(89 days)
To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Agatha-A-H2010." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device can be marketed and specifies its intended use and regulatory class.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Mr. Chris Montalbano Midian International 5821 NW 28th Street Lauderhill, Florida 33313
K983374 Re : Agatha-A-H2010 Trade Name: Requlatory Class: I Product Code: EFS Dated: September 18, 1998 September 25, 1998 Received:
Dear Mr. Montalbano:
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 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). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Montalbano
through 542 of the Act for devices under the Electronic chrough Sta Or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberized in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets processor with your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regarddiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known):
Device Name: Agatha -A-H2010
Indications For Use: To Remove adherent plaque and
FOOD, debris from the teeth and oral mucosa,
to Educ.e tooth decay in patients who are
Reduce
Physically unable to perform brushing.
To Prevent Aspiration, which may be associated
with michanical brushing only in these patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation of
(Division Sign-Off) Ponnali C. Division of Dental, Infection Contro and General Hospital Devices
1983374 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.6510 Oral irrigation unit.
(a)
Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.