(3 days)
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.
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.
The provided text describes the MT-Bone device and its substantial equivalence to a predicate device (PIEZOSURGERY TOUCH, K122322). However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or details of a study proving the device meets said criteria in the way typically found for AI/ML-based medical devices.
The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics, indications for use, and general safety/performance testing. There is no mention of an algorithm, AI, or machine learning in the context of device function.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this document, as they pertain to a different type of device or evaluation method.
Here's a breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:
1. Table of acceptance criteria and the reported device performance:
The document states that a series of non-clinical bench performance tests were conducted to evaluate the efficacy and safety of the device. The "acceptance criteria" are implied by the statement "All tests passed successfully" or "The testing showed that..." without quantitative metrics.
| Bench performance testing category | Implied Acceptance Criteria (Pass/Fail) | Reported Device Performance |
|---|---|---|
| Electrical safety | Complies with IEC 60601-1 | Considered electrically safe. |
| EMC | Complies with IEC 60601-1-2 | Demonstrated electromagnetic compatibility. |
| Biocompatibility | Complies with ISO 10993-1 and FDA guidance | Relevant parts are biocompatible. |
| Reprocessing | Efficacy of cleaning and sterilization processes | Efficacy shown for relevant parts. |
| Software and Firmware | Complies with IEC 62304+A1, FDA guidance | Developed and positively validated. |
| Performance Testing – Bench (Boosted PIEZOSURGERY Inserts) | Improved performance, amplitude/frequency requirements, reduced time vs. predicate | Confirmed improved performance, met amplitude/frequency, reduced time. |
| Performance Testing – Bench (PIEZODRILL Inserts) | Intra osseous temperature, soft tissue safety, amplitude/frequency requirements, reduced time vs. predicate | Met requirements on intra osseous temperature, soft tissue safety, amplitude/frequency, reduced time. |
| Usability Testing | Satisfactory installation, configuration, assembly, GUI understanding, clinical procedure evaluation, positive KOL feedback | Passed successfully, usability validated, increased performance perceived by KOLs. |
| Cadaver Lab | Performance, safety, benefits, usability, equivalence to predicate, compliance to GSPR | Requirements confirmed, equivalence to predicate demonstrated, compliance to GSPR. |
| Distribution testing | Transport simulation (ASTM D4169), sterile barrier maintenance, electrical safety after transport | Passed all tests, packaging compliant, all items worked properly. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified for any of the non-clinical tests. For the cadaver lab, it refers to "clinicians" but no number of cadavers or specific cases is given.
- Data Provenance: Not explicitly stated for any of the tests. It's internal testing by the manufacturer (Mectron S.p.A., Italy).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: For Usability Testing, it mentions "KOLs feedback and evaluations" (Key Opinion Leaders) but does not specify the number or their qualifications. For the Cadaver Lab, it states "clinicians" but again, no number or qualifications are provided.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the tests described are primarily bench, software, and usability/cadaver lab evaluations, not diagnostic accuracy studies requiring adjudication of ground truth by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device described is a surgical instrument (piezoelectric ultrasonic device), not an imaging or diagnostic AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a surgical instrument requiring human operation. There is no mention of a standalone algorithm component that performs autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical bench tests, "ground truth" is typically defined by engineering specifications, regulatory standards (e.g., IEC, ISO), and performance targets for the device's physical functions (e.g., amplitude, frequency, temperature, cutting efficacy).
- For Usability and Cadaver Lab tests, the "ground truth" or validation came from "KOLs feedback and evaluations" and "evaluation process conducted by clinicians," implying expert assessment of performance, safety, benefits, and usability.
8. The sample size for the training set:
- Not applicable. The document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. The document does not describe an AI/ML device that requires a training set.
{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)
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)
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."
{3}------------------------------------------------
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/aCarasco - GE 16042, Italy |
| FDA Registration Number: | 3003933619 |
| 510(k) Owner: | Mectron S.p.A.Via Loreto, 15/aCarasco - GE 16042, Italy |
| 510(k) Preparer and Contact: | Ms. Chiara AcunzoRegulatory Affairs Senior SpecialistMectron S.p.A.Telephone: +39 0185 35361Cell: +39 3371542452Email: |
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 |
|---|---|---|---|
| PIEZOSURGERYTOUCH | 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.
