The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the PIEZON BUILT-IN KIT, which is an ultrasonic scaler intended for dental cleaning. The primary claim for substantial equivalence is that the new device is essentially the same as a previously cleared predicate device (PIEZON 150), with the main difference being that the components are integrated into a dental chair rather than being a standalone unit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A Table of Acceptance Criteria and the Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the sense of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for an AI/CADe device. Instead, the acceptance criteria are related to engineering performance, electrical safety, electromagnetic compatibility, and functional integration, demonstrating that the reconfigured device performs equivalently to its predicate.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Risk Management	All identified risks are reduced to acceptable levels.	A Risk Assessment was performed for the configurable kit as a standalone product and an additional risk analysis for its integration as a subsystem in a dental chair. All residual risks post-mitigation were deemed acceptable.
Functional Specifications & Components	No changes to functional specifications or components.	The proposed device and predicate device use the "same internal componentry" and "same attached accessories."
Biocompatibility	Patient-contacting components are biocompatible and equivalent to the predicate.	Biocompatibility assessment was performed according to ISO 10993-1. No new testing was necessary as all patient contacting components are identical to the cleared predicate (Piezon 150, K132443).
Electrical Safety	Conforms to relevant electrical safety standards.	Electrical Safety is equivalent to the predicate device based on IEC 60601-1. All tests passed, and conformance is confirmed.
Electromagnetic Compatibility (EMC)	Conforms to relevant EMC standards.	Electromagnetic Compatibility is equivalent to the predicate device based on IEC 60601-1-2. All tests passed, and conformance is confirmed.
Integration/Functional Performance	The device functions correctly when integrated into the dental chair; performance is not impacted by the change in housing.	"functional testing was completed on the integrated product to confirm product functionality." This included "verification of device installation into the chair as per installation specifications and confirmation of product functionality." All tests were successfully performed and all acceptance criteria were met.
Safety and Effectiveness Questions	Does not raise new questions of safety or effectiveness.	"No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of testing."

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

The document does not describe a "test set" in the context of a clinical study or AI model validation with patient data. The testing performed is related to engineering verification and validation of the device's physical and electrical properties, and its functional integration.

Sample Size: Not applicable in the context of patient data. The "sample" for testing would be units of the device (PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED) and their integration within dental chairs. The document states "All tests were successfully performed," implying sufficient physical units were tested to demonstrate compliance.
Data Provenance: Not applicable in the sense of patient data origin. The "data" comes from engineering tests performed by the manufacturer. It is internal company data.
Retrospective or Prospective: Not applicable in the sense of patient data. The engineering tests were implicitly prospective (i.e., designed and executed to verify the new product configuration).

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

Not applicable. This device is an ultrasonic scaler, a physical medical device, not a diagnostic AI/CADe system requiring expert-adjudicated ground truth from medical images. The "ground truth" for its performance is derived from engineering standards, functional tests, and comparison to the predicate device's proven performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for image interpretation or diagnosis described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an ultrasonic scaler, not an AI/CADe system for diagnostic assistance. Therefore, an MRMC study is not relevant to its clearance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence claim relies on:

Engineering Standards: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
Functional Verification: Demonstrating that the device operates as intended in its new integrated configuration.
Predicate Equivalence: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (PIEZON 150). The argument is that since the new device uses the same internal components and technology and only differs in its housing (integrated into a dental chair vs. standalone), its performance is inherently equivalent.
Risk Analysis: A detailed risk assessment confirming that the change in housing does not introduce new or unacceptable risks.

8. The Sample Size for the Training Set

Not applicable. 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. As above, this is not an AI/ML device.

In summary, the provided document details a 510(k) submission for a traditional medical device (ultrasonic scaler) where the primary evidence for substantial equivalence comes from engineering testing and a comparison to a predicate device, rather than a clinical study involving patient data or AI model performance metrics. The "acceptance criteria" and "proof" relate to the physical and electrical performance of the device and its safe integration into a dental chair.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2019

E.M.S Electro Medical Systems S.A % Christina Henza Regulatory Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave #286 Libertyville, Illinois 60048

Re: K191079

Trade/Device Name: Piezon Built-in Kit, Piezon Built-in Kit LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: Class II Product Code: ELC Dated: May 20, 2019 Received: May 20, 2019

Dear Christina Henza:

This letter corrects our substantially equivalent letter of August 16, 2019.

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 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.

Digitally signed by Michael E. Michael E. Adiodha -S Date: 2019.11.01 07:05:39 Adiodha -S -04'00'

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191079

Device Name PIEZON BUILT-IN KIT

Indications for Use (Describe) Scaling:

Removal of supragingival and subgingival calculus
Removal of stains
Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary for PIEZON BUILT-IN KIT - K191079

Date: August 8, 2019 l.

ll. SUBMITTTER/ 510(K) HOLDER

E.M.S. Electro Medical Systems S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Primary Contact:

Suzanne FASSIO-HARDY, Regulatory Affairs Manager - Dental Direct: +41 22 99 44 771 Email: sfassiohardy@ems-ch.com

Submission Contact:

Christina Henza Regulatory Affairs Consultant 872 S. Milwaukee Ave #286 Libertyville, IL 60048 +1 262 220 3463 chenza@ultralifescience.com

III. DEVICE NAME
Proprietary Name: PIEZON BUILT-IN KIT Common/Usual Name: Ultrasonic scaler Classification Name: Ultrasonic scaler (872.4850) Device Class: II Product Code: ELC

IV. PREDICATE DEVICES

E.M.S. Electro Medical Systems S.A., Piezon 150 (K132443 cleared on 11/22/2013). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

V. DEVICE DESCRIPTION

The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which

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is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

VI. INDICATIONS FOR USE
Scaling:
Removal of supragingival and subgingival calculus
Removal of stains
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE
The proposed device and the predicate device have equivalent technological characteristics. The proposed device and the predicate device are both manufactured using the same internal componentry. The devices meet the same performance specifications and the change in presentation from a stand alone device to a built in device has been validated.

The safety and effectiveness questions regarding the change in presentation from a stand alone device to a built in device are whether the device maintains electrical safety / compatibility characteristics and whether the use is adequately described within the instructions. These questions apply to both the proposed device and the predicate; the proposed device does not raise different questions of safety and efficacy.

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Therefore, the proposed devices, PIEZON BUILT-IN KIT & PIEZON BUILT-IN KITLED, meets substantial equivalence requirements with regards to the legally marketed predicate PIEZON 150 (K132443 cleared on 11/22/2013).

