The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications:

Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits.

Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.

Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation.

Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Device Description

The Compact Piezo P2K and Powercare are multipurpose piezoelectric ultrasonic scaler sub-assembly devices intended to be incorporated into a dental unit/table-top device and used for ultrasonic treatment in scaling. periodontics, endodontics and prosthetics dental applications.

The Compact Piezo P2K and Powercare devices are intended to be supplied as modular sub-assemblies devices to OEM manufacturers of dental units.

The subject devices consist of an ultrasonic generator, a handpiece with cord, a range of insert tips, a torque wrench and a wiring connections kit.

The subject devices are intended to be assembled inside a dental unit and connected to the unit's electrical supply by the wiring connections kit provided.

The handpiece cord is connected directly to the ultrasonic generator from which it receives the functional drive signals, including those for water supply from the dental unit for water irrigation. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted by the dental unit's controls.

The Compact Piezo P2K and the Power Care devices use a piezoelectric transducer inside the handpiece to generate the insert tip oscillation. The ultrasonic transducer uses four piezoceramic disks to convert the generator's electrical signal to ultrasonic mechanical vibration of the insert tip.

A key function of the ultrasonic generator is to locate the optimal frequency of the transducer/insert tip and then to drive the output at this resonant frequency.

AI/ML Overview

The provided text describes the "Compact Piezo P2K" and "Powercare" ultrasonic scalers and their "510(k) Summary," which is an submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing a new device to an existing one, rather than presenting novel clinical studies with specific acceptance criteria and performance metrics for the new device itself.

Therefore, the text does not contain the information requested for a detailed description of acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trial reports or performance validation studies for devices demonstrating new functionalities or efficacy claims.

Instead, the document focuses on demonstrating that the Compact Piezo P2K and Powercare devices are substantially equivalent to predicate devices (Piezosurgery 3 and SP Newtron Module). This means the acceptance criteria are implicitly related to meeting the standards and characteristics of the predicate devices and relevant industry standards.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

A table of acceptance criteria and the reported device performance:
- The document does not outline specific, quantitative acceptance criteria for the Compact Piezo P2K and Powercare's clinical performance (e.g., successful calculus removal rate, time to complete a procedure, patient discomfort levels).
- It lists non-clinical testing for compliance with standards (IEC 60601-1 for safety, IEC 60601-1-2 for EMC, and tip vibrational mode testing). While these are criteria, they are not presented with specific performance values or a table format in the document. The implicit "performance" is compliance with these standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set is mentioned because this is a 510(k) submission based on substantial equivalence, not a standalone clinical efficacy study for the new device.
- The non-clinical testing for compliance would have involved specific test setups, but the document doesn't provide details on sample sizes for these internal engineering tests.
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 there is no mention of a human-read clinical test set requiring ground truth establishment by experts. The "ground truth" for non-clinical compliance testing would be established by reference to the specified standard requirements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no mention of a clinical test set requiring adjudication.
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-powered diagnostic tool, and no MRMC studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests mentioned (safety, EMC, tip vibration), the "ground truth" is defined by the technical specifications and requirements of the referenced standards (IEC 60601-1, IEC 60601-1-2, and internal tip design specifications).
The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of available information related to acceptance criteria and "study" (non-clinical testing):

1. Table of implicit Acceptance Criteria and Reported "Performance" (Compliance):

Acceptance Criterion Type	Specific Standard/Requirement	Reported Performance
Electrical Safety	Compliance with IEC 60601-1	"Testing to confirm compliance with the safety requirements of standard IEC 60601-1" (i.e., met)
EMC (Electromagnetic Compatibility)	Compliance with IEC 60601-1-2	"Testing to confirm compliance with the EMC requirements of standard IEC 60601-1-2" (i.e., met)
Tip Vibrational Mode	Ensure desired vibrational mode occurs at a frequency within the specified range for the device (for each tip design)	"Each tip design is tested to ensure that the desired vibrational mode occurs at a frequency within the specified range for the device" (i.e., met)
Intended Use	Substantial equivalence to predicate devices for scaling, periodontics, endodontics, restorative/prosthetics applications	Argued to be substantially equivalent to Piezosurgery 3 (K091227) and SP Newtron Module (K033764).
Technology	Uses piezoelectric ultrasonic technology similar to predicate devices.	Confirmed: "The subject devices and the predicate devices use same piezoelectric ultrasonic technology."

2. Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Training Set, Training Ground Truth:
As explained above, these sections are not applicable to the information provided in this 510(k) summary, which focuses on substantial equivalence rather than original clinical efficacy studies or AI performance validation. The document states "Non-clinical testing of the device components covered by this 510(k) submission includes" the tests listed above, indicating these were internal verification tests against established standards.

Summary

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Image /page/0/Picture/0 description: The image shows the word "mectron" in a simple, sans-serif font. The letters are evenly spaced and the word is presented in a straightforward manner. The image appears to be a logo or a simple text representation of the word.

