(105 days)
The indications for use are:
- Relief or reduction of pain;
- Reduction of muscle spasm;
- Joint contracture; and
- Local increase in circulation.
Not Found
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter confirming that the Accusonic Advantage – AA 170 device is substantially equivalent to legally marketed predicate devices.
This type of document primarily focuses on regulatory approval rather than providing details about specific performance acceptance criteria or the study data used to establish them. It mentions general controls and regulations but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Information on experts for ground truth or adjudication methods.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- Training set sample size or how its ground truth was established.
To obtain this information, you would typically need to refer to the full 510(k) submission summary or technical reports related to the device's testing and validation, which are not included in this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Metron Medical Australia Pty. Ltd % Mr. David Mitchell Manager, R & D 57 Aster Avenue Carrum Downs, Victoria 3201 Australia
4 2012 MAY
Re: K120171
Trade/Device Name: Accusonic Advantage – AA 170 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI Dated: April 4, 2012 Received: April 4, 2012
Dear Mr. Mitchell:
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 - Mr. David Mitchell
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/CDRHOffices/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/MedicalDeyices/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/Resourcesfor You/Industry/default.htm.
for
Sincerely yours.
Einel Keith
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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510 (k) NUMBER (IF KNOWN): DEVICE NAME:
K120171 Accusonic Advantage - AA 170
INDICATIONS FOR USE:
The indications for use are:
- Relief or reduction of pain; 1.
-
- Reduction of muscle spasm;
-
- Joint contracture; and
- Local increase in circulation. 4.
Over-The-Counter-Use NO AND/OR YES Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
.
Division Sign-Off
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Divisionative Devices
510(k) Number K120171
N/A