PIEZOTOME M+, PIEZOTOME M+ Handpiece

K163610 · Satalec-Acteon Group · JDX · May 19, 2017 · Orthopedic

Device Facts

• Record ID: K163610
• Device Name: PIEZOTOME M+, PIEZOTOME M+ Handpiece
• Applicant: Satalec-Acteon Group
• Product Code: JDX · Orthopedic
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, endodontics, scaling, prosthesis and oral surgery.

Device Story

PIEZOTOME M+ is an electromedical ultrasonic surgical system; console with LCD touch screen controls ultrasonic power and irrigation flow. System uses two reusable handpieces (NEWTRON LED for dental; PIEZOTOME M+ for bone surgery) equipped with piezoelectric transducers; transducers convert electrical signals from console into mechanical micro-vibrations. Tips attach to handpieces to perform cutting, drilling, or smoothing of bone/teeth. Multifunction footswitch allows hands-free operation in sterile environments. Irrigation pump delivers solution to cool site and rinse debris. Used in operating theaters or dental offices by surgeons and dental practitioners. Output provides precise bone/tooth manipulation; benefits include controlled surgical cutting and reduced cross-contamination risk via footswitch and sterile single-use accessories.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing compared ultrasonic and irrigation characteristics against predicates. Biocompatibility testing performed per ISO 10993-1 for limited contact (<24 hours). Electrical safety and EMC testing conducted per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Console-based ultrasonic system; piezoelectric transducer handpieces. Materials: Polyphenylsulfone (PPSU) handpieces, stainless steel/medical-grade tips. Power: 100-230 VAC, 50-60 Hz. Connectivity: Wired handpieces and footswitch. Sterilization: Autoclave (132°C/4 min) for reusable parts; single-use sterile accessories. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI ES 60601-1.

Indications for Use

Indicated for use by qualified dental practitioners and surgeons for cutting bone, bone substitutes, and metal, and for dental procedures including periodontics, endodontics, scaling, prosthesis, and oral surgery. Applicable to general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Piezoelectric System (K100410)
• PIEZOTOME 2 (K091331)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: [phone] email: [e-mail]

01.b. Contact Person:

Argie ZOUBROULIS SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: [phone] Ext. 390 856-222-4726 Fax: Email: [e-mail]

| 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,<br>HBE, HWE | K100410 | April 28, 2010 |
| PIEZOTOME 2 | SATELEC | DZI | K091331 | Dec 11, 2009 |

|--|

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

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.

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

Image /page/4/Picture/18 description: The image shows the logo for ACTEON. The logo is in a dark gray color and is in all caps. There is a blue swoosh that starts at the bottom left of the logo and curves up and around the left side of the word.

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www.acteondroub.c

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Additional Information - February 17, 2017

### V - INDICATION FOR USE

Piezotome® M+ is an ultrasonic system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for 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, endodontics, scaling, prosthesis and oral surgery.

### VI - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES (SUBSTANTIAL EQUIVALENCE)

A comparison Between PIEZOTOME M+ et The Predicate Devices is present in Table 02.