{6}------------------------------------------------
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-BoneSubject Device | PIEZOSURGERY TOUCHPredicate Device - K122322 | Identical / Different | |
| 1 | Manufacturer | MECTRON SPAVia Loreto 15/a16042 Carasco - Italy | MECTRON SPAVia Loreto 15/a16042 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 AndAccessoriesSubsequent Product Code: ELC Scaler, Ultrasonic | Primary Product code: DZI (Bone Cutting Instrument AndAccessoriesSubsequent 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 togenerate mechanical micro-vibration of associated inserts,to perform cutting of bony structures in the proceduresdefined by its intended use. | PIEZOSURGERY TOUCH is a surgical system that uses ultrasonicenergy to generate mechanical micro-vibration of associatedinserts, to perform cutting of bony structures in the proceduresdefined by its intended use. | Similar to Predicate Device.Optimized device setting for PIEZOSURGERY channel.Dedicated channel for bone hole preparation addressedto Implantology indication for use (PIEZODRILLchannel).These differences do not impact safety or clinicalperformance. |
| 9 | Indications for use | MT-Bone is a piezoelectric ultrasonic device, consisting ofhandpieces and associated tip inserts, intended for:• Bone cutting, osteotomy, osteoplasty and drilling in avariety 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 oforal 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-BoneSubject Device | PIEZOSURGERY TOUCHPredicate Device - K122322 | Identical / Different | |
| implantology, periodontal surgery, surgical orthodonticand surgical endodontic procedures;Scaling applications, including:Scaling: All general procedures for removal ofsupragingival and interdental calculus & plaquedeposits:Periodontology: Periodontal therapy anddebridement for all types of periodontal diseases,including periodontal pocket irrigation and cleaning;Endodontics: All treatments for root canal reaming,irrigation, revision, filling, gutta-percha condensationand retrograde preparation;Restorative and Prosthetics: Cavity preparation,removal of prostheses, amalgam condensation,finishing of crown preparations and inlay/onlaycondensation. | surgery, surgical orthodontic and surgical endodonticprocedures;Scaling applications, including:Scaling: All general procedures for removal of supragingivaland interdental calculus & plaque deposits;Periodontology: Periodontal therapy and debridement for alltypes of periodontal diseases, including periodontal pocketirrigation and cleaning;Endodontics: All treatments for root canal reaming, irrigation,revision, filling, gutta-percha condensation and retrogradepreparation;Restorative and Prosthetics: Cavity preparation, removal ofprostheses, amalgam condensation, finishing of crownpreparations and inlay/onlay condensation. | |||
| 10 | Intended patientpopulation | 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 besterilized prior use? | YES | YES | Identical to Predicate Device |
| 14 | TechnologicalCharacteristics(Mechanism of action) | Piezoelectric ultrasonic technology which generatesmechanical micro-vibrations of the insert tips. Thepiezoelectric transducer uses piezoceramic disks toconvert the generator's electrical signal to ultrasonicvibration of the insert tip. | Piezoelectric ultrasonic technology which generates mechanicalmicro-vibrations of the insert tips. The piezoelectric transducer usespiezoceramic disks to convert the generator's electrical signal toultrasonic vibration of the insert tip. | Identical to Predicate Device |
| 15 | Main Components ofthe device | • Control unit with integrated irrigation peristaltic pump,electric power supply and ultrasonic generator.• PIEZOSURGERY MT and PIEZODRILL MT ultrasonichandpieces and cord.• Torque wrenches to tighten the inserts on thehandpiece.• Footswitch with cord.Bracket for irrigation solution bag.• Power supply cord.• Range of insert tips to be used according to the dentalapplications defined by intented use.• Other accessories (make reference to the "List ofAccessories" of the eSTAR submission) | • Control unit with integrated irrigation peristaltic pump, electricpower 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 dentalapplications defined by intented use.Other accessories (make reference to the "List of Accessories"of the eSTAR submission) | Similar to Predicate DeviceThis difference does not impact safety or clinicalperformance |
| Table 1.1. Comparison Table for determination of Substantial Equivalence between MT-Bone device and Predicate Device | ||||
| Item for comparison | MT-BoneSubject Device | PIEZOSURGERY TOUCHPredicate Device - K122322 | Identical / Different | |
| 16 | InterfacesHandpieces | Two different piezoelectric handpieces can be connectedto the device control unit. Dedicated connectors and inputports ensure correct connections. Both handpieces encasepiezoelectric transducers responsible for generation andtransmission of micrometric vibrations to the insert tipsconnected at ultrasonic frequencies.- PIEZOSURGERY MT handpiece is intended for all theclaimed indications for use of the device;PIEZODRILL MT handpiece is dedicated to implant sitepreparation. Its usage in conjunction with dedicated inserttips allows the precise, efficient and safe drilling of holes ofdifferent diameters and depths within hard mineralizedtissue | One piezoelectric handpiece can be connected to the devicecontrol unit. PIEZOSURGERY TOUCH handpiece, and all claimedindications for use of the device can be performed using it." | Similar to Predicate Device.PIEZOSURGERY MT handpiece comprises exactly thesame piezozelectric transducer of thePIEZOSURGERY TOUCH handpiece and can performall the indications for use claimed by thePIEZOSURGERY TOUCH device. The PIEZODRILLMT handpiece comprises a piezoelectric transducerspecifically designed to allow more efficient bonedrilling when used in conjunction with dedicated inserttips. Optimized with I higher efficiency of the former, asa consequence of improved drilling efficiency andintraoperative usability.These differences do not impact safety or clinicalperformance. |
| 17 | InterfacesFootswitch | Footswitch connected to the control console by means of acord | 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. Adjustableirrigation flow rate. | Irrigation bag connected to a peristaltic pump. Adjustable irrigationflow rate. | Identical to Predicate Device |
| 19 | Ultrasound Frequency | 24 kHz to~36 kHz | 24 kHz to~36 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 | ElectromagneticCompatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to Predicate Device |
| 24 | