(64 days)
Not Found
No
The summary describes a functional electrical stimulation (FES) cycle ergometer with a motorized cycle, FES controller, electrodes, and a database interface. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device's intended uses, such as "relaxation of muscle spasms," "prevention or retardation of disuse atrophy," "increasing local blood circulation," and "maintaining or increasing range of motion," are all therapeutic applications.
No
The device is described as a Functional Electrical Stimulation (FES) cycle ergometer intended for rehabilitation purposes such as muscle relaxation, prevention of disuse atrophy, increasing blood circulation, and maintaining/increasing range of motion. It focuses on therapeutic outcomes rather than diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a motorized cycle ergometer, an FES controller/stimulator, stimulation cables, and cutaneous electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, maintaining or increasing range of motion) are all related to physical rehabilitation and therapy. They do not involve the examination of specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The device is a Functional Electrical Stimulation (FES) cycle ergometer. This is a physical therapy device that applies electrical stimulation to muscles to induce contractions and facilitate exercise. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts directly with the patient's body through electrodes.
In summary, the RT300-S/SP is a therapeutic device used for physical rehabilitation, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The RT300-S (adult version) and RT300-SP (pediatic version) 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-SP (pediatic version), is intended for population ages 4 to 12 years.
Product codes
GZI
Device Description
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)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremity
Indicated Patient Age Range
Adult version: Not specified
Pediatric version: 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
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 with able bodied subjects: The RT300-S was tested on able bodied subjects to confirm correct operation of the system including correct detection of electrode off conditions with varying skin impedances.
- Testing with spinal cord injured subjects: The RT300-S is being utilized in clinical studies involving spinal cord injured subjects.
- Testing the remote database interface: The RT300-S remote database interface was tested at a clinic utilizing multiple RT300-S systems.
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:
- Review of user documentation for predicate device
- Review of 510(k) submission for predicate device
- Output characteristic measurement of new device
- Conduct of system testing
Clinical Testing:
- Testing with able bodied subjects to confirm correct operation of the system including correct detection of electrode off conditions with varying skin impedances.
- Testing with spinal cord injured subjects (clinical studies are ongoing).
- Testing the remote database interface 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 technological characteristics as the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness. The safety and effectiveness of using a motor to simulate the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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: 800 609-9166
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.
1
(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 | |
| running custom software. | Uses custom controller | |
| running custom software. | ||
| Stimulator (energy delivered) | 0-140mA charge balanced | |
| stimulator | 0-140mA charge balanced | |
| stimulator | ||
| Flywheel | Uses motor to create | |
| flywheel effect with reduced | ||
| weight and space. | Uses heavy mechanical | |
| flywheel. | ||
| Seating | Allows user to remain in | |
| their own seating, e.g | ||
| wheelchair eliminating the | ||
| need for transfer. | Includes a dedicated seating | |
| arrangement. | ||
| Passive cycling | Utilizes motor to provide | |
| assistance during passive | ||
| cycling. | Requires manual assistance | |
| to provide power during | ||
| passive cycling. | ||
| Database interface | Utilizes database interface | |
| for storage and retrieval of | ||
| patient therapy settings and | ||
| 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 | |
| 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. |
2
| Clinical Test | Description |
|---|---|
| Testing with able bodied subjects | The RT300-S was tested on able bodied subjects to |
| confirm correct operation of the system including | |
| correct detection of electrode off conditions with | |
| varying skin impedances. | |
| Testing with spinal cord injured subjects | The RT300-S is being utilized in clinical studies |
| involving spinal cord injured subjects. | |
| Testing the remote database interface | The RT300-S remote database interface was tested |
| 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.
3
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
4
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
5
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