The Sonendo Gentle Wave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Procedure Instrument or Molar CrossFire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo Gentle Wave Premolar CrossFire™ Procedure Instrument, the system is indicated for premolar teeth.

Device Description

The Sonendo GentleWave X System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave X System is comprised of a Console, and disposable single-use Handpieces and accessories. The Handpiece is offered for molar, anterior and premolar treatments. A Molar Handpiece (original or CrossFire™ model) is intended to be used on 1st and 2nd molar teeth. An Anterior/Premolar (APM) Handpiece is intended to be used on anterior and pre-molar teeth and CrossFire™ Premolar Handpiece is intended for pre-molar teeth only. The Sonendo GentleWave X System delivers a stream of treatment fluids into the pulp chamber of the tooth. The treatment fluids delivered to the tooth are 3% Sodium Hypochlorite (NaOCl) solution and an 8% Ethylenediaminetetraacetic acid (EDTA) utilized in traditional endodontic treatments.

AI/ML Overview

Based on the provided text, the device in question is the Sonendo GentleWave X System, an ultrasonic scaler used for root canal therapy.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in numerical targets (e.g., "accuracy > 90%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sonendo GentleWave System cleared under K160905). The acceptance is therefore based on showing that the new device performs as intended and equivalently to the predicate device through various non-clinical performance tests.

Here's a table summarizing the performance tests conducted (which imply the acceptance criteria are to pass these tests) and the reported outcome:

Test Category	Specific Test	Implied Acceptance Criteria (Pass/Fail)	Reported Device Performance
Performance Verification	Thermal test	Pass (demonstrates proper thermal operation)	"performed and passed"
	Cavitation test	Pass (demonstrates effective cavitation)	"performed and passed"
	Hydroacoustic test	Pass (demonstrates effective hydroacoustic action)	"performed and passed"
	Cleaning test	Pass (demonstrates effective cleaning)	"performed and passed"
	Apical pressure test	Pass (demonstrates acceptable apical pressure)	"performed and passed"
	Apical extrusion test	Pass (demonstrates acceptable apical extrusion)	"performed and passed"
Human Factors	Human Factor Evaluation (per FDA Guidance)	Pass (demonstrates safe and effective usability)	"performed and passed"
Software Validation	Software Validation (moderate level of concern)	Pass (demonstrates software functions as intended)	"performed and passed"
Biocompatibility	Cytotoxicity, Sensitization, Irritation	Pass (demonstrates biological safety)	"performed and passed"
	Material Mediated Pyrogenicity	Pass (demonstrates non-pyrogenic materials)	"performed and passed"
	Acute Systemic Toxicity	Pass (demonstrates no acute systemic toxicity)	"performed and passed"
Safety & EMC	Electromagnetic Compliance & Electrical Safety	Pass (demonstrates compliance with safety standards)	"performed and passed"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify exact sample sizes for each of the non-clinical performance tests (e.g., how many units were tested for the thermal test, or how many simulated canals were cleaned for the cleaning test). It simply states that "All necessary performance testing has been conducted."
Data Provenance: The data is all non-clinical bench testing. The country of origin is not explicitly stated for the testing, but the company (Sonendo, Inc.) is located in California, USA. The testing is prospective in the sense that it was conducted specifically to support this premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable (N/A) because the study relies on non-clinical bench testing and engineering verification, not human expert assessment of medical images or patient outcomes. The "ground truth" for these engineering tests are established engineering specifications and measurement standards.

4. Adjudication Method for the Test Set

N/A. Since the testing is automated or standardized bench testing with objective measurements (e.g., temperature, pressure, electrical parameters), there is no need for human adjudication of results in the way it would be applied to clinical image readings. The results are typically compared against pre-defined engineering limits or specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improvement with AI vs. without AI assistance.

No. The document explicitly states: "No clinical data is submitted in support of this Premarket Notification." This means no MRMC study was conducted, and therefore no effect size for human reader improvement with AI assistance is reported. The device is not an AI-assisted diagnostic tool; it is a physical medical device for root canal therapy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.

