(24 days)
The indications for use are:
- Relief or reduction of pain; 1.
- Reduction of muscle spasm; 2.
- Joint contracture; and 3.
-
- Local increase in circulation.
Modification to: Accusonic Plus, Model AP-100
The provided document is a 510(k) clearance letter from the FDA for a device called "Accusonic Plus, Model AP-100." This letter indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use (relief or reduction of pain, reduction of muscle spasm, joint contracture, and local increase in circulation).
However, the letter does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications. These types of details would typically be found in the 510(k) summary or the full submission, which are not provided here.
Therefore, I cannot fulfill your request with the given input. The information you are asking for is not present in this regulatory clearance letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2001
Mr. Rob H. Hopkins Technical Director Metron Medical Australia P/L 57 Aster Avenue Carrum Downs, Victoria, Australia
Re: K011955
Trade Name: Modification to: Accusonic Plus, Model AP-100 Regulation Number: 890.5300 Regulatory Class: II Product Code: IMI Dated: June 19, 2001 Received: June 22, 2001
Dear Mr. Hopkins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Rob H. Hopkins
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific arin vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The caughestions on the promotion and advertising of your device, (201) 594-4639. Rudinonally, 2011 - 12:50 pm prease contact the Orifice or Compilation (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
BMitchellurd
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) NUMBER (IF KNOWN):
DEVICE NAME:
Accusonic Plus - AP100
INDICATIONS FOR USE:
The indications for use are:
- Relief or reduction of pain; 1.
- Reduction of muscle spasm; 2.
- Joint contracture; and 3.
-
- Local increase in circulation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
BMutakee tro
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO11955 510(k) Number _
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.