The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

Device Description

The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

The medical device consists of the following components that are also included in the scope of delivery:

Control unit (PB-510, PB-520, and PB-530)
Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q)
Foot control (wired, wireless)
A Power supply, instruction for use and other accessories

The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications:

Scaling-tips
Periodontic-tips
Implant-cleaning-tips
Endodontic-tips
Tips for restoration and prosthetics

With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal).

Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).

AI/ML Overview

This document is a marketing clearance (510(k)) for a dental device, the Proxeo ULTRA. It details the device's characteristics and its equivalence to previously cleared predicate devices. Since this is a 510(k) summary for a physical medical device (ultrasonic scaler), not a diagnostic or AI-powered software, the typical acceptance criteria and study designs that involve metrics like sensitivity, specificity, or reader studies with AI assistance are not applicable in the same way they would be for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, performance data (bench testing, biocompatibility, electrical safety, reprocessing validation), and adherence to relevant standards. It does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics for diagnostic or AI-based devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are not relevant or reported for this type of device clearance.

Instead, the "acceptance criteria" for a device like the Proxeo ULTRA are primarily met by demonstrating that it performs as intended (as shown by bench testing) and is as safe and effective as existing legally marketed devices.

Here's how the information would typically be presented if it were an AI/ML device, alongside an explanation of why it's not applicable here:

Based on the provided FDA 510(k) summary for the Proxeo ULTRA (an ultrasonic dental scaler), the requested information regarding acceptance criteria and study designs for AI/ML performance metrics is NOT applicable.

This document is for a physical medical device and demonstrates substantial equivalence through:

Technical Characteristics Comparison: Showing similar design, operating principles, and materials to predicate devices.
Performance Data: This primarily involves non-clinical testing to ensure the device functions as intended and meets safety standards, rather than diagnostic accuracy or clinical outcome studies in the context of AI.

Therefore, the following specific information cannot be extracted from this document:

A table of acceptance criteria and the reported device performance (in terms of AI/diagnostic metrics): Not applicable. The "performance" is demonstrated through bench testing, biocompatibility, electrical safety, and reprocessing validation, ensuring the device operates as specified and is safe.
Sample sizes used for the test set and the data provenance: Not applicable. There isn't a "test set" of clinical data for diagnostic performance. Bench testing is mentioned, but specific sample sizes for its components are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established for an ultrasonic scaler.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. There is no AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Instead, for this device, the "acceptance criteria" are implied by the demonstration of substantial equivalence, which includes:

Manufacturing and Safety Standards Compliance: The device complies with relevant IEC standards (IEC 60601-1, IEC 80601-2-60, IEC 60601-1-2) for electrical safety and EMC.
Biocompatibility: Evaluation according to ISO 10993 series.
Reprocessing Validation: Validation per FDA Guidance for Medical Devices.
Bench Testing: Functional testing (application, settings, features) per device specifications.
Software Verification: Compliance with IEC 62304 and FDA guidance for software, given its moderate level of concern.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing (bench, biocompatibility, electrical safety, reprocessing, software verification) that demonstrates the device performs as intended and is as safe and effective as its predicate devices. The document explicitly states: "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device... and the reference device..."

Summary

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July 14, 2023

W&H Dentalwerk Buermoss GmbH Gerhard Weidler Regulatory Affairs Manager Ignaz-Glaser-Strasse 53 Buermoos, Salzburg 5111 AUSTRIA

Re: K223173

Trade/Device Name: Proxeo ULTRA (PB-510, PB-520 and PB-530) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 21, 2023 Received: June 23, 2023

Dear Gerhard Weidler:

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.

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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/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 medical devices and radiation-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 -S

Michael E. Adjodha, M.ChE. 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

510(k) Number (if known) K223173

Device Name Proxeo ULTRA (PB-510, PB-520 and PB-530)

Indications for Use (Describe)

Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

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

Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K223173

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DATE PREPARED	July 13, 2023
APPLICANT	W&H Dentalwerk Buermoos GmbHIgnaz-Glaser-Straße 535111 BürmoosAustria0043 - 6274/6236-00043 - 6274/6236-55
CONTACT PERSON	Mag. Dr. Gerhard WeidlerRegulatory Affairs Manager0043 - 6274/6236-9339gerhard.weidler@wh.com

1 Device Name:

Trade Name:	Proxeo ULTRA (PB-510, PB-520 and PB-530)
Common Name:	Proxeo ULTRA
Device Classification Name:	Ultrasonic scaler

Classification / Product Code: വ

The Proxeo ULTRA can be classified according to following device name and product code:

Device	RegulationDescription	RegulationMedicalSpecialty	ReviewPanel	ProductCode	RegulationNumber	DeviceClassification
Scaler,Ultrasonic	Ultrasonicscaler	Dental	Dental	ELC	872.4850	2

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Predicate Device / Reference Device: 3

Device	PredicateDevice	ReferenceDevice	510(k)Number	510(k) Holder
Scaler,Ultrasonic	Multipiezo Pro	--------	K140965	Mectron Spa
	--------	Piezon 250	K132445	E.M.S. ELECTROMEDICAL SYSTEMSS.A.

