(138 days)
Not Found
No
The summary describes a functional electrical stimulation (FES) cycle ergometer with various components and functionalities related to muscle stimulation and exercise. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The testing described is focused on the electrical stimulation and mechanical aspects of the device, not on algorithmic learning or adaptation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for general rehabilitation, including relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion, all of which are therapeutic applications.
No
The Intended Use / Indications for Use describe therapeutic applications like relaxation of muscle spasms and increasing local blood circulation, not diagnostic purposes. While it integrates a pulse oximeter for displaying and recording pulse and SpO2 levels, this is for monitoring during therapy, not for diagnosing a medical condition.
No
The device description explicitly lists multiple hardware components, including a cycle ergometer, arm crank, FES controller with built-in stimulator, wireless stimulators, cables, electrodes, and a stimwear garment. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for physical rehabilitation through functional electrical stimulation and cycling. This involves applying electrical stimulation to muscles to induce contractions and facilitate movement, which is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device components are all related to a physical therapy system (cycle ergometer, stimulators, electrodes, cables, etc.). There are no components or descriptions related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is a therapeutic and rehabilitative device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The RT300 (adult and pediatric version) are intended for general rehabilitation for:
- a. Relaxation of muscle spasms
- b. Prevention or retardation of disuse atrophy
- c. Increasing local blood circulation
- d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 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 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 – SA100044 for children)
- an optional motorized arm crank (RTI part number PP102663)
- an FES controller with built in 6 channel stimulator (RTI part number SA100090)
- up to 5 additional wireless single channel stimulators (RTI part number 4 FA106897)
- a leg and optional arm stimulation cable (either bilateral or unilateral) 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 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
Upper or lower extremity, erector spinae and abdominal muscle groups.
Indicated Patient Age Range
The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
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 RT50 stimulation: The RT300 with 5 additional RT50 stimulation channels was validated with five able bodied individuals. The RT50 in standalone mode was validated with five able bodied individuals.
Clinical Test: Testing additional muscle groups: The RT50 clinical testing included testing of abdominal and erector spinae stimulation.
Clinical Test: Testing the Stimwear garment: The RT300 with the Stimwear garment was validated on one able bodied individual.
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 up to 5 additional channels of electrical stimulation utilizing the RT50 to the upper and lower extremities, erector spinae and abdominal muscle groups has been demonstrated during validation testing. The safety and effectiveness of utilizing Stimwear and carbon electrodes 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 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
AUG 0 5 2009
510(k) Summary
Note: Changes from K072398 RT300 Summary of Safety and Effectiveness are shown in italics.
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
Prepared on June 22nd 2009.
(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) Common name: Powered Muscle Stimulator Classification name: External functional neuromuscular stimulator
(3) Identification of the legally marketed device to which the submitter claims equivalence:
RESTORATIVE THERAPIES, INC. product: "RT300", K072398, a class 2 device
THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to Stimwear only.
HASOMED GMBH product: "REHASTIM & REHAMOVE", K073237, a class 2 device. Relates to stand alone stimulator use only.
(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) 2
1
- ന an FES controller with built in 6 channel stimulator (RTI part number SA100090)
- up to 5 additional wireless single channel stimulators (RTI part number 4 FA106897)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which ട് connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation ଚି channels)
- an interface to a remote database for the storage and retrieval of therapy 7 settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and ക SpO2 levels and provision of alarming based on the data
- ക 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 cvcle 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 RT300 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 is for prescription use only.
The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
(6) Technological Characteristics
The function of the RT300 is the same as the predicate devices however there are certain technological similarities and differences as described below:
| Technology | RT300 | Predicate K072398 | Predicate K841112 | Predicate K073237 |
|---|---|---|---|---|
| Power source (energy used) | Mains power and rechargeable battery for RT50 stimulators | Mains power | N/A | N/A |
| Controller | Based on Pocket PC | Based on Pocket PC | N/A | N/A |
| Technology | RT300 | Predicate | ||
| K072398 | Predicate | |||
| K841112 | Predicate | |||
| K073237 | ||||
| running custom | ||||
| software. | running | |||
| custom | ||||
| software. | ||||
| Stimulator | ||||
| (energy | ||||
| delivered) | Built in AC | |||