JAN 2 4 2011

medical technology

Mectron S.p.A. Vla Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Flsc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 I,v. mectron@mectron.com

KIO 2218

510(k) Summary in accordance with 21 CFR 807.92 ·

Device Name:	Compact Piezo P2KPowercare
Type of 510(k) submission:	Traditional
Date of Submission:	4 August 2010
Manufacturer:	Mectron SpaVia Loreto, 15, Carasco, GE 16042, Italy
FDA Registration Number:	3003933619
510(k) Owner:	Mectron SpaVia Loreto, 15, Carasco, GE 16042, Italy
510(k) Contact:	Roger GrayVP, Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania, 10, 00153 Rome, ItalyTel: +39 06 578 2665Fax: +39 06 574 3786
Trade name:	Compact Piezo P2KPowercare
Common Name:	Ultrasonic scaler
Class:	Class II
Product Code:	ELC
Classification Regulation:	21 CFR 872.4850:Ultrasonic scaler
Predicate devices:	Piezosurgery 3 (K091227) and SP Newtron Module (K033764)

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medical technology

Mectron S.p. Vla Loreto, 15/A 16042 Carasco - GF (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Flsc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 i.v. mectron@mectron.com

Device Description:

The Compact Piezo P2K and Powercare devices are intended to be supplied as modular sub-assemblies devices to OEM manufacturers of dental units.

The subject devices consist of an ultrasonic generator, a handpiece with cord, a range of insert tips, a torque wrench and a wiring connections kit.

The subject devices are intended to be assembled inside a dental unit and connected to the unit's electrical supply by the wiring connections kit provided.

A key function of the ultrasonic generator is to locate the optimal frequency of the transducer/insert tip and then to drive the output at this resonant frequency.

Indications for Use: The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications:

Scaling:

All general procedures for removal of supragingival and interdental calculus7plaque deposits.

Periodontology:

Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.

Endodontics:

All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation.

Restorative and Prosthetics:

Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Non-clinical testing:

Non-clinical testing of the device components covered by this 510(k) submission includes:

Testing to confirm compliance with the safety requirements of standard IEC 60601-1 ●
Testing to confirm compliance with the EMC requirements of standard IEC 60601-1-2 .
Each tip design is tested to ensure that the desired vibrational mode occurs at a frequency within the . specified range for the device

Technological Characteristics and Substantial Equivalence:

The Compact PiezoP2K and Powercare are substantially equivalent to the predicate devices Piesurgery 3, The Compact Rezor ZR and Towerours and Sablandiry - Module, cleared under 510(k) reference K033764.

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medical technology

Mectron S.n.A Vla Loreto. 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Flsc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 I.v. mectron@mectron.com

The subject devices and the predicate devices use same piezoelectric ultrasonic technology to generate the mechanical micro-vibration of the insert tips for the ultrasound treatments.

Both the subject devices, and the predicate device SP Newtron Module are ultrasonic scalers (product code ELC) intended for use in the following dental applications

· Scaling treatments
· Periodontal treatments
· Endodontics treatments
· Restorative/Conservative treatments.

Predicate device Piezosurgery 3 (product codes DZI, ELC), is cleared by FDA for all the same dental applications as claimed above for the subject devices except for the restorative/conservative treatments.

The Compact Piezo P2K and Powercare devices comply with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

Conclusion

The Compact Piezo P2k and the Powercare and the predicate devices share the same general intended use and technology.

The differences that exist between the subject devices and the predicate devices relating to technical specifications, performance and intended use are minor and do not affect the safety and effectiveness of the Compact Piezo P2K and Powercare.

Therefore the data presented in this submission demonstrates the similarities in the intended use/indications of use and technology between the Compact Piezo P2K, Powercare and the predicate devices, the Piezosurgery 3 and SP Newtron Module, and thus supports a finding of substantial equivalence between the subject devices and the referenced predicate devices which are already in commercial distribution in the United States.

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

Mectron S.P.A. C/O Mr. Roger Grav Donawa Lifescience Consulting SRL Piazza Albania 10 Rome, Italy 00153

JAN 2 4 201

Re: K102218

Trade/Device Name: Compact Piezo P2K and Powercare Devices Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 13, 2011 Received: January 18, 2011

Dear Mr. Gray:

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 111 (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- Mr. Gray

Enclosure

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 20 to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Anthony D. anta

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K102218

Indications for Use Statement

Indications for Use

510(k) Number (if known): Not known

Device Name: Compact Piezo P2K and Powercare devices

Indications for Use: The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications:

Scaling:

All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology:

Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.

Endodontics:

All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation.

Restorative and Prosthetics:

Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

RS.BeeRTOS for Dr.Summer
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Dontal Devices

Division Control, Dental Devices

510(k) Number: K102218

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.