Ultrasonic scaler

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 21, 2017 Nanning Vv Dental Co., Ltd. Liang Chaojun Vice General Manager 4th Floor,north Bld. No.1 , Zhengxin Tech Zone, No. 2, Gaoxin 7 Rd. Nan Ning, 530007 CN Re: K163414 Trade/Device Name: Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: elc Dated: October 25, 2017 Received: October 27, 2017 Dear Liang Chaojun: 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. 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 {1}------------------------------------------------ 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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Image /page/1/Picture/8 description: The image shows the name "Mary S. Runner -S" in a large, bold font. The text is black and appears to be on a white background. The letters are clearly legible and evenly spaced. for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163414 Device Name Ultrasonic Scaler Indications for Use (Describe) The ultrasonic scaler is intended to: - 1. Remove supra and sub gingival calculus deposits and stain from the teeth; - 2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3.Clean and irrigate root canals | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K163414 510(k) SUMMARY (As Required by 21 CFR 807.92) ## 1. Date Prepared October 2nd, 2017 #### 2. Submitter;s Information | Company Name: | NANNING VV DENTAL CO., LTD. | |------------------|-----------------------------------------------| | Company Address: | 4th floor,North Bld. No.1, Zhengxin Tech Zone | | | No. 2, Gaoxin 7 Rd., Nanning, China 530007 | | Fax: | 0086-771-580-1312 | #### 3. Device Information | Trade Name: | | |--------------------|--| | Models: | | | Product Code: | | | Regulation Number: | | | Device Class: | | Ultrasonic Scaler VET-W3, VST-W3, VET-1 and VST-1 ELC 21 CFR 872.4850 Class II #### 4. Identification of Predicate Devices Predicate I | Manufacturer: | Nanning Baolai Medical Instruments Co., Ltd. | |----------------------|----------------------------------------------| | Trade Name: | Ultrasonic scaler P7 | | Product Code: | ELC | | Classification Name: | Ultrasonic Scaler | | Regulation Number : | 21 CFR 872.4850 | | FDA 510 (k) #: | K140233 | #### 5. Description of the Device The Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler models VET-W3 and VST-W3 connect to an external water supply and delivers water via connected handpiece. [510(k)] Application SECTION 7 - 1 of 5 {4}------------------------------------------------ Ultrasonic scaler consists of main generator, VE and VS handpiece, optional scaler tips (G series, P series, E series), power adapter and foot switch; The main part is as follows: - 1. Power adapter: DC 24V, input frequency: 3-20W 2. Main engine: The main engine is the major part of the circuit control, including ultrasonic pulse circuit, modulator circuit and oscillatory circuit. It is used for converting the ultrasonic oscillatory signal to ultrasonic mechanical oscillatory signal by magnifying and improving the vibrating frequency. 3. Handpiece: It mainly converts the signal from circuit,which will drive the ultrasonic scaler tips vibrating. 4. Scaler tip: The scaler tip is used to remove the calculus and plague by vibrating on the teeth surface. ## 6. Indications For Use The ultrasonic scaler is intended to: 1.Remove supra and sub gingival calculus deposits and stain from the teeth; 2.Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3.Clean and irrigate root canals ## 7. Technological Characteristics The ultrasonic scaler is powered by the piezoelectric technology, which is also employed by the predicate device. The electric power is transduced into high- frequency vibration via an ultrasonic transducer. The proposed ultrasonic scaler connects to an external water supply and delivers water via connected handpiece. | Items | K163414 Proposed Device | K140233 Predicate Device<br>Ultrasonic scaler P7 | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>For Use | The ultrasonic scaler is intended to:<br>1.Remove supra and sub gingival<br>calculus deposits and stain from<br>the teeth; | The ultrasonic scaler is intended<br>to:<br>1.Remove supra and sub gingival<br>calculus deposits and stain from the<br>teeth; | | | 2. Carry out periodontal pocket lavage<br>with simultaneous ultrasonic tip<br>movement;<br>3. Clean and irrigate root canals. | 2. Carry out periodontal pocket<br>lavage with simultaneous<br>ultrasonic tip movement;<br>3. Clean and irrigate root canals. | | Operation<br>Controls | | | | | Sterilization:<br>Handpiece: autoclaved under high<br>temperature 135°C/pressure 0.22MPa.