The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains from teeth
• Intended for use in dental and periodontal applications performed by an ultrasonic scaler.

Device Description

The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.

The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.

The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).

The modifications made to the miniPiezon to produce the PIEZON 150 include:
• Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
• Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
• One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
• Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
• Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically for the PIEZON 150 ultrasonic scaler. It states that no clinical testing was conducted for this submission. Instead, substantial equivalence was determined based on non-clinical performance testing and comparison to predicate devices.

Therefore, the requested information regarding acceptance criteria derived from a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as these types of studies were not performed or reported for this submission.

Here's a summary of what can be gathered, addressing the relevant points from your request:

1. A table of acceptance criteria and the reported device performance

The document states: "Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements."

While the document generally states that "functional and performance requirements" were met, it does not explicitly list quantitative acceptance criteria for these functional performance aspects, nor does it provide specific "reported device performance" metrics against such criteria in a measurable way beyond stating they were satisfied.

The comparison table (sections 3 and 4 of the input) highlights the technological characteristics of the proposed device and predicate devices, which implicitly defines the expected performance by showing similarity. For instance:

Item for Comparison	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (PIEZON 150)
Indications for Use	Must be substantially equivalent to predicate devices for periodontal pocket lavage, scaling, root planing, and calculus/stain removal.	Matches the indications for use of the EMS miniPiezon (K953026).
Treatment Site	Subgingival and supragingival application.	Subgingival and supragingival.
Function	Ultrasonic scaling.	Ultrasonic scaling.
Mechanism of action	Ultrasonic energy.	Ultrasonic energy.
Components	Control unit, foot pedal, handpiece, instruments, water hose.	Control unit, foot pedal, Piezon Handpiece/LED, instruments, water hose.
Power supply	External 24V/30V transformer, 50-60 Hz.	External 30V transformer, 50-60 Hz.
Ultrasonic power adjustment	Panel buttons or rotary ring.	Power control knob using a potentiometer (modification for improved control).
Water adjustment	Connection to external water supply, knob/ring for flow control.	Connection to external water supply, rotating knob for control of water flow rate.
Output performance specifications	Maximum output ~8W, frequency range 24-32 kHz (based on predicates).	Maximum output: 8 Watts, frequency range: 24-32 kHz.
Power range	0-100% (Standard), 0-37.5% (Perio) or similar clinical ranges.	Standard: 0-100%, Perio: 0-37.5% (reflecting clinical utility and safety for specific procedures).

The "reported device performance" essentially aligns with the characteristics of the predicate devices, and any noted "improvements" (like the potentiometer for power regulation) are presented as enhancing an already acceptable functionality.

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. No clinical test set data was used. Non-clinical performance testing was conducted, but details on sample sizes or data provenance for these engineering tests are not provided.

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. No clinical studies requiring expert ground truth were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies requiring adjudication were conducted.

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. This device is an ultrasonic scaler, not an AI-based diagnostic tool, and therefore MRMC studies are not relevant. No such study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical studies requiring ground truth were conducted. Substantial equivalence was based on non-clinical performance and comparison to predicate devices, implying that the established safety and efficacy of the predicate devices serve as the "ground truth" for the modified device's expected performance.

8. The sample size for the training set
Not applicable. No algorithm training was performed for this hardware device.

9. How the ground truth for the training set was established
Not applicable. No algorithm training was performed and therefore no ground truth for a training set was established.

Summary

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NOV 2 2 2013

PIEZON 150 Special 510(k): Device Modification 510(k) Summary (per 21 CFR 807.92(c)) K132443

1. SUBMITTER/510(K) HOLDER

E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00

Date Prepared: October 24, 2013

2. DEVICE NAME

Proprietary Name:	PIEZON 150
Common/Usual Name:	Ultrasonic Scaler
Classification Name:	Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC)

3. PREDICATE DEVICES

The proposed PIEZON 150 is a modification of the E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026).

The Piezon Handpiece LED that is compatible with the proposed device was described in the 510(k) premarket notification for the Piezon Master 700 (K093000).

The instruments used with the PIEZON 150 were previously cleared by FDA:

· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniMaster Ultrasonic Scaler (K050710)
· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., EMS Kermit (K992504)
· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026)
· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 400 (K896749)
· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 600 (K022328)
· E.M.S. ELECTRO MEDICAL SYSTEMS S.A., Piezon Master 700 (K093000)

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4. DEVICE DESCRIPTION

The modifications made to the miniPiezon to produce the PIEZON 150 include:

· Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
· Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
· One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
· Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
· Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

5. INTENDED USE

The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:

Periodontal pocket lavage with simultaneous ultrasonic tip movement .
. Scaling and root planing

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. Removal of supra and subgingival calculus and stains from teeth

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

The proposed PIEZON 150 is similar in design and materials to the parent miniPiezon. Both the proposed and parent devices are ultrasonic scalers consisting of a control unit housing an ultrasonic generator that produces piezo-electric vibrations to perform the scaling function. The working instrument for both the proposed and predicate devices is the handpiece, which is connected to a control unit via a handpiece cord. A scaling instrument specific to a particular scaling procedure is attached to the end of the handpiece. Both the proposed and predicate ultrasonic scalers connect to an external water supply and deliver water via the connected handpiece.

Differences between the proposed PIEZON 150 and the predicate miniPiezon and the Piezon Master 700 are limited to the compatible handpieces and the control unit modifications to improve ergonomics and ultrasonic power control described in Section 4. The similarities and differences between the proposed and parent devices are illustrated in the table at the end of this section.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 150 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical testing was conducted for this submission.