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Substantial Equivalence Table
Item for Comparison		Proposed Device(PIEZON BUILT-IN KIT & PIEZON BUILT-INKIT LED)	Predicate Device(PIEZON 150)	Variation
ulatory Informat	Name	PIEZON BUILT-IN KIT & PIEZON BUILT-INKIT LED	Piezon 150	N/A
	510(k)#	K191079	K132443	N/A
	Predicates	K132443	K953026 & K093000	N/A
	Product Code	ELC	ELC	Same.
	Class	2	2	Same.
	CombinationProduct	No	No	Same.
	RegulationNumber	872.4850	872.4850	Same.
	RegulationGeneric Name	Ultrasonic scaler	Ultrasonic scaler	Same.
tended us	RegulationIntended Use	"for use during dental cleaning andperiodontal (gum) therapy to removecalculus deposits from teeth by applicationof an ultrasonic vibrating scaler tip to theteeth"	"for use during dental cleaning andperiodontal (gum) therapy to removecalculus deposits from teeth byapplication of an ultrasonic vibratingscaler tip to the teeth"	Same.
	Indications	Scaling:- Removal of supragingival and subgingival calculus- Removal of stains	The PIEZON 150 is a device for deliveringultrasonic movement and water to astainless steel tip which is used by adentist or dental Hygienist. TheIndications for use are:- Periodontal pocket lavage withsimultaneous ultrasonic tip movement- scaling and root planning- Removal of supra and subgingivalcalculus and stains from teeth.	Equivalent.
	Contraindications	lt is recommended not to treat patientswith a cardiac pacemaker or a defibrillatorwith this product. The functionality ofthese devices may be affected by the highfrequencies of the ultrasonic oscillations.	Ultrasonic oscillations may preventcardiac pacemakers and defibrillatorsfrom functioning properly. Therefore, werecommend that patients with a cardiacpacemaker or a defibrillator should notbe treated with this product	Same.
Substantial Equivalence Table
		Proposed Device(PIEZON BUILT-IN KIT & PIEZONBUILT-IN KIT LED	Predicate Device(PIEZON 150)	Explanation ofVariation
nological Characterist	Anatomical sites	Teeth and soft tissues in themouth.	Teeth and soft tissues in the mouth	Same.
	Specific Treatment site	Supragingival	Supra and Subgingival	Equivalent.
	Contact duration	Limited ≤ 24 hours	Limited ≤ 24 hours	Same.
	Biocompatibility	Biocompatible	Biocompatible	Same.
	Patient ContactMaterial	Stainless SteelbbSuEPDMStainless steel: AISI 316LTitaniumcoc	Stainless SteelPPSUEPDMStainless steel: AISI 316LTitaniumcoc	Same.
	Sterility	Provided non-sterile	Provided non-sterile	Same.
	Shelf life	unrestricted	unrestricted	Same.
	General purpose	dental cleaning and periodontal(gum) therapy	dental cleaning and periodontal (gum)therapy	Same.
	Treatment	Ultrasonic Scaling	Ultrasonic Scaling	Same.
	Mechanism oftreatment	application of an ultrasonicvibrating scaler tip to the teeth	application of an ultrasonic vibrating scalertip to the teeth	Same.
	Service pressure to theturbine connection:Water	1 to 2.2 bar (1000-2200 hPa) witha service flow of 50-80 ml/min.)	1 to 2.2 bar (1000-2200 hPa) with a serviceflow of 50-80 ml/min.)	Same.
	Service pressure to theturbine connection: Air	Static pressure 2.7 to 3.5 bar(2700-3500 hPa	Static pressure 2.7 to 3.5 bar (2700-3500hPa	Same.
	Electric power supply	24 VAC ± 10%33 VDC + 10%●	100-240 VAC●50-60Hz●●30VDC	Equivalent.
	Ultrasonic generator	EJ-110F/A (configuration of EJ-110A/D)	EJ-110A/D	Same
	Maximum poweroutput	8 Watt	8 Watt	Same
	Frequency	24 to 32 kHz	24 to 32 kHz	Same
	Mode	Continuous	Continuous	Same
	Water delivery system	Connection to external watersupply	Connection to external water supply	Same
	Cruise control	Yes	Yes	Same
	Software	ES-002 rev a, version 1.5	ES-002 rev a, version 1.5	Same
	Control Light	Option with LED driver	Option with LED driver	Same
	Handpiece	EN-060/OS with LEDEN-061/OS without LED	EN-060 (FT-223#) with LEDEN-061 (FT-215#) without LED	Same
	Operating conditions	+10 °C to +40 °C30% to 75% relative humidityAltitude max. 3000	+10 °C to +40 °C30% to 75% relative humidityAltitude max. 3000	Same
	Transport and storageconditions	-10 °C to +40 °C10% to 95% relative humidity500 hPa to 1060 hPa air pressure	-10 °C to +40 °C10% to 95% relative humidity500 hPa to 1060 hPa air pressure	Same
	Housing	Installed into dental chair	Stand alone device	Equivalent.

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VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

A Risk Assessment was performed to review associated risks for this configurable Piezon kit assembly which consists of parts for ultrasonic treatment that are incorporated into a dental unit (chair). This initial risk assessment includes clinical and device specific risks for the PIEZON BUILT-IN KIT alone. An additional risk analysis was performed to address the risk of the product as a subsystem of a treatment unit (dental chair) to include any additional or changed risks that arise from the inclusion of the kit as a component of a dental chair. The combination of these two Risk Analyses were prepared to determine the necessary safety measures in design and manufacturing. The risks related to all applicable hazards which were identified for the PIEZON BIK have been reduced to the acceptable level by mitigation. Therefore, all residual risks postmitigation have been deemed acceptable for this design.

There are no changes to any functional specifications or components included in this submission. The proposed device and the predicate device are both manufactured using the same internal componentry, and the same attached accessories; the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

Biocompatibility

Biocompatibility assessment was performed according to ISO 10993-1 and no testing was necessary since all patient contacting components are identical to the cleared predicate – Piezon 150 (K132443).

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical Safety and Electromagnetic Compatibility are equivalent to the predicate device based on IEC 60601-1 & IEC 60601-1-2. All tests passed and conformance is confirmed.

Integration Testing:

To verify that the removal of the housing unit and incorporation into a dental chair does not impact the performance of the BIK, functional testing was completed on the integrated product to confirm product functionality. Integration testing includes both verification of device installation into the chair as per installation specifications and confirmation of product functionality.

All tests were successfully performed and all acceptance criteria were met, thus confirming that the PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED satisfactorily meet requirements. No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of testing.

IX. CONCLUSIONS

Based on the information and supporting documentation provided in the premarket notification, the PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED are substantially

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equivalent to the cited predicate device. Testing demonstrates that the PIEZON BUILT-IN KIT fulfills prospectively defined 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.