Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a piezoelectric ultrasonic device for oral surgery, focusing on mechanical vibrations and performance testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.

Therapeutic

Yes.
The device is used for bone cutting, osteotomy, osteoplasty, drilling, scaling applications, and various dental procedures, all of which are considered therapeutic interventions aimed at treating conditions or restoring function.

Diagnostic

No

This device is used for surgical procedures like bone cutting, drilling, and scaling, which are therapeutic interventions rather than diagnostic processes. It does not analyze patient data or provide information for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts" and describes its physical mechanism of action (generating mechanical micro vibrations). This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes the device as being used for surgical procedures directly on the patient's oral tissues (bone cutting, scaling, etc.). This is an in vivo application, meaning it's used within a living organism.
Device Description: The description reinforces the in vivo nature by explaining how the device uses ultrasonic vibrations to interact with mineralized structures within the oral cavity.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, which is the core function of an IVD.

Therefore, the MT-Bone is a surgical device used directly on the patient, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
Scaling applications, including:
Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits:

· Periodontology: Periodontal therapy and debridement for all types of periodontal diseases. including periodontal pocket irrigation and cleaning;

· Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;

· Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Product codes

DZI, ELC

Device Description

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery.

MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts.

This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces.

The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Infant, children, adolescent, and adult population

Intended User / Care Setting

Not Found

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

Bench performance testing was conducted and included:

Electrical safety: The device was positively tested according to IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 80601-2-60:2019. The device is considered electrically safe.
EMC: The device was positively tested according to IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 for electromagnetic compatibility. The device demonstrated electromagnetic compatibility.
Biocompatibility: The device was positively tested according to ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1". Biological evaluation was done on the device system with identification of critical devices and components. All tests passed successfully, showing that relevant parts are biocompatible.
Reprocessing: The reusable device and components (handpiece, torque wrench and insert) were validated for cleaning (manual and automated) and sterilization processes. All tests passed successfully, showing the efficacy of reprocessing procedures.
Software and Firmware: The software used in the devices was developed and positively validated according to IEC 62304+A1, the FDA guidance "Content of Premarket Submissions for Device Software Functions", clause 14 of IEC/EN 60601-1 third edition, and CEI EN 60601-1-4+A1.
Performance Testing – Bench:
- For boosted PIEZOSURGERY inserts, pre-clinical tests confirmed: improved performance compared to PIEZOSURGERY touch; requirements on amplitude and frequency; reduced time to complete procedures compared to PIEZOSURGERY touch.
- For PIEZODRILL inserts, tests confirmed: requirements on intra osseous temperature; requirements on soft tissue safety; requirements on amplitude and frequency; reduced time to complete the procedure compared to PIEZOSURGERY touch.
Usability Testing: Tests included simulation of installation, configuration, and assembly; understanding of graphical interface; and clinical procedures evaluation on implant site preparation, osteotomy, and osteoplasty. All tests passed successfully. KOLs feedback indicated validated usability and a perceived increase in performance for osteotomy, osteoplasty, and pilot hole preparation.
Cadaver Lab: Confirmed requirements on performance, safety, benefits, and usability. A comparative evaluation between MT-Bone and predicate PIEZOSURGERY touch was performed by clinicians, collecting data to demonstrate equivalence and compliance to relevant safety and performance requirements.
Distribution testing: Transport simulation (ASTM D4169), verification of sterile barrier maintenance of single use components, and electrical safety verification after transport simulation were performed. All tests passed, concluding packaging compliance with transportation rules.

Key Metrics

Not Found

Predicate Device(s)

K122322

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

August 19, 2024

Mectron S.p.A. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K242432

Trade/Device Name: MT-Bone Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: August 15, 2024 Received: August 16, 2024

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

Submission Number (if known)

K242432

Device Name

MT-Bone

Indications for Use (Describe)

MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
Scaling applications, including:
Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits:

· Periodontology: Periodontal therapy and debridement for all types of periodontal diseases. including periodontal pocket irrigation and cleaning;

· Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;

· Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

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)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a horizontal line and a series of gray circles below it. The contact information includes the company name, address (Via Loreto, 15/A, 16042 Carasco - GE, Italy), and telephone number (+39 0185 35361).

