(184 days)
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.
The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes.
The provided text is related to an FDA 510(k) clearance for the AMPCARE ESP™ Therapy System, a powered muscle stimulator. However, it does not contain information about acceptance criteria or specific study data proving the device meets those criteria.
The document states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was cleared based on its similarity to existing devices, and typically, a 510(k) submission doesn't require new clinical efficacy studies if substantial equivalence can be established through technological characteristics and performance data demonstrating it's as safe and effective as a predicate device.
To answer your specific questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed engineering report for the device. The current document is primarily an FDA clearance letter.
Therefore, I cannot provide the requested table and study details based on the input 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 (800) 638-2041 or (301) 796-7100 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 (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 -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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