VitalStim(R) Plus Electrotherapy System

K153224 · Djo, LLC · IPF · Feb 17, 2016 · Physical Medicine

Device Facts

• Record ID: K153224
• Device Name: VitalStim(R) Plus Electrotherapy System
• Applicant: Djo, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation. Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. VMS waveform is a square symmetrical biphasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS TM waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function. VitalStim waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Nonmechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional. sEMG is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

Device Story

VitalStim Plus is a 4-channel electrotherapy and 2-channel sEMG biofeedback system. It delivers square symmetrical biphasic electrical pulses to facial and neck muscles to treat dysphagia and muscle atrophy. Input consists of surface EMG signals from patient musculature; device processes these signals to provide biofeedback and trigger electrical stimulation. Output is delivered via lead wires and electrodes to the patient. Used in clinical settings by physicians or licensed health professionals. Device features Bluetooth connectivity to PC software for data management. Benefits include muscle re-education, relaxation of spasms, and prevention of disuse atrophy in patients with neurological or post-traumatic swallowing dysfunction. System is battery-powered and portable compared to the desktop predicate.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), home healthcare environment (IEC 60601-1-11), and nerve/muscle stimulator performance (IEC 60601-2-10). Wireless coexistence testing confirmed performance in 2.4 GHz environments. Software verification conducted per FDA guidance.

Technological Characteristics

Battery-powered (4x1.5V AA) 4-channel electrotherapy system. Delivers square symmetrical biphasic waveforms (VMS and VitalStim). Features sEMG biofeedback, Bluetooth connectivity, and timer-based auto-shutoff. Regulated current output. Complies with 21 CFR 898 for patient lead safety. Dimensions: 3.5"W x 5.9"H x 1.37"D. Weight: 0.35lb.

Indications for Use

Indicated for patients with oropharyngeal dysphagia and head/neck disorders requiring muscle re-education of swallowing musculature. Contraindicated for mechanical causes of dysphagia requiring surgical intervention (e.g., obstructing tumors).

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

• VitalStim Experia (K070425)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

February 17, 2016

Djo, LLC Natalia Shirina Regulatory Affairs Specialist 3 1430 Decision Street Vista, California 92081

Re: K153224

Trade/Device Name: VitalStim® Plus Electrotherapy System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, HCC Dated: January 14, 2016 Received: January 19, 2016

Dear Natalia Shirina:

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

{1}------------------------------------------------

the quality systems (OS) 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 -A

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) K153224

Device Name VitalStim® Plus Electrotherapy System

Indications for Use (Describe)

For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.

Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is K153224.

| Submitted by: | DJO, LLC<br>1430 Decision Street<br>Vista, CA 92081<br>FDA Establishment Registration: 2020737 |
|------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Natalia Shirina<br>Regulatory Affairs Specialist 3<br>760-734-5534 |
| Date Summary Prepared: | February 8, 2016 |
| Trade Name: | VitalStim® Plus Electrotherapy System |
| Classification Name: | Stimulator, muscle, powered (21 CFR 890.5850)<br>Device, Biofeedback (21 CFR 882.5050) |
| Product Code: | IPF, Stimulator, muscle, powered<br>HCC, Device, Biofeedback |
| Regulatory Class: | Class II |
| Predicate Device: | VitalStim Experia (K070425)<br>Class II |

### Device Description:

The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.

#### Indications for Use:

For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.

- . Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

{4}------------------------------------------------

#### Intended Uses- VMS™M Waveform

VMS waveform is a square symmetrical biphasic waveform with the application for use on the musculature of the face.

The intended uses are:

Optional application of sEMG biofeedback with Muscle Stimulation VMS TM waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function.

#### Intended Uses- VitalStim Waveform

VitalStim waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are:

The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Nonmechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional.

#### Intended Uses- Surface EMG

sEMG is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are:

The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

#### Technological Comparison to Predicate Devices:

Based on the critical functional characteristics and indications for use, the VitalStim® Plus Electrotherapy System is substantially equivalent to the VitalStim Experia device (K070425). Both are Class II devices, powered muscle stimulator, biofeedback devices, subject to 21 CFR 890.5850 and 21 CFR 882.5050. Both devices are for prescription use only and the indications for use are the same.