+39 0185 351374

medical technology www.mectron.com mectron@mectron.com

K242432

Section: 510(k) Summary in accordance with 21 CRF 872.4120

Data: August 08, 2024

1. Administrative Information

Type of 510(k) submission:	Traditional 3P 510(k)
Device Common Name:	Drill, Bone, Powered Scaler, Ultrasonic
Regulation description:	Bone cutting instrument and accessories
Proprietary names of the device:	MT-Bone
Manufacturer:	Mectron S.p.A.
Via Loreto, 15/a
Carasco - GE 16042, Italy
FDA Registration Number:	3003933619
510(k) Owner:	Mectron S.p.A.
Via Loreto, 15/a
Carasco - GE 16042, Italy
510(k) Preparer and Contact:	Ms. Chiara Acunzo
Regulatory Affairs Senior Specialist
Mectron S.p.A.
Telephone: +39 0185 35361
Cell: +39 3371542452
Email:

Device identification: 2.

Regulatory Class: ............................Class II Classification Regulation: ....21 CFR 872.4120: Bone cutting instrument and accessories Product Codes: ....................................Primary [DZI] ..............................................................................................................................................................................

Review Panel: ..................................................Dental

4

Image /page/4/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a horizontal line and a series of gray circles below it. The contact information includes the company name, address (Via Loreto, 15/A, 16042 Carasco - GE, Italy), and telephone number (+39 0185 35361).

hnology

Identification of the Predicate / Reference Devices 3.

Predicate device:

The Substantial Equivalence of the subject device is based on the predicate device.

Trade Name	Manufacturer	Product Code	510(k) Number
PIEZOSURGERY
TOUCH	Mectron S.p.A.	DZI, ELC	K122322

Device description 4.

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery.

MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts.

This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces.

The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

5. Indications for Use

MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

. Bone cutting, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
. Scaling applications, including:
- Scaling: All general procedures for removal of supragingival and interdental calculus & o plaque deposits;
- Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, O including periodontal pocket irrigation and cleaning;
- Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha O condensation and retrograde preparation;
- Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam O condensation, finishing of crown preparations and inlay/onlay condensation.

5

Image /page/5/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo consists of the word "mectron" in orange, with a gray line and several gray circles underneath. The contact information includes the company's address, which is Via Loreto, 15/A, 16042 Carasco – GE (Italy), and their telephone number, which is +39 0185 35361.

Fax +39 0185 351374

medical technology www.mectron.com mectron@mectron.com

6. Comparison of the proposed device and the predicate device

A comparison of the subject device with the predicate device is shown in the following Table 1.1.

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Image /page/6/Picture/0 description: The image contains the word "mectron" in orange font. Below the word is a gray line with five gray circles of increasing size along the line. The circles are evenly spaced along the line.

medical technology

Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco - GE (Italy)

	Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device
	Item for comparison	MT-Bone
Subject Device	PIEZOSURGERY TOUCH
Predicate Device - K122322	Identical / Different
1	Manufacturer	MECTRON SPA
Via Loreto 15/a
16042 Carasco - Italy	MECTRON SPA
Via Loreto 15/a
16042 Carasco - Italy	Identical to Predicate Device
2	510(k) Number	Subject of this submission	K122322	N/A
3	Regulation panel	Dental	Dental	Identical to Predicate Device
4	Regulation Number	21 CFR 872.4120	21 CFR 872.4120	Identical to Predicate Device
5	Product Code	Primary Product code: DZI (Bone Cutting Instrument And
Accessories
Subsequent Product Code: ELC Scaler, Ultrasonic	Primary Product code: DZI (Bone Cutting Instrument And
Accessories
Subsequent Product Code: ELC Scaler, Ultrasonic	Identical to Predicate Device
6	Classification	Class II	Class II	Identical to Predicate Device
7	Device type	Tabletop device	Tabletop device	Identical to Predicate Device
8	Function	MT-Bone is a surgical system that uses ultrasonic energy to
generate mechanical micro-vibration of associated inserts,
to perform cutting of bony structures in the procedures
defined by its intended use.	PIEZOSURGERY TOUCH is a surgical system that uses ultrasonic
energy to generate mechanical micro-vibration of associated
inserts, to perform cutting of bony structures in the procedures
defined by its intended use.	Similar to Predicate Device.
Optimized device setting for PIEZOSURGERY channel.
Dedicated channel for bone hole preparation addressed
to Implantology indication for use (PIEZODRILL
channel).
These differences do not impact safety or clinical
performance.
9	Indications for use	MT-Bone is a piezoelectric ultrasonic device, consisting of
handpieces and associated tip inserts, intended for:
• Bone cutting, osteotomy, osteoplasty and drilling in a
variety of oral surgical procedures, including	PIEZOSURGERY TOUCH is a piezoelectric ultrasonic device,
consisting of handpieces and associated tip inserts, intended for:
• Bone cutting, osteotomy, osteoplasty and drilling in a variety of
oral surgical procedures, including implantology, periodontal	Identical to Predicate Device
	Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device
	Item for comparison	MT-Bone
Subject Device	PIEZOSURGERY TOUCH
Predicate Device - K122322	Identical / Different
		implantology, periodontal surgery, surgical orthodontic
and surgical endodontic procedures;
Scaling applications, including:
Scaling: All general procedures for removal of
supragingival and interdental calculus & plaque
deposits:
Periodontology: Periodontal therapy and
debridement for all types of periodontal diseases,
including periodontal pocket irrigation and cleaning;
Endodontics: All treatments for root canal reaming,
irrigation, revision, filling, gutta-percha condensation
and retrograde preparation;
Restorative and Prosthetics: Cavity preparation,
removal of prostheses, amalgam condensation,
finishing of crown preparations and inlay/onlay
condensation.	surgery, surgical orthodontic and surgical endodontic
procedures;
Scaling applications, including:
Scaling: All general procedures for removal of supragingival
and interdental calculus & plaque deposits;
Periodontology: Periodontal therapy and debridement for all
types of periodontal diseases, including periodontal pocket
irrigation and cleaning;
Endodontics: All treatments for root canal reaming, irrigation,
revision, filling, gutta-percha condensation and retrograde
preparation;
Restorative and Prosthetics: Cavity preparation, removal of
prostheses, amalgam condensation, finishing of crown
preparations and inlay/onlay condensation.
10	Intended patient
population	Infant, children, adolescent, and adult population	Infant, children, adolescent, and adult population	Identical to Predicate Device
11	Contact duration	Limited ≤ 24 hours	Limited ≤ 24 hours	Identical to Predicate Device
12	Biocompatibility	Biocompatible	Biocompatible	Identical to Predicate Device
13	Parts need to be
sterilized prior use?	YES	YES	Identical to Predicate Device
14	Technological
Characteristics
(Mechanism of action)	Piezoelectric ultrasonic technology which generates
mechanical micro-vibrations of the insert tips. The
piezoelectric transducer uses piezoceramic disks to
convert the generator's electrical signal to ultrasonic
vibration of the insert tip.	Piezoelectric ultrasonic technology which generates mechanical
micro-vibrations of the insert tips. The piezoelectric transducer uses
piezoceramic disks to convert the generator's electrical signal to
ultrasonic vibration of the insert tip.	Identical to Predicate Device
15	Main Components of
the device	• Control unit with integrated irrigation peristaltic pump,
electric power supply and ultrasonic generator.
• PIEZOSURGERY MT and PIEZODRILL MT ultrasonic
handpieces and cord.
• Torque wrenches to tighten the inserts on the
handpiece.
• Footswitch with cord.
Bracket for irrigation solution bag.
• Power supply cord.
• Range of insert tips to be used according to the dental
applications defined by intented use.
• Other accessories (make reference to the "List of
Accessories" of the eSTAR submission)	• Control unit with integrated irrigation peristaltic pump, electric
power supply and ultrasonic generator.
• Piezosurgery ultrasonic handpiece and cord.
• Torque wrench to tighten the inserts on the handpiece.
• Footswitch with cord
• Bracket for irrigation solution bag.
• Power supply cord.
• Range of insert tips to be used according to the dental
applications defined by intented use.
Other accessories (make reference to the "List of Accessories"
of the eSTAR submission)	Similar to Predicate Device
This difference does not impact safety or clinical
performance
	Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device
	Item for comparison	MT-Bone
Subject Device	PIEZOSURGERY TOUCH
Predicate Device - K122322	Identical / Different
16	Interfaces
Handpieces	Two different piezoelectric handpieces can be connected
to the device control unit. Dedicated connectors and input
ports ensure correct connections. Both handpieces encase
piezoelectric transducers responsible for generation and
transmission of micrometric vibrations to the insert tips
connected at ultrasonic frequencies.

