RT600

{0}------------------------------------------------ K103366 APR - 4 2011 ## RT600 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: 800 609-9166 Prepared on March 28, 2011. ## (2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name: Proprietary name: RT600 (FES upright ergometer) Powered Muscle Stimulator Common name: Classification name:External Functional Neuromuscular Stimulator #### (3) Identification of the legally marketed device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: "RT300", K090750, a class 2 device ## (4) A description of the device that is the subject of the premarket notification submission. The RT600 is a Functional Electrical Stimulation (FES) upright elliptical ergometer which is composed of: - a motorized upright ergometer (RTI part number SA211257) ﮯ - an FES controller with built in 6 channel stimulator (RTI part number വ SA109413) - up to 5 additional wireless single channel stimulators (RTI part number က FA106897) - a stimulation cable which connects the controller / stimulator to cutaneous ধ electrodes - cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels) റ - an interface to a remote database for the storage and retrieval of therapy റ settings and the storage of therapy session logs - 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 - a stimwear garment incorporating electrodes for lower extremity cycling in ထ population ages 12 and above (RTI part number FA105486) {1}------------------------------------------------ This system allows a person with impaired lower extremity movement to undertake upright elliptical 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 RT600 is 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 RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above. The RT600 is for prescription use only. (6) Technological Characteristics The function of the RT600 is the same as the predicate devices however there are certain technological similarities and differences as described below: | Technology | RT600 | RT300 predicate: K090750 | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ergometer | Upright elliptical ergometer | Cycle ergometer | | Power source<br>(energy used) | Mains power and<br>rechargeable battery for RT50<br>stimulators | Mains power and<br>rechargeable battery for RT50<br>stimulators | | Controller | Based on Pocket PC running<br>custom software. | Based on Pocket PC running<br>custom software. | | Stimulator<br>(energy<br>delivered) | Built in AC mains powered 0-<br>140mA 6 channel charge<br>balanced stimulator. | Built in AC mains powered 0-<br>140mA 6 channel charge<br>balanced stimulator. | | Additional<br>stimulation<br>channels | Up to 5 additional wireless<br>battery powered stimulation<br>channels delivering 0-140mA<br>charge balanced stimulation. | Up to 5 additional wireless<br>battery powered stimulation<br>channels delivering 0-140mA<br>charge balanced stimulation. | | | | | | Stand alone<br>stimulation<br>mode | Wireless battery powered<br>stimulation channels may be<br>used in stand alone mode with<br>out the cycle ergometer. | Wireless battery powered<br>stimulation channels may be<br>used in stand alone mode with<br>out the cycle ergometer. | | Stimwear<br>garment | Stimwear garment<br>incorporating electrodes<br>available for lower extremity<br>cycling, ages 12 and above. | Stimwear garment<br>incorporating electrodes<br>available for lower extremity<br>cycling, ages 12 and above. | | Muscles<br>available for<br>stimulation | Quadriceps, hamstrings,<br>gluteals, gastroc, anterior<br>tibialis, abdominals, erector<br>spinae. | Quadriceps, hamstrings,<br>gluteals, gastroc, anterior<br>tibialis, shoulder, biceps,<br>triceps, anterior, posterior and<br>middle deltoid, wrist, grasp,<br>abdominals, erector spinae. | | Flywheel | Uses leg motor to create<br>flywheel effect with reduced<br>weight and space. | Uses leg / arm crank motor to<br>create flywheel effect with<br>reduced weight and space. | | Hoist | Utilizes powered hoist to<br>position user in upright partial<br>body weight supported<br>position. | Allows user to remain in their<br>own seating, e.g wheelchair<br>eliminating the need for<br>transfer. | | Passive<br>cycling | Utilizes motor to provide<br>assistance during passive<br>cycling. | Utilizes motor to provide<br>assistance during passive<br>cycling. | | Database<br>interface | Utilizes database interface for<br>storage and retrieval of patient<br>therapy settings and storage of<br>session logs. | Utilizes database interface for<br>storage and retrieval of patient<br>therapy settings and storage of<br>session logs. | | Motorized arm<br>crank | No arm crank is provided. | Allows active / passive arm<br>cycling with FES | | Pulse<br>oximeter<br>interface | Utilizes pulse and SpO2 data for<br>display, recording and alarming | Utilizes pulse and SpO2 data<br>for display, recording and<br>alarming | | Bilateral or<br>Unilateral<br>stimulation | Uses bilateral or unilateral<br>stimulation. | Uses bilateral or unilateral<br>stimulation. | {2}------------------------------------------------ Table 1 Device technology comparison (b) Performance data Non clinical testing to determine equivalence has been primarily composed of the following tests: {3}------------------------------------------------ | 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 RT600 upright elliptical<br>ergometer. | The RT600 with 5 additional RT50<br>stimulation channels was validated with<br>ten SCI individuals. | ## RTI concludes that: The RT600 has the same intended use as the RT300 predicate device. The RT600 has the same output characteristics as the predicate device. The RT600 utilizes the same control system as the predicate device including controller, motor controller and drive assembly. The different technological characteristics do not raise new questions of safety and effectiveness. In conclusion, RTI's clinical and non-clinical testing has demonstrated that the RT600 is as safe and effective as the predicate devices. {4}------------------------------------------------ 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 with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Restorative Therapies Inc % Mr. Andrew Barriskill 907 S. Lakewood St Baltimore, MD 21224 APR - 4 2011 Re: K103366 Trade Name: RT600 (FES upright ergometer) Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: March 3, 2011 Received: March 4, 2011 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {5}------------------------------------------------ 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. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Zelezn Melvin R. Baldwin, MD 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 {6}------------------------------------------------ # Indications for Use 510(k) Number: K103366 RT600 functional electrical stimulation stepper ergometer Device Name: Indications for use: The RT600 is 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 RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above. Prescription Use X (Part 21 CFR 801 Subpart D) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K103366 Page 1 of 1