requiring dedicated seating transfers.

Clinical Evidence

Bench testing included verification of output characteristics, system performance, and predicate documentation review. Clinical testing included able-bodied subjects to confirm system operation and electrode-off detection across varying skin impedances. Device also utilized in clinical studies involving spinal cord injured subjects. Remote database interface validated at a clinic using multiple systems.

Technological Characteristics

Mains-powered FES cycle ergometer. Controller based on Pocket PC running custom software. Stimulator delivers 0-140mA charge-balanced pulses via 6 stimulation channels (12 cutaneous electrodes). Features motorized flywheel effect, user-specific seating compatibility, and remote database connectivity. Sterilization not specified.

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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K 060032

## 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 March 81 2006.

(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) |
|----------------------|-----------------------------------------|
| Common name: | Powered Muscle Stimulator |
| 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) T
- an FES controller / stimulator (RTI part number SA100090) ଧ
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part 3 number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015) 4
- an interface to a remote database for the storage and retrieval of therapy settings and the storage 5 of therapy session logs

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:

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

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

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## (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 used) | Mains power | Mains power |
| Controller | Based on Pocket PC<br>running custom software. | Uses custom controller<br>running custom software. |
| Stimulator (energy delivered) | 0-140mA charge balanced<br>stimulator | 0-140mA charge balanced<br>stimulator |
| Flywheel | Uses motor to create<br>flywheel effect with reduced<br>weight and space. | Uses heavy mechanical<br>flywheel. |
| Seating | Allows user to remain in<br>their own seating, e.g<br>wheelchair eliminating the<br>need for transfer. | Includes a dedicated seating<br>arrangement. |
| Passive cycling | Utilizes motor to provide<br>assistance during passive<br>cycling. | Requires manual assistance<br>to provide power during<br>passive cycling. |
| Database interface | Utilizes database interface<br>for storage and retrieval of<br>patient therapy settings and<br>storage of session logs. | No database interface. |

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

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| Clinical Test | Description |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing with able bodied subjects | The RT300-S was tested on able bodied subjects to<br>confirm correct operation of the system including<br>correct detection of electrode off conditions with<br>varying skin impedances. |
| Testing with spinal cord injured subjects | The RT300-S is being utilized in clinical studies<br>involving spinal cord injured subjects. |
| Testing the remote database interface | The RT300-S remote database interface was tested<br>at a clinic utilizing multiple RT300-S systems. |

RTI concludes that:

The RT300-S has the same intended use as the predicate device. The RT300-S has the same ാഥ്യൂഗ്യ r he N root o had the benice. The different technological characteristics do not raise new onestions of safety and effectiveness. The safety and effectiveness of using a motor to simulate the quodions of early and enceal 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.

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/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

Restorative Therapies, Inc. c/o Mr. Andrew Barriskill CEO 2363 Boston Street Baltimore, Maryland 21224

Re: K060032

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: February 14, 2006 Received: February 15, 2006

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 docs not mean that FDA has made a determination that vour 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Heike Leuner co

Mark N. Melkerson 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): K060032

RT300-S and RT300-SP Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

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

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

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

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)

Helle Lund

Page 1 of _

Division of General, Restorative, and Neurological Devices

**510(k) Number** K060032