(308 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The system's operation is described as delivering stimulation based on angle information, which is a deterministic control mechanism, not indicative of AI/ML.
Yes
The device is intended for general rehabilitation, including relaxation of muscle spasms, prevention of disuse atrophy, increasing circulation, maintaining range of motion, and muscle re-education, all of which are therapeutic purposes.
No
The device description, intended use, and performance studies clearly indicate that the RT300 is a therapeutic device (a Functional Electrical Stimulation (FES) cycle ergometer) used for rehabilitation and muscle stimulation, not for diagnosing conditions. While it does interface with a pulse oximeter for displaying and recording pulse and SpO2 levels, this is for monitoring during therapy, not for diagnostic purposes.
No
The device description explicitly lists multiple hardware components, including a motorized cycle ergometer, motorized arm crank, FES controller with stimulators, wireless stimulators, cables, electrodes, and an interface to a pulse oximeter. While software controls the system, it is an integral part of a larger hardware system.
Based on the provided information, the RT300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the RT300 is for general rehabilitation purposes, focusing on physical functions like muscle relaxation, preventing atrophy, increasing circulation, maintaining range of motion, and muscle re-education. These are all related to the physical body and its movement, not the analysis of biological samples.
- Device Description: The device description details a system involving a cycle ergometer, electrical stimulators, electrodes, and software to facilitate physical activity through Functional Electrical Stimulation (FES). This is a physical therapy device.
- Lack of Biological Sample Analysis: There is no mention of the RT300 being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on functional outcomes (like increased NRS scores, Berg scores, range of motion, etc.) and safety endpoints (adverse reactions, erythema, muscle strain, etc.). These are typical endpoints for physical rehabilitation devices, not IVDs.
- Predicate Devices: The predicate devices listed (RT300 and Xcite Clinical Station) are also described as rehabilitation devices utilizing electrical stimulation.
In summary, the RT300 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 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
-
- Muscle re-education
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.
The RT300 is for prescription use only.
Product codes
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 up to two 6 channel stimulators (RTI part number SA216172)
- Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
- A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
- Cutaneous electrodes (up to 24 electrodes for up to 12 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 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 erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.
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
4 to 12 years (pediatric version), 12 and above (surface electrical stimulation garment version)
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)
Clinical Testing: The study was a multi-arm study with patients serving as their own control to evaluate the safety and effectiveness of external functional neuromuscular stimulators operating at high pulse widths (500-3000 usec) stimulation. Subjects used multi-muscle, high frequency, and pulse width with the RT300 stimulator to generate neuromuscular activity. Subjects were evaluated for 4 interventions: Cycling with Lower Extremity NMES, Lower Extremity NMES, Trunk NMES, and Upper Extremity NMES. Additionally, pediatric subjects were assessed.
Cycling with Lower Extremity NMES:
- Intervention: Fifteen (15) patients undertook activity based therapy using NMES during cycling on an RT300 cycle.
- Primary safety endpoint: Treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
- Effectiveness: Fifteen (15) patients completed 434 cycling sessions. 3 had normal erythema and none had an adverse reaction, blancheable erythema, muscle strain, joint strain nor fracture. The intervention met its primary endpoint with no adverse reactions or other injuries.
Lower Extremity NMES:
- Intervention: Thirty-three (33) patients undertook activity based therapy using NMES during the following motor tasks: lying supine, sit to stand, standing.
- Primary effectiveness endpoint: Clinically significant improvements in functional outcome measures including Adult Neuromuscular Recovery Scale (NRS), Berg Balance Scale, Biodex Dynamometer Torque test for Force Production from Maximum Voluntary Contractions (MVC), Overground Standing Test.
- Primary safety endpoint: Treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
- Effectiveness: Twenty-three (23) patients increased their NRS by 16%, their lower extremity NRS by 11%. 15 patients increased their Berg scores by 47%. MVC torque increased for 8 lower extremity muscle groups by a minimum of 152% to a maximum 3796%. 8 patients increased their Overground Standing Test times by 7108%. The intervention met its primary endpoint.
- Safety: After 920 sessions, twenty-seven (27) patients experienced no adverse reactions, 8 patients experienced normal erythema, 1 patient experienced blancheable erythema, and none experienced muscle strain, joint strain nor fracture.
