ULTRASONIC SURGERY

{0}------------------------------------------------ KI21620 # DEC 1 1 2012 1 ## 510(k) Summary #### Owner Information 1) Name: DMETEC CO., LTD. 2) Address: 402-603 Techno-Park, 193 Yakdae-Dong, Wonmi-Ku, Bucheon City, KOREA - 3) Phone Number: 82-32-234-0011 - 4) FAX Number: 82-32-234-1444 - 5) Name of Contact Person: Hong-Geun, Lee - 6) Date the Summary was Prepared: 05/11/2012 #### Device Information - 1) Common Name: Bone cutting instrument and accessories - 2) Trade Name: Ultrasonic Surgery - 3) Model Number(s): SmarThor - 4) Classification Name: Drill, Bone, Powered - 5) Requlation Number: 872.4120 #### Predicate Device Information - 1) 510(k) Number: K072146 - 2) Trade Name: EMS Piezon Master Surgery - 3) Product Code: DZI #### Description of the Device This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside {1}------------------------------------------------ ## Specifications of unit: Model: Supply voltage: Supply frequency: Power input: Device life Output characteristics(Ultrasonic output): Type of protection against electric shock: Degree of protection against electric shock: Specification of transformer Output characteristics of transformer: SmarThor DC 24V 50 / 60 Hz 24 VA 5years Maximum output power with load:50W Frequency range available: 24-32kHz. Class 1, with transformer Applied part type BF AC100-250V, 50-60Hz DC 24V #### Intended Use The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. 1) Product Name: Ultrasonic Surgery 2) Model: SmarThor {2}------------------------------------------------ | | DMETEC<br>(SmarThor) | EMS<br>(Piezon Master Surgery) | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | 510(k) reference | | K072146 | | Indication for use | The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. | The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry | | UNIT | | | | Supply voltage | 24V DC | 100-240 V AC | | Power consumption(max) | 50W max | 105VA | | OUTPUT CHARACTERISTICS | | | | Maximum output power with load | 50W | 25W | | Frequency range available | 24-32 kHz | 24-32 kHz | | TRANSFORMER | | | | Input | 100-240 VAC, 50-60Hz | 100/220 VAC/50-60Hz | | Output | 24V DC/ 2.7A | 24V AC/ 1.25A | | MAIN COMPONENT | | | | | 1 Unit Body<br>1 Hand-piece<br>1 Tip | 1 Unit Body<br>1 Hand-piece<br>5 Tips | | MATERIAL | | | | Tip(contact with patient) | Stainless steel | Stainless steel | : ## Summary of Technical Characteristics Compared to the Predicate Device {3}------------------------------------------------ ### Brief Discussion of Nonclinical Tests (if applicable) For biocompatibility, in vitro cytotoxicity test, skin sensitization test and oral mucosa irritation test were conducted. During the in vitro cytotoxicity test, no evidence of causing cell lysis or toxicity was found and it was evaluated as Grade 0 on the criteria of ISO 10993-5:2009. As for skin sensitization, sensitization scores were zero and the sensitization rates were observed 0% at 24 hours. As for oral mucosa irritation test, no mortality was observed, no changes in body weight were observed, and there were no differences in saline and test group. For electric safety and electromagnetic compatibility, the device was tested according to IEC 60601-1:1988 + A1:1991 + A2:1995 and IEC 60601-1-2: 2007 and the device was found to meet the requirements of the standards. Software validation report shows that the device is substantially equivalent and performs as it should. ### Brief Discussion of Clinical Tests (if applicable) Comparison with the predicate indicates they are similar in functions and efficiency, and the post market experience proves that it is substantially equivalent. #### Conclusion from Nonclinical and Clinical Tests (if applicable) Biocompatibility tests, electric safety test and electromagnetic compatibility test show that the device meets the requirements of those standards. Literatures and post market experience show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specification . and performance. Thus, we conclude that SmarThor are substantially equivalent to the predicate device. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three thick, curved lines. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 December 11, 2012 DMETEC Company, Limited C/O Mr. Daniel Nam General Manager PATS Corporation 4568 West 155 Street, Suite 104 Los Angeles, California 90004 Re: K121620 Trade/Device Name: Ultrasonic Surgery (SmarThor) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 14, 2012 Received: November 23, 2012 Dear Mr. Nam: We have reviewed vour 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. {5}------------------------------------------------ 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/ucm115809.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, Kwame O. Ulmer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K121620 Device Name: Ultrasonic Surgery (SmarThor) Indications For Use: The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) · Concurrence of CDRH, Office of Device Evaluation (ODE) 2012.12.11 Susan Runner DDS, MA -1:3:22:33 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of __ 1 510(k) Number,