This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

Device Description

The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM or NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).

AI/ML Overview

The provided text describes the regulatory submission for the Satelec NEWTRON P5 and NEWTRON P5 B.LED ultrasonic scalers, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through novel performance data.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" for the new device, nor does it present device performance against a pre-defined set of criteria in a table format. Instead, it relies on demonstrating similarity to legally marketed predicate devices.

The performance data that is reported is in the context of similarity:

Acceptance Criteria (Implied: Similarity to Predicate)	Reported Device Performance (NEWTRON P5 vs. Satelec SUPRASSON P5 NEWTRON K050895)
Irrigation Flow	Similar measured values
Current delivered in the Piezoelectric Handpiece	Similar measured values

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

The document states, "Clinical Data is not needed for this 510(k) process." Performance data was primarily based on bench testing. Therefore, there is no sample size for a clinical test set, nor is there information on data provenance in terms of country of origin or retrospective/prospective nature for clinical data. The bench tests involved comparing measured values, so the "sample size" would relate to the number of units tested during the bench comparison. This specific number is not provided, but it would typically be a small N for engineering verification.

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. Since no clinical data or human-in-the-loop performance study was conducted, there are no experts establishing ground truth for a test set in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for the performance evaluation appears to be the measured physical parameters from the predicate device.

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

Not applicable. As no clinical test set requiring expert interpretation or adjudication was used, there is no mention of an adjudication method.

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 an ultrasonic scaler. The submission focuses on demonstrating substantial equivalence based on technological characteristics and bench performance, not on AI assistance or human reader performance.

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

Not applicable. This is a medical device (ultrasonic scaler), not an AI algorithm. The performance evaluation was done through bench testing of its physical characteristics (irrigation flow, current) by comparing it to a predicate device.

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

The "ground truth" for the performance evaluation in this 510(k) submission is the measured physical properties and performance characteristics of legally marketed predicate devices. The new device aims to be "similar" in these aspects. specifically:

Bench Test Measurements: Irrigation Flow and Current delivered in the Piezoelectric Handpiece (for K050895).
Technological Characteristics: Piezoelectricity Technology, materials (self-extinguishing material UL94V-0), user interface principles, energy sources, output energy, and light function principles (for K071424).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or corresponding ground truth establishment process.

Summary

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Additional Information - October 30, 2013

This Summary of Safety And Effectiveness is submitted in accordance with 21 CFR 807.92. c.

01 - Administrative Information

01- a. Type of 510(k) submission:

These documents constitute a Traditional 510(k) Submission.

July 16, 2013 01- b. Submission date:

01-c. 510(k) Submitter:

SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex France Telephone: 011-33-556-340-607 011-33-556-349-292 Fax: E-Mail: philippe.girard@acteongroup.com

01-d. Contact Person:

Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext. 390 Telephone: Fax: 856-222-4726 E-Mail: rick.rosati@us.acteongroup.com

· 01- e. Establishment Registration Number 8044015

02 - Device Information

02-a. Trade Name of Device: NEWTRON P5 NEWTRON P5 B.LED 02-b. Common Name of Device: Ultrasonic Scaler 02-c. Classification Regulation: 21 CFR 872.4850 02-d. Medical Device Class: ll 02-e. Panel: Dental ELC 02-f. Product Code:

Pre-Market Notification 510(k) Submission for NEWTRON P5 By SATELEC K132267 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 30, 2013

03 - Identification of Legally Marketed Predicate(s)

The Substantial Equivalence (SE) of the Satelec New Device is based on the Predicate Devices identified in the Table 01.

N°	Trade Name	Manufacturer	Product Code	510(k) number	Date Cleared
1	SUPRASSON P5 NEWTRON	SATELEC	ELC	K050895	April 20, 2005
2	ProUltra Piezo Ultrasonic	SATELEC	ELC	K113430	February 23, 2012
3	PMAX NEWTRON XS	SATELEC	ELC	K071424	August 24, 2007

Table 01 - Identification of Legally Marketed Predicate Devices

04 - Description of the Device

The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012),

Principles of operation:

An electrical signal emitted by the medical device is supplied to the dental ultrasonic Handpiece. This is connected to the medical device via a cord. The Handpiece comprises a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. Mechanical vibrations are transmitted to a tip or a dental file attached to the end of the ultrasonic Handbiece.

Scientific principles:

The ultrasonic mechanical vibrations transmitted to the tip or to the dental file attached to the end of the ultrasonic Handpiece remove dental plaque and / or dental tartar.