Trunk NMES:
- Intervention: Thirteen (13) patients undertook activity based therapy using NMES during the following motor tasks: sit, sit up and reverse sit up.
- Primary effectiveness endpoint: Clinically significant improvements in functional outcome measures including Adult Neuromuscular Recovery Scale (NRS), Berg Balance Scale, Modified Functional Reach, Independent Sitting, and Trunk Scale.
- Primary safety endpoint: Treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
- Effectiveness: Eleven (11) patients increased their NRS by 18%, 5 patients increased their Berg scores by 50%. Modified reach scale increased 9 patients by 196%. Independent Sitting times increased in 3 patients 26583%. Trunk scale increased in 2 patients by 180%. The intervention met its primary endpoint.
- Safety: After 172 sessions, ten (10) patients experienced no adverse reactions, 3 patients experienced normal erythema, 1 patient experienced blancheable erythema, and none experienced muscle strain, joint strain nor fracture.
Upper Extremity NMES:
- Intervention: Fourteen (14) patients undertook activity based therapy using NMES during different motor tasks including reaching, grasping, pressing overhead, manipulating materials, and opening a door.
- Primary effectiveness endpoint: Clinically significant improvements in functional outcome measures including Adult Neuromuscular Recovery Scale (NRS), Modified Functional Reach, Bilateral Upper Extremity Basic Strength, and Modified Ashworth Upper Extremity scale.
- Primary safety endpoint: Treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
- Effectiveness: Eleven (11) patients increased their NRS by 8%, Modified reach scale increased in 4 patients by 122%. Bilateral Upper Extremity Basic Strength increased in 3 patients by 8% and Modified Ashworth Upper Extremity scale increased in 3 patients by 3%. The intervention met its primary endpoint.
- Safety: After 65 sessions, seven (7) patients experienced no adverse reactions, 8 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.
Pediatric NMES:
- Intervention: 8 patients between the ages of 2 and 13 yrs old undertook activity based therapy for the upper, trunk and lower extremities using NMES during different motor tasks (eg. reaching, grasping, standing).
- Primary effectiveness endpoint: Clinically significant improvements in functional outcome measures including Pediatric Neuromuscular Recovery Scale (NRS) and Segmental Assessment of Trunk Control (SATCo).
- Primary safety endpoint: Treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
- Effectiveness: Four (4) patients increased their NRS by 88% and 3 patients increased their SATCo by 35%.
- Safety: After 324 sessions, 8 patients experienced no adverse reactions, 6 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Improvement percentages for various functional outcome measures.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three heads, suggesting a focus on people and services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
Restorative Therapies, Inc. Andrew Barriskill CEO 1434 Fleet St. Baltimore, Maryland 21231
Re: K162470
Trade/Device Name: RT300 FES Cycle Ergometer Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: June 7, 2017 Received: June 8, 2017
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 device
1
related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162470
Device Name RT300 FES Cycle Ergometer
Indications for Use (Describe)
The RT300 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
-
Muscle re-education
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. The RT300 is for prescription use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
RT300 510(k) Summary
(1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
Restorative Therapies Inc 1434 Fleet St Baltimore, MD 21231
Contact Person: Andrew Barriskill Phone: 800 609-9166
Prepared on July 16, 2016.
(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: External Functional Neuromuscular Stimulator Classification name:External Functional Neuromuscular Stimulator (21 CFR 882.5810) Regulatory Class: II Product Code: GZI
(3) Identification of the legally marketed device to which the submitter claims equivalence:
RESTORATIVE THERAPIES, INC. product: "RT300", K090750 RESTORATIVE THERAPIES, INC. product: "Xcite Clinical Station", K160614
(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 SA100044 for children)
-
An optional motorized arm crank (RTI part number PP102663)
-
An FES controller with up to two 6 channel stimulators (RTI part number SA216172)
Image /page/3/Picture/15 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a sans-serif font, stacked vertically. To the left of the letters is a stylized graphic of curved lines that converge to a point. The logo is in a light blue color.
| Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|
| Page: | 1 | of | 10 | Version | 2 | EN211366 |
4
-
Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
-
A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
-
Cutaneous electrodes (up to 24 electrodes for up to 12 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 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 erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.
(5) Indications for Use:
The RT300 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
-
- Muscle re-education
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.
The RT300 is for prescription use only.