The differences between the VitalStim® Plus Electrotherapy System and the predicate devices are considered to be minor by nature. Any differences in technological characteristics are explained in this submission to demonstrate that these differences do not raise new issues of safety and effectiveness.

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

| Characteristic | New Device | Predicate Device | Similar/<br>Different |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k) Number | K153224 | K070425 | Similar |
| Device Name, Model | VitalStim® Plus Electrotherapy<br>System, Model 5923-3 | VitalStim Experia, Model<br>5950 | Similar |
| Manufacturer | DJO, LLC | DJO, LLC 510(k)<br>sponsor:<br>Chattanooga Group | Similar |
| Type of device | A non-implantable, battery<br>powered, hand held, electrical<br>muscle conditioning device used<br>for the treatment of medical<br>purposes to apply an electrical<br>current to stimulate and re-<br>educate the swallowing<br>musculature (pharyngeal<br>contractions) in the treatment of<br>dysphagia from any etiology<br>except mechanical causes that<br>would need surgical intervention<br>(e.g., obstructing tumors) | A non-implantable,<br>mains powered, desktop,<br>electrical muscle<br>conditioning device used<br>for the treatment of<br>medical purposes to<br>apply an electrical<br>current to stimulate and<br>re-educate the<br>swallowing musculature<br>(pharyngeal contractions)<br>in the treatment of<br>dysphagia from any<br>etiology except<br>mechanical causes that<br>would need surgical<br>intervention (e.g.,<br>obstructing tumors) | Similar |
| Connection of device to electrodes | Lead wires | Lead wires | Similar |
| Indications for Use | For VMS™ and VitalStim<br>Waveforms and sEMG<br>Triggered Stimulation.<br>- Muscle re-education by<br>application of external<br>stimulation to the muscles<br>necessary for pharyngeal<br>contraction. | For VMS™ and<br>VitalStim Waveforms,<br>High Voltage Pulsed<br>Current (HVPC) and<br>sEMG Triggered<br>Stimulation.<br>- Muscle re-education by<br>application of external<br>stimulation to the<br>muscles necessary for<br>pharyngeal contraction. | Similar |
| Power Source(s) | 6V (4x1.5V AA battery cells) | 100-240V - 1.3 A Main<br>P. Supply | Different |
| Characteristic | New Device | Predicate Device | Similar/<br>Different |
| VMS™-Square Symmetrical Biphasic | Yes | Yes | Similar |
| HVPC™-Monophasic Pulsed | No | Yes | Different |
| VitalStim™ - Square Symmetrical Biphasic | Yes | Yes | Similar |
| Patient Leakage Current: Normal Condition & Single Fault Condition | | | |
| Channel 1 | <100μA | <100μA | Similar |
| Channel 2 | <100μA | <100μA | Similar |
| Channel 3 | <100μA | <100μA | Similar |
| Channel 4 | <100μA | <100μA | Similar |
| Number of Output Channels | Four | Four | Similar |
| Synchronous or Alternating? | Synchronous and Alternating | Synchronous and<br>Alternating | Similar |
| Regulated Current or Regulated Voltage? | Regulated current (all channels) | Regulated current (all<br>channels) | Similar |
| Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Similar |
| Automatic Shut Off? | Yes (timer) | Yes (timer) | Similar |
| Patient Override Control? | Yes | Yes | Similar |
| Biofeedback Feature | Yes | Yes | Similar |
| Indicator Display<br>- On/Off Status? | Yes | Yes | Similar |
| Compliance with 21 CFR 898? | Yes, leads with conductive<br>connection to a patient are<br>constructed such that no<br>conductive connection remote<br>from the patient can contact earth<br>or hazardous voltages. | Yes, leads with<br>conductive connection to<br>a patient are constructed<br>such that no conductive<br>connection remote from<br>the patient can contact<br>earth or hazardous<br>voltages. | Similar |
| Weight | 0.35lb | 6lbs | Different |
| Dimensions in inches [W x H x D] | 3.5"Wx5.9"Hx1.37"D | 9.75"W x8.75"H x<br>12.75"D | Different |