05 - Intended Use

This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

06 - Performance Data

It has been determined in the Section 019 "Performance Testing - Bench" that the Satelec New Device and Predicate Device Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005) are similar because the measured values of the frigation Flow and the values of the Current delivered in the Piezoelectric Handpiece are similar.

Clinical Data is not needed for this 510(k) process.

Pre-Market Notification 510(k) Submission for NEWTRON P5 By SATELEC K132267 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 30, 2013

07 - Tests and Used Standards

Electromagnetic Compatibility Test:

The Electromagnetic Compatibility Tests have been performed according to IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential Electromagnetic compatibility - Requirements and tests performance - Collateral standard: (Edition 3).

Electrical Safety Tests:

The Electrical Safety Tests have been performed according to IEC60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (General).

Sterilization Validation:

The Sterilizability Tests have been performed according to ISO 17665-1.2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2: 2009 of Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.

08 - Technological characteristics of the Device compared to the Predicate Devices

Technological characteristics of the Satelec New Device are the Predicate Devices.

Technological Perspective:

The Satelec New Device and the Predicate Devices use the same technology (Piezoelectricity Technology).

Material perspective:

The Satelec New Device and the Predicate Devices are very similar because the casings are made in self-extinguishing material (UL94V-0).

Design perspective:

The Satelec New Device and the Predicate Devices are very similar because they use:

The same Principle of User's interface. ।
A Piezoelectric Handpiece. -

Energy source perspective:

The Satelec New Device and the Predicate Device nº 1:

-Use the same input energy source (Electric Mains Power Supply).
Deliver the same output energy source (ultrasonic micro-vibration). -
Deliver the same Handpiece Current Values. -
Deliver a similar irrigation Flow values for considered clinics. -

Pre-Market Notification 510(k) Submission for NEWTRON P5 Bv SATELEC K132267 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 30, 2013

Light function perspective:

The Satelec New Device and the Predicate Device nº3:

-Use the same principle of LED ring.
Use the same principle of Optical Guide. l
-Use the same quantity of LEDs on the LED ring.
Use the same reference of LEDs. -
-Use the same color of light.

The Light Function does not induce rise temperature on the clinical site.

09 - Determination of substantial equivalence

The Satelec New Device has same Indication Statement as the Predicate Devices Satelec ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012), Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005) and Satelec PMAX NEWTRON XS (K071424, cleared August 24, 2007).

The Satelec New Device is similar in terms of technological characteristics as the Predicate Devices Satelec ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012), Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005) and Satelec PMAX NEWTRON XS (K071424, cleared August 24, 2007).

The Satelec New Device is similar in terms of Performance Data as the Predicate Devices Satelec ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012), Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005) and Satelec PMAX NEWTRON XS (K071424. cleared August 24, 2007).

The Satelec New Device is similar in terms of Light function as the Predicate Device Satelec PMAX NEWTRON XS (K071424, cleared August 24, 2007).

The Satelec New Device is efficient and safe for the Intended Uses. The identified differences have no impact on the Intended use, Safety and Effectiveness of the Satelec New Device is the similar as of the Predicate Devices. The Satelec New Device and Predicate Devices are manufactured by SATELEC.

10 - Conclusion

Satelec New Device is Substantially Equivalent (SE) to the Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005), Satelec ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012), and Satelec PMAX NEWTRON XS (K071424, cleared August 24, 2007).

End of Section

Pre-Market Notification 510(k) Submission for NEWTRON P5 By SATELEC K132267 - Traditional 510(k) - Confidential Document - Version 02

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Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - October 30, 2013

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Pre-Market Notification 510(k) Submission for NEWTRON P5 By SATELEC K132267 - Traditional 510(k) - Confidential Document - Version 02

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

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

March 10, 2014

Mr. Rick Rosati SATELEC C/O ACTEON, Inc. 124 Gaither Drive. Suite 140 Mt. Laurel, NJ 08054

Re: K 132267

Trade/Device Name: Newtron P5, Newtron P5 B.led Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 31, 2014 Received: February 3, 2014

Dear Mr. Rosati:

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. Iisting 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 - Mr. Rosati

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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

ErinFDAth-S

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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Section 005 - Indication for Use Additional Information - October 30, 2013

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K132267

Device Name:

NEWTRON P5 NEWTRON P5 B.LED

Indications for Use:

This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

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

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Runner-S
2023.03.07
17:53:36 -05'00'

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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.