| | New Device | Predicate Device #1<br>(PD#1) | Predicate Device #2<br>(PD#2) | |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade /<br>Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| Intended Use | Piezotome® M+ is an<br>ultrasonic surgical<br>system consisting of<br>handpieces<br>and<br>associated tips, for<br>cutting bone, bone<br>substitutes and metal.<br>The system can be<br>used for osteotomy,<br>osteoplasty,<br>decorticating, drilling,<br>shaping,<br>and<br>smoothing of bones<br>and teeth, in a variety<br>of surgical<br>procedures, including<br>general orthopaedic,<br>otolaryngological,<br>maxillofacial,<br>oral,<br>hand,<br>foot,<br>neurosurgical<br>spine,<br>and<br>plastic/reconstructive<br>surgery.<br>Piezotome® M+ is to<br>supply utilities to and<br>serve as a base for<br>dental tools such as<br>ultrasonic<br>scaler,<br>bone<br>cutting<br>instrument<br>and<br>accessories for use by<br>qualified<br>dental<br>practitioners<br>in<br>periodontics | The Piezoelectric<br>System, distributed by<br>Synthes, is an<br>ultrasonic surgical<br>system consisting of<br>handpieces and<br>associated tips, for<br>cutting bone, bone<br>substitutes and metal.<br>The system can be<br>used for osteotomy,<br>osteoplasty,<br>decorticating, drilling,<br>shaping, and<br>smoothing of bones<br>and teeth, in a variety<br>of surgical<br>procedures, including<br>general orthopaedic,<br>otolaryngological,<br>maxillofacial, oral,<br>hand, foot,<br>neurosurgical spine,<br>and<br>plastic/reconstructive<br>surgery. | The intended use of<br>the SATELEC<br>PIEZOTOME 2 is to<br>supply utilities to and<br>serve as a base for<br>dental tools such as<br>ultrasonic scaler,<br>bone cutting<br>instrument and<br>accessories for use by<br>qualified dental | Substantially<br>equivalent to<br>PD#1 for Bone<br>Surgery clinical<br>application - No<br>impact.<br>Substantially<br>equivalent to<br>PD#2 for Dental<br>clinical<br>application - No<br>impact |
| | New Device | Predicate Device #1<br>(PD#1) | Predicate Device #2<br>(PD#2) | Equivalence |
| Trade /<br>Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | |
| Knumber | Unknown<br>endodontics, scaling,<br>prosthesis and oral<br>surgery. | K100410 | K091331<br>practitioners in<br>periodontics,<br>endodontics, scaling,<br>prosthesis and oral<br>surgery. | |
| Code Product | JDX | JDX | DZI | Identical to<br>PD#1 |
| Subsequent product<br>Codes | DZI, ERL, HBE, HWE | DZI, ERL, HBE, HWE | / | Identical to<br>PD#1 |
| Part | 888 - Orthopedic<br>Device | 888 - Orthopedic<br>Device | 872 - Dental devices | Identical to<br>PD#1 |
| Regulation Number | 21 CFR 888.4580 | 21 CFR 888.4580 | 21 CFR 872.4120 | Identical to<br>PD#1 |
| Regulation<br>Identification | A sonic surgical<br>instrument is a hand-<br>held device with<br>various accessories or<br>attachments, such as<br>a cutting tip that<br>vibrates at high<br>frequencies, and is<br>intended for medical<br>purposes to cut bone<br>or other materials,<br>such as acrylic | A sonic surgical<br>instrument is a hand-<br>held device with<br>various accessories or<br>attachments, such as<br>a cutting tip that<br>vibrates at high<br>frequencies, and is<br>intended for medical<br>purposes to cut bone<br>or other materials,<br>such as acrylic | A bone cutting<br>instrument and<br>accessories is a metal<br>device intended for<br>use in reconstructive<br>oral surgery to drill or<br>cut into the upper or<br>lower jaw and may be<br>used to prepare bone<br>to insert a wire, pin, or<br>screw. The device<br>includes the manual<br>bone drill and wire<br>driver, powered bone<br>drill, rotary bone<br>cutting handpiece,<br>and AC-powered<br>bone saw | Identical to<br>PD#1 |
| Regulation Name | Sonic surgical<br>instrument and<br>accessories<br>attachments | Sonic surgical<br>instrument and<br>accessories<br>attachments | Bone Cutting<br>Instrument and<br>Accessories | Identical to<br>PD#1 |
| Regulatory Class | II | II | II | Identical to<br>PD#1 and PD#2 |
| Principle of operation | | | | |
| Principle | An electrical signal emitted by the medical device is supplied to the dental<br>piezo-ultrasonic Handpiece. It comprises a piezoelectric ceramic<br>transducer, which converts the electrical signal into ultrasonic vibrations.<br>Mechanical vibrations are transmitted to a tip attached to the end of the<br>ultrasonic Handpiece | | | Identical to<br>PD#1 and PD#2 |
| Dimensions of the Console | | | | |
| Height / Depth /<br>Witdh (mm) | 149.5 / 339.9 / 472.9 | 149.5 / 339.9 / 472.9 | 149.5 / 339.9 / 472.9 | Identical to<br>PD#1 and PD#2 |
| Power Supply | | | | |
| Supply Voltage<br>(VAC) | 100 to 230 | 100 to 230 | 100 to 230 | Identical to<br>PD#1 and PD#2 |
| Frequency (Hz) | 50 to 60 | 50 to 60 | 50 to 60 | Identical to<br>PD#1 and PD#2 |
| Power Consumption<br>(VA) | 150 | 150 | 150 | Identical to<br>PD#1 and PD#2 |
| | New Device | Predicate Device #1<br>(PD#1) | Predicate Device #2<br>(PD#2) | |
| Trade /<br>Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| | | Electrical Safety Classification | | |
| Equipment<br>Classification | Class 1 | Class 1 | Class 1 | Identical to<br>PD#1 and PD#2 |
| Electrical Type | BF Type | BF Type | BF Type | Identical to<br>PD#1 and PD#2 |
| Additional earth | Equipotential plug | Equipotential plug | Equipotential plug | Identical to<br>PD#1 and PD#2 |
| | | Applied Parts on the Console | | |
| of<br>Quantity<br>connectors<br>for<br>Applied Parts | 2 | 2 | 2 | Identical to<br>PD#1 and PD#2 |
| Localization | Right and left of the<br>front panel…