AMPCARE ESP THERAPY SYSTEM

K131222 · Ampcare, LLC · IPF · Oct 31, 2013 · Physical Medicine

Device Facts

• Record ID: K131222
• Device Name: AMPCARE ESP THERAPY SYSTEM
• Applicant: Ampcare, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes. The AMPCARE ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. AMPCARE ES cutaneous electrodes are indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Story

AMPCARE ESP™ Therapy System is a powered muscle stimulator used for pharyngeal muscle re-education. The system consists of the AMPCARE ES™ stimulator and AMPCARE ES cutaneous electrodes. It functions by delivering external electrical stimulation to muscles involved in pharyngeal contraction. The device is intended for use by healthcare professionals in a clinical setting to assist in the rehabilitation of swallowing function. By stimulating the target muscles, the device aims to facilitate muscle re-education, potentially improving pharyngeal function and patient outcomes related to dysphagia.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Powered muscle stimulator; consists of an electrical stimulator unit and cutaneous electrodes. Operates via external electrical stimulation for muscle re-education. Class II device under 21 CFR 890.5850.

Indications for Use

Indicated for muscle re-education via external electrical stimulation of muscles required for pharyngeal contraction in patients requiring such therapy.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

## October 31, 2013

AMPCARE, LLC c/o Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 280-A Richardson, TX 75080

Re: K131222

Trade Name: AMPCARE ESP™ Therapy System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: October 15, 2013 Received: October 16, 2013

Dear Ms. Rutherford:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Ms. Diane Rutherford

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 -S

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

Enclosure

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# Indications for Use

510(k) Number (if known): K131222

Device Name: AMPCARE ESP™ Therapy System

Indications For Use:

The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes.

The AMPCARE ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

AMPCARE ES cutaneous electrodes are indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Prescription Use X (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 Center for Devices and Radiological Health (CDRH)

**Joyce M. Whang -S**

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