N/A (for "algorithm only"). The device's performance is not primarily based on an "algorithm only" in the sense of a standalone AI diagnostic tool. It's a system with hardware and software. The "performance verification" tests assess the overall device's functional performance standalone, in a bench setting, against its specifications. The software validation is for the embedded software controlling the device, not a standalone AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's acceptance is based on engineering specifications, recognized consensus standards (e.g., ISO, IEC), and established physical principles. For example, the "cleaning test" would likely have a pre-defined objective measure of cleanliness that constitutes "ground truth" for successful cleaning. Similarly, pressure and temperature measurements have objective "ground truth" values defined by physics and instrumentation. There is no biological or clinical ground truth (like pathology or outcomes data) used in this submission.

8. The Sample Size for the Training Set

N/A. As no clinical data or AI/machine learning model dependent on a training dataset was used or submitted for this premarket notification, there is no "training set" in the context of AI model development.

9. How the Ground Truth for the Training Set Was Established

N/A. (See point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 5, 2021

Sonendo, Inc Lyle VerPlanck Director of Regulatory Affairs & Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

Re: K203302

Trade/Device Name: GentleWave X Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 6, 2020 Received: November 9, 2020

Dear Lyle VerPlanck:

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 aware 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.

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Confidential

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name GentleWave X

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)

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 Drug 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

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

General Information
510(k) number:	K203302
Date Summary Prepared:	February 3, 2021
Submitted by:	Sonendo, Inc.22061 Merit Circle, Suite 102Laguna Hills, CA 92653
Establishment RegistrationNumber:	3010817521
Contact Person:	Lyle VerPlanckDirector of Regulatory Affairs & Quality AssurancePhone: (949) 667-7260FAX: (949) 305-5201E-mail: lverplanck@sonendo.com
Reason for PremarketNotification:	New model of GentleWave System
Trade Name:	GentleWave X
Regulation Name:	Ultrasonic Scaler
Review Panel :	Dental
Classification Regulation:	872.4850
Product Code:	ELC
Regulatory Class:	Class II
Predicate Device:	Sonendo GentleWave System via K160905

{4}------------------------------------------------

Device Description

The Sonendo GentleWave X System delivers a stream of treatment fluids into the pulp chamber of the tooth. The treatment fluids delivered to the tooth are 3% Sodium Hypochlorite (NaOCl) solution and an 8% Ethylenediaminetetraacetic acid (EDTA) utilized in traditional endodontic treatments.

The design of this device incorporated the consensus standards listed in Table 1.

RecognitionNumber	StandardDesignationNumber	Standard Title
2-258	ISO 10993-1	Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess
2-245	ISO 10993-5	Biological evaluation of medical devices - Part 5: Testsfor in vitro cytotoxicity
2-174	ISO 10993-10	Biological evaluation of medical devices - Part 10: Testsfor irritation and skin sensitization
2-255	ISO 10993-11	Biological evaluation of medical devices - Part 11: Testsfor systemic toxicity
19-4	IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
19-8	IEC 60601-1-2	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential perform
4-262	IEC 80601-2-60	Particular requirements for the basic safety and essentialperformance of dental equipment
5-114	IEC 62366-1	Medical devices - Part 1: Application of usabilityengineering to medical devices

Table 1 - Recognized Consensus Standards

{5}------------------------------------------------

Indications for Use

The Sonendo GentleWave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Procedure Instrument orMolar CrossFire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo GentleWave Premolar CrossFire™ Procedure Instrument, the system is indicated for premolar teeth.