PIEZOSURGERY MT handpiece is intended for all the
claimed indications for use of the device;
PIEZODRILL MT handpiece is dedicated to implant site
preparation. Its usage in conjunction with dedicated insert
tips allows the precise, efficient and safe drilling of holes of
different diameters and depths within hard mineralized
tissue | One piezoelectric handpiece can be connected to the device
control unit. PIEZOSURGERY TOUCH handpiece, and all claimed
indications for use of the device can be performed using it." | Similar to Predicate Device.
PIEZOSURGERY MT handpiece comprises exactly the
same piezozelectric transducer of the
PIEZOSURGERY TOUCH handpiece and can perform
all the indications for use claimed by the
PIEZOSURGERY TOUCH device. The PIEZODRILL
MT handpiece comprises a piezoelectric transducer
specifically designed to allow more efficient bone
drilling when used in conjunction with dedicated insert
tips. Optimized with I higher efficiency of the former, as
a consequence of improved drilling efficiency and
intraoperative usability.
These differences do not impact safety or clinical
performance. |
| 17 | Interfaces
Footswitch | Footswitch connected to the control console by means of a
cord | Footswitch connected to the control console by means of a cord | Identical to Predicate Device |
| 18 | Irrigation System | Irrigation bag connected to a peristaltic pump. Adjustable
irrigation flow rate. | Irrigation bag connected to a peristaltic pump. Adjustable irrigation
flow rate. | Identical to Predicate Device |
| 19 | Ultrasound Frequency | 24 kHz to36 kHz | 24 kHz to36 kHz | Identical to Predicate Device |
| 20 | Vibration amplitude | $10 \mu m + 250 \mu m$ | $10 \mu m + 250 \mu m$ | Identical to Predicate Device |
| 21 | Electrical power input | 100-240 V ~ 50/60 Hz | 100 - 240 V - 50/60 Hz. | Identical to Predicate Device |
| 22 | Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to Predicate Device |
| 23 | Electromagnetic
Compatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to Predicate Device |
| 24 | Device contains
software? | YES | YES | Similar to Predicate Device
This difference does not impact safety or clinical
performance |
| 25 | User interface | Touch screen (monitor) | Touch screen (keypad) | Similar to Predicate Device
Optimized user interface. This difference does not
impact safety or clinical performance |
| 26 | Connectivity | Wireless | No connection | Optimization of the device with the introduction of IoT
board (ESP32) for wireless connection. The FW/SW
that the IoT board manages is a non-medical SW. |
| | Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device | | | |
| | Item for comparison | MT-Bone
Subject Device | PIEZOSURGERY TOUCH
Predicate Device - K122322 | Identical / Different |
| | | | | The connection does not impact safety, clinical
performance, basic performance, or the intended
purpose of the medical device. |
| 27 | FW/SW -
Device management | C | Assembler | Similar to Predicate:
A porting from Assembler to C was performed
maintaining the same management and the same work
mode.
This difference does not impact safety or clinical
performance |
| 28 | FW/SW -
UI management | Qt e C++ | C | Similar to Predicate:
This difference does not impact safety or clinical
performance. They are consequences of the User
interface optimization. |
| 29 | FW/SW -
Internal
communications
management
communication
protocol. | SSTP-EVO Protocol | SPI Communication | Optimization of the device. Communication between
microprocessors is enhanced with the new proprietary
This difference does not impact safety or clinical
performance. |
| 30 | Dimensions:
(HxWxD) | 330 x 260 x 162 mm (L x l x H) | 300 x 250 x 95 mm (L x l x H) | Similar to Predicate Device since all the devices have
dimensions and weights consistent with the tabletop
use. |
| | Weight (approx) | 4,7kg | 3,2 Kg | |

