Xcite Clinical Station

K160614 · Restorative Therapies, Inc. · IPF · Dec 16, 2016 · Physical Medicine

Device Facts

• Record ID: K160614
• Device Name: Xcite Clinical Station
• Applicant: Restorative Therapies, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Xcite Clinical Station is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion The Xcite system is for prescription use only.

Device Story

Xcite Clinical Station is a multichannel Functional Electrical Stimulation (FES) system for general rehabilitation. Input: therapy settings managed via tablet PC. Operation: tablet-controlled stimulators deliver coordinated electrical pulses (0-140mA, 50-500usec, 10-100Hz) to peripheral nerves via cutaneous electrodes. Output: electrical stimulation to specific muscle groups (quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, shoulder, deltoids, wrist, abdominals, erector spinae). Used in clinical settings by healthcare providers to facilitate muscle re-education, increase circulation, and prevent atrophy. System includes tablet, up to two 6-channel stimulators, stimulation cables, electrodes, mobile cart, and remote database interface for therapy logs/settings. Benefits: non-invasive muscle activation, improved range of motion, and post-surgical thrombosis prevention.

Clinical Evidence

Bench testing only. Validation testing performed on the Xcite Clinical Station with 12 stimulation channels using five neurologically impaired individuals. Electrical safety and EMC testing confirmed compliance with IEC60601-1, ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, and IEC60601-2-10.

Technological Characteristics

Multichannel FES system; tablet-based controller; up to two 6-channel DC-powered stimulators (0-140mA, 50-500usec, 10-100Hz); cutaneous electrodes; mobile cart; remote database interface. Standards: IEC60601-1, ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, IEC60601-2-10. Mains and rechargeable battery power.

Indications for Use

Indicated for general rehabilitation in patients requiring muscle spasm relaxation, disuse atrophy prevention/retardation, local blood circulation increase, muscle re-education, post-surgical calf stimulation for venous thrombosis prevention, and range of motion maintenance/increase. Prescription use only.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Elpha 2000 (K032954)
• RT300 (K090750)

Submission Summary (Full Text)

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

December 16, 2016

Restorative Therapies Inc. Scott Simcox CTO 1434 Fleet Street Baltimore, Maryland 21231

Re: K160614

Trade/Device Name: Xcite Clinical Station Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI Dated: November 22, 2016 Received: November 23, 2016

Dear Mr. Simcox:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K160614

Device Name Xcite Clinical Station

Indications for Use (Describe) The Xcite Clinical Station is intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- 6. Maintaining or increasing range of motion

The Xcite system 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)

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# 510(k) Summary

This 510(k) of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92

#### (1) Submitter:

Andrew Barriskill Restorative Therapies Inc 1434 Fleet St Baltimore, MD 21231

Phone: [phone]

Prepared on February 1, 2016.

#### (2) Device Name and Regulatory Classification:

| Proprietary name: | Xcite Clinical Station ("Xcite") |
|------------------------|----------------------------------------------|
| Common name: | Powered Muscle Stimulator |
| Device Classification: | Class II |
| Classification name: | Powered Muscle Stimulator |
| Product code: | IPF (21 CFR 890.5850), GZI (21 CFR 882.5810) |

#### (3) Predicate Device:

DANMETER A/S product: "Elpha 2000", K032954, a class II device RESTORATIVE THERAPIES, INC. product: "RT300", K090750, a class II device

#### (4) Device Description:

Xcite is a multichannel Functional Electrical Stimulation (FES) system that delivers electrical stimulation to peripheral nerves in a coordinated fashion to facilitate various activities. The system is composed of:

- A tablet computer –
- 2 Up to two 6 channel stimulators
- One or two stimulation cable(s) which connects the stimulator to cutaneous ന electrodes
- ব cutaneous electrodes
- 5 an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- a mobile cart

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

Xcite is intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- 6. Maintaining or increasing range of motion

Xcite is for prescription use only.

THESE INDICATIONS FOR USE ARE THE STANDARD INDICATIONS FOR USE AS PER FDA GUIDANCE DOCUMENT "GUIDANCE DOCUMENT FOR POWERED MUSCLE STIMULATOR 510(K)S".

We have included the Elpha 2000 (K032954) as a second predicate device solely to demonstrate the additional two indications, number 4 and 5 above, which are not indications for use of RT300 (K090750).

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### (6) Technological Characteristics

