(398 days)
For use in pressurized self-contained water devices.
For use in cleaning lines in dental units by leaving the solution (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination.
For use in operative procedures to dedicated coolant (water) line for air or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the lubing.
Not Found
I am sorry, but the provided documents do not contain information typically found in a study describing acceptance criteria and device performance. The documents are a regulatory letter from the FDA regarding a 510(k) submission for a device called "Bio-2000" and the device's indications for use.
To fulfill your request, I would need a different type of document, such as:
- A clinical study report
- A performance evaluation report
- A regulatory submission document that includes detailed testing results.
The current documents only state that the device is "substantially equivalent" to legally marketed predicate devices and outline its intended uses for cleaning dental unit lines and improving operative procedures by reducing microbial contamination. They do not provide:
- A table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.).
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing sets.
- Sample size for a training set.
Therefore, I cannot extract the requested information from the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 NOV
Dr. Thad Overmyer Micrylium Laboratories Suite 118 1755 West University Drive Phoenix Tempe), Arizona 85281
Re : K973765 Bio-2000 Trade Name: Regulatory Class: I Product Code: EIA Dated: September 16, 1998 Received: October 2, 1998
Dear Dr. Overmyer:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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
{1}------------------------------------------------
Page 2 - Dr. Overmyer
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.
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) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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
i.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a black and white drawing of a symmetrical design. The design features a central, roughly square shape with a pattern of dots and lines. Radiating outward from each side of the central shape are four curved, pointed shapes, resembling stylized leaves or petals. The overall impression is that of a stylized flower or a decorative emblem.
Micrylium Laboratories
1755 West University Drive Suite 118 Phoenix (Tempe) Arizona 85281
TEL (602) 736-1773 736-1481 FAX (602) greenteam@micrylium.com eMAIL
510 K ........................................................................................................................................................................
8102000
INDICATIONS FOR USE
For use in pressurized self-contained water devices. 1.
For use in cleaning lines in dental units by leaving the solution 2. (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination.
For use in operative procedures to dedicated coolant (water) line for air 3. or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the lubing.
Micrylium Laboratories
Do not write below this line
4————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quarr
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Infection of
510(k) Number
Prescription Use (Per 12 CFR 801.109)
V
OR
Over the Counter Use (Optional Format 1-2-96)
i :
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.