| mains powered | ||||
| 0-140mA 6 | ||||
| channel charge | ||||
| balanced | ||||
| stimulator. | Built in AC | |||
| mains | ||||
| powered 0- | ||||
| 140mA 6 | ||||
| channel | ||||
| charge | ||||
| balanced | ||||
| stimulator. | N/A | N/A | ||
| Additional | ||||
| stimulation | ||||
| channels | Up to 5 | |||
| additional | ||||
| wireless | ||||
| battery | ||||
| powered | ||||
| stimulation | ||||
| channels | ||||
| delivering 0- | ||||
| 140mA charge | ||||
| balanced | ||||
| stimulation. | Additional | |||
| stimulation | ||||
| channels not | ||||
| available. | N/A | N/A | ||
| Stand alone | ||||
| stimulation | ||||
| mode | Wireless | |||
| battery | ||||
| powered | ||||
| stimulation | ||||
| channels may | ||||
| be used in | ||||
| stand alone | ||||
| mode with out | ||||
| the cycle | ||||
| ergometer. | Stand alone | |||
| mode not | ||||
| available. | N/A | Stimulator | ||
| "can be used | ||||
| as a portable | ||||
| or stationary | ||||
| device for | ||||
| training and | ||||
| rehabilitation | ||||
| applications" | ||||
| Stimwear | ||||
| garment | Stimwear | |||
| garment | ||||
| incorporating | ||||
| electrodes | ||||
| available for | ||||
| low extremity | ||||
| cycling, ages | ||||
| 12 and above. | Stimwear | |||
| garment not | ||||
| available. | Available | |||
| stimwear | ||||
| garment | ||||
| incorporating | ||||
| electrodes. | N/A | |||
| Muscles | ||||
| available for | ||||
| stimulation | Quadriceps, | |||
| hamstrings, | ||||
| gluteals, | ||||
| gastroc, anterior | Quadriceps, | |||
| hamstrings, | ||||
| gluteals, | ||||
| gastroc | N/A | N/A | ||
| Technology | RT300 | Predicate | ||
| K072398 | Predicate | |||
| K841112 | Predicate | |||
| K073237 | ||||
| tibialis, shoulder, | ||||
| biceps, triceps, | ||||
| anterior, | ||||
| posterior and | ||||
| middle deltoid, | ||||
| wrist, grasp, | ||||
| abdominals, | ||||
| erector spinae. | anterior | |||
| tibialis, | ||||
| shoulder, | ||||
| biceps, | ||||
| triceps, | ||||
| anterior, | ||||
| posterior and | ||||
| middle | ||||
| deltoid, wrist, | ||||
| grasp | N/A | N/A | ||
| 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. | N/A | N/A | ||
| 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. | N/A | N/A | ||
| Passive cycling | Utilizes motor to | |||
| provide | ||||
| assistance | ||||
| during passive | ||||
| cycling. | Utilizes | |||
| motor to | ||||
| provide | ||||
| assistance | ||||
| during | ||||
| passive | ||||
| cycling. | N/A | N/A | ||
| 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. | N/A | N/A | ||
| Technology | RT300 | Predicate | ||
| K072398 | Predicate | |||
| K841112 | Predicate | |||
| K073237 | ||||
| Motorized arm | ||||
| crank | Allows active / | |||
| passive arm | ||||
| cycling with FES | Allows active | |||
| / passive | ||||
| arm cycling | ||||
| with FES | N/A | N/A | ||
| Pulse oximeter | ||||
| interface | Utilize pulse and | |||
| SpO2 data for | ||||
| display, | ||||
| recording and | ||||
| alarming | Utilize pulse | |||
| and SpO2 | ||||
| data for | ||||
| display, | ||||
| recording | ||||
| and alarming | N/A | N/A | ||
| Bilateral or | ||||
| Unilateral | ||||
| stimulation | Uses bilateral or | |||
| unilateral | ||||
| stimulation | ||||
| cables. | Uses | |||
| bilateral or | ||||
| unilateral | ||||
| stimulation | ||||
| cables. | N/A | N/A |
2
. . . . .
:
:
3
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the fir
and the control of the county of
4
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 | |
| 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 RT50 stimulation | The RT300 with 5 additional RT50 |
| stimulation channels was validated with | |
| five able bodied individuals. | |
| The RT50 in standalone mode was | |
| validated with five able bodied | |
| individuals. |
5
| Clinical Test | Description |
|---|---|
| Testing additional muscle groups. | The RT50 clinical testing included |
| testing of abdominal and erector spinae | |
| stimulation . | |
| Testing the Stimwear garment | The RT300 with the Stimwear garment |
| was validated on one able bodied | |
| individual. |
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 up to 5 additional channels of electrical stimulation utilizing the RT50 to the upper and lower extremities, erector spinae and abdominal muscle groups has been demonstrated during validation testing. The safety and effectiveness of utilizing Stimwear and carbon electrodes 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 devices.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three thick, curved lines forming the body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Restorative Therapies, Inc % Andrew Barriskill CEO 907 South Lakewood Ave Baltimore, MD 21224
AUG 0 5 2009
Re: K090750
Trade Name: RT300 Functional Electrical Stimulation (FES) Cycle Ergometer Regulation Number: 21 CFR §882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: July 15, 2009 Received: July 16, 2009
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 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 of medical devicerelated adverse events) (21 CFR 803); 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.
7
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Rua U. Thm, mo
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
8
Indications for Use
510(k) Number: K090750
Device Name: RT300 Functional Electrical Stimulation (FES) cycle ergometer
Indications For Use:
Prescription Use
The RT300 (adult and pediatric version) are intended for general rehabilitation for:
- a. Relaxation of muscle spasms
- b. Prevention or retardation of disuse atrophy
- c. Increasing local blood circulation
- d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
X
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above. .
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices | Page 1 of 1 |
| 510(k) Number | K090750 |
AND/OR
Over-The-Counter Use