The Sonendo GentleWave(R) 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 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Device Description

The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.

AI/ML Overview

The provided text is a 510(k) summary for the Sonendo GentleWave System, seeking to demonstrate substantial equivalence to a previously cleared predicate device (K160905). This document does not describe an artificial intelligence (AI) or machine learning (ML) device, nor does it detail a study involving human experts validating AI performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria for AI, ground truth establishment by experts for AI, MRMC studies for AI, standalone AI performance) are not applicable to the content of this document.

The document discusses performance data related to:

Root Canal Cleaning Efficacy
Apical Pressure
Sterilization (Sterility Assurance)

These tests are for the physical device's function, not for an AI algorithm's diagnostic or analytical performance.

Summary

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Sonendo, Inc Eric Simon Director, Regulatory Affairs and Quality Assurance 26061 Merit Circle Laguna Hills. California 92653

March 16, 2019

Re: K190359

Trade/Device Name: Sonendo GentleWave System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: February 14, 2019 Received: February 15, 2019

Dear Eric Simon:

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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.03.16
10:08:18 -04'00'

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K190359

Device Name Sonendo Gentle Wave(R) System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

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7. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Sonendo, Inc.
DATE PREPARED:	February 14, 2019
CONTACT PERSON:	Eric Simon26061 Merit Circle, Suite 102Laguna Hills, CA 92653Phone: 949.766.3636Fax: 949.305.5201
TRADE NAME:	Sonendo GentleWave® System
COMMON NAME:	Sonic Cleaning and Irrigation System
CLASSIFICATIONNAME:	Ultrasonic Scaler
DEVICECLASSIFICATION:	Class 2, per 21 CFR 872.4850
REVIEWING PANEL:	Dental
ESTABLISHMENTREGISTRATION NO.	3010817521
PRODUCT CODE	ELC

PREDICATE DEVICES: Sonendo GentleWave® System (K160905)

Description of the Device Subject to Premarket Notification:

Indication 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 2nd molar teeth. When used with the Sonendo GentleWave® Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

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Substantially Equivalent To:

The Sonendo GentleWave® System is a modified device of the existing Sonendo GentleWave® System. The modified Sonendo GentleWave® System is substantially equivalent in intended use, principal of operation and technological characteristics to the Sonendo GentleWave® System cleared under premarket notification K160905.

Technical Characteristics:

The Sonendo GentleWave® System has similar physical and technical characteristics to the predicate device. The modification to the Molar Handpiece design is merely to decrease the footprint in which the end user is currently required to store the device prior to use and to reduce the waste footprint of the device. The modification separates the handle and tip (sealing surface/nozzle) portions of the handpiece with the handle portion changing from a single-use to a reusable/re-sterilizable component whereas the tip portion of the handpiece remains a single-use gamma irradiated sterilized component.

Technical Characteristics	Sonendo GentleWave® System(modified)	Sonendo GentleWave®System (K160905)
Function	Preparation, cleaning and irrigation or rootcanal	SAME
Principle of Operation	Generation of hydroacoustic waves andfluid motion. The tip of the device isplaced inside the tooth during cleaning.Hydroacoustics are created by thewater stream flowing through the guidetube and coming into contact with thefluid inside the tooth at the distal tip.The fluid stream is dispersed anddeflected by the distal end plate of thetube creating hydrodynamics (fluidmotion) within the tooth.	SAME
Treatment Site	Root canal	SAME
Components	Control UnitIrrigation reservoirsFoot pedalHandpieceAccessories	SAME
Treatment times	Fixed or User selected	SAME
Treatment fluidconcentration	Default mode at the concentrationvalue identical to the predicate or 3setting options to decrease theconcentrations of the fluids	SAME
Handpiece Sterilization	Molar Handpiece Handle: Steamsterilized via autoclaveMolar Handpiece Tip: GammaIrradiation	Gamma Irradiation
Handpiece SterilityAssurance Level (SAL)	10-6	SAME
Consumable Shelf Life	1 Year	SAME

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Each of the technical attributes are present in the predicate device. The modification to Handpiece does not affect the substantial equivalent nature of the modified device, as this change is merely to increase manufacturability. decrease the footprint in which the end user is currently required to store the device prior to use, and to reduce the waste footprint of the device. The modification separates the handle and tip (sealing interface/ nozzle) portions of the handpiece with the handle portion changing from a single-use to a reusable/re-sterilizable component whereas the tip portion of the handpiece remains a single-use gamma irradiated sterilized component.

Performance Data:

All necessary performance testing has been conducted for the Sonendo GentleWave® System to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Testing included:

Root Canal Cleaning Efficacy
Apical Pressure
Sterilization (Sterility Assurance)

Basis for Determination of Substantial Equivalence:

The indications for use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The Sonendo GentleWave® System is similar to the predicate device and is determined by Sonendo, Inc. to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.