The Indications for Use described in the numbered items above are not identical to the predicate device, however, the differences do not alter the intended
| Wide pulse width 510(k) submission | Project | R&D | |||||
|---|---|---|---|---|---|---|---|
| RTI | Page: | 2 | of | 10 | Version | 2 | EN211366 |
5
therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for general rehabilitation.
(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 | RT300 predicate:
K090750 | Xcite predicate
K160614 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Ergometer | Cycle ergometer | Cycle ergometer | No ergometer |
| Power
source
(energy
used) | Mains power and
rechargeable battery for
RT50 stimulators | Mains power and
rechargeable battery for
RT50 stimulators | Mains power and
rechargeable
battery for RT60
and RT50
stimulators |
| Controller | Based on Tablet PC
running custom
software. | Based on Pocket PC
running custom
software. | Based on tablet
PC running
custom software. |
| Stimulator
(energy
delivered) | Built in AC mains
powered 0-140mA 6
channel charge
balanced stimulator.
Optionally, the RT300
can accommodate two
6-channel stimulators for
a total of 12 channels. | Built in AC mains
powered 0-140mA 6
channel charge
balanced stimulator. | Up to 2 DC
powered 0-140mA
6 channel charge
balanced
stimulators
("RT60"s). |
| Stimulation
pulse width | Up to 3,000usec | Up to 500usec | Up to 500usec |
| 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. | Up to 4 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 standalone mode
without the cycle
ergometer. | Wireless battery
powered stimulation
channels may be used
in standalone mode
without the cycle
ergometer. | Always used in
standalone
stimulation mode. |
| Stimwear | Stimwear garment | Stimwear garment | No stimwear |
Image /page/5/Picture/6 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal sans-serif font. To the left of the letters are two curved teal lines that form a vertical oval shape. The logo is simple and modern.
| Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|
| Page: | 3 | of | 10 | Version | 2 | EN211366 |
6
| Technology | RT300 | RT300 predicate:
K090750 | Xcite predicate
K160614 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| garment | incorporating electrodes
available for lower
extremity cycling, ages
12 and above. | incorporating electrodes
available for lower
extremity cycling, ages
12 and above. | garment. |
| 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. | Quadriceps,
hamstrings,
gluteals, gastroc,
anterior tibialis,
shoulder, biceps,
triceps, anterior,
posterior and
middle deltoid,
wrist extensors
and flexors, 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. | 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 |
| Passive
cycling | Utilizes motor to provide
assistance during
passive cycling. | Utilizes motor to
provide assistance
during passive cycling. | 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. | 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 with FES | 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 | Utilize pulse and
SpO2 data for
display, recording
and alarming |
| Bilateral or
Unilateral
stimulation | Uses bilateral or
unilateral stimulation. | Uses bilateral or
unilateral stimulation. | Uses bilateral or
unilateral
stimulation. |
| Image: RTI logo | Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|---|
| Page: | 4 | of 10 | Version | 2 | EN211366 |
7
| Technology | RT300 | RT300 predicate:
K090750 | Xcite predicate
K160614 |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 1.Relaxation of muscle
spasms
2.Prevention or
retardation of disuse
atrophy
3.Increasing local blood
circulation; and
4.Maintaining or
increasing range of
motion
5. Muscle re-education
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.
The RT300 is for
prescription use only. | 1.Relaxation of muscle
spasms
2.Prevention or
retardation of disuse
atrophy
3.Increasing local blood
circulation; and
4.Maintaining or
increasing range of
motion
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.
The RT300 is for
prescription use only. | 1.Relaxation of
muscle spasms
2.Prevention or
retardation of
disuse atrophy
3.Increasing local
blood circulation
4.Maintaining or
increasing range
of motion
5.Muscle re-education |
Table 1 Device technology comparison
(b) Performance data
Non clinical testing to determine equivalence has been primarily composed of the following tests:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the RT300, consisting of the tablet, leg ergometer, arm ergometer, 2 RT60s and stimulation cable. The system complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-11 standards for safety and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: The software for this device was considered "moderate" level
| Wide pulse width 510(k) submission | Project | R&D | |||||
|---|---|---|---|---|---|---|---|
| RTI | Page: | 5 | of | 10 | Version | 2 | EN211366 |
8
of concern, since a failure of latent flaw in the software could directly result in minor injury to the patient or operator.
