This device is intended/ indicated for use for 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.

AI/ML Overview

This document, K120922, is a 510(k) premarket notification for the Guardian Dysphagia dual channel NMES unit. It directly states that no clinical testing was required or performed to demonstrate substantial equivalence for this device. Therefore, the device performance is not proven through a study but rather through bench testing and a comparison to a predicate device.

Given this, I cannot provide detailed answers to many of your questions as they pertain to clinical studies and data. However, I can extract information related to the "acceptance criteria" (which in this context refers to the characteristics compared for substantial equivalence) and the "study" (which in this case means the non-clinical bench testing).

Here's the breakdown based on the provided document:

Device Acceptance Criteria and Performance (Based on Substantial Equivalence Claim)

The "acceptance criteria" for this device are implicitly the characteristics of the predicate device (K070425 Chattanooga VitalStim Experia) that the Guardian Dysphagia Dual Channel NMES unit must meet or be substantially equivalent to. The "reported device performance" is the Guardian's characteristics as measured during bench testing or as designed.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Predicate (K070425 Chattanooga VitalStim Experia)	K120922 (Guardian Dysphagia Dual Channel NMES) (Reported Performance/Characteristic)
Output Configuration	Dual Channel, electrically Isolated with miniature safety connectors	SAME
Output Waveform	AC Mode: Rectangular symmetrical biphasic with zero net DC	SAME
Regulated current or voltage	Constant current	Constant current
Patient Voltage (no load)	100 Volts max	SAME
Automatic Overload Trip	For 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 circuit	SAME. Trip point measured: 23 k ohm. Can withstand permanent short or open circuit
Intensity Control	Dual intensity potentiometers: 0-25 mA peak current output, adjustable current. Constant current regulation from 0 to 4000 ohms load minimum	SAME
Pulse Rate	Fixed, 80 Hz	SAME
Pulse Shape	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).	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 Display	LCD symbol	LCD Symbol: Triggers at 6.6 volts
Ramp down/ramp up and rest time	Down: 0.75 s. Up: 0.75 s. Off: 1.0 s	Down: 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 seconds.	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 seconds.
Distance between electrodes	30 mm	30 mm
Electrode Dimensions	Conductive 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) - Note: Larger electrode conductive area on Guardian vs. predicate
Electrode Conductive Surface Area	Surface area of 0.882 sq. In. for two electrodes	Surface area of 1.14 sq. In. for two electrodes - Note: Larger electrode conductive area on Guardian vs. predicate
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 Channels	2	2
Power Source	2 AA cells	9 Volt Alkaline battery - Note: Different power source, justified by equivalent functional performance.
Start up current	Not specified	Zero mA.

Study Information (Non-Clinical Bench Testing)

As explicitly stated in the document: "9- Clinical test discussion: Not applicable/not required." Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated regarding "samples." Bench testing involves measuring characteristics of the device itself. It would typically be a single device or a small representative batch of devices.
Data Provenance: The testing was "Bench testing consisted of:" which implies in-house testing by the manufacturer. No country of origin for data is stated beyond the manufacturer being located in Mount Vernon, Ohio, USA. The testing is prospective (i.e., performed for this submission), not retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For bench testing of electrical safety, EMC, and oscillometric properties, "ground truth" is established by adherence to recognized engineering standards (IEC 60601-1, IEC 60601-1-2) and FDA recommendations. The "experts" would be the test engineers and the standards bodies themselves. No specific number of experts or their qualifications are mentioned as they would not be "establishing ground truth" in the way a clinical expert panel would for image review or diagnosis.

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

Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., medical image reading). For bench testing, results are quantitative measurements against defined standards.

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. This is a physical electronic device, not an AI or imaging device. No MRMC studies were conducted.

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

No. This is a physical electronic device, and performance relates to its electrical and mechanical characteristics, not an algorithm's diagnostic performance. The bench tests are "standalone" in the sense that they measure the device's intrinsic characteristics.

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

Ground truth for bench testing: Defined by international standards (IEC 60601-1, IEC 60601-1-2), FDA recommendations for electrical stimulators, and the manufacturer's design specifications. These are objective engineering and regulatory standards.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design specifications and characteristics of the predicate device served as the "target" or baseline for the substantial equivalence claim.

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

Not Applicable. See point 8.

Summary

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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 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:

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 VitalStimExperia	K120922, Guardian Dysphagia DualChannel NMES
Output configuration	Dual Channel, electrically Isolated withminiature safety connectors	SAME
Output waveform	AC Mode: Rectangular symmetrical biphasicwith 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 thisand shuts off the current. The currentindicator shows this by flashing "0". Trippoint measured: 33 k ohm. Can withstandpermanent short or open circuit	SAME.Trip point measured: 23 k ohm.Can withstand permanent short oropen 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 mApeak current output, adjustable current.Constant current regulation from 0 to 4000ohms load minimum	SAME
Pulse Rate	Fixed, 80 Hz	SAME
Pulse shape	Positive square wave of 300 µs widthfollowed by an interphase interval of 100 µsfollowed by a negative square wave of 300µs width symmetric in shape and amplitudeto that of the positive square wave (andtherefore charge balanced).	Positive square wave of 300 µs widthfollowed by an interphase interval of100 µs followed by a negative squarewave of 300 µs width symmetric inshape and amplitude to that of thepositive square wave (and thereforecharge balanced).
Low battery indicator display	LCD symbol	LCD Symbol:Triggers at 6.6 volts
Ramp down/ramp up and resttime.	Down: 0.75 s. Up: 0.75 s.Off: 1.0 s	Down: 0.75 s. Up: 0.75 s.Off: 1.0 s
Rest Period:	Each 57.5 seconds of operation, the unitwill reduce power down to zero power for aperiod of 1 second. The power ramps downto zero and back up to the preset powerover a total time of 2.5 seconds	Each 57.5 seconds of operation, theunit will reduce power down to zeropower for a period of 1 second. Thepower ramps down to zero and backup to the preset power over a totaltime of 2.5 seconds
Distance between electrodes	30 mm	30 mm
Electrode dimensions	Conductive area: 0.75" round. 19 mm x 2contacts)	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)
Electrodeconductivesurfacearea	Surface area of 0.882 sq. In. for twoelectrodes	Surface area of 1.14 sq. In. for twoelectrodes
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 independentchannels	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 (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

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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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Regulation Number and Section

N/A