9. SUMMARY OF OTHER INFORMATION

No other information is available.

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10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 150 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in the table at the end of this section.

Item forComparison	PIEZON 150(FT-215#)Piezon HandpieceProposed	PIEZON 150(FT-223#)Piezon HandpieceLEDProposed	Piezon Master 700K093000	EMS miniPiezonK953026
Indications for Use	The PIEZON 150 is a device for delivering ultrasonicmovement and water to a stainless steel tip which is usedby a dentist or dental hygienist. The indications for useare:• Periodontal pocket lavage with simultaneousultrasonic tip movement• Scaling and root planning• Removal of supra and subgingival calculus and stainsfrom teeth• Intended for use in dental and periodontal applicationsperformed by an ultrasonic scaler.	The PIEZON 150 is a device for delivering ultrasonicmovement and water to a stainless steel tip which is usedby a dentist or dental hygienist. The indications for useare:• Periodontal pocket lavage with simultaneousultrasonic tip movement• Scaling and root planning• Removal of supra and subgingival calculus and stainsfrom teeth• Intended for use in dental and periodontal applicationsperformed by an ultrasonic scaler.	The Piezon Master 700 is anultrasonic scaler intended foruse in the following dentaland periodontal applications:• Removing supra andsubgingival calculusdeposits and stains fromteeth• Periodontal pocket lavagewith simultaneousultrasonic tip movement• Scaling and root planing• Releasing crowns, bridges,inlays, and posts as well ascondensing gutta percha• Plugging for amalgamcondensation• Amalgam burnishing• Preparing, cleaning andirrigating root canals• Cavity preparation• Cementing inlays andonlays• Retrograde preparation ofroot canals	The miniPiezon is adevice for deliveringultrasonic movement andwater to a stainless steeltip which is used by adentist or dentalhygienist. Theindications for use are:• Periodontal pocketlavage withsimultaneous ultrasonictip movement• Scaling and rootplanning• Removal of supra andsubgingival calculusand stains from teeth• Intended for use indental and periodontalapplications performedby an ultrasonic scaler.
Treatment Site	Subgingival andsupragingival	Subgingival andsupragingival	Subgingival andsupragingival	Subgingival andsupragingival
Function	Ultrasonic scaling	Ultrasonic scaling	Ultrasonic scaling	Ultrasonic scaling
Mechanism of action	Ultrasonic energy	Ultrasonic energy	Ultrasonic energy	Ultrasonic energy
Components	• Control Unit• Foot pedal• Piczon Handpiece*• Instruments+• Water hose with screwedconnector on device	• Control Unit• Foot pedal• Piezon Handpiece*LED• Instruments+• Water hose withscrewed connectoron device	• Control Unit• Foot pedal• Piezon Handpiece LED• Instruments*• Irrigation liquid bottle	• Control Unit• Foot pedal• Universal PiezonHandpiece• Instruments+• Water hose withquick connector ondevice
Power supply	• External 30V transformer• 50-60 Hz	• External 30Vtransformer• 50-60 Hz	• Internal transformer 24V• 50-60 Hz	• External 24Vtransformer• 50-60 Hz
Ultrasonic poweradjustment	Power control knob using apotentiometer	Power control knobusing a potentiometer	Touch sensitive zones onfront panel of housing	• Adjustment key "-"or "+" on the panelof housing

Comparison Table for Determination of Substantial Equivalence PIEZON 150, EMS miniPiezon, and Piezon Master 700

E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Additional Information - K132443

October 24, 2013

CONFIDENTIAL APPENDIX C - Page 4 of 5

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Item forComparison	PIEZON 150(FT-215#)Piezon HandpieceProposed	PIEZON 150(FT-223#)Piezon HandpieceLEDProposed	Piezon Master 700K093000	EMS miniPiezonK953026
Water adjustment	• Connection to externalwater supply• Rotating knob for controlof water flow rate	• Connection toexternal watersupply• Rotating knob forcontrol of waterflow rate	• Rotary ring on handpiecehose	• Connection to externalwater supply• Rotating knob forcontrol of water flowrate
Output performancespecifications	• Maximum output: 8Watts• Frequency range: 24-32kHz	• Maximum output:8Watts• Frequency range: 24-32 kHz	• 0-12W (max. powerdelivered is 8W)• 24 - 32 kHz	• Maximum output: 8W• Frequency range: 25-32kHz
Power range	• Standard: 0-100%• Perio0-37.5%	• Standard: 0-100%• Perio0-37.5%	• Standard:0-100%• Endo: 0 - 50%	0-100%

*Previously cleared in K093000

*Previously cleared in K093000
*All instruments previously cleared (see Section 3)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2013

E.M.S. Electro Medical Systems S.A. C/O Aptiv Solutions Ms. Cynthia J.M. Nolte Director, Medical Device Regulatory Services 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K132443

Trade/Device Name: PIEZON 150 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Product Code: ELC Dated: October 24, 2013 Received: October 25, 2013

Dear Ms. Nolte:

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. 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 warrantics. 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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Page 2 - Ms. Nolte

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mary BDAner-S

Kwame Ulmer M.S. Acting Division 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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K132443

Indications for Use

510(k) Number (if known):

Device Name: PIEZON 150

Indications for Use:

The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hyglenist. The indications for use are:

Periodontal pocket lavage with simultaneous ultrasonic tip movement .
. Scaling and root planing
Removal of supra and subgingival calculus and stains from teeth .

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner -S
FDA 21
08.15.1996 -05'00'

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.