The PIEZON 250 is a device for delivering ultrasonic movement and irrigant 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
Removal of supra and subgingival calculus and stains from teeth

Device Description

The proposed PIEZON 250 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. In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and 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 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

AI/ML Overview

The provided document describes a 510(k) submission for a device modification of the PIEZON 250 ultrasonic scaler. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies and acceptance criteria as would be the case for novel devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for new device validation, is largely not applicable in this context.

However, I can extract information related to the "non-clinical performance testing" which serves a similar function for device modifications.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" as would be seen for a clinical trial or algorithm validation study. Instead, it refers to fulfilling "design inputs" and meeting "functional and performance requirements" through non-clinical testing.

The basis for substantial equivalence is listed as:

Intended Use: Identical to predicate (dental and periodontal applications, scaling, root planing, removal of calculus and stains).
Treatment Site: Identical to predicate (subgingival and supragingival).
Function: Identical to predicate (ultrasonic scaling).
Mechanism of Action: Identical to predicate (ultrasonic energy).
Components: Mostly identical, with modifications in the control unit, handpieces, and irrigation system being the primary differences.

Implicit Acceptance Criteria (derived from the substantial equivalence claim and non-clinical testing summary):

Acceptance Criteria (Implied)	Reported Device Performance (Summary Statement)
Device fulfills all design inputs.	"Non-clinical performance testing demonstrates that all design inputs for the PIEZON 250 were satisfied by the design outputs."
Device meets electrical safety requirements.	"the device meets electrical safety... requirements."
Device meets electromagnetic compatibility requirements.	"the device meets ... electromagnetic compatibility requirements."
Device meets functional and performance requirements.	"the device meets ... functional and performance requirements."
New components/modifications (e.g., irrigant delivery, handpieces, power control) perform as intended and do not introduce new safety or effectiveness concerns compared to predicate devices.	The document explicitly states: "Differences between the proposed PIEZON 250 and the predicate miniPiezon and Piezon Master 700 are limited to the irrigant delivery system, compatible handpieces, and the control unit modifications to improve ergonomics and ultrasonic power control... The overall design of the irrigant delivery system for the PIEZON 250, including the peristaltic pump and the compatible irrigation solutions, is identical to that of the predicate Piezon Master 700... The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 250 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. The document states "No clinical testing was conducted for this submission." The evaluation relied on non-clinical performance testing and comparison to predicate devices, not a clinical test set.
Data Provenance: Not applicable for a clinical test set. The non-clinical testing would typically be performed in a lab setting by the manufacturer (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland).

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 as no clinical test set was used and no ground truth was established by experts in the context of a clinical study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set was used.

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 is not an AI device, and no MRMC comparative effectiveness study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the regulatory determination of safety and effectiveness for the predicate devices (miniPiezon and Piezon Master 700). The PIEZON 250 demonstrates substantial equivalence to these already cleared devices through non-clinical testing and comparison of technological characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device submission.

Summary

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PIEZON 250 Special 510(k): Device Modification 510(k) Summary (per 21 CFR 807.92(c))

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:	+44 (0)22 994 47 00

Date Prepared: August 2, 2013

2. DEVICE NAME

Proprietary Name:	PIEZON 250
Common/Usual Name:	Ultrasonic Scaler
Classification Name:	Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC)

3. PREDICATE DEVICES

The proposed PIEZON 250 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 250 were previously cleared for E.M.S.ELECTRO MEDICAL SYSTEMS S.A:

· miniMaster Ultrasonic Scaler (K050710)
· EMS Kermit (K992504)
· miniPiezon (K953026)
· Piezon Master 400 (K896749)
· Piezon Master 600 (K022328)
· Piezon Master 700 (K093000)

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. SESCRIPTION

In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.

The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and 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 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

The modifications made to the miniPiezon to produce the PIEZON 250 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. In EJ-110, the Light command, Motor/Solenoid valve command and Pedal command have been added.
· Replacement of external water supply connection with an irrigating liquid bottle to supply irrigant to the handpiece via a peristaltic pump

5. INTENDED USE

The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:

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. . . . . . . . . . . . . . .

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

6. Summary of Technological Characteristics Compared to the Predicate DEVICES

The proposed PIEZON 250 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.

Unlike the predicate miniPiezon, the proposed PIEZON 250 does not have a connection to an external water supply. Instead, the proposed PIEZON 250 contains an irrigating liquid bottle that is mounted at the back of the control unit which supplies irrigating liquid to the connected handpiece via a peristaltic pump. The overall design of the irrigant delivery system for the PIEZON 250, including the peristaltic pump and the compatible irrigation solutions, is identical to that of the predicate Piezon Master 700 with the exception that the Piezon Master 700 allows the user to choose between two irrigating liquid bottles.

Differences between the proposed PIEZON 250 and the predicate miniPiezon and Piezon Master 700 are limited to the irrigant delivery system, 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 250 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance The similarities in intended use, operational characteristics, and requirements. functional technological characteristics between the proposed PIEZON 250 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices.

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No clinical testing was conducted for this submission.

9. SUMMARY OF OTHER INFORMATION

No other information is available.

10. Conclusions Drawn from Non-Clinical and Clinical Tests

The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 250 and the predicate miniPiezon 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 below.

Item forComparison	PIEZON 250(FT-216#)Piezon handpieceProposed	PIEZON 250(FT-224#)Piezon handpiece LEDProposed	Piezon Master 700K093000	EMS miniPiezonK953026
Indications for Use	Intended for use in dentaland periodontalapplications performedby an ultrasonic scaler.	Intended for use indental and periodontalapplications performedby an ultrasonic scaler.	Intended for use indental and periodontalapplications performedby an ultrasonic scaler.	Intended for use in dentaland periodontalapplications performed byan 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• Piezon handpiece*• Instruments+• Irrigating liquid bottle	• Control Unit• Foot pedal• Piezon handpieceLED• Instruments+• Irrigating liquidbottle	• Control Unit• Foot pedal• Piezon handpiece• Instruments+• Irrigating liquidbottle	• Control Unit• Foot pedal• Universal Piezonhandpiece• Instruments+• Water hose with quickconnector on device

Comparison Table for Determination of Substantial Equivalence

*Previously cleared in K093000

All instruments previously cleared (see Section 3)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

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

Re: K132445

Trade/Device Name: PIEZON 250 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 25, 2013 Received: November 6, 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 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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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 (OS) 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/ReportaProblem/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 yours,

Kwame O. Ulmer -S

for

Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known): K 132445

PIEZON 250 Device Name:

Indications for Use:

..............................................................................................................................................................................

The PIEZON 250 is a device for delivering ultrasonic movement and irrigant 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 .
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)

Mary S. Runner -S 2013.12.04 07:46:28 -05'00'

E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Special 510{k} Device Modification: PIEZON 250 August 2, 2013

Page xv

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.