(103 days)
Not Found
No
The summary describes a functional electrical stimulation cycle ergometer with standard components and functionalities, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a functional electrical stimulation (FES) cycle ergometer intended for general rehabilitation to address conditions like muscle spasms, disuse atrophy, and limited range of motion, all of which are therapeutic applications.
No
The device is a Functional Electrical Stimulation (FES) cycle ergometer intended for therapy (muscle spasms, disuse atrophy, blood circulation, range of motion), not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components, including a motorized cycle ergometer, FES controller/stimulator, stimulation 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 of the RT300-S/SP is for general rehabilitation purposes involving muscle stimulation and exercise. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a cycle ergometer with functional electrical stimulation (FES). It interacts directly with the patient's body (muscles) to induce contractions and facilitate movement. IVD devices, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is clearly designed for physical rehabilitation and therapeutic intervention, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The RT300-S (adult version) and RT300-SP (pediatric 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
Product codes (comma separated list FDA assigned to the subject device)
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 1 SA100044 for children)
- 2 an FES controller / stimulator (RTI part number SA100090)
- 3 a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels ির্ব and 10 muscle groups, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy 5 settings and the storage of therapy session logs
- 6 an optional motorized arm crank (RTI part number PP102663)
- 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.
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
Not Found
Indicated Patient Age Range
The RT300-SP (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
Testing the unilateral stimulation mode: The unilateral stimulation mode was validated with five able bodied 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 unilateral stimulation mode was validated with five able bodied individuals.
RTI concludes that:
The RT300-S has the same intended use as the predicate device. The RT300-S 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 stimulation has been demonstrated over the development period of the RT300-S.
In conclusion, RTI's clinical and non clinical testing has demonstrated that the RT300-S 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-S Summary of Safety and Effectiveness
(1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
SEP 1 0 2007
Andrew Barriskill Restorative Therapies Inc 907 South Lakewood Ave Baltimore, MD 21224
Phone: 800 609-9166
Prepared on August 29th, 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-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:
RESTORATIVE THERAPIES, INC. product: "RT300-S", K071113, 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 1 SA100044 for children)
- 2 an FES controller / stimulator (RTI part number SA100090)
- 3 a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels র্ব and 10 muscle groups, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy 5 settings and the storage of therapy session logs
- 6 an optional motorized arm crank (RTI part number PP102663)
- 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.
1
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
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
(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 K071113 |
|---|---|---|
| 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 motor to create flywheel effect with reduced weight and space. | Uses 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 without FES | Allows active / passive arm cycling without FES |
| Pulse oximeter interface | Utilize pulse and SpO2 | Utilize pulse and SpO2 |
2
| data for display, recording and alarming | data for display, recording and alarming | |
|---|---|---|
| Bilateral or Unilateral stimulation | Uses bilateral or unilateral stimulation cables. | Uses bilateral stimulation cable. |
(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 unilateral stimulation mode | The unilateral stimulation mode was |
| validated with five able bodied | |
| individuals. |
RTI concludes that:
The RT300-S has the same intended use as the predicate device. The RT300-S 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 stimulation has been demonstrated over the development period of the RT300-S.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Restorative Therapies, Inc. % Mr. Andrew Barriskill CEO 907 South Lakewood Avenue Baltimore, MD 21224
SEP 1 0 2007
RE: K071486
Trade/Device Name: RT300-S and RT300-SP FES Cycle Ergometer Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 24, 2007 Received: August 27, 2007
Dear Dr. 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
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely your 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): K071486
Device Name: RT300-S and RT300-SP
Indications For Use:
The RT300-S (adult version) and RT300-SP (pediatric 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 (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)
Polo Vlar
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number `/ko1/94