(171 days)
The RT300-S (adult version) and RT300-SP (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-SP (pediatric version), is intended for population ages 4 to 12 years.
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
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).
RT300-S Acceptance Criteria and Supporting Study
The RT300-S and RT300-SP devices are Functional Electrical Stimulation (FES) cycle ergometers intended for general rehabilitation. The substantial equivalence determination for K050036 is based on its comparison to the predicate device, THERAPEUTIC ALLIANCES, INC. product: "ERGYS" (K841112).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the RT300-S and RT300-SP are implicitly defined by demonstrating substantial equivalence to the predicate device, "ERGYS" (K841112), based on intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (RT300-S/SP) |
|---|---|
| Same intended use as predicate device | RT300-S/SP has the same intended use for general rehabilitation: relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, maintaining/increasing range of motion. |
| Same output characteristics as predicate device | RT300-S/SP has 0-140mA charge-balanced stimulator, same as predicate. |
| Technological differences do not raise new safety/effectiveness questions | - Power source: Mains power (same as predicate)- Controller: Pocket PC-based custom software (different from predicate's custom controller). The safety and effectiveness of the controller has been demonstrated over its development.- Stimulator: 0-140mA charge-balanced (same as predicate)- Flywheel: Motorized to create flywheel effect (different from predicate's heavy mechanical flywheel). Safety and effectiveness "extensively demonstrated" by ongoing clinical use of the motorized ergometer without the stimulation component.- Seating: Allows user to remain in their own seating (different from predicate's dedicated seating)- Passive cycling: Utilizes motor assistance (different from predicate's manual assistance). Safety and effectiveness "extensively demonstrated" by ongoing clinical use of the motorized ergometer without the stimulation component. |
| Performance to specification (non-clinical) | System testing conducted to verify performance to specification. Specific metrics not detailed but implied by the successful testing. |
| Correct operation, including electrode off detection (clinical) | Tested on able-bodied subjects to confirm correct operation and detection of electrode off conditions with varying skin impedances. |
2. Sample Size Used for the Test Set and Data Provenance
- Able-bodied subjects: "able bodied subjects" - specific number not provided.
- Spinal cord injured subjects: "spinal cord injured subjects" - specific number not provided.
- Data Provenance: Not explicitly stated, but the submission is from a US company (Restorative Therapies Inc, Baltimore, MD), suggesting the testing likely occurred in the US. The phrase "European Infotoneous in the U.S.A." for the motorized ergometer suggests some broader context of use, but the immediate testing is not localized. It is prospective for the able-bodied and spinal cord injured subjects, as the device is being utilized or was tested for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This submission is for a therapeutic device that relies on physical performance and functional equivalence rather than diagnostic interpretation requiring expert-established ground truth. The "ground truth" here is the physical function and safety of the device as tested.
4. Adjudication Method
Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a therapeutic device, not an imaging or diagnostic device that would typically involve human readers for interpretation. The comparison is between the performance of the new device and a predicate device.
6. Standalone Performance Study
Yes, a standalone study of the algorithm/device performance was conducted. This includes:
- Non-clinical testing: Output characteristic measurements of the new device to confirm technical specifications and comparison to the predicate. System testing to verify performance to specification.
- Clinical testing:
- Testing with able-bodied subjects to confirm correct operation of the system, including correct detection of electrode off conditions with varying skin impedances.
- The RT300-S "is being utilized in clinical studies involving spinal cord injured subjects," indicating further evaluation of the device in its target population.
7. Type of Ground Truth Used
The "ground truth" in this context is based on:
- Technical specifications and performance standards: Non-clinical tests confirmed the device met its technical specifications and demonstrated output characteristics equivalent to the predicate.
- Observed physical operation and safety: Clinical testing on able-bodied subjects confirmed the "correct operation of the system" and safety features like electrode off detection.
- Clinical utility/ongoing use: The ongoing clinical use in spinal cord injured subjects further supports its intended function, and the "extensive demonstration" of safety and effectiveness of the motorized ergometer (without stimulation) through ongoing clinical use in Europe and the USA for the "flywheel" and "passive cycling" components.
8. Sample Size for the Training Set
Not applicable. No "training set" in the machine learning sense is mentioned or implied for this device. The development process would have involved iterative design and testing, but not a formal machine learning training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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JUN 27 2005
RT300-S Summary of Safety and Effectiveness
(1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
Andrew Barriskill Restorative Therapies Inc 2363 Boston St Baltimore, MD 21224
Phone: 310 691-5467
Prepared on June 24th 2005.
(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) Powered Muscle Stimulator Common name: Classification name:Powered Muscle Stimulator
(3) Identification of the legally marketed device to which the submitter claims equivalence:
THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device
(4) A description of the device that is the subject of the premarket notification submission.
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized cycle ergometer (RTI part number SA100047 for adults and ← SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090) ଧ
- a stimulation cable which connects the controller / stimulator to cutaneous ತಿ electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part ব number FA100015)
This system allows a person with impaired lower extremity movement to undertake cvcle 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:
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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 |
|---|---|---|
| Power source (energyused) | Mains power | Mains power |
| Controller | Based on Pocket PCrunning custom software. | Uses custom controllerrunning custom software. |
| Stimulator (energydelivered) | 0-140mA chargebalanced stimulator | 0-140mA chargebalanced stimulator |
| Flywheel | Uses motor to createflywheel effect withreduced weight andspace. | Uses heavy mechanicalflywheel. |
| Seating | Allows user to remain intheir own seating, e.gwheelchair eliminatingthe need for transfer. | Includes a dedicatedseating arrangement. |
| Passive cycling | Utilizes motor to provideassistance duringpassive cycling. | Requires manualassistance to providepower during passivecycling. |
(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 for | Confirm technical specifications for |
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| predicate device | completion 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 with able bodied subjects | The RT300-S was tested on able bodiedsubjects to confirm correct operation of thesystem including correct detection ofelectrode off conditions with varying skinimpedances. |
| Testing with spinal cord injuredsubjects | The RT300-S is being utilized in clinicalstudies involving spinal cord injured subjects. |
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 using a motor to simulate the oredicate device's mechanical flywheel and provide passive cycling assistance has been extensively demonstrated in particular by the ongoing clinical use of the motorized ergometer without the stimulation component both in the European Infotoneous in the U.S.A. The safety and effectiveness of the controller 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines beneath it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2005
Mr. Andrew Barriskill Restorative Therapies Incorporated 2263 Boston Street Baltimore, Maryland 21224
Re: K050036
Trade/Device Name: RT300-S and RT300-SP Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: April 26, 2005 Received: April 26, 2005
Dear Ms. Barriskill:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications forchered above and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to coninered prior to May 20, 1977) in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, uterefore, thanks of the Act include requirements for annual registration, listing of general condolo provisions of ractice, 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 your device is elaborired dontrols. 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 I least be advised that I Driv issuality over device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any 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 Of It Fart 6077, accems (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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Page 2 - Mr. Andrew Barriskill
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maneting of substantial equivalence of your device to a legally premarket notification: "The PDT intoclassification 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 If you desire specific acrite for your as (240) 276-0120 . Also, please note the regulation entitled, Colliact the Office of Compuner as (21 t minication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The RT300-S (adult version) and RT300-SP (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-SP (pediatric version), is intended for population ages 4 to 12 years.
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Page 1 of
Muriam C. Provost
(Division Signer or Designee)
(Division Sign-Off) Division of General, Restorative and New of General, Resto
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).