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

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 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 a 510(k) submission for a dental ultrasonic scaler, the NEWTRON P5 XS B.LED. The submission focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing and comparison of technological characteristics, rather than a de novo study with acceptance criteria for device performance in a clinical setting. Therefore, many of the requested elements regarding acceptance criteria and study details (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable or not provided in this type of submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicitly stated "acceptance criteria" in the traditional sense of a clinical trial showing performance against a benchmark. Instead, the "acceptance" is based on demonstrating similarity to predicate devices in key performance areas.

Parameter Evaluated	Predicate Device Performance (Satelec PMAX NEWTRON XS - K071424)	NEWTRON P5 XS B.LED Performance	Acceptance/Similarity Criteria
Irrigation Flow	Measured values	Similar measured values	Similar irrigation flow values for considered clinics. Demonstrated through bench testing (Section 019 "Performance Testing - Bench").
Current delivered in Piezoelectric Handpiece	Measured values	Similar measured values	Similar current delivered in the piezoelectric handpiece. Demonstrated through bench testing (Section 019 "Performance Testing - Bench").
Electromagnetic Compatibility	Conforms to IEC 60601-1-2:2007	Conforms to IEC 60601-1-2:2007	Compliance with the standard. (Tests performed according to IEC 60601-1-2:2007).
Electrical Safety	Conforms to IEC60601-1:2005	Conforms to IEC60601-1:2005	Compliance with the standard. (Tests performed according to IEC60601-1:2005).
Sterilization Validation	Conforms to ISO 17665-1:2006 and ISO 17665-2:2009	Conforms to ISO 17665-1:2006 and ISO 17665-2:2009	Compliance with the standards. (Tests performed according to ISO 17665-1:2006 and ISO 17665-2:2009).
Technological Characteristics	Same technology (Piezoelectricity), casing material (UL94V-0), user interface, handpiece type	Same technology (Piezoelectricity), casing material (UL94V-0), user interface, handpiece type	"Similar" and "same" technological characteristics as predicate devices. The identified differences have no impact on intended use, safety, and effectiveness.
Energy Source	Same input (Electric Mains), same output (ultrasonic micro-vibration), same Handpiece Current, similar Irrigation Flow	Same input (Electric Mains), same output (ultrasonic micro-vibration), same Handpiece Current, similar Irrigation Flow	"Same" and "similar" energy source parameters as predicate devices.
Light Function	Same principle of LED ring, Optical Guide, quantity of LEDs, reference of LEDs, color of light	Same principle of LED ring, Optical Guide, quantity of LEDs, reference of LEDs, color of light	"Same" light function as predicate devices; does not induce temperature rise.

2. Sample sized used for the test set and the data provenance

Test Set Size: Not applicable. No clinical test set with human subjects/data was used for this 510(k) submission. The testing involved bench data and comparison of technical specifications to predicate devices.
Data Provenance: Not applicable. The "data" primarily consists of engineering specifications, performance measurements (irrigation flow, current) from bench testing, and comparisons to predicate device data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was performed.

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-powered diagnostic imaging tool, and no MRMC study was conducted or is relevant to this device's regulatory pathway.

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

Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics.

7. The type of ground truth used

The "ground truth" for this submission is based on bench testing results and technical specifications of the NEWTRON P5 XS B.LED compared against the established safety and effectiveness of the legally marketed predicate devices. The claim is that the new device is "similar" and therefore equally safe and effective.

8. The sample size for the training set

Not applicable. There is no AI component, and thus no "training set."

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

Not applicable. There is no AI component, and thus no "training set" or corresponding ground truth establishment.

Summary

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Additional Information - October 31, 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.

01- b. Submission date: July 19, 2013

01-с. 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

Contact Person: 01-d.

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

Establishment Registration Number: 8044015 01- e.

02 - Device Information

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

Pre-Market Notification 510(k) Submission for NEWTRON P5 XS B.LED By SATELEC K132322 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 31, 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 handpiece.

Scientific principles:

The ultrasonic mechanical vibrations transmitted 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 PMAX NEWTRON XS (K071424, cleared August 24, 2007) are similar because the measured values of the Irrigation 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 XS B.LED By SATELEC K132322 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 31, 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 performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (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 Device.

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 n°3:

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

Pre-Market Notification 510(k) Submission for NEWTRON P5 XS B.LED By SATELEC K132322 - Traditional 510(k) - Confidential Document - Version 02

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Additional Information - October 31, 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. -
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 Device 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 identified differences have no impact on the Intended use, Safety and Effectiveness. 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 XS B.LED By SATELEC K132322 - Traditional 510(k) - Confidential Document - Version 02

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Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - October 31, 2013

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Pre-Market Notification 510(k) Submission for NEWTRON P5 XS B.LED By SATELEC K132322 - Traditional 510(k) - Confidential Document - Version 02

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

March 11, 2014

Satelec-Acteon Group Mr. Rick Rosati Quality Manager 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054

Re: K132322

Trade/Device Name: NEWTRON P5 EX B.LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 10, 2014 Received: February 11, 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, 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 - 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/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/Reportal?roblem/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.

Image /page/6/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by a signature. Below the signature, the text reads "Tejashri Purohit-Sheth, M.D.," "Clinical Deputy Director," and "DAGRID."

Erin J. 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 31, 2013

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K132322

Device Name:

NEWTRON P5 XS 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 prosiblesis.

Prescription Use × (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)

S. Runner -S -04'00'

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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.