Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.

AI/ML Overview

The provided text describes Sonendo Material A, a root canal filling resin, and its FDA 510(k) clearance based on substantial equivalence to a predicate device, iRoot SP Root Canal Sealer (K080917).

However, the document does not contain any information about an AI/ML powered device, nor does it provide details about acceptance criteria for an AI/ML product, performance metrics typically associated with AI/ML (e.g., accuracy, sensitivity, specificity, AUC), or studies involving human readers or ground truth established by experts/pathology for an AI model.

The "Performance Data" section of the document refers to bench testing to demonstrate physical-chemical properties and biocompatibility, which are standard for medical devices like root canal filling resins, not AI/ML software.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details. The input document pertains to a traditional medical device (root canal filling resin) and its regulatory clearance process.

Summary

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October 22, 2018

Sonendo, Inc. Eric Simon Director of Regulatory Affairs and Quality Assurance, Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, California 92653

Re: K181922

Trade/Device Name: Sonendo Material A Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: July 17, 2018 Received: July 18, 2018

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 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

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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.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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.

Mary S. Runner -S3

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
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Indications for Use

510(k) Number (if known)	K181922
Device Name	Sonendo Material A
Indications for Use (Describe)	Permanent obturation of the root canal following root canal treatment.

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)

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7.0 510(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:	July 17, 2018
CONTACT PERSON:	Eric Simon26061 Merit Circle, Suite 102Laguna Hills, CA 92653Phone: 949.766.3636Fax: 949.305.5201
TRADE NAME:	Sonendo Material A
COMMON NAME:	Resin, Root Canal Filling
CLASSIFICATION NAME:	Root canal filling resin
DEVICE CLASSIFICATION:	Class 2, per 21 CFR 872.3820
REVIEWING PANEL:	Dental
ESTABLISHMENT REGISTRATION NO.	3010817521
PRODUCT CODE	KIF

PREDICATE DEVICES: iRoot SP Root Canal Sealer (K080917)

Substantially Equivalent To:

The Sonendo Material A is substantially equivalent in intended use, principle of operation and technological characteristics to the iRoot Canal Sealer (K080917).

Description of the Device Subject to Premarket Notification:

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Indication for Use:

Permanent obturation of the root canal following root canal treatment.

Device Comparison Table:

	SonendoMaterial A(SubjectDevice)	iRoot SP Root CanalSealer (PredicateDevice - K080917)	Discussion/Justification ofDifferences
Indicationfor Use	Permanentobturation of theroot canalfollowing rootcanal treatment	Permanent obturation of theroot canal following vitalpulp-extirpationPermanent obturation of theroot canal followingremoval of infected ornecrotic pulp and placementof intracanal dressings	Equivalent
BasicChemicalComposition	Sodium alginate,glycerol, calciumsulfate, calciumtungstate, sodiumpyrophosphate,polysorbate 60,zinc oxide,fumed silica,ytterbiumfluoride, bariumborosilicate	Zirconium oxide, dicalciumsilicate, calcium hydroxide,calcium phosphatemonobasic, filler, thickeningagent	iRoot SP Root Canal Sealer wasidentified as the predicate device due tothe subject device having similarmaterials and delivery form (i.e.premixed ready-to-use injectable paste)to the predicate. The predicate device iscomposed of lubricants, a radiopaqueagent and thickening agents as does thesubject device. Results of bench andbiocompatibility testing completed inalignment with ISO 6876 and ISO10993-1, respectively demonstrate thatany material differences between thesubject device and predicate device donot raise any new questions as to safetyand effectiveness. Therefore, it isconcluded that Sonendo Material A issubstantially equivalent to the predicatedevice.
Standard	ISO 6876ISO 10993-1	ISO 6876ISO 10993-1	Equivalent
TreatmentSite	Root canal	Root Canal	Equivalent
Sterile	Non-sterile	Non-sterile	Equivalent
Packaging	Pre-loadedsyringe	Pre-loaded syringe	Equivalent

Performance Data:

Sonendo Material A has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP Root Canal Sealer. Bench tests include: flow, working time, setting time, film thickness, solubility, and radiopacity in alignment with ISO 6876.

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Biocompatibility test results demonstrate that Sonendo Material A is non-mutagenic, non-cytotoxic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.

Conclusion:

Sonendo Material A and its predicate device have the same intended use, provides similar chemical, physical and biocompatible properties, and comparable performance specifications to iRoot SP Root Canal Sealer. The subject and predicate devices are packaged in similar materials and utilize similar methods of application. Any differences in the technological characteristics do not raise new issues of safety or effectiveness.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.