Sonendo GentleWave System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 1, 2015 Sonendo, Inc. Ms. Jenny Fam Senior Director of Regulatory Affairs 26061 Merit Circle, Suite 101 Laguna Hills, California 92653 Re: K143448 Trade/Device Name: Sonendo GentleWave™ System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 30, 2015 Received: March 31, 2015 Dear Ms. Fam: 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. {1}------------------------------------------------ Page 2 - Ms. Jenny Fam 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 5.0 Indications for Use Statement ### INDICATIONS FOR USE STATEMENT 510(k) Number (if known): __K143448 Device Name: Sonendo GentleWave System Indications for Use: The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar Handpiece, the System is indicated for 1 and 200 molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth. AND/OR Prescription Use X (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page _1_ of _1__ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like symbol on the left, followed by the word "SONENDO" in a bold, sans-serif font. The wave symbol is made up of several parallel lines that curve to create a sense of motion. The word "SONENDO" is in black, and there is a registered trademark symbol to the right of the word. # 510(k) Summary K143448 This 510(k) summary information is being submitted in accordance with 21 CFR 807.92 | Applicant | Sonendo, Inc. | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------| | Date Prepared | April 28, 2015 | | Contact | Jenny Fam<br>Senior Director, Regulatory Affairs<br>26061 Merit Circle, Suite 101<br>Laguna Hills, CA 92653<br>949-766-3636 | | Trade Name | Sonendo GentleWave™ System | | Common Name | Sonic Cleaning and Irrigation System<br>Ultrasonic Scaler | | Classification | Ultrasonic Scaler | | Device Classification | Class II per 21 CFR 872.4850 | | Product Code | ELC | | Predicate Devices | Primary: Sonendo OmniClean Endotherapy System (K133752)<br>Reference: EMS Piezon Master 700 (K093000) | #### Substantial Equivalence: The Sonendo GentleWave System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo OmniClean Endotherapy System (K133752) and the EMS Piezon Master 700 (K093000). ### Description of the Device Subject to Premarket Notification: The Sonendo GentleWave System (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister. The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only. #### Indications for Use: The Sonendo GentleWave System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black capital letters. The wave design is made up of several parallel curved lines, and the word "SONENDO" is in a sans-serif font, with a registered trademark symbol next to the "O". 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth. #### Technological Characteristics: The Sonendo GentleWave System has similar physical and technological characteristics to the predicate devices. The differences in physical (weight, dimensions) and electrical (power usage) characteristics when compared to the EMS Piezon Master do not affect substantial equivalence. | Characteristics | Sonendo GentleWave<br>System (K143448) | Primary Predicate:<br>Sonendo OmniClean<br>Endotherapy System<br>(K133752) | Reference Predicate:<br>EMS Piezon Master 700<br>(K093000) | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Sonendo GentleWave<br>System is intended to<br>prepare, clean and irrigate<br>teeth indicated for root<br>canal therapy. When<br>used with the Molar<br>Handpiece, the System is<br>intended to prepare, clean<br>and irrigate 1st and 2nd<br>molar teeth indicated for<br>root canal therapy. When<br>used with the<br>Anterior/Premolar<br>Handpiece, the System is<br>intended to prepare, clean<br>and irrigate anterior and<br>premolar teeth indicated<br>for root canal therapy. | The Sonendo OmniClean<br>System is intended to<br>prepare, clean and irrigate<br>1st and 2nd molar teeth<br>indicated for root canal<br>therapy. | Intended for use in the<br>following dental and<br>periodontal applications:<br>● Preparing, cleaning and<br>irrigating root canals<br>● Retrograde preparation<br>of root canals<br>● Removing supra and<br>sub-gingival calculus<br>deposits and stains from<br>teeth<br>● Periodontal pocket<br>lavage with simultaneous<br>ultrasonic tip movement<br>● Scaling and root planning<br>● Releasing crowns,<br>bridges, inlays and posts<br>as well as condensing<br>gutta percha<br>● Plugging for amalgam<br>condensation<br>● Cavity preparation,<br>cementing inlays and<br>onlays | | Principle of Operation | Generation of<br>hydroacoustic waves and<br>fluid motion. The tip of the<br>device is placed in or on<br>top of the tooth during<br>cleaning. Hydroacoustics<br>are created by the<br>treatment fluid stream<br>flowing through the<br>enclosure and coming into<br>contact with the fluid<br>inside the tooth at the<br>distal tip. The fluid stream<br>is dispersed and deflected<br>by the deflection plate of<br>the enclosure creating<br>hydrodynamics (fluid<br>motion) within the tooth. | Generation of<br>hydroacoustic waves and<br>fluid motion. The tip of the<br>device is placed in or on<br>top of the tooth during<br>cleaning. Hydroacoustics<br>are created by the water<br>treatment fluid