ELEVANCE

{0}------------------------------------------------ K120239 510(k) Special Midmark Corporation Elevance | 6. 510(k) Summary or 510(k) Statement | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k) SUMMARY | | | AUG 2 4 2012 | | 510(k) Owner | Midmark Corporation<br>60 Vista Drive<br>Versailles, Ohio 45380-0286<br>TEL: 937-526-8249 | | Contact person | Robyn Scopis<br>Regulatory Consultant to Midmark Corp.<br>Regulatory Specialists, Inc.<br>3722 Ave. Sausalito<br>Irvine, CA 92606<br>TEL: 949.422.3853<br>FAX: 949.552.2821<br>EMAIL: robyn@regulatoryspecialists.com | | Date summary was prepared | August 22, 2012 | | Name of device | Elevance | | Common Name | Dental Delivery Unit | | Classification Name | Unit, Operative Dental | | Regulation | 872.6640 | | Product Code | EIA | | Unmodified Device | Midmark Procenter Instrument Delivery System<br>K003090 | | Description | | ### Description The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments. {1}------------------------------------------------ K120239 510(k) Special Midmark Corporation Elevance ## Intended Use The Midmark Elevance Instrument Delivery System is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and lowvoltage electricity to hand-held dental instruments. Technological Characteristics The Unmodified Device and the Elevance were compared in the following areas and found to have similar technological characteristics and to be · equivalent: ・ Indications for Use > Function of Handpiece Accessories Performance of Handpiece Accessories The Unmodified Device and the Elevance were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the Elevance: Centrally located controls for instruments Touch Pad on the Control Settings Air and Water Adjustment made via proportional solenoid valves The following non-clinical performance tests were conducted: Qualification Run evaluation to verify design EN 60601-1-2:2007 Part 1-2 EN 61000-3-2:2006 +A1:2009 +A2:2009 Part 3-2 EN 60601-1-2:2007 Part 1-2 IEC 60601-1 Part 1 ISO 7494-1:2004 ISO 7494-2:2003 Conclusions from non-clinical performance data After performing non-clinical performance studies, the data shows that the Elevance demonstrates substantial equivalence to the predicate as a Dental Delivery Unit. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Midmark Corporation C/O Ms. Robyn Scopis Regulatory Consultant Regulatory Specialists, Incorporated 1801 Edgecliff Drive Fullerton, California 92831 Re: K120239 Trade/Device Name: Elevance Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2012 Received: August 21, 2012 Dear Ms. Scopis: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. AUG 2 4 2012 {3}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Susan Runner Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Special Midmark Corporation Elevance K12.02.32 ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ TBD Device Name: Elevance Indications for Use: The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runne Division Sign-Off) . livision of Anesthesiology, General Hospital nfection Control, Dental Devices Page _ 1 _ of _ 1 10(k) Number: K120039 1 of 1 | Regulatory Specialists, Inc.