<br>Scaler tip: autoclaved under high<br>temperature and high pressure | Sterilization:<br>Handpiece: autoclaved<br>under high temperature 135°C/pressure<br>0.22MPa. Scaler tip: autoclaved under<br>high temperature and pressure. | | Display<br>Modes | Corresponding signal of external<br>display driver circuit lights up<br>corresponding LED. | Corresponding signal of external<br>display driver circuit lights<br>up corresponding LED. | | Measurement<br>Items | Remove calculus or plaque on surface<br>of teeth in oral cavity, cleaning and<br>irrigation of root canals. | Remove calculus or plaque on surface<br>of teeth in oral cavity, cleaning and<br>irrigation of root canals. | | Power<br>Supply | input voltage : 30VDC 50HZ<br><br>output power : 3-20W | input voltage : 24VDC 1.5A 50HZ<br><br>output power : 3-20W | | Operating<br>conditions | temperature : 5℃~40℃<br>relative humidity : 30%~80%<br>pressure : 50kPa~106kPa | temperature : 5℃~40℃<br>relative humidity : 30% ~ 80%<br>pressure : 50kPa~106kPa | | Storage<br>conditions | temperature : -10℃~+50℃<br>relativehumidity ≤ 80%<br>pressure50kPa~106kPa | temperature : -10℃~+50℃<br>relativehumidity ≤ 80%<br>pressure50kPa~106kPa | | Handpiece of<br>ultrasonic<br>scaler | Working principle: Piezoelectric<br>effect, the ultrasonic vibration signal<br>is converted to ultrasonic mechanical<br>vibration signal. | Working principle: Piezoelectric effect,<br>the ultrasonic vibration signal is<br>converted to ultrasonic mechanical<br>vibration signal. | | Tips of<br>ultrasonic<br>scaler | Mechanical vibration transmitted<br>from the handpiece is converted to<br>the vibration of the scaler tip, then<br>removes calculus or plaque from the<br>teeth. | Mechanical vibration transmitted from<br>the handpiece is converted to the<br>vibration of the scaler tip, then<br>removes calculus or plaque from the<br>teeth. | | Electrical<br>Safety | IEC 60601-1 | IEC 60601-1 | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | | performance | IEC 61205 | IEC 61205 | | Biocompati-<br>bility | ISO 10993-5,<br>ISO 10993-10 | ISO 10993-5,<br>ISO 10993-10 | | Software<br>Level of<br>Concern | Moderate | Moderate | ### 8. Substantial Equivalence Table # [510(k)] Application SECTION 7 - 2 of 5 {5}------------------------------------------------ [510(k)] Application SECTION 7 - 3 of 5 {6}------------------------------------------------ The proposed device has same intended use, similar product design, same sterilization condition, safety standards as the predicate device. The slight difference is the power supply, the input voltage of proposed device is 30V DC , the input voltage of predicate device is 15V DC, both of them could meet the electricity safety standard IEC 60601-1, the difference does not affect the substantial equivalence in effectiveness and safety. ### Non-clinical Testing: The following bench testing was conducted in order to support substantial equivalence of the proposed device: - IEC 60601-1:2006+A1:2012 medical electrical equipment -- part 1: general ● requirements for basic safety and essential performance - . IEC 60601-1-2:2007 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. - IEC 61205:2001 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics. - . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. Clinical Testing: Clinical evaluation is not applicable for the proposed device. #### 9. Conclusion [21 CFR 807.92(b)(3)] The VET-W3, VST-W3,VET-1 and VST-1 ultrasonic scaler have the same intended use, similar product design, same sterilization conditions and the same technological characteristics as the predicate device. Nonclinical testing further supports the substantial equivalence of the proposed device to its predicate device. Therefore, the proposed device is substantially equivalent to its predicate device. ## [510(k)] Application SECTION 7 - 4 of 5 {7}------------------------------------------------ PSC Publishing Services (301) 443-6740 Fir