| 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 Testing
Clinical testing consisted of a multi-arm study with patients serving as their own control. The protocol's objective was to evaluate the safety and effectiveness of external functional neuromuscular stimulators operating at high pulse widths (500-3000 usec) stimulation. Subjects used multi-muscle, high frequency, and pulse width with the RT300 stimulator to generate neuromuscular activity. Subjects were evaluated for 4 interventions; Cycling with Lower Extremity NMES (NeuroMuscular Electrical Stimulation), Lower Extremity NMES, Trunk NMES, and Upper Extremity NMES. Additionally pediatric subjects were assessed
Cycling with Lower Extremity NMES
Intervention:
Fifteen patients (15) undertook activity based therapy using NMES during cvcling on an RT300 cycle.
Primary safety endpoint:
The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
Effectiveness
The primary endpoint for the Cycling intervention focused on the risk assessment of cycling with high pulse width (500-3000 usec, with 8 patients receiving the maximum of 3000us) stimulation. Fifteen (15) patients completed 434 cycling sessions - 3 had normal erythema and none had an adverse reaction, blancheable erythema, muscle strain, joint strain nor fracture. Therefore this intervention met its primary endpoint with no adverse reactions or other injuries.
Lower Extremity NMES
Intervention:
R
| Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|
| Page: | 6 | of | 10 | Version | 2 | EN211366 |
9
Thirty-three (33) patients undertook activity based therapy using NMES during the following motor tasks: lying supine, sit to stand, standing.
Primary effectiveness endpoint:
Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale (NRS), Berg Balance Scale, Biodex Dynamometer Torque test for Force Production from Maximum Voluntary Contractions (MVC), Overground Standing Test.
Primary safety endpoint:
The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
Effectiveness
The primary endpoint for the Lower Extremity intervention focused on the changes to the outcome measures after intervention with high pulse width (500-3000 usec, with 10 patients receiving the maximum of 3000us). Twenty-three (23) patients increased their NRS by 16% (average pre assessment score of 5.43 to average post of 6.45), their lower extremity NRS by 11% (3.27 to 3.71); 15 patients increased their Berg scores by 47% (average pre assessment score of 6.8 to average post of 10); MVC torque increased for 8 lower extremity muscle groups (Right and Left knee extensors, Right and Left plantarflexors and Right and Left dorsiflexors) in an average of 9 patients by a minimum of 152% (average torque in Nm at pre assessment of 3.5 to a post assessment of 7.13) increase in right plantarflexor torque output to a maximum 3796% (average torque in Nm at pre assessment of 0.1 to a post of 21.87) for left plantarflexor output, and 8 patients increased their Overground Standing Test times by 7108% (average pre time standing of 0 to average post time of 300 seconds). Therefore this intervention met its primary endpoint of an increase in all outcome measures.
Safetv
After 920 sessions twenty-seven (27) patients experienced no adverse reactions, 8 patients experienced normal erythema. 1 patient experienced blancheable erythema and none experienced muscle strain, joint strain nor fracture.
Trunk NMES
Intervention:
Thirteen (13) patients undertook activity based therapy using NMES during the following motor tasks: sit, sit up and reverse sit up.
Primary effectiveness endpoint:
Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale
Image /page/9/Picture/14 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal color, with a stylized teal line to the left of the letters. The line is curved, resembling a stylized "K" shape.
| Wide pulse width 510(k) submission | Project | R&D | ||
|---|---|---|---|---|
| Page: | 7 of 10 | Version | 2 | EN211366 |
10
(NRS), Berg Balance Scale, Modified Functional Reach, Independent Sitting, and Trunk Scale.
Primary safety endpoint:
The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
Effectiveness
The primary endpoint for the Lower Extremity intervention focused on the changes to the outcome measures after intervention with high pulse width (500-3000 usec with 2 patients receiving the maximum of 3000us) stimulation. Eleven (11) patients increased their NRS by 18% (average pre assessment score of 5.26 to average post of 5.81), 5 patients increased their Berg scores by 50% (average pre assessment score of 9 to average post of 14); Modified reach scale increased 9 patients by 196% (average reach in inches at pre assessment of 6.45 to a post assessment of 18): Independent Sitting times increased in 3 patients 26583% (pre assessment time of 0 seconds to a post of 600 seconds); Trunk scale increased in 2 patients by 180% (pre assessment score of 0 to a post of 4). Therefore this intervention met its primary endpoint of an increase in all outcome measures.