stream<br>flowing through the<br>enclosure and coming into<br>contact with the fluid<br>inside the tooth at the<br>distal tip. The fluid stream<br>is dispersed and deflected<br>by the deflection plate of<br>the enclosure creating<br>hydrodynamics (fluid<br>motion) within the tooth. | Generation of hydroacoustic<br>waves and fluid motion | | Characteristics | Sonendo GentleWave<br>System (K143448) | Primary Predicate:<br>Sonendo OmniClean<br>Endotherapy System<br>(K133752) | Reference Predicate:<br>EMS Piezon Master 700<br>(K093000) | | Treatment Site | Root canal | Root canal | Various, including Root<br>canal | | Components | Console (Control Unit),<br>Irrigation Fluid Reservoirs,<br>Foot Pedal, Handpiece<br>and Accessories | Console (Control Unit),<br>Irrigation Fluid Reservoirs,<br>Foot Pedal, Handpiece<br>and Accessories | Control Unit, Irrigation Fluid<br>Reservoirs, Foot Pedal,<br>Handpiece and Instruments | | Irrigation Fluids | 3% Sodium Hypochlorite<br>(NaOCI) solution and 8%<br>EDTA solution | 3% Sodium Hypochlorite<br>(NaOCI) solution and 8%<br>EDTA solution | Various, including 0.3%<br>Sodium Hypochlorite<br>(NaOCI) solution and low<br>grade acids | | Handpiece Type | Two (2) Offered: Molar<br>Handpiece and<br>Anterior/Premolar<br>Handpiece | One (1) Offered: Molar<br>Handpiece | Universal Handpiece with<br>various attachments. | | Sterility: Handpiece | Sterile, Single Use Only | Sterile, Single Use Only | User sterilized, Reusable | | Sterility: Console | Non-Sterile, User<br>Disinfected, Reusable | Non-Sterile, User<br>Disinfected, Reusable | Non-Sterile, User<br>Disinfected, Reusable | | Materials | Medical Grade Materials | Medical Grade Materials | Medical Grade Materials | | Flow rate | With Molar Handpiece:<br>45±10 ml/min<br>With Anterior/Premolar<br>Handpiece: 35±10 ml/min | With Molar Handpiece:<br>50±10 ml/min | 50 ml/min | | Maximum Ultrasonic<br>Output | 21 watts | 21 watts | 12 watts | | Frequency range | With Molar Handpiece:<br>0.5-14 kHz<br>With Anterior/Premolar<br>Handpiece: 0.5-32 kHz | Molar Handpiece: 0.5-14<br>kHz | 24-32 kHz | | Supply voltage | 100-240V, 50-60Hz | 100-120V, 50-60Hz<br>120-240V, 50-60Hz | 100-240 VAC/ 50-60 Hz | | Power usage | 6 VA | 6 VA | 80 VA | | EN 60601-1<br>classification | Class I Applied Part, Type<br>B, IP 20, unit | Class I Applied Part, Type<br>B, IP 20, unit | Class I Applied Part, Type<br>BF, IP 20, unit | | Weight | 60 kg | 59 kg | 2.4 kg | | Unit Dimensions (mm) | 305 x 584 x 1066 | 305 x 584 x 1066 | 225 x 280 x 295 | | Operating conditions | 10°-40°C, 30-75% Rh | 10°-40°C, 30-75% Rh | 10°-40°C, 30-75% Rh | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black letters. The wave design is made up of several curved lines that create a sense of movement. The word "SONENDO" is in a sans-serif font, and there is a small circle to the right of the word. The differences do not impact substantial equivalence as the differences in the indications and technical specifications are within the range of the identified predicates. ### Performance Data: All necessary performance testing has been conducted on the Sonendo GentleWave System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests, which were conducted in accordance with noted standards: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized "S" made up of several curved lines on the left, followed by the word "SONENDO" in a bold, sans-serif font. A small circle, likely a registration mark, is present to the upper right of the "O" in "SONENDO". The logo is simple and modern. | Test | Consensus Standard/FDA Guidance/Description | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterility | Sterile per ISO 11137-1,-2, Sterilization of health care products - Radiation Sterilization | | Biocompatibility | Biocompatible per ISO 10993-1, -5, -10, -11, Biological Evaluation of Medical Devices | | Electromagnetic<br>Compliance and<br>Electrical Safety | Certified per IEC 60601-1 General Requirements for Basic Safety and Essential<br>Performance and IEC 60601-1-2 Medical Electrical Equipment: Safety, Radiofrequency<br>Emissions and Electromagnetic Immunity. | | Software | Validated per FDA Guidance: Guidance for the Content of Premarket Submissions for<br>Software Contained in Medical Devices, 2005. | | Thermal Test | Internal Test Method: Determined the temperature generated on the external surface of<br>the tooth when receiving treatment with the device. | | Cavitation Test | Internal Test Method: Evaluated transient cavitation bubbles which clean root canals. | | Hydroacoustics Test | Internal Test Method: Demonstrated hydroacoustic characteristics of the device. | | Cleaning Test | Internal Test Method: Demonstrated cleaning efficacy of the device on extracted teeth. | | Apical Pressure Test | Internal Test Method: Determined the hydraulic pressure exerted at the apical terminus<br>of the root canal during use of the device. | | Apical Extrusion Test | Internal Test Method: Measured the relative volume of treatment fluid extruded through<br>the apical terminus during use of the device. | # Basis for Determination of Substantial Equivalence: Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Sonendo GentleWave System is substantially equivalent to existing legally marketed devices.