K Number
K120922
Device Name
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Date Cleared
2013-02-07

(317 days)

Product Code
Regulation Number
890.5850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
Device Description
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.
More Information

Not Found

No
The summary describes a standard neuromuscular stimulation device and does not mention any AI or ML capabilities.

Yes
The device is described as treating patients suffering from dysphagia and helping them regain control of muscles used to swallow, indicating a therapeutic purpose.

No
The device description states its purpose is "Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction" and "to regain control of muscles used to swallow food and drink liquids without aspirating." This describes a therapeutic, not a diagnostic, function.

No

The device description explicitly states it is a "lightweight battery powered dual channel neuromuscular stimulation device," indicating it is a hardware device that delivers electrical stimulation. The summary also mentions "Software/Hardware Validation" and the use of electrodes and lead wires, further confirming it is not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states the device is a "neuromuscular stimulation device used for treating patients suffering from dysphagia." It applies external stimulation to muscles.
  • Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to directly stimulate muscles.

Therefore, the Guardian Dysphagia dual channel NMES falls under the category of a therapeutic device, not an in vitro diagnostic device.

N/A

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

Product codes (comma separated list FDA assigned to the subject device)

IPF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pharyngeal muscles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070425

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).

0

  • 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 740-397-7838. Fax 740-397-6112 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)
CharacteristicPredicate K070425 Chattanooga VitalStim
ExperiaK120922, Guardian Dysphagia Dual
Channel NMES
Output configurationDual Channel, electrically Isolated with
miniature safety connectorsSAME
Output waveformAC Mode: Rectangular symmetrical biphasic
with zero net DCSAME
Regulated current or voltageConstant currentConstant current
Patient voltage100 Volts max, no loadSAME
Automatic overload tripFor high resistance the circuit detects this
and shuts off the current. The current
indicator shows this by flashing "0". Trip
point measured: 33 k ohm. Can withstand
permanent short or open circuitSAME.
Trip point measured: 23 k ohm.
Can withstand permanent short or
open circuit

7- Basis for a determination of substantial equivalency

1

CharacteristicPredicate K070425 Chattanooga VitalStimK120922, Guardian Dysphagia Dual
ExperiaChannel NMES
Intensity ControlDual intensity potentiometers: 0-25 mA
peak current output, adjustable current.
Constant current regulation from 0 to 4000
ohms load minimumSAME
Pulse RateFixed, 80 HzSAME
Pulse shapePositive square wave of 300 µs width
followed by an interphase interval of 100 µs
followed by a negative square wave of 300
µs width symmetric in shape and amplitude
to that of the positive square wave (and
therefore charge balanced).Positive square wave of 300 µs width
followed by an interphase interval of
100 µs followed by a negative square
wave of 300 µs width symmetric in
shape and amplitude to that of the
positive square wave (and therefore
charge balanced).
Low battery indicator displayLCD symbolLCD Symbol:
Triggers at 6.6 volts
Ramp down/ramp up and rest
time.Down: 0.75 s. Up: 0.75 s.
Off: 1.0 sDown: 0.75 s. Up: 0.75 s.
Off: 1.0 s
Rest Period:Each 57.5 seconds of operation, the unit
will reduce power down to zero power for a
period of 1 second. The power ramps down
to zero and back up to the preset power
over a total time of 2.5 secondsEach 57.5 seconds of operation, the
unit will reduce power down to zero
power for a period of 1 second. The
power ramps down to zero and back
up to the preset power over a total
time of 2.5 seconds
Distance between electrodes30 mm30 mm
Electrode dimensionsConductive area: 0.75" round. 19 mm x 2
contacts)105 x 55 mm with liner,
74 x 36 mm fabric, Conductive area:
0.875" diameter round, 2 contacts.
(22.5 mm diameter) silver film/gel
(round, x 2) (K083756)
Electrode
conductive
surface
areaSurface area of 0.882 sq. In. for two
electrodesSurface area of 1.14 sq. In. for two
electrodes
Additional characteristics
Timer60 minutes60 minutes
Pulse width300 µ sec300 µ sec
Pulse current range0-25 mA0-25 mA
Number of independent
channels22
Power source2 AA cells9 Volt Alkaline battery
Start up currentNot specifiedZero 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.

2

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

3

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 (800) 638-2041 or (301) 796-7100 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

4

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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