Electronic Submission Template And Resource (eSTAR) — MT-Bone Rev.03

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Image /page/7/Picture/0 description: The image features the word "mectron" in orange font. Below the word is a horizontal gray line with five gray circles of increasing size along the line. The circles are evenly spaced along the line.

medical technology

Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco - GE (Italy)

8

mectron +0-0-0-0

medical technology

Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco - GE (Italy)

9

Image /page/9/Picture/0 description: The image contains the word "mectron" in orange font. Below the word is a gray line with five gray circles of increasing size along the line. The circles are evenly spaced along the line.

medical technology

Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco - GE (Italy)

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Image /page/10/Picture/0 description: The image shows the word "mectron" in orange font. Below the word "mectron" are six circles in a row. The circles are in shades of gray and blue.

Mectron S n A Società a socio unico Via Loreto. 15/A 042 Carasco – GE (Italy) el. +39 0185 35361 Fax +39 0185 351374

al technology

www.mectron.com mectron@mectron.com

Substantial Equivalence Discussion

The proposed device and the predicate device PIEZOSURGERY TOUCH (K122322 cleared on 12/06/2012) have the intended use substantially identical.

The proposed device and the predicate device share also many identical features, including identical/equivalent principle of operation and technological characteristics.

The differences identified in the above table 1.1 clearly have no impact on safety or effectiveness of the device. Any differences identified in above table does not introduce any new questions regarding safety and effectiveness.

These considerations are also confirmed by the performance test carried out in comparison with the predicate device PD1.

The data presented in this submission demonstrates the identities existing between the MT-Bone device and the predicate device, and thus support a finding of substantial equivalence between the subject device and the referenced predicated device, already in commercial distribution in the United States.

7. Summary of Non-Clinical Testing

The following table summarizes the relevant bench performance testing concluded on the MT-Bone system.

| Bench performance

testing category	Test description
Electrical safety	The device was positively tested according to IEC 60601-1-2:2014, IEC 60601-
1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013,
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 80601-2-60:2019 for
electrical safety.

| | According to the results and evidence reported within test report the device MT-
Bone is considered electrically safe. |
| EMC | The device was positively tested according to IEC 60601-1-2:2014, IEC 60601-1-
2:2014/AMD1:2020 for electromagnetic compatibility.

According to the results and evidence reported within test report the device MT-
Bone has demonstrated electromagnetic compatibility. |
| Biocompatibility | The device was positively tested according to ISO 10993-1 and FDA guidance
Use of International Standard ISO 10993-1.

Biological evaluation was done on the device system with identification of the
critical devices and components. The Biological Evaluation Plan and Report
summarizes the endpoints identified for the device according to its intended use
(time and type of contact).

All tests passed successfully.

The testing showed that the relevant parts of the subject devices are
biocompatible. |
| Reprocessing | The reusable device and components (handpiece, torque wrench and insert) were
validated in terms of cleaning (both manual and automated) and for sterilization
processes.

All tests passed successfully.

The testing showed the efficacy of the reprocessing procedures applied to the
relevant parts of the subject devices. |
| Software and Firmware | The software used in the various modules embedded within the devices was
developed and positively validated according to:
IEC 62304+A1. The FDA guidance " Content of Premarket Submissions for Device
Software Functions" The requirements of clause 14 of IEC/EN 60601-1 third edition |
| Bench performance
testing category | Test description |
| | The requirements of CEI EN 60601-1-4+A1 (identical to the International |
| | Standard IEC 60601- 1- 4+A1), for the countries in which the standard is
still valid. |
| Performance Testing –
Bench | A series of tests evaluated the efficacy and safety of reusable inserts, providing
valuable insights into their performance and ensuring the highest standards of
quality and patient well-being. |
| | For boosted PIEZOSURGERY inserts the pre-clinical tests confirmed: |
| | The improvement of performance with respect to PIEZOSURGERY touch; The requirements on amplitude and frequency; The reduced time to complete the procedures with respect to PIEZOSURGERY touch. |
| | For PIEZODRILL inserts: |
| | The requirements on intra osseous temperature; The requirements on soft tissue safety; The requirements on amplitude and frequency; The reduced time to complete the procedure with respect to PIEZOSURGERY touch. |
| Usability Testing | The usability tests included: |
| | - simulation of the installation, configuration and assembly of the device in
accordance with the user manual. |
| | - Understanding of the graphical interface relating to functional screens and
support screens. |
| | - clinical procedures evaluation on implant site preparation, osteotomy and
osteoplasty. |
| | The usability tests passed successfully. Analyzing all the KOLs feedback and
evaluations, the usability of the device, considering in particular all the new
aspects (GUI, PIEZOSURGERY MT and PIEZODRILL MT handpieces, K11
torque wrench, PD inserts) results validated according to the test objectives. |
| | Furthermore, the validation in terms of clinical procedures highlights a well
perceived increase of the performance of the most representative inserts used for
osteotomy, osteoplasty and pilot hole preparation. |
| Cadaver Lab | The cadaver lab confirmed the requirements on performance, safety, benefits and
usability. The evaluation process conducted by clinicians in the cadaver lab has
been comparative between the new device MT-Bone and its predicate
PIEZOSURGERY touch. |
| | By comparing the MT-Bone system with the predicate device, clinicians have
assessed its improvements, advantages, or potential limitations in clinical
applications for which it is intended. |
| | This comparative analysis has also collected data to demonstrate the equivalence
of the MT-Bone device to its predicate legacy PIEZOSURGERY touch device and
the compliance to the relevant general safety and performance requirements. |
| Distribution testing | Transport simulation (according to ASTM D4169), verification of the sterile barrier
maintenance of the single use components and electrical safety verification on the
device after transport simulation were done on the device system configuration. |
| | The verification of the sterile barrier maintenance of the single use components
passed all the performed tests. |
| | All the controls on the components after the tests performed in external
laboratories were conducted and all the items worked properly. |
| | Electrical safety tests, done internally by V&V department, resulted
in |
| Bench performance
testing category | Test description |
| | To conclude, all tests in this report are considered successfully passed, so the
packaging of the device is compliant with all relative standards that specify the
transportation rules. |

11

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Mectron S.p.A.
Società a socio unico
Via a socio as socio unico
Via 427eto, descripto de (Italy)
Tel. 4-39001850 3510374

medical technology

www.mectron.com
mectron@mectron.com

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Mectron S.p.A. Società a socio unico Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374

medical technology

www.mectron.com mectron@mectron.com

Summary of Clinical Testing 8.

Animal or clinical testing were not required to prove MT-Bone substantial equivalence when compared to the predicate device.

CONCLUSION 9.

Based on the comparative analysis and testing contained within this submission, it is concluded that the MT-Bone device has intended use, safety and effectiveness profile, and technological characteristics, substantially equivalent to the identified predicate device which are already in commercial distribution in the United States.