The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.

AI/ML Overview

The provided text describes the Sonendo Endotherapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.

The document states that "All necessary performance testing has been conducted for the Sonendo Endotherapy System to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." It then lists the types of testing performed:

Simulated Use
EMC and Electrical Safety
Thermal Safety
Hydroacoustics
Apical Extrusion and Pressure
Cleaning

However, it does not provide details on:

A table of acceptance criteria and reported device performance
Sample sizes used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
Stand-alone algorithm performance
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The document focuses on establishing substantial equivalence based on intended use, principle of operation, and technological characteristics, rather than reporting detailed performance against specific acceptance criteria.

Summary

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Section 6

K130025

510(k) Summary

JUN 1 1 2013

6. 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:	December 29, 2012
CONTACT PERSON:	Dan W. MillerSonendo, Inc.26061 Merit Circle, Suite 101Laguna Hills, CA 92653Phone: (949) 766.3636 x 544
TRADE NAME:	Sonendo Endotherapy System
COMMON NAME:	Sonic Cleaning and Irrigation System
CLASSIFICATIONNAME:	Ultrasonic Scaler
DEVICECLASSIFICATION:	Class 2, per 21 CFR 872.4850
PRODUCT CODE	ELC
PREDICATE DEVICES:	EMS Piezon Master 700 (K093000)Sonic Air MM 1500+ (MID) (K081268)

Substantially Equivalent To:

The Sonendo Endotherapy System is substantially equivalent in intended use, principal of operation and technological characteristics to the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268).

Description of the Device Subject to Premarket Notification:

Indication for Use:

The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

Technical Characteristics:

The Sonendo Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:

Sonendo, Inc. Sonendo Endotherapy System

Page 11 of 85 Deficiencies Response 130610

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Characteristics	Sonendo EndotherapySystem	EMS Piezon Master 700(K093000)	Sonic Air MM 1500 +(MID) (K081268)
Function	Preparation cleaning andirrigation of root canals	Various, includingpreparation, cleaning andirrigation of root canals	Preparation cleaning andirrigation of root canals
Principle ofOperation	Generation ofhydroacoustic waves andfluid motion.The tip of the device isplaced inside the toothduring cleaning.Hydroacoustics is createdby the water streamflowing through the guidetube and coming intocontact with the fluidinside the tooth at the distaltip.The fluid stream isdispersed and deflected bythe distal end plate of thetube creatinghydrodynamics (fluidmotion) within the tooth.	Generation ofhydroacoustic waves andfluid motion.The tip of the device isplaced inside the toothduring cleaning.A piezoelectric element isused to create vibration inthe tip of the devicecreating hydrodynamics(fluid motion) within thetooth.	Generation ofhydroacoustic waves andfluid motion.The tip of the device isplaced inside the toothduring cleaning.Air is used to createvibration in the tip of thedevice creatinghydrodynamics (fluidmotion) within the tooth.The tip of the devicediscontinues moving if itcomes in contact with thewalls of a canal.
Treatment Site	Root canal	Various, including Rootcanal	Root canal
Components	Control UnitIrrigation reservoirsFoot pedalHandpieceAccessories	Control UnitIrrigation reservoirsFoot pedalHandpieceInstruments	HandpieceInstruments

Performance Data:

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

. Simulated Use
EMC and Electrical Safety .
Thermal Safety .
Hydroacoustics .
Apical Extrusion and Pressure ●
Cleaning .

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Section 6 Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Sonendo Endotherapy System is determined by Sonendo, Inc., to be substantially equivalent to existing legally marketed devices.

Sonendo, Inc. Sonendo Endotherapy System

Page 13 of 85 K130025 Deficiencies Response 130610

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2013

Mr. Dan W. Miller Sonendo, Incorporated 26061 Merit Circle, Suite 101 LAGUNA HILLS CA 92653

Re: K130025

Trade/Device Name: Sonendo Endotherapy System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 7, 2013 Received: May 16, 2013

Dear Mr. Miller:

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.

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Page 2 - Mr. Miller

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 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 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/ResourcesforYou/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,

Kwame Ulmer, M.S. Acting Division 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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Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K |30 025

Device Name: Sonendo Endotherapy System

Indications for Use:

The Sonendo Endotherapy System is intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy.

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)

Andrew I. Steen
2013.06.11 11:50:37 -04'00'

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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Anesthesions 37.
Infection Control, Dental Devices

K130525 510(k) Number:_

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.