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

| Technology | Xcite | RT300 predicate:<br>K090750 | Elpha 2000<br>predicate:<br>K032954 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ergometer | No ergometer | Cycle ergometer | No ergometer |
| Power<br>source<br>(energy<br>used) | Mains power and<br>rechargeable battery<br>for RT60 stimulators | Mains power and<br>rechargeable battery<br>for RT50 stimulators | Battery powered,<br>alkaline or Ni-Cd |
| Controller | Based on tablet PC<br>running custom<br>software. | Based on Pocket PC<br>running custom<br>software. | Custom |
| Stimulator<br>(energy<br>delivered) | Up to 2 DC powered 0-<br>140mA 6 channel<br>charge balanced<br>stimulators (“RT60”s). | Built in AC mains<br>powered 0-140mA 6<br>channel charge<br>balanced stimulator. | 0-100mA 2<br>channels |
| Additional<br>stimulation<br>channels | N/A | Up to 5 additional<br>wireless battery<br>powered stimulation<br>channels delivering 0-<br>140mA charge<br>balanced stimulation. | N/A |
| FES<br>parameters | 0-140mA<br>50-500usec<br>10-100Hz | 0-140mA<br>50-500usec<br>10-100Hz | 0-100mA<br>200-400usec<br>2-100Hz |
| Stand alone<br>stimulation<br>mode | Always used in stand<br>alone stimulation<br>mode. | Wireless battery<br>powered stimulation<br>channels may be used<br>in stand alone mode<br>with out the cycle<br>ergometer. | Always used in<br>stand alone<br>stimulation<br>mode. |
| Stimwear<br>garment | No stimwear garment. | Stimwear garment<br>incorporating<br>electrodes available<br>for lower extremity<br>cycling, ages 12 and<br>above. | N/A |
| Muscles<br>available for<br>stimulation | Quadriceps,<br>hamstrings, gluteals,<br>gastroc, anterior<br>tibialis, shoulder, | Quadriceps,<br>hamstrings, gluteals,<br>gastroc, anterior<br>tibialis, shoulder, | Not specified. |
| Technology | Xcite | RT300 predicate:<br>K090750 | Elpha 2000<br>predicate:<br>K032954 |
| | anterior, posterior and<br>middle deltoid, wrist<br>extensors and flexors,<br>grasp, abdominals,<br>erector spinae. | anterior, posterior and<br>middle deltoid, wrist,<br>grasp, abdominals,<br>erector spinae. | |
| Flywheel | N/A | Uses leg / arm crank<br>motor to create<br>flywheel effect with<br>reduced weight and<br>space. | N/A |
| Passive<br>cycling | N/A | Utilizes motor to<br>provide assistance<br>during passive cycling. | N/A |
| Database<br>interface | Utilizes database<br>interface for storage<br>and retrieval of patient<br>therapy settings and<br>storage of session<br>logs. | Utilizes database<br>interface for storage<br>and retrieval of patient<br>therapy settings and<br>storage of session<br>logs. | No database. |
| Motorized<br>arm crank | N/A | Allows active / passive<br>arm cycling with FES | N/A |
| Pulse<br>oximeter<br>interface | N/A | Utilize pulse and SpO2<br>data for display,<br>recording and<br>alarming | N/A |
| Bilateral or<br>Unilateral<br>stimulation | Uses bilateral or<br>unilateral stimulation. | Uses bilateral or<br>unilateral stimulation. | Not specified. |
| Indications | 1.Relaxation of muscle<br>spasms<br>2.Prevention or<br>retardation of disuse<br>atrophy<br>3.Increasing local<br>blood circulation<br>4.Muscle re-education<br>5.Immediate post-<br>surgical stimulation of<br>calf muscles to prevent<br>venous thrombosis; and | 1.Relaxation of muscle<br>spasms<br>2.Prevention or<br>retardation of disuse<br>atrophy<br>3.Increasing local<br>blood circulation; and<br>4.Maintaining or<br>increasing range of<br>motion | 1.Relaxation of<br>muscle spasms<br>2.Prevention or<br>retardation of<br>disuse atrophy<br>3.Increasing<br>local blood<br>circulation<br>4.Muscle re-<br>education<br>5.Immediate<br>post-surgical<br>stimulation of<br>calf muscles to prevent<br>venous thrombosis; and |
| Technology | Xcite | RT300 predicate:<br>K090750 | Elpha 2000<br>predicate:<br>K032954 |
| | 6.Maintaining or<br>increasing range of<br>motion | | prevent venous<br>thrombosis; and<br>6.Maintaining or<br>increasing range<br>of motion |

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Table 1 Device technology comparison

## (7) Performance data

Non-clinical testing to determine equivalence has been primarily composed of the following tests:

| Test or procedure | Description |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Review of user documentation for<br>predicate devices | Ensure that equivalent functionality is<br>specified and implemented in the new<br>device. |
| Output characteristic measurement of<br>new device | Confirm technical specifications for<br>completion of new device details in<br>comparison tables |
| Conduct of system testing | Conduct system testing to verify<br>performance to specification. |

| Validation Testing | Description |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Testing the Xcite Clinical Station | The Xcite Clinical Station with 12<br>stimulation channels was evaluated<br>with five neurologically impaired<br>individuals. |

#### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Xcite Clinical Station. The system complies with Electromagnetic Compatibility and Electrical Safety The Xcite system conforms to the following standards; IEC60601-1, ANSI/AAMI ES60601-1,IEC60601-1-2, IEC60601-1-11, and IEC60601-2-10.

#### RTI concludes that:

Xcite Clinical Station has the same intended use as the RT300 and Elpha 2000 predicate devices.

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Xcite utilizes the same FES stimulators and stimulation control system as the RT300 predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.

In conclusion, RTI's testing and validation testing has demonstrated that Xcite is as safe and effective as the predicate devices.