(86 days)
Not Found
No
The description focuses on functional electrical stimulation and cycle ergometry, with no mention of AI or ML technologies. The performance studies are based on technical specifications and validation testing, not AI/ML model performance.
Yes
The device is intended for the prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion, which are therapeutic applications.
No
The device's intended uses are focused on therapy and rehabilitation (muscle relaxation, preventing atrophy, increasing circulation, maintaining range of motion), not on diagnosing diseases or conditions.
No
The device description clearly lists multiple hardware components including a motorized cycle ergometer, arm crank, FES controller/stimulator, cables, and electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for general rehabilitation purposes, focusing on muscle function, circulation, and range of motion. This involves direct interaction with the patient's body for therapeutic effect.
- Device Description: The device is a physical therapy system that applies electrical stimulation to muscles and provides cycling exercise. It measures physiological parameters like pulse and SpO2, but these are for monitoring the patient's condition during therapy, not for diagnosing a disease or condition based on in vitro analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is entirely focused on physical intervention and monitoring during rehabilitation.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RT300 adult and pediatric versions are 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
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
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)
- an FES controller / stimulator (RTI part number SA100090)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 12 electrodes for up to 6 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
This system allows a person with impaired upper or lower extremity movement to undertake cycle 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
Not Found
Indicated Patient Age Range
Adult and pediatric. The RT300 pediatric version is intended for population ages 4 to 12 years.
Intended User / Care Setting
Not Found
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
Not Found
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 upper extremity stimulation. The RT300 upper extremity stimulation was validated with five able bodied individuals.
Key results:
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 both bilateral and unilateral electrical stimulation to the upper extremities 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 device.
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
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: 800 609-9166
NOV 2 1 2007
Prepared on July 20th, 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 (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", K071486, a class 2 device
(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) വ
- an FES controller / stimulator (RTI part number SA100090) ന
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects র্ব the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels) 5
- an interface to a remote database for the storage and retrieval of therapy settings 6 and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 7 levels and provision of alarming based on the data
This system allows a person with impaired upper or lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked upper or lower extremity
1
muscle contractions) and passively (utilizing power developed by the ergometer's motor).
(5) Statement of the intended use of the device:
The RT300 adult and pediatric versions are 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 RT300 pediatric version is intended for population ages 4 to 12 years.
(6) Technological Characteristics
The function of the RT300 is the same as the predicate device however there are certain technological similarities and differences as described below:
| Technology | RT300 | Predicate K071486 |
|---|---|---|
| Power source (energy | ||
| used) | Mains power | Mains power |
| Controller | Based on Pocket PC | |
| running custom software. | Based on Pocket PC | |
| running custom software. | ||
| Stimulator (energy | ||
| delivered) | 0-140mA charge | |
| balanced stimulator | 0-140mA charge | |
| balanced stimulator | ||
| 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 | Allows user to remain in | |
| their own seating, e.g | ||
| wheelchair eliminating | ||
| the need for transfer. | 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 | Allows active / passive | |
| arm cycling without 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 | Uses bilateral or | Uses bilateral or |
2
| stimulation | unilateral stimulation | unilateral stimulation |
|---|---|---|
| cables. | cables. |
(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 | |
| 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 upper extremity stimulation | The RT300 upper extremity stimulation |
| was validated with five able bodied | |
| individuals. |
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 both bilateral and unilateral electrical stimulation to the upper extremities 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 device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Restorative Therapies, Inc. % Mr. Andrew Barriskill CEO 907 South Lakewood Avenue Baltimore, Maryland 21224
NOV 2 1 2007
Re: K072398
Trade/Device Name: RT300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 21, 2007 Received: August 27, 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 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.
4
Page 2 - Mr. Andrew Barriskill
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K072398
Device Name: RT300
Indications For Use:
The RT300 adult and pediatric versions are 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 RT300 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)
Mark A. Milliken
Distion of General, Restorative. and Neurological Devi
510(k) Number
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