(139 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and basic control systems for FES. There is no mention of adaptive algorithms, learning from data, or any other characteristic typically associated with AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly lists medical conditions for which the device is intended, such as "Relaxation of muscle spasms" and "Prevention or retardation of disuse atrophy," clearly indicating a therapeutic purpose.
No
The Intended Use/Indications for Use section describes therapeutic purposes (e.g., relaxation of muscle spasms, prevention of disuse atrophy) and does not mention diagnosis. The device description also focuses on rehabilitation and stimulation for movement.
No
The device description explicitly lists multiple hardware components including a motorized elliptical ergometer, FES controller with built-in stimulator, wireless stimulators, stimulation cables, and cutaneous electrodes. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, the RT200 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the RT200 is for general rehabilitation purposes involving muscle stimulation and exercise. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system for functional electrical stimulation and exercise, not for analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
In summary, the RT200 is a therapeutic device used for physical rehabilitation, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
The RT200 is intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:
- a motorized elliptical ergometer (RTI part number SA110444)
- an FES controller with built in 6 channel stimulator (RTI part number SA109413)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- 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 recumbent elliptical ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, biceps, triceps, anterior, posterior and middle deltoid, wrist, grasp, abdominals, erector spinae.
Indicated Patient Age Range
12 and above.
Intended User / Care Setting
Prescription Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The RT200 with 5 additional RT50 stimulation channels was validated with seven SCI individuals.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical testing to determine equivalence has been primarily composed of the following tests:
- Review of user documentation for predicate device: Ensure that equivalent functionality is specified and implemented in the new device.
- Review of 510(k) submission for predicate device: Confirm technical specifications for completion of predicate details in comparison tables.
- Output characteristic measurement of new device: Confirm technical specifications for completion of new device details in comparison tables.
- Conduct of system testing: Conduct system testing to verify performance to specification.
Clinical Test: Testing the RT200 recumbent elliptical ergometer and simultaneous upper and lower extremity stimulation. The RT200 with 5 additional RT50 stimulation channels was validated with seven SCI individuals.
RTI concludes that:
The RT200 has the same intended use as the RT300 predicate device.
The RT200 has the same output characteristics as the predicate device. The RT200 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 RT200 is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
K!03370
APR - 5 2011
RT200 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 5, 2010.
(2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name:
RT200 (FES elliptical ergometer) Proprietary name: 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
THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to seat only.
(4) A description of the device that is the subject of the premarket notification submission.
The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:
- a motorized elliptical ergometer (RTI part number SA110444) ←
- an FES controller with built in 6 channel stimulator (RTI part number যে SA109413)
- up to 5 additional wireless single channel stimulators (RTI part number ന FA106897)
- a stimulation cable which connects the controller / stimulator to cutaneous ব electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels) 5
- an interface to a remote database for the storage and retrieval of therapy റ settings and the storage of therapy session logs
1
- 7 an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- ထ 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 recumbent elliptical 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 RT200 is intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT200 is for prescription use only.
(6) Technological Characteristics
The function of the RT200 is the same as the predicate devices however there are certain technological similarities and differences as described below:
| Technology | RT200 | RT300 predicate: K090750 |
|---|---|---|
| Ergometer | Recumbent elliptical ergometer | Cycle ergometer |
| Power source | ||
| (energy used) | Mains power and | Mains power and |
| rechargeable battery for RT50 | ||
| stimulators | rechargeable battery for RT50 | |
| stimulators | ||
| Controller | Based on Pocket PC running | |
| custom software. | Based on Pocket PC running | |
| custom software. | ||
| Stimulator | ||
| (energy | ||
| delivered) | Built in AC mains powered 0- | |
| 140mA 6 channel charge | Built in AC mains powered 0- | |
| 140mA 6 channel charge | ||
| balanced stimulator. | balanced stimulator. | |
| Additional | ||
| stimulation | ||
| channels | Up to 5 additional wireless | |
| battery powered stimulation | ||
| channels delivering 0-140mA | ||
| charge balanced stimulation. | Up to 5 additional wireless | |
| battery powered stimulation | ||
| channels delivering 0-140mA | ||
| charge balanced stimulation. | ||
| Stand alone | ||
| stimulation | ||
| mode | Wireless battery powered | |
| stimulation channels may be | ||
| used in stand alone mode with | ||
| out the cycle ergometer. | Wireless battery powered | |
| stimulation channels may be | ||
| used in stand alone mode with | ||
| out the cycle ergometer. | ||
| Stimwear | ||
| garment | Stimwear garment | |
| incorporating electrodes | Stimwear garment | |
| incorporating electrodes |
2
| Technology | RT200 | RT300 predicate: K090750 |
|---|---|---|
| available for lower extremity cycling, ages 12 and above. | available for lower extremity cycling, ages 12 and above. | |
| Muscles available for stimulation | Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, biceps, triceps, anterior, posterior and middle deltoid, wrist, grasp, abdominals, erector spinae. | Quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, biceps, triceps, anterior, posterior and middle deltoid, wrist, grasp, abdominals, erector spinae. |
| Flywheel | Uses leg / arm crank motor to create flywheel effect with reduced weight and space. | Uses leg / arm crank motor to create flywheel effect with reduced weight and space. |
| Seating | Utilizes built in seat as per K841112. | Allows user to remain in their own seating, e.g wheelchair eliminating the need for transfer. |
| Passive cycling | Utilizes motor to provide assistance during passive cycling. | Utilizes motor to provide assistance during passive cycling. |
| Database interface | Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs. | Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs. |
| Motorized arm crank | Allows active / passive arm cycling with FES. Arm crank is mechanically linked to the leg crank for simultaneous use. | Allows active / passive arm cycling with FES |
| Pulse oximeter interface | Utilize pulse and SpO2 data for display, recording and alarming | Utilize pulse and SpO2 data for display, recording and alarming |
| Bilateral or Unilateral stimulation | Uses bilateral or unilateral stimulation cables. | Uses bilateral or unilateral stimulation cables. |
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 | |
| predicate device | Ensure that equivalent functionality is |
| specified and implemented in the new | |
| device. | |
| Review of 510(k) submission for | |
| predicate device | Confirm technical specifications for |
| completion of predicate details in |
3
| Test or procedure | Description |
|---|---|
| comparison tables | |
| Output characteristic measurement of | |
| new device | Confirm technical specifications for |
| completion of new device details in | |
| comparison tables | |
| Conduct of system testing | Conduct system testing to verify |
| performance to specification. |
| Clinical Test | Description |
|---|---|
| Testing the RT200 recumbent elliptical | |
| ergometer and simultaneous upper and | |
| lower extremity stimulation. | The RT200 with 5 additional RT50 |
| stimulation channels was validated with | |
| seven SCI individuals. |
RTI concludes that:
The RT200 has the same intended use as the RT300 predicate device.
The RT200 has the same output characteristics as the predicate device. The RT200 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 RT200 is as safe and effective as the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is facing right and slightly upward. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern 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 - 5 2011
Re: K103370
Trade Name: RT200 (FES recumbent elliptical ergometer) Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: March 8, 2011 Received: March 9, 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
Page 2 - Mr. Andrew Barriskill
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,
Q.k. Thomsen for
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: K103370
RT200 functional electrical stimulation elliptical ergometer Device Name:
Indications for use:
The RT200 is intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
The RT200 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_