(36 days)
Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).
Control III® Elite
I am sorry, but based on the provided document, the information required to answer your request is not present. The document is a clearance letter from the FDA for a device called "Control III® Elite" and an "Indication For Use Statement." It does not contain details about acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment for the device's performance evaluation.
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SEP 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne R. Whitehair Director Maril Products, Incorporated 320 West 6th Street Tustin, California 92780
Re : K992661 Control III® Elite Trade Name: Requlatory Class: II Product Code: LRJ Dated: July 29, 1999 Received: August 9, 1999
Dear Ms. Whitehair:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 —Ms. Whitehair
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 described in your sia equivalence of your device to a legally finding of bubbeandlariesults in a classification for your marketed predicate and the 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on compriated as (oo advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulacion entifica, "Mibbianding by sorbility", "Other general information on your responsibilities under the Act may be Information of your wise of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at feb corr free namber (e: //www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timo N. A. Ulatowski
Timo Direct or Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(K) Number (if known): Unknown
Device Name: Control III® Elite
Indication For Use:
Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ or Over-The-Counter Use X
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K99261
510(k) Number __
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(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 § 880.9.