(111 days)
BIOFREE INHIBITS AND CONTROLS THE GROWTH OF BACTERIA, BIOFILM, ENDOTOXINS, FUNGUS, AND ALGAE PROVIDING ANTIMICROBIAL SURFACE IS REGENERATED WITH THE CONTINUOUS USE OF A STERISIL WATER PRE-TREATMENT PRODUCT. BIOFREE IS INTENDED TO BE USED WITH DISTILLED, DEIONIZED, OR REVERSE OSMOSIS WATER. EFFICACY FOR TAP WATER HAS NOT BEEN DETERMINED. THIS PRODUCT IS NOT INTENDED TO PROVIDE STERILE WATER.
BIO-FREE TUBING AND BOTTLE FOR DENTAL OPERATIVE UNIT
This document, an FDA 510(k) clearance letter for the "Bio-Free Tubing and Bottle for Dental Operative Unit," primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way clinical or AI/software validation studies would.
Therefore, I cannot extract the requested information (acceptance criteria table, study sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text for the following reasons:
- Type of Device: The device is hardware (tubing and bottle). The document pertains to its substantial equivalence for use in dental operative units, indicating it's a physical product, not a software algorithm or AI.
- Nature of the Document: This is an FDA clearance letter based on a 510(k) submission. A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves comparing design, materials, indications for use, and performance characteristics (if any are relevant and different from the predicate) rather than conducting extensive new clinical performance studies with acceptance criteria in the manner you're asking about for AI/software.
- Missing Information: The document explicitly states the device "inhibits and controls the growth of bacteria, biofilm, endotoxins, fungus, and algae," and that "efficacy for tap water has not been determined," but it does not provide any data or study details (like sample sizes, expert involvement, or statistical results) to back these claims or to define acceptance criteria for these claims.
The closest thing to "performance" mentioned is the antimicrobial function. However, the document does not describe a study to prove this performance, nor does it list specific acceptance criteria for "controlling growth." It mostly mentions the intended function and limitations (e.g., efficacy not determined for tap water).
In summary, the provided FDA 510(k) clearance letter does not contain the detailed study and acceptance criteria information you are seeking, as its purpose is regulatory clearance based on substantial equivalence, not a detailed technical performance report.
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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 stylized eagle head with three horizontal lines extending from the back of the head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
APR - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard W. Hanson Official Correspondent Dental Components, Incorporated 305 North Springbrook Road P.O. Box 228 NewBerg, Oregon 97132-0228
Re: K033925
Trade/Device Name: Bio-Free Tubing and Bottle for Dental Operative Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 19, 2004 Received: March 23, 2004
Dear Mr. Hanson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hanson
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); good manufacturing practice requirements as set 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
K033925 510(k) Number (if known): గుట BIO -FREE TUBING AND BOTTLE FOR DENTAL GREATIVE Device Name: Indications For Use:
BIOFREE " NHIGHTS AND CONTROLS THE GROWTH OF BACTERIA, BIOFIUM, ENDOTOXINS, FUNGUS, AND ALGAE PROVIDING ANTIMICROBIAL SURFACE IS REGENERATED WITH THE THE
CONTINUOUS USE OF A STERISIL WATER PRE. TREATIMAT PRODUCT . BIOFREE IS INTENDED TO BE USED WITH DISTILLERS, DELOWIZED, OSMOSIS WATER. EFFICACY FOR TAP WATER HAS NOT OR REVERSE DETERMINED , THIS PRODUCT IS NOT INTENDED TO PANING ਤਿੰਦਾ ਹੈ। STERILE WATER.
Prescription Use _ Ì (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Burton for Dr. S. Sumner
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number
Page 1 of
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§ 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.