## Basic Device Characteristics – Comparison with Predicate Device

{6}------------------------------------------------

# Output Specifications – Comparison with Predicate Device
VitalStim™ Square Symmetrical Biphasic Waveform Specification Matrix

| Characteristic | New Device | Predicate Device | Similar/<br>Different |
|--------------------------------|--------------------------------|-----------------------------------|-----------------------|
| Waveform | Symmetrical Biphasic (DC Zero) | Symmetrical Biphasic<br>(DC Zero) | Similar |
| Shape | Square | Square | Similar |
| Maximum Output Current (± 30%) | | | |
| 500Ω | 25mA | 25mA | Similar |
| 1000Ω | 25mA | 25mA | Similar |

{7}------------------------------------------------

| 2000Ω | 25mA | 25mA | Similar |
|--------------------------------------------------------------------------------------------------|----------------|---------------|-----------|
| 2500Ω | 25mA | 25mA | Similar |
| 10000Ω | 7mA | 12mA | Different |
| Pulse Width | Fixed 300 µsec | Fixed 300µsec | Similar |
| Frequency Hz | Fixed 80 Hz | Fixed 80Hz | Similar |
| Ramp Time | 2sec | 2sec | Similar |
| For multiphasic waveforms only: | Yes | Yes | Similar |
| Symmetrical phases? | Yes | Yes | Similar |
| Phase Duration (include units) (state range,<br>if applicable) (both phases, if<br>asymmetrical) | Fixed 300µsec | Fixed 300µsec | Similar |
| Net Charge [µC/pulse] | 0 µC | 0 µC | Similar |
| Stim + EMG Biofeedback | Yes | Yes | Similar |

Output Specifications – Comparison with Predicate Device VMS™ Square Symmetrical Biphasic Waveform Specification Matrix

| Characteristic | New Device | Predicate Device | Similar/<br>Different |
|--------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------|-----------------------|
| Waveform | Symmetrical Biphasic (DC Zero) | Symmetrical Biphasic<br>(DC Zero) | Similar |
| Shape | Square | Square | Similar |
| Maximum Output Current (± 30%) | | | |
| 500Ω | 25mA | 25mA | Similar |
| 1000ΩΩ | 25mA | 25mA | Similar |
| 2000ΩΩ | 25mA | 25mA | Similar |
| 2500Ω | 25mA | 25mA | Similar |
| 10000ΩΩ | 7mA | 12mA | Different |
| Pulse Width | 60-300 usec | 100 - 300psec | Different |
| Frequency Hz | 1 to 80 Hz | 5 to 80 Hz | Different |
| Ramp Time | 0-3 sec | 2 sec | Different |
| For multiphasic waveforms only: | Yes | Yes | Similar |
| Symmetrical phases? | Yes | Yes | Similar |
| Phase Duration (include units) (state range,<br>if applicable) (both phases, if<br>asymmetrical) | 60-300usec | 100 - 300usec | Different |
| Stim + EMG Biofeedback | Yes | Yes | Similar |

Although there are minor differences in the maximum output current, the physical dimensions, and the batteries used as a power source, the most significant difference between the two devices is the absence of HVPC™-Monophasic Pulsed waveform.

The intended use of the HVPC™-Monophasic Pulsed waveform of the VitalStim Experia device is the same as the VMS waveform offered in both the VitalStim Plus and the VitalStim

{8}------------------------------------------------

Experia devices. HVPC™-Monophasic Pulsed waveform is only an optional application of the same intended use. The same intended use can be achieved by the VMS waveform. Therefore, absence of HVPC™-Monophasic Pulsed waveform does not raise any question in regards to safety and effectiveness and is substantially equivalent.

### Performance Testing:

Electrical Safety and Electromagnetic Compatibility: The VitalStim® Plus Electrotherapv System was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.

- . IEC 60601-1 for basic safety and essential performance
- IEC 60601-1-2 for electromagnetic compatibility ●
- IEC 60601-1-6 for usability ●
- IEC 60601-1-11 for home healthcare ●
- IEC 60601-2-10 for performance of nerve and muscle stimulators ●

FCC Testing: The VitalStim® Plus Electrotherapy System was tested to FCC requirements and found to comply with the requirements of the following regulation:

- FCC Part 15 Subpart B:2008 Class B .
- FCC CFR Title 47 Part 15 Subpart C .

Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.

Wireless Coexistence Testing: The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.

### Conclusion:

Based on the performance testing and the supporting documentation, it can be concluded that the VitalStim® Plus Electrotherapy System is as safe and effective as, and substantially equivalent to, the predicate device.