Substantial Equivalence Summary and Discussion

The table below includes a comparison between the new device and the predicate device:

Characteristic	Predicate Device	Proposed Device
510(k) Clearance #	K160905	TBD
Console Model	GentleWave®	GentleWave™ X
Indications for Use	The Sonendo GentleWave Systemis intended to prepare, clean, andirrigate teeth indicated for rootcanal therapy. When used withthe Sonendo GentleWave MolarHandpiece, the System is indicatedfor 1st and 2nd molar teeth.When used with the SonendoGentleWave Anterior/PremolarHandpiece, the System is indicatedfor anterior and premolar teeth.	The Sonendo GentleWave X Systemis intended to prepare, clean, andirrigate teeth indicated for root canaltherapy. When used with theSonendo GentleWave MolarProcedure Instrument or MolarCrossFire™ Procedure Instrument,the System is indicated for 1st and2nd molar teeth. When used withthe Sonendo GentleWaveAnterior/Premolar ProcedureInstrument, the System is indicatedfor anterior and premolar teeth.When used with the SonendoGentleWave Premolar CrossFire™Procedure Instrument, the system isindicated for premolar teeth.
New Contraindications	---	Primary dentitionPatients with sensitivity to NaOCland / or EDTA
Function	Preparation, cleaning and irrigationof root canal	Identical as predicate
Characteristic	Predicate Device	Proposed Device
Principal of Operation	Generation of hydroacoustic wavesand fluid motion via application ofsonic energy	Identical as predicate
Treatment Site	Root Canal	Identical as predicate
Components	Control UnitIrrigation reservoirsFoot pedalHandpieceHand piece Accessories	Identical as predicate
Duration of treatmentapplication	7 minutes or less	Identical as predicate
Treatment fluidConcentration	Fixed	Identical as predicate
Fluid Containers	1 × 500 mL NaOCl irrigationsolution1 × 250 mL EDTA irrigationsolution1 × 2000 mL distilled water forirrigation	1 × 1360 mL NaOCl irrigationsolution1 × 540 mL EDTA irrigationsolution1 × 2650 mL distilled water forirrigation
Material	Medical grade material	Identical as predicate
Biocompatibility	Biocompatible per 10993	Identical as predicate
Handpiece models	Molar Handpiece (original model),Anterior/Premolar Handpiece	Molar Handpiece (original orCrossFire™ model ),Anterior/Premolar Handpiece,Premolar CrossFire™ modelHandpiece
Handpiece Sterilization	Sterile (Gamma)Single useSterility Assurance Level (SAL) 10-6	Identical as predicate
Consumable Shelf Life	1 year	Identical as predicate

Table 1 - Comparison of Predicate and Proposed Devices

{6}------------------------------------------------

The proposed device has the same intended use, function, principal of operation, control mechanism, sterilization and shelf life as the predicate device. The indications for use is slightly changed to add new models of the handpiece within the scope of the predicate device indications

{7}------------------------------------------------

for use. To highlight that the use of GentleWave X system is limited to treat permanent teeth only, contraindication for primary dentition teeth is added. Furthermore, to minimize any potential adverse reaction, the device is contraindicated for use on patients with a known sensitivity to NaOCl and/ or EDTA. The new handpiece models are added to increase manufacturability and there is no change in the handpiece operating principal. The new Console model has increased capacity, with larger bottle sizes to facilitate more treatments cycles. The new model is designed to improve customer interface, product reliability and manufacturability. Performance testing is completed to show the equivalency between the proposed and predicate devices.

Non-Clinical Performance Testing

All necessary performance testing has been conducted on the Sonendo GentleWave System X to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. The following bench testing in accordance with standards listed in Table 1 was performed and passed to support the substantial equivalence of the subject device:

Performance Verification
- Thermal test O
- Cavitation test O
- Hydroacoustic test O
- Cleaning test O
- Apical pressure test o
- Apical extrusion test o
Human Factor Evaluation per the FDA Guidance Document "Applying Human Factors and Usability ● Engineering to Medical Devices"
Software Validation for moderate level of concern per the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
. Biocompatibility
- Cytotoxicity, sensitization, irritation, material mediated pyrogenicity, and acute systemic 0 toxicity
Electromagnetic Compliance and Electrical Safety

Clinical Data

No clinical data is submitted in support of this Premarket Notification.

Conclusion

The Sonendo GentleWave X System is a new model of the existing Sonendo GentleWave® System. The Sonendo GentleWave X System is substantially equivalent to the Sonendo GentleWave System cleared under premarket notification K160905.

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.