GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

K120922 · Selectivemed Components, Inc. · IPF · Feb 7, 2013 · Physical Medicine

Device Facts

• Record ID: K120922
• Device Name: GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
• Applicant: Selectivemed Components, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended/ indicated for use for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

Device Story

Guardian Dysphagia dual channel NMES is a battery-powered neuromuscular stimulation device for treating dysphagia. It delivers electrical stimulation to pharyngeal muscles to assist in regaining swallowing control and preventing aspiration. Operated by healthcare providers in hospitals, nursing homes, and clinics, the device uses dual channels to deliver constant current, biphasic, charge-balanced waveforms. It features fixed pulse rates, adjustable intensity, and programmed ramp/rest cycles. The provider applies compatible electrodes to the patient's neck; the device output is monitored via an LCD display. By stimulating the muscles necessary for pharyngeal contraction, the device facilitates muscle re-education, potentially improving patient swallowing function.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-12), and software/hardware validation per ISO 14971:2007 and FDA guidance.

Technological Characteristics

Powered muscle stimulator; dual-channel; constant current output; biphasic, charge-balanced waveform (300 µs pulse width); 9V alkaline battery powered; 60-minute timer; 30 mm electrode spacing. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Software validation per FDA guidance.

Indications for Use

Indicated for muscle re-education via external stimulation of pharyngeal muscles in patients with dysphagia. 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

• Chattanooga VitalStim Experia (K070425)

Submission Summary (Full Text)

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- 1- Date summary prepared: December 23, 2012
- 2- Owner/submitter/applicant/sponsor information:

FDA Registration # 1528764 SELECTIVE MED™ COMPONENTS, INC 504 Harcourt Road Suite D Mount Vernon, Ohio 43050 Tel [phone]. Fax [phone] Contact name: Mr Richard Fisher III, President

3- Device information:

Common/usual/classification name: Powered Muscle Stimulator Device name: Guardian Dysphagia dual channel NMES unit (abbreviation: lithe Guardian") FDA 3 letter code IPF, FDA regulation number: 21 CFR: 890.5850 Regulation medical specialty Physical Medicine, Class 2

- 4- Substantial equivalency is claimed against the following predicate device(s): 510k number Trade or Proprietary or Model Name Manufacturer: K070425 Chattanooga VitalStim Experia Chattanooga Group, a division of Encore Medical
- 5- Description of the device:

Guardian Dysphagia dual channel NMES is a lightweight battery powered dual channel neuromuscular stimulation device used for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended patient outcome is to regain control of muscles used to swallow food

- and drink liquids without aspirating.
It is to be used with Guardian 150 electrode or other compatible electrodes cleared for the same indications for use, as well as lead wires.

6- Intended use {Indications for use:

This device is intended/ indicated for use for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

| (comparison table) | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Characteristic | Predicate K070425 Chattanooga VitalStim<br>Experia | K120922, Guardian Dysphagia Dual<br>Channel NMES |
| Output configuration | Dual Channel, electrically Isolated with<br>miniature safety connectors | SAME |
| Output waveform | AC Mode: Rectangular symmetrical biphasic<br>with zero net DC | SAME |
| Regulated current or voltage | Constant current | Constant current |
| Patient voltage | 100 Volts max, no load | SAME |
| Automatic overload trip | For high resistance the circuit detects this<br>and shuts off the current. The current<br>indicator shows this by flashing "0". Trip<br>point measured: 33 k ohm. Can withstand<br>permanent short or open circuit | SAME.<br>Trip point measured: 23 k ohm.<br>Can withstand permanent short or<br>open circuit |

7- Basis for a determination of substantial equivalency

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| Characteristic | Predicate K070425 Chattanooga VitalStim | K120922, Guardian Dysphagia Dual |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Experia | Channel NMES |
| Intensity Control | Dual intensity potentiometers: 0-25 mA<br>peak current output, adjustable current.<br>Constant current regulation from 0 to 4000<br>ohms load minimum | SAME |
| Pulse Rate | Fixed, 80 Hz | SAME |
| Pulse shape | Positive square wave of 300 µs width<br>followed by an interphase interval of 100 µs<br>followed by a negative square wave of 300<br>µs width symmetric in shape and amplitude<br>to that of the positive square wave (and<br>therefore charge balanced). | Positive square wave of 300 µs width<br>followed by an interphase interval of<br>100 µs followed by a negative square<br>wave of 300 µs width symmetric in<br>shape and amplitude to that of the<br>positive square wave (and therefore<br>charge balanced). |
| Low battery indicator display | LCD symbol | LCD Symbol:<br>Triggers at 6.6 volts |
| Ramp down/ramp up and rest<br>time. | Down: 0.75 s. Up: 0.75 s.<br>Off: 1.0 s | Down: 0.75 s. Up: 0.75 s.<br>Off: 1.0 s |
| Rest Period: | Each 57.5 seconds of operation, the unit<br>will reduce power down to zero power for a<br>period of 1 second. The power ramps down<br>to zero and back up to the preset power<br>over a total time of 2.5 seconds | Each 57.5 seconds of operation, the<br>unit will reduce power down to zero<br>power for a period of 1 second. The<br>power ramps down to zero and back<br>up to the preset power over a total<br>time of 2.5 seconds |
| Distance between electrodes | 30 mm | 30 mm |
| Electrode dimensions | Conductive area: 0.75" round. 19 mm x 2<br>contacts) | 105 x 55 mm with liner,<br>74 x 36 mm fabric, Conductive area:<br>0.875" diameter round, 2 contacts.<br>(22.5 mm diameter) silver film/gel<br>(round, x 2) (K083756) |
| Electrode<br>conductive<br>surface<br>area | Surface area of 0.882 sq. In. for two<br>electrodes | Surface area of 1.14 sq. In. for two<br>electrodes |
| Additional characteristics | | |
| Timer | 60 minutes | 60 minutes |
| Pulse width | 300 µ sec | 300 µ sec |
| Pulse current range | 0-25 mA | 0-25 mA |
| Number of independent<br>channels | 2 | 2 |
| Power source | 2 AA cells | 9 Volt Alkaline battery |
| Start up current | Not specified | Zero mA. |

8- Non-clinical test discussion: Bench testing consisted of:

Electrical Safety in accordance with IEC 60601-1

EMC Testing in accordance with IEC 60601-1-2

Oscillometric testing in accordance with FDA Recommendations for Electrical Stimulators, Software/Hardware Validation, Risk Analysis according to ISO 14971:2007 and FDA's Guidance for 510(k)s for Devices Containing Software (2005).

9- Clinical test discussion: Not applicable/not required.

10- Conclusion: In reviewing the table above and the test results, we conclude that our device is substantially equivalent based on technological characteristics, construction, and indications for use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

February 7,2013

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

SelectiveMed™ Components, Incorporated % Mr. Daniel Kamm . 8870 Ravello Court Naples, Florida 34114

Re: K120922

Trade/Device Name: Guardian Dysphagia Dual Channel NMES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: January 22, 2013 Received: January 30, 2013

#### Dear Mr. Kamm:

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

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Page 2 - Mr. Daniel Kamm

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 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/CDRHQffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K120922

Device Name: Guardian Dysphagia dual channel NMES unit

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

BrianD.P.ullin -S

Division of Neurological and Physical Medicine Devices 510(k) Number:

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