4 Device Description:

The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

The medical device consists of the following components that are also included in the scope of delivery:

Control unit (PB-510, PB-520, and PB-530)
Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q) >
Foot control (wired, wireless)
A Power supply, instruction for use and other accessories

V Scaling-tips
Periodontic-tips
V Implant-cleaning-tips
Endodontic-tips
Tips for restoration and prosthetics

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Indications for Use ട്

Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontics application and preparation of tooth enamel.

Technological Characteristics 6

The technological characteristics of Proxeo Ultra are the technological characteristics of the predicate device.

	W&H DentalwerkBürmoos GmbH –Proxeo Ultra(New Device)	Mectron Spa–Multipiezo Pro(Predicate Device)	EMS Electro MedicalSystems SA –Piezon 250(Reference Device)	Result
DeviceName	Proxeo Ultra	Multipiezo Pro	Piezon 250	---
RegulationNumber	872.4850	872.4850	872.4850	Identical
Class	II	II	II	Identical
ProductCode	ELC	ELC	ELC	Identical
RegulationGenericName	Ultrasonic scaler	Ultrasonic scaler	Ultrasonic scaler	Identical
Indicationsfor Use	Drive unit with apiezoceramicoscillating system,which moves the tipin a linear oscillation.The drive unit is usedfor the removal ofsupragingivalcalculus andsubgingivalconcretions and forendodonticapplication andpreparation of toothenamel.	The Multipiezo Pro andMultipiezo arepiezoelectric ultrasonicdental scalers intendedfor use, with theappropriate associatedtip inserts, in thefollowing dentalapplications:> Scaling: All generalprocedures forremoval ofsupragingival/subgingival andinterdentalcalculus/ plaquedeposits	The Piezon 250 is adevice for deliveringultrasonic movementand irrigant to astainless-steel tipwhich is used by adentist or dentalhygienist. Theindications for useare:> Periodontalpocket lavagewithsimultaneousultrasonic tipmovement	Equivalent
	W&H DentalwerkBürmoos GmbH –Proxeo Ultra(New Device)	Mectron Spa–Multipiezo Pro(Predicate Device)	EMS Electro MedicalSystems SA –Piezon 250(Reference Device)	Result
		> Periodontology:Periodontaltherapy anddebridement for alltypes ofperiodontaldiseases, includingperiodontal pocketirrigation andcleaning> Endodontics: Alltreatments for rootcanal reaming,irrigation, revision,filling, gutta-perchacondensation andretrogradepreparationRestorative andProsthetics: All generalrestorative proceduresincluding cavitypreparation, removal ofprostheses, amalgamcondensation, finishingof crown preparations,inlay/onlaycondensation,implants/restorationscleaning.	> Scaling and rootplanningRemoval of supraand subgingivalcalculus and stainsfrom teeth
Functions	The basic function isthe conversion ofelectrical energy intomechanical energy(linear oscillation).	The Multipiezo Prodevice is dentalpiezoelectric ultrasonicdevice that useultrasonic energy togenerate mechanicalmicro-vibration of theinserts to perform thedental proceduresdefined in theirintended use.	Ultrasonic scaling	Identical
Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile	Identical
	W&H DentalwerkBürmoos GmbH –Proxeo Ultra(New Device)	Mectron Spa–Multipiezo Pro(Predicate Device)	EMS Electro MedicalSystems SA –Piezon 250(Reference Device)	Result
Electricpowersupply	100-230 V ± 10%50-60 Hz	100-240 VAC50-60 Hz	100-240 VAC50-60 Hz	Equivalent
OperatingMode	ContinuousOperation	Continuous Operation	Continuous Operation	Identical
Electricclassification	B	B	BF	Equivalent
Ultrasonicfrequency	22-35 kHz	24-36 kHz	24-32 kHz	Equivalent
Foot control	> wireless> wired	> wired	> wired	Equivalent
Components	> Control Unit> Handpiece (indifferent versions)> Foot control (indifferent versions)> Power supply,instruction for use> Scaler tips	> Control Unit> Handpiece> Foot control> Power supply> Scaler tips	> Control Unit> Handpiece> Foot control> Instruments> Irrigating liquidbottle	Equivalent

6.1 Device Characteristics Table

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6.2 Summary of Technological Characteristics

The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.

Performance Data: 7

Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K140965) and the reference device (K132445).

7.1 Biocompatibility

An evaluation of biocompatibility according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ISO 10993-18 and ISO 10993-23 was performed.

Electromagnetic Compatibility and Electrical Safety 7.2

Electrical safety and EMC testing were conducted. The Proxeo ULTRA is in compliance with IEC 60601-1, IEC 80601-2-60 as well as IEC 60601-1-2.

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7.3 Re-processing Validation

Reprocessing validation was provided per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Cleaning and intermediate level disinfection validation was provided for the control unit and foot controller. Cleaning and sterilization validation was provided for the scaler tips and handpieces.

7.4 Bench Testing

Functional testing of the Proxeo ULTRA to test the application, settings, and features per the device specifications requirements.

8 Software:

Software verification according to IEC 62304 and the FDA Guidance Document for Software Contained in Medical Device was conducted and the necessary software documentation according to the defined moderate level of concern was provided.

Substantial Equivalence Summary / Conclusion: ி

Based on available 510(k) information provided herein, our Proxeo ULTRA is considered to be substantially equivalent to the predicate device Multipiezo Pro and the reference device Piezon 250 in terms of indication for use, materials and technology, design and performance specifications.

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.