GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER

{0}------------------------------------------------ # MAY 1 0 2002 K021258 #### 8.0 510(k) Summary | Submitted by: | David Link, Vice President<br>EXPERTech Associates, Inc.<br>100 Main Street, Suite 120<br>Phone (978) 371-0066<br>Fax (978) 371-1676 | |---------------|--------------------------------------------------------------------------------------------------------------------------------------| |---------------|--------------------------------------------------------------------------------------------------------------------------------------| April 30, 2002 Date of summary Germ Terminator Toothbrush Sanitizer Device name Toothbrush Sanitizer Common name Classification name Toothbrush, Manual The subject device is substantially equivalent to the Otres Toothbrush Predicate devicc Sanitizer (K003517). The Germ Terminator uses steam heat to sanitize two manual toothbrushcs Description or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle. Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized. The Germ Terminator is designed to sanitize up to two manual Intended use toothbrushes or two toothbrush heads between uses. The Germ Terminator is intended for over the counter use. The subject device sanitizes by means of steam heat and the predicate Tcchnological device sanitizes by means of activated oxygen (ozone). Characteristics Laboratory testing demonstrated that toothbrushes treated in the Germ Testing Terminator are effectively sanitized. {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare. The caduceus is depicted with a single staff entwined by two snakes. MAY 1 0 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Germ Terminator Corporation Mr. Donald J. Sherratt Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779 Re: K021258 Trade/Device Name: Germ Terminator GT 100 Toothbrush Sanitizer Regulation Number: 872.6855 Regulation Name: Toothbrush, Manual Regulatory Class: I Product Code: MCF Dated: May 2, 2002 Received: May 3, 2002 Dear Mr. Sherratt: 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 Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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. {2}------------------------------------------------ #### Page 2 - Mr. Sherratt 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html Sincerely vours, Patruco Cucurella Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ of Page_ 510(k) Number (if known): Device Name: Germ Terminator Toothhrush Sanitizer Indications For Usc: The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter." ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Ryan (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)