The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.

The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.

The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted by the user.

Range: Green, Ultrasound power: Low, Procedure: Periodontics mainly
Range: Yellow, Ultrasound power: Medium, Procedure: Endodontics mainly
Range: Blue, Ultrasound power: High, Procedure: Prophylaxis mainly
Range: Orange, Ultrasound power: Very high, Procedure: Prosthesis or Specific treatment modalities

Liquid irrigation is provided by two 300 mL self-contained solution tanks and the Newtron LED handpiece provides light and air functions. The light is provided by a light ring consisting of high-performance light-emitting diodes (LED) in the handpiece and air is delivered to the handpiece for air irrigation through connection of the control unit to the user's dental surgery's medical quality filtered air distribution system.

AI/ML Overview

This 510(k) premarket notification (K071424) for SATELEC's Pmax Newtron XS ultrasonic scaler primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics of the new device. Therefore, a direct response to some of the requested points is not possible from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or reported device performance metrics in the way typically found in studies for new features or algorithmic performance. The submission relies on establishing substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes a medical device (ultrasonic scaler), not a software algorithm that would typically have a "test set" in the context of AI/ML performance evaluation. The submission focuses on device characteristics and intended use.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a study requiring expert-established ground truth.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. The submission relies on demonstrating the safety and effectiveness of the device by showing its substantial equivalence to a legally marketed predicate device (Suprasson® P5 Newtron, K050895). The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study and Acceptance Criteria (as per the 510(k) submission model):

The "study" in a 510(k) submission for substantial equivalence is a comparison of the new device to a predicate device. The acceptance criterion is that the new device (Pmax Newtron XS) is substantially equivalent to the predicate device (Suprasson® P5 Newtron, K050895) in terms of:

Intended Use: Both are ultrasonic scalers for use by qualified dental practitioners in prophylaxis, periodontics, endodontics, and prosthesis.
Technological Characteristics: Both use piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling.
Performance: The submission asserts that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Pmax Newtron XS." While specific performance data is not provided in this summary, the FDA's clearance implies they were satisfied with the provided evidence of comparable performance and safety.

The FDA's letter states: "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...". This acts as the "proof" that the device meets the acceptance criteria of substantial equivalence.

Summary

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K071424

Steve Salesky

AUG 2 4 2007

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		9. SMDA Summary of Safety and Effectiveness - "510(k) Summary"	A AND - AN A - AND - - - CARRANT -------
	- Call Children Commended on Children Children C. Children Comments of

A. Submitter Information
SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292

Contact Person:

SATELEC c/o Acteon, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800 289-6367 Ext. 40 Fax: 856 222-4726 E-mail: steve.salesky@us.acteongroup.com

Date Prepared: May 11, 2007

B. Device Identification

Common Usual Name: Ultrasonic scaler

Proprietary Name: Pmax Newtron XS

C. Identification of Predicate Device

Device Applicant 510(k) No. Date Cleared Suprasson® P5 Newtron Satelec K050895 April 20, 2005

The Satelec Pmax Newtron XS is substantially equivalent to the predicate device by Satelec, the Suprasson® P5 Newtron (K050895) previously cleared by the FDA and currently marketed.

D. Device Description

The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.

The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.

The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted

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K071424

2032

by the user.

Range	Ultrasound power	Procedure
Green	Low	Periodontics mainly
Yellow	Medium	Endodontics mainly
Blue	High	Prophylaxis mainly
Orange	Very high	Prosthesis or Specifictreatment modalities

E. Substantial Equivalence

The Pmax Newtron XS and the predicate device, Suprasson® P5 Newtron (K050895) are both ultrasonic scalers for use in conventional dentistry by qualified dental practitioners. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Pmax Newtron XS.

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Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SATELEC C/O Mr. Steve Salesky Quality Manager Acteon, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

AUG 2 4 2007

Re: K071424

Trade/Device Name: Pmax Newtron XS Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 13, 2007 Received: August 15, 2007

Dear Mr. Salesky:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Salesky

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suptile K. Michael Duis
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071424

Indications for Use

510(k) Number:

Device Name:

Pmax Newtron XS

Indications for Use:

The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications:

Periodontics Endodontics Scaling Prosthesis

Please refer to the attached listing for a detailed description.

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)

Suse Riser

(Civision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K171461

Page 1 of 2

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K071424
2072

INDICATIONS FOR USE Pmax Newtron XS

Periodontics:

Root planing .
. Initial therapy
Treatment of periodontal pockets .
Treatment of furcations .
Maintenance therapy .
. Implant maintenance

Endodontics:

Canal preparation .
Canal cleaning ●
. Canal filling
Gutta percha condensation .
. Treatment resumption
Retro Surgery .
Micro Retro Surgery .

Scaling (prophylaxis):

. Interdental junction treatment
Tooth neck and subgingival treatment .
. Treatment of large deposits
Treatment of coating and tobacco stains .
Interproximal treatment .

Prosthesis (conservative/restorative):

. Inlay/onlay condensation
Amalgam plugging .
Loosening prostheses (bridge, crown, post, pivot ... ) .

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.