Safety
After 172 sessions ten (10) patients experienced no adverse reactions, 3 patients experienced normal erythema. 1 patient experienced blancheable erythema and none experienced muscle strain, joint strain nor fracture.
Upper Extremity NMES
Intervention:
Fourteen (14) patients undertook activity based therapy using NMES during different motor tasks including reaching, grasping, pressing overhead, manipulating materials, and opening a door.
Primary effectiveness endpoint:
Clinically significant improvements in functional outcome measures. These measures included evaluation using the Adult Neuromuscular Recovery Scale (NRS), Modified Functional Reach, Bilateral Upper Extremity Basic Strength, and Modified Ashworth Upper Extremity scale.
Primary safety endpoint:
The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
Effectiveness
The primary endpoint for the Upper Extremity intervention focused on the outcome measures after intervention with high pulse width (500-3000 usec with 1
Image /page/10/Picture/16 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a sans-serif font, stacked vertically. To the left of the letters is a curved line that resembles a parenthesis. The color of the logo is a light blue.
| Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|
| Page: | 8 | of | 10 | Version | 2 | EN211366 |
11
patient receiving the maximum of 3000us) stimulation. Eleven (11) patients increased their NRS by 8% (average pre assessment score of 3.91 to average post of 4.08), Modified reach scale increased in 4 patients by 122% (average reach in inches at pre assessment of 1.5 to a post assessment of 5.8); Bilateral Upper Extremity Basic Strength increased in 3 patients by 8% (pre assessment scale 2 to 2.1 post assessment) and Modified Ashworth Upper Extremity scale increased in 3 patients by 3%. Therefore this intervention met its primary endpoint of an increase in all outcome measures.
Safety
After 65 sessions seven (7) patients experienced no adverse reactions, 8 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.
Pediatric NMES
Intervention:
8 (eight) patients between the ages of 2 and 13 yrs old undertook activity based therapy for the upper, trunk and lower extremities using NMES during the different motor tasks (eg. reaching, grasping, standing).
Primary effectiveness endpoint:
Clinically significant improvements in functional outcome measures. These measures included evaluation using the Pediatric Neuromuscular Recovery Scale (NRS) and Segmental Assessment of Trunk Control (SATCo),
Primary safety endpoint:
The primary safety endpoint consisted of treatment-related adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
Effectiveness
The primary endpoint for the Lower Extremity intervention focused on the outcome measures after intervention with high pulse width (500-1000 usec with all 8 patients receiving the maximum of 1000us) stimulation. Four (4) patients increased their NRS by 88% (average pre assessment score of 2.38 to average post of 4.13) and 3 patients increased their SATCo by 35% (pre assessment score of 8 to a post of 10.7)
Safetv
After 324 sessions 8 patients experienced no adverse reactions, 6 patients experienced normal erythema, and none experienced blancheable erythema, muscle strain, joint strain nor fracture.
Summary
Image /page/11/Picture/15 description: The image shows the logo for RTI International. The logo consists of the letters "RTI" in a teal sans-serif font. To the left of the letters are two curved teal lines that form a stylized abstract shape. The logo is simple and modern in design.
| Wide pulse width 510(k) submission | Project | R&D | |||
|---|---|---|---|---|---|
| Page: | 9 | of 10 | Version | 2 | EN211366 |
12
Based on the clinical performance as documented in the clinical testing, the RT300 was found to have a safety and effectiveness profile that is similar to the predicate device
RTI concludes that:
The RT300 has the same intended use as the RT300 predicate device.
The RT300 with available wider stimulation pulses utilizes the same stimulators and control system as the predicate device including controller, stimulators, motor controller and drive assembly. The different technological characteristics do not raise new questions of safety and effectiveness.
In conclusion, RTI's clinical testing has demonstrated that the RT300 is as safe and effective as the predicate devices.
Image /page/12/Picture/7 description: The image shows the logo for RTI International. The logo features the letters "RTI" in a sans-serif font, with the "R" and "I" in a darker shade of blue than the "T". To the left of the letters, there are two curved lines that resemble a stylized "X". The overall design is simple and modern.
| Wide pulse width 510(k) submission | Project | R&D | ||||
|---|---|---|---|---|---|---|
| Page: | 10 | of | 10 | Version | 2 | EN211366 |