K Number

Device Name

Manufacturer

RESTORATIVE THERAPIES INC.

Date Cleared

2011-04-04

(139 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K090750

Predicate For

N/A

Intended Use

The RT600 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

The RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

Device Description

The RT600 is a Functional Electrical Stimulation (FES) upright elliptical ergometer which is composed of:

a motorized upright ergometer (RTI part number SA211257)
an FES controller with built in 6 channel stimulator (RTI part number SA109413)
up to 5 additional wireless single channel stimulators (RTI part number FA106897)
a stimulation cable 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 lower extremity movement to undertake upright elliptical ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RT600 device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document is a 510(k) premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria for novel performance.

Therefore, the "acceptance criteria" for the RT600 are demonstrating that its technological characteristics and performance are substantially equivalent to the predicate device (RT300, K090750) and that these differences do not raise new questions of safety and effectiveness.

The "reported device performance" is essentially the conclusion that the RT600 meets this standard of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance
Intended Use: Same as predicate device (RT300)	Met: The RT600 has the same intended use as the RT300.
Output Characteristics: Same as predicate device (RT300)	Met: The RT600 has the same output characteristics as the predicate device.
Control System: Utilizes the same control system as predicate device (RT300)	Met: The RT600 utilizes the same control system as the predicate device, including controller, motor controller, and drive assembly.
Technological Differences: Do not raise new questions of safety and effectiveness	Met: The different technological characteristics (detailed in the "Technological Characteristics" table) do not raise new questions of safety and effectiveness.
Safety and Effectiveness: As safe and effective as the predicate device (RT300)	Met: RTI's clinical and non-clinical testing has demonstrated that the RT600 is as safe and effective as the predicate devices.

Study Information

The document describes non-clinical and a single clinical test conducted to support the substantial equivalence claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size for Clinical Test: 10 Spinal Cord Injury (SCI) individuals.
Data Provenance: Not explicitly stated, but the submission is to the U.S. FDA, implying the data would be relevant to U.S. regulatory standards. It's not specified if it's retrospective or prospective, but clinical validation studies are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. The clinical test involved "validation with ten SCI individuals," but details on ground truth establishment or expert involvement for this purpose are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices, not for a functional electrical stimulation ergometer.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The RT600 is a physical FES ergometer device, not an algorithm-only diagnostic or AI product. Its performance inherently involves human interaction (the user and possibly a clinician for setup/supervision).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the clinical test, the "ground truth" implicitly refers to the device's ability to provide the intended therapeutic effects (relaxation of muscle spasms, prevention of disuse atrophy, increasing circulation, maintaining/increasing range of motion) in SCI individuals. However, the specific metrics or "ground truth" used for validation within the study (e.g., physiological measurements, standardized functional scales) are not detailed in this summary.

8. The sample size for the training set

Not applicable / not provided. The device is not described as an AI/ML system that utilizes a "training set" in the conventional sense. Its development would involve engineering design, testing, and validation, rather than a data-driven training pipeline for an algorithm.

9. How the ground truth for the training set was established

Not applicable. As a hardware device for FES, it does not have a "training set" or "ground truth" for training in the context of AI/ML. Its design and functional validation would be based on established physiological principles and engineering standards.

Summary

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K103366
APR - 4 2011

RT600 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 March 28, 2011.

(2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name:

Proprietary name: RT600 (FES upright ergometer) Powered Muscle Stimulator Common name: Classification name:External Functional Neuromuscular Stimulator

(3) Identification of the legally marketed device to which the submitter claims equivalence:

RESTORATIVE THERAPIES, INC. product: "RT300", K090750, a class 2 device

(4) A description of the device that is the subject of the premarket notification submission.

The RT600 is a Functional Electrical Stimulation (FES) upright elliptical ergometer which is composed of:

a motorized upright ergometer (RTI part number SA211257) ﮯ
an FES controller with built in 6 channel stimulator (RTI part number വ SA109413)
up to 5 additional wireless single channel stimulators (RTI part number က FA106897)
a stimulation cable which connects the controller / stimulator to cutaneous ধ electrodes
cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels) റ
an interface to a remote database for the storage and retrieval of therapy റ settings and the storage of therapy session logs
an interface to a pulse oximeter for the display and recording of pulse and 7 SpO2 levels and provision of alarming based on the data
a stimwear garment incorporating electrodes for lower extremity cycling in ထ population ages 12 and above (RTI part number FA105486)

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(5) Statement of the intended use of the device:

The RT600 is intended for general rehabilitation for:

1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Maintaining or increasing range of motion

The RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

The RT600 is for prescription use only.

(6) Technological Characteristics

The function of the RT600 is the same as the predicate devices however there are certain technological similarities and differences as described below:

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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:

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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 RT600 upright ellipticalergometer.	The RT600 with 5 additional RT50stimulation channels was validated withten SCI individuals.

RTI concludes that:

The RT600 has the same intended use as the RT300 predicate device.

The RT600 has the same output characteristics as the predicate device. The RT600 utilizes the same control system as the predicate device including controller, motor controller and drive assembly. The different technological characteristics do not raise new questions of safety and effectiveness.

In conclusion, RTI's clinical and non-clinical testing has demonstrated that the RT600 is as safe and effective as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Restorative Therapies Inc % Mr. Andrew Barriskill 907 S. Lakewood St Baltimore, MD 21224

APR - 4 2011

Re: K103366

Trade Name: RT600 (FES upright ergometer) Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: March 3, 2011 Received: March 4, 2011

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{5}------------------------------------------------

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 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Zelezn
Melvin R. Baldwin, MD

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: K103366

RT600 functional electrical stimulation stepper ergometer Device Name:

Indications for use:

The RT600 is intended for general rehabilitation for:

1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Maintaining or increasing range of motion

The RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

Prescription Use X (Part 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103366

Page 1 of 1

Regulation Number and Section

§ 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).

Technology	RT600	RT300 predicate: K090750
Ergometer	Upright elliptical ergometer	Cycle ergometer
Power source(energy used)	Mains power andrechargeable battery for RT50stimulators	Mains power andrechargeable battery for RT50stimulators
Controller	Based on Pocket PC runningcustom software.	Based on Pocket PC runningcustom software.
Stimulator(energydelivered)	Built in AC mains powered 0-140mA 6 channel chargebalanced stimulator.	Built in AC mains powered 0-140mA 6 channel chargebalanced stimulator.
Additionalstimulationchannels	Up to 5 additional wirelessbattery powered stimulationchannels delivering 0-140mAcharge balanced stimulation.	Up to 5 additional wirelessbattery powered stimulationchannels delivering 0-140mAcharge balanced stimulation.

Stand alonestimulationmode	Wireless battery poweredstimulation channels may beused in stand alone mode without the cycle ergometer.	Wireless battery poweredstimulation channels may beused in stand alone mode without the cycle ergometer.
Stimweargarment	Stimwear garmentincorporating electrodesavailable for lower extremitycycling, ages 12 and above.	Stimwear garmentincorporating electrodesavailable for lower extremitycycling, ages 12 and above.
Musclesavailable forstimulation	Quadriceps, hamstrings,gluteals, gastroc, anteriortibialis, abdominals, erectorspinae.	Quadriceps, hamstrings,gluteals, gastroc, anteriortibialis, shoulder, biceps,triceps, anterior, posterior andmiddle deltoid, wrist, grasp,abdominals, erector spinae.
Flywheel	Uses leg motor to createflywheel effect with reducedweight and space.	Uses leg / arm crank motor tocreate flywheel effect withreduced weight and space.
Hoist	Utilizes powered hoist toposition user in upright partialbody weight supportedposition.	Allows user to remain in theirown seating, e.g wheelchaireliminating the need fortransfer.
Passivecycling	Utilizes motor to provideassistance during passivecycling.	Utilizes motor to provideassistance during passivecycling.
Databaseinterface	Utilizes database interface forstorage and retrieval of patienttherapy settings and storage ofsession logs.	Utilizes database interface forstorage and retrieval of patienttherapy settings and storage ofsession logs.
Motorized armcrank	No arm crank is provided.	Allows active / passive armcycling with FES
Pulseoximeterinterface	Utilizes pulse and SpO2 data fordisplay, recording and alarming	Utilizes pulse and SpO2 datafor display, recording andalarming
Bilateral orUnilateralstimulation	Uses bilateral or unilateralstimulation.	Uses bilateral or unilateralstimulation.