MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881

{0}------------------------------------------------ NOV 1 2 2003 Image /page/0/Picture/1 description: The image shows the word "Miele" in a bold, sans-serif font. The word is white and is set against a black background. The letters are large and fill the frame, making the brand name easily recognizable. The image appears to be a logo or branding element for the company Miele. # 510 (K) Summary This 510 (K) Summary information is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR807.81 Subpart E- Pre-market Notification Procedures. | Product | Miele G7881 Dental Thermal Disinfector | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510 (K) number | K031799 | | Legally Marketed<br>Device | Substantial equivalence of the Miele G7881 Dental Thermal Disinfector exists to<br>the Miele G7781 Dental Thermal Disinfector (K950518). The cycle parameters<br>for high-level disinfection have not been changed from the G7781 Dental<br>Thermal Disinfector. | | Description | The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueous<br>cleaning and simultaneous thermal disinfection of dental instruments and<br>accessories. It operates with three spray arms on three different levels. A<br>powerful circulation pump moves 2.8 gallons of water at a rate of 105<br>gallons/minute. The specially designed jets on the spray arms spray the water<br>onto the wash load at a low pressure (About 13 psi) to prevent any goods from<br>being washed off the racks. | | Functional design | The complete unit is made of electro-polished stainless steel, the exterior is<br>additionally powder coated. The unit is equipped with a microcomputer control.<br>An integrated water softener ensures consistently high water quality; the steam<br>condenser comes standard and minimizes contaminated aerosols and odor<br>affecting the environment. | | Performance | The Thermal Disinfection Process | | Characteristics | The thermal disinfection process relies upon the two physical parameters,<br>temperature (93°C/200°F) and time (10 minutes) minimum. These parameters<br>are easy to control, therefore, errors are improbable. The cycle parameters for<br>high level disinfection have not been changed from the G7781 Dental Thermal<br>Disinfector. | | Intended Use | High Level Disinfection | | | The G7881 Dental Thermal Disinfector is suitable for automatic treatment of<br>dental instruments and accessories. It cleans and in the disinfection programs<br>simultaneously disinfects at 93°C/200°F instruments and accessories. The high<br>level disinfection showed a 6-log reduction of an appropriate myco bacterium<br>species. Since the cycle parameters have not been changed from the G7781 Dental<br>Thermal Disinfector additional testing was not necessary. | {1}------------------------------------------------ KC 317 99 #### Instruments suitable for processing in the thermal disinfector All instruments, accessories and other items to be cleaned and disinfected in the G7881 Dental Thermal Disinfector must be heat resistant to a temperature of up to 95°C/203°F and corrosion resistant in the presence of heat and alkalinity. ## Comparison to Legally marketed Device G7881 External size: H33.5"xW23.5"xD23.5" Wash chamber Size H19.5"xW21"x19.5" Circulation Pump with a turnover volume of 105 Gallons/minute 3 spray arms Thermal disinfection at 93°C/200°F/10 minutes Microcomputer control for higher accuracy and safety Digital display Disinfection control light for higher level of safety 26 Fault codes displayed for easy servicing Optional dosing system for liquid detergents for accurate and reproducible dosage One liquid door dispenser Programmable alarm when program is finished G7781 External size: H33.5"xW23.5"xD23.5" Wash chamber Size H19.5"xW21"x19.5" Circulation Pump with a turnover volume of 105 Gallons/minute 3 spray arms Thermal disinfection at 93°C/200°F/10 minutes Microcomputer control for higher accuracy and safety Digital display Disinfection control light for higher level of safety 9 Fault codes displayed for easy servicing Optional dosing system for liquid detergents for accurate and reproducible dosage One liquid door dispenser No alarm sounds when program is finished #### Non-clinical tests Changes for G7881 are limited to the control panel. Because high level disinfection cycles parameters were not changed from K950518 it was not necessary to perform additional testing, however additional testing was done in accordance with German Health Authority guidelines Federal Health Report 1980:23:364-35-65. All studies proved physical removal or thermal inactivation to a sufficient degree. {2}------------------------------------------------ ## Conclusions The G 7881 Dental Thermal Disinfector does clean instruments contaminated with blood, extremely well. The surface temperatures reach 93°C/200° for at least 10 minutes resulting in high-level disinfection. The cycle parameters from the predicate device are retained for the G7881 Dental Thermal Disinfector. The wash action combined with the thermal inactivation reduces the amount of live bacteria on the instruments by more than log-6 as demonstrated in the previous submission. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble waves or ribbons. The overall design is simple and monochromatic. Public Health Service NOV 1 2 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Steve Polinski Regulatory Affairs Miele Inc. 9 Independence Way Princeton, New Jersey 08540 Re: K031799 Trade/Device Name: Milele G7881 Dental Thermal Disinfector Regulation Number: 880.6992 Regulation Name: Medical Washer-Disinfector Regulatory Class: II Product Code: LDS Dated: October 13, 2003 Received: October 14, 2003 Dear Mr. Polinski: 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. {4}------------------------------------------------ Page 2 -Mr. Polinski 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) 594-4618. 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, Patrice Curenton, Ph.D. 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Miele" in a bold, sans-serif font. The letters are white and stand out against a black background. The word appears to be a logo or brand name, possibly for a company or product. October 2003 K031799 # Statement of Indication for Use The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles: | Program | Program Description | | | | | | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------|---------------------------|------------------------------------------------|---------------------------------| | | 1. Pre-wash | 2. Cleaning<br>and/or<br>thermal<br>disinfection | 3. Interim<br>rinse I<br>with<br>Neutralization | 4. Interim<br>rinse II | 5. Final<br>rinse 1)<br>and/or<br>disinfection | 6. Drying<br>(extra<br>program) | | Wash | X<br>Cold<br>water<br>intake | X<br>Cleaning<br>60°C/3' | | X<br>Cold water<br>intake | X<br>Rinse<br>65°C/1'<br>(DI)<br>DOS 2 | X | | Rinse (cold) | | | X<br>Rinse<br>Cold water | | | | | Drain | Susanna F. Barw<br>(Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices<br>510(k) Number: K081799 | | | | | | | Disinfection<br>vario | X<br>Cold<br>Water<br>Intake | X<br>Cleaning<br>55°C/5' | X<br>DOS 3 | X<br>Cold Water<br>intake | X<br>Rinse and<br>Disinfection<br>93°C/10' | X | | Disinfection<br>93°C-10' | | X<br>Disinfection<br>93°C/10' | X<br>DOS 3 | | X<br>Rinse<br>75°C/3'<br>(DI)<br>DOS 2 | X | X= Sections included in a program (with temperature/temperature holding time)