ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT

K092202 · Eswallow USA · IPF · Feb 10, 2011 · Physical Medicine

Device Facts

• Record ID: K092202
• Device Name: ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
• Applicant: Eswallow USA
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Story

Dual-channel, battery-operated electrical stimulator for surface electrode application; delivers bipolar symmetrical constant current to pharyngeal muscles for re-education. Output current adjustable 0-25 mA in 1 mA increments; fixed pulse repetition rate of 80 Hz. Device housed in plastic enclosure; powered by alkaline batteries. Used in clinical settings to assist patients with dysphagia. Healthcare providers apply electrodes and adjust stimulation parameters to facilitate pharyngeal contraction, aiming to improve swallowing function through muscle re-education.

Clinical Evidence

Bench testing only. Testing included electrode resistance, output accuracy, software validation, and EMC compatibility testing to demonstrate performance comparable to the predicate device.

Technological Characteristics

Dual-channel electrical stimulator; constant current source; bipolar symmetrical waveform. Fixed pulse rate 80 Hz; intensity 0-25 mA. Plastic enclosure; alkaline battery powered. Surface electrode interface. Software-controlled output.

Indications for Use

Indicated for muscle re-education via external stimulation of pharyngeal muscles. Patient population not explicitly defined by age or gender; intended for use under prescription.

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

• Vital Stim (K023347)

Submission Summary (Full Text)

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# 510(k) SUMMARY

2202

FEB 1 0 2011

### K092202 eSWALLOW™ USA Device: eSWALLOW™ Dysphagia Therapy Unit Page 1 of 2, 510(k) Summary

| Date Prepared | February 9, 2011 |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary prepared by: | William H. "Bill" Ingram, President |
| Applicant | eSwallow USA |
| Device Name | Dysphagia Therapy Unit |
| Trade Name | eSWALLOW™ USA<br>3477 Creek Circle<br>Guntersville, AL 35976<br><br>Phone: [phone]<br>Toll Free: 866-964-3102<br>Sales: 800-455-3101<br>FAX: [phone] |
| Common Name | Electrical Stimulator |
| Classification | Class: II<br>Product Code: IPF<br>Regulation: 21 CFR<br>890.5850 |
| Identification of<br>Predicate Devices and<br>Summary of Substantial<br>Equivalence | The eSWALLOW™ Dysphagia Therapy Unit is substantially<br>equivalent with respect to intended use, design, risks, device<br>characteristics and performance aspects to:<br>Vital Stim, K023347, CHATTANOOGA GROUP |
| Device Description | This device is a dual channel battery operated electrical stimulator<br>for use with skin surface electrodes. The output current in each<br>channel can be adjusted from 0-25 ma in 1 ma increments. The<br>pulse repetition rate is fixed at 80 Hz. The output waveform is<br>bipolar symmetrical constant current. |

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#### eSWALLOW™ Dysphagia Therapy Unit Page 2 of 2, 510(k) Summary

| Intended Use and<br>Indications | This device is intended for muscle re-education by application of<br>external stimulation to the muscles necessary for pharyngeal<br>contraction. |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics and<br>Substantial Equivalence | The eSWALLOW™ Dysphagia Therapy unit has many similar<br>technological characteristics and is substantially equivalent to the<br>predicate.<br><br>The method of use for the eSWALLOW™ device is exactly the same<br>as the predicate.<br><br>The materials used in the eSWALLOW™ are also similar to those<br>used in the predicate. Both devices use an electronic circuit board<br>mounted inside a plastic box. Both units are powered by alkaline<br>batteries. Both units use constant current sources and have nearly<br>identical pulse widths, intensities, and open circuit voltages. The<br>output circuit design provides a constant current source allowing<br>for variations in electrode resistances. |
| Performance<br>Testing/Data | Tests were performed on the device which demonstrated that the<br>device performs comparably to and is substantially equivalent to<br>the predicate device. Tests include: Electrode resistance, output<br>accuracy, Software Validation, and EMC compatibility testing. |
| Conclusion | Because the technological characteristics and intended use are<br>nearly identical to the predicate device (including pulse type, rate,<br>and output) we have determined that the eSWALLOW™ device is<br>substantially equivalent to the predicate device. |

.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

FEB 10 201

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

eSWALLOWTM USA % Kamin & Associates Mr. Daniel Kamm. P.E. 8870 Ravello Court Naples, Florida 34114

Re: K092202

Trade/Device Name: eSWALLOWIM Dysphagia Therapy Kit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: December 8, 2010 Received: December 14, 2010

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

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Page 2 -- Mr. Daniel Kamm, P.E. --

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-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 100-1050.

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/CDRHOffices/ucm113809.html 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 tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely vours.

A.j. B. 12 h
for.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and . Radiological Health

Enclosure

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## INDICATIONS FOR USE

### 510(k) Number (if known): K092202 Device Name: eSWALLOW™ Dysphagia Therapy Kit

This device is intended for 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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092202

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