Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electromechanical and ultrasonic aspects of the device, with no mention of AI or ML capabilities. The software validation is described according to general medical device software guidance, not specific to AI/ML.

Therapeutic

Yes
The device is used to perform surgical procedures such as osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, which are therapeutic interventions.

Diagnostic

No

The description explicitly states its function as an "ultrasonic surgical system" used for "cutting bone, bone substitutes and metal" and performing various surgical procedures. It does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a console, footswitch, handpieces, tips, and irrigation tubings. While it contains software for controlling settings, it is an electromechanical system with significant hardware elements.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical system for cutting bone, bone substitutes, and metal in various surgical procedures. It also mentions use for dental procedures like scaling and oral surgery. This is a surgical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details a console, handpieces, tips, footswitch, and irrigation system. These are all components of a surgical instrument, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or providing diagnostic information based on such analysis.

The device is a surgical tool used directly on the patient for therapeutic and procedural purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.

Product codes (comma separated list FDA assigned to the subject device)

JDX, HWE, DZI, ERL, HBE

Device Description

PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.

PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips,

The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values)

The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.

The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.

The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

General Orthopaedic, Otolaryngological, Maxillofacial, Oral, Hand, Foot, Neurosurgical Spine, and Plastic/Reconstructive Surgery.
Oral Sphere
General

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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). (Recognition Number 5-64).

Electrical Safety Tests: The Electrical Safety Tests have been performed according to IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (General). (Recognition Number 5-71) included USA and Canadian Deviations.

Additional Safety Mark: PIEZOTOME M+ is in accordance with ANSI / AAMI ES 60601-1: 2005 / (R) 2012 and bears the *c BVS **us marking, related to the file number GSAA.

Software Verification and Validation: Software Verification activities were conducted and documented according to the document named "Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. Moreover, the Software System included in PIEZOTOME M+ is strictly the same Software as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009).

Performance Testing bench: The comparison of performances between PIEZOTOME M+ and Predicate Devices has been performed.

The Technical Characteristics for Bone Surgery Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Devices Piezoelectric System (K100410, cleared April 28, 2010) and PIEZOTOME 2 (K091331, cleared December 11, 2009). The Technical Characteristics for Dental Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009). The Bone Surgery Tips for PIEZOTOME M+ are similar as the Bone Surgery Tips of the Predicate Device Piezoelectric System (K100410, cleared April 28, 2010).

Sterilization Validation: The Sterilizability Tests have been performed according to applicable Standards for Re-Usable accessories and Single Use Accessories provided under Sterile State.

Biocompatibility Validation: The Biocompatibility Tests have been performed according to applicable Standards for Accessories in contact to the Patient. Tests were conducted according to the ISO 10993-1 Standard and 510(k) Memorandum - #G95-1 Table 1 "Initial Evaluation Tests for Consideration requirements (Body Contact: External communicating Device - Type of Tissue / Bone Dentin Communicating - Contact Duration: A limited less than 24 hours).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100410, K091331

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.4580 Sonic surgical instrument and accessories/attachments.

(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

May 19, 2017

SATELEC % Ms. Argie Zoubroulis Quality Manager ACTEON, Inc. 124 Gaither Drive, Suite #140 Mt. Laurel, New Jersey 08054

Re: K163610

Trade/Device Name: PIEZOTOME M+, PIEZOTOME M+ Handpiece Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic Surgical Instrument and Accessories/Attachments Regulatory Class: Class II Product Code: JDX, HWE, DZI, ERL, HBE Dated: April 19, 2017 Received: April 21, 2017

Dear Ms. Zoubroulis :

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 Actinclude 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerelv.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163610

Device Name PIEZOTOME M+

Indications for Use (Describe)

Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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Additional Information - February 17, 2017

Summary of Safety And Effectiveness [As Required by 21 CFR 807.92.c]

I - SUBMITTER

01.a. 510(k) Submitter:

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

01.b. Contact Person:

Argie ZOUBROULIS SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800-289-6367 Ext. 390 856-222-4726 Fax: Email: argie.zoubroulis@acteongroup.com

01.c. Establishment Registration Number:	8044015
01.d. Date Prepared:	November 29, 2016
01.e. Type of 510(k) submission:	Traditional 510(k) Submission.

II - DEVICE

02.a. Trade Name of Device:	PIEZOTOME M+
02.b. Common Name of Device:	Sonic surgical instrument and accessories / attachments
02.c. Classification Regulation:	21 CFR 888.4580
02.d. Regulation Identification:	A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic
02.e. Medical Device Class:	II
02.f. Panel:	Orthopedic

Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02

Image /page/3/Picture/10 description: The image shows the logo for ACTEON. The logo consists of the word "ACTEON" in a dark gray, sans-serif font. A light blue curved line is located to the left of the word, starting below the "A" and extending upwards and to the left. The logo is simple and modern.

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Additional Information - February 17, 2017

JDX 02.g. Product Code:

HWE, DZI, ERL, HBE 02-h. Subsequent Product Codes:

III - PREDICATE DEVICES

The Substantial Equivalence (SE) of PIEZOTOME M+ is based on the Predicate Devices identified in the Table 01.

Trade Name	Manufacturer	Product Code	510(k) number	Date Cleared
Piezoelectric System	SATELEC	JDX, DZI, ERL,
HBE, HWE	K100410	April 28, 2010
PIEZOTOME 2	SATELEC	DZI	K091331	Dec 11, 2009

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SATELEC Piezoelectric System Predicate Device has not been subject to a design-related recall. SATELEC PIEZOTOME 2 Predicate Device has not been subject to a design-related recall.

IV - DEVICE DESCRIPTION