(138 days)
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.
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 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).
This 510(k) premarket notification for the RT300 Functional Electrical Stimulation (FES) cycle ergometer describes the device's substantial equivalence to previously marketed devices. The document highlights technological characteristics and the results of non-clinical and clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria with quantifiable metrics for a specific performance characteristic (e.g., a minimum sensitivity or maximum error rate). Instead, the acceptance is based on demonstrating "safety and effectiveness" and "equivalence" to predicate devices through various tests.
The reported device performance is qualitative, stating that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in functionality | "Ensure that equivalent functionality is specified and implemented in the new device." |
| Conformance to technical specifications | "Confirm technical specifications for completion of predicate details in comparison tables" and "Confirm technical specifications for completion of new device details in comparison tables." The detailed comparison tables (see section 4) indirectly serve as performance targets by showing that the RT300 either matches or improves upon the predicate devices' specifications, particularly regarding additional stimulation channels and muscle groups. |
| Verification of performance to specification | "Conduct system testing to verify performance to specification." (No specific quantitative results provided in the summary) |
| Safety and effectiveness of additional stimulation channels | "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." |
| Safety and effectiveness of Stimwear garment | "The safety and effectiveness of utilizing Stimwear and carbon electrodes has been demonstrated during validation testing." |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the clinical testing conducted for the new features of the RT300.
- Sample Sizes:
- RT50 stimulation (standalone and with RT300): Five able-bodied individuals.
- Stimwear garment: One able-bodied individual.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the small sample sizes and the nature of the testing (validation of new features on able-bodied individuals), it is most likely a prospective study conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of "experts" to establish a ground truth in the traditional sense for the clinical testing. The validation appears to be focused on functional performance and safety directly observed or measured in able-bodied individuals, rather than diagnostic interpretation. Therefore, there's no mention of a traditional ground truth established by independent experts (like radiologists for imaging devices).
4. Adjudication Method for the Test Set
Not applicable. As there were no multiple "readings" or interpretations that would require adjudication (e.g., in a diagnostic setting), no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is not an imaging or diagnostic device where human reader interpretations are compared. The clinical testing mentioned focused on validating the functional aspects and safety of the electrical stimulation features.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The submission describes a "stand alone stimulation mode" for the wireless battery-powered stimulation channels (RT50). It states: "The RT50 in standalone mode was validated with five able bodied individuals." This indicates a test of the device's function without being integrated into the larger RT300 cycle ergometer system, which aligns with the concept of standalone performance for that specific component.
7. Type of Ground Truth Used
The "ground truth" for the clinical validation appears to be the direct observation and measurement of the device's functional integrity and safety in able-bodied individuals. This would include verifying that:
- The stimulator delivers stimulation as intended.
- The stimulation does not cause adverse effects.
- The Stimwear garment properly conducts electrical stimulation.
- The additional muscle groups can be stimulated.
This is distinct from, for example, pathology reports for cancer detection or outcome data for therapeutic efficacy, as the primary goal here is demonstrating equivalence and safety of the FES technology itself, especially for its new features.
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI models. The RT300 is an FES device, not a diagnostic algorithm that would typically require a training set of data. The "system testing" mentioned might involve some internal data for calibration or software development, but it's not described as a formal training set for an AI/ML component.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML model.
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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
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- 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 | PredicateK072398 | PredicateK841112 | PredicateK073237 |
| running customsoftware. | runningcustomsoftware. | |||
| Stimulator(energydelivered) | Built in ACmains powered0-140mA 6channel chargebalancedstimulator. | Built in ACmainspowered 0-140mA 6channelchargebalancedstimulator. | N/A | N/A |
| Additionalstimulationchannels | Up to 5additionalwirelessbatterypoweredstimulationchannelsdelivering 0-140mA chargebalancedstimulation. | Additionalstimulationchannels notavailable. | N/A | N/A |
| Stand alonestimulationmode | Wirelessbatterypoweredstimulationchannels maybe used instand alonemode with outthe cycleergometer. | Stand alonemode notavailable. | N/A | Stimulator"can be usedas a portableor stationarydevice fortraining andrehabilitationapplications" |
| Stimweargarment | Stimweargarmentincorporatingelectrodesavailable forlow extremitycycling, ages12 and above. | Stimweargarment notavailable. | Availablestimweargarmentincorporatingelectrodes. | N/A |
| Musclesavailable forstimulation | Quadriceps,hamstrings,gluteals,gastroc, anterior | Quadriceps,hamstrings,gluteals,gastroc | N/A | N/A |
| Technology | RT300 | PredicateK072398 | PredicateK841112 | PredicateK073237 |
| tibialis, shoulder,biceps, triceps,anterior,posterior andmiddle deltoid,wrist, grasp,abdominals,erector spinae. | anteriortibialis,shoulder,biceps,triceps,anterior,posterior andmiddledeltoid, wrist,grasp | N/A | N/A | |
| Flywheel | Uses leg / armcrank motor tocreate flywheeleffect withreduced weightand space. | Uses leg /arm crankmotor tocreateflywheeleffect withreducedweight andspace. | N/A | N/A |
| Seating | Allows user toremain in theirown seating, e.gwheelchaireliminating theneed fortransfer. | Allows userto remain intheir ownseating, e.gwheelchaireliminatingthe need fortransfer. | N/A | N/A |
| Passive cycling | Utilizes motor toprovideassistanceduring passivecycling. | Utilizesmotor toprovideassistanceduringpassivecycling. | N/A | N/A |
| Databaseinterface | Utilizesdatabaseinterface forstorage andretrieval ofpatient therapysettings andstorage ofsession logs. | Utilizesdatabaseinterface forstorage andretrieval ofpatienttherapysettings andstorage ofsession logs. | N/A | N/A |
| Technology | RT300 | PredicateK072398 | PredicateK841112 | PredicateK073237 |
| Motorized armcrank | Allows active /passive armcycling with FES | Allows active/ passivearm cyclingwith FES | N/A | N/A |
| Pulse oximeterinterface | Utilize pulse andSpO2 data fordisplay,recording andalarming | Utilize pulseand SpO2data fordisplay,recordingand alarming | N/A | N/A |
| Bilateral orUnilateralstimulation | Uses bilateral orunilateralstimulationcables. | Usesbilateral orunilateralstimulationcables. | N/A | N/A |
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. . . . .
:
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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 forpredicate device | Ensure that equivalent functionality isspecified and implemented in the newdevice. |
| Review of 510(k) submission forpredicate device | Confirm technical specifications forcompletion of predicate details incomparison tables |
| Output characteristic measurement ofnew device | Confirm technical specifications forcompletion of new device details incomparison tables |
| Conduct of system testing | Conduct system testing to verifyperformance to specification. |
| Clinical Test | Description |
|---|---|
| Testing the RT50 stimulation | The RT300 with 5 additional RT50stimulation channels was validated withfive able bodied individuals.The RT50 in standalone mode wasvalidated with five able bodiedindividuals. |
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| Clinical Test | Description |
|---|---|
| Testing additional muscle groups. | The RT50 clinical testing includedtesting of abdominal and erector spinaestimulation . |
| Testing the Stimwear garment | The RT300 with the Stimwear garmentwas validated on one able bodiedindividual. |
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.
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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.
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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
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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
§ 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).