The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the BioSonic US200 Ultrasonic Scaler, which is an ultrasonic scaling unit for dental procedures. It is a Class II device (Regulation Number 872.4850, Product Code ELC).

This document does not contain the specific acceptance criteria and detailed study results for a device that uses a test set for performance evaluation in the way typically expected for AI/ML-driven devices. This is because the BioSonic US200 Ultrasonic Scaler is a hardware device, not an AI/ML software device.

The "studies" referenced are non-clinical performance tests conducted to ensure safety and effectiveness in comparison to a predicate device, focusing on electrical and mechanical aspects, and material compatibility. There are no mentions of "test sets", "ground truth", "experts", "adjudication methods", "MRMC studies", or "standalone performance" in the context of assessing an algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as those categories are not applicable to the type of device and submission described.

However, I can extract information about the type of tests performed and the general conclusion regarding acceptance criteria (though not specific numerical criteria for performance metrics).

Here's what I can extract regarding the device's testing and intended performance from the document:

General Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Reported Device Performance/Conclusion
Safety and Effectiveness (overall)	The BioSonic US200 Ultrasonic Scaler is "as safe, as effective, and performs as well as or better than the predicate device BioSonic Scaler system (K983727, 21 CFR 872.4850, product code ELC)." This implies meeting relevant standards and predicate device performance.
Electrical Safety and Electromagnetic Compatibility (EMC)	Meets the requirements of IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests).
Software Verification	Software verification was conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (No specific performance metrics are given, but compliance with the guidance is stated.)
Mechanical/Physical Performance	Non-clinical tests included: - Frequency testing (e.g., verifying 25kHz or 30kHz operation). - Power testing. - Tip displacement testing. - Insert extraction testing.
Material Compatibility	Materials compatibility testing with cleaning and disinfecting agents was performed.
Substantial Equivalence to Predicate	The device's indications for use are identical to the predicate. Technological characteristics are substantially equivalent with minor differences (mechanism to change modes, automatic frequency detection, removable autoclavable sheath) that "do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate." This is the overarching acceptance criterion for 510(k) clearance.

Why the other requested information cannot be provided from this document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device's non-clinical testing. "Test sets" in this context refer to electrical/mechanical measurements, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" usually refers to diagnostic accuracy in AI/ML, not the physical properties of an ultrasonic scaler.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for this hardware device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

This document solely concerns the FDA's 510(k) clearance of a traditional, non-AI medical device based on its physical and electrical performance and comparison to a predicate device.

Summary

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July 1, 2024

Dent4You AG Tricia Cregger Global Regulatory Affairs Manager Bahnhofstrasse 2 Heerbrugg, 9435 SWITZERLAND

Re: K240801

Trade/Device Name: BioSonic US200 Ultrasonic Scaler (60034537) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: March 22, 2024 Received: March 25, 2024

Dear Tricia Cregger:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240801

Device Name

BioSonic US200 Ultrasonic Scaler (60034537)

Indications for Use (Describe)

Ultrasonic Applications for:

All sub-qingival and supra-qingival scaling and routine prophylaxis procedures.
Periodontal therapy

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) #:	K240801	510(k) Summary	Prepared on: 2024-06-26
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Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Dent4You AG
Applicant Address	Bahnhofstrasse 2 Heerbrugg 9435 Switzerland
Applicant Contact Telephone	330-916-8904
Applicant Contact	Dr. Tricia Cregger
Applicant Contact Email	tricia.cregger@coltene.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	BioSonic US200 Ultrasonic Scaler (60034537)
Common Name	Ultrasonic scaler
Classification Name	Scaler, Ultrasonic
Regulation Number	872.4850
Product Code(s)	ELC
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K983727	BioSonic Ultrasonic Scaler System	ELC
Device Description Summary		21 CFR 807.92(a)(4)
The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.
Intended Use/Indications for Use		21 CFR 807.92(a)(5)
Ultrasonic Applications for:- All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.- Periodontal therapy
Indications for Use Comparison		21 CFR 807.92(a)(5)
The indications for use of the BioSonic US200 Ultrasonic Scaler are identical to the indicatrions for use of the predicate device, the BioSonic Ultrasonic Scaler System.
Technological Comparison		21 CFR 807.92(a)(6)
The BioSonic US200 Ultrasonic Scaler (subject device) and the BioSonic Ultrasonic Scaler System are both ultrasonic scalers for sub-gingival and supra-gingival scaling and routine prophylaxis procedures and periodontal therapy. The indications for use are identical and the technological characteristics are substantially equivalent with only minor differences, including the mechanism to change from

and the technological characteristics are substantially equivalent with only minor differences, including the mechanism to change from NORMAL to Turbo Mode, the automatic frequency detection of the scaler insert, and the removable autoclavable sheath. These minor differences do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate

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Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing was conducted to verify that the proposed BioSonic US200 Ultrasonic Scaler meets the requirements of IEC 60601-1 and IEC 60601-1-2. Software verification of the device were conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" Performance Testing – Bench, of this Premarket Submission, contains detailed information regarding the proposed BioSonic Scaler including testing protocols, test objectives, test articles, test methods and procedures, and acceptance criteria.

Non-clinical tests performed to establish substantial equivalence to the including frequency testing. power testing, tip displacement testing, insert extraction testing and, and materials compatibility testing with cleaning and disinfecting agents.

Not Applicable

Based on the non-clinical performance data the proposed BioSonic Scaler is as safe, as effective, and performs as well as or better than the predicate device BioSonic Scaler system (K983727, 21 CFR 872.4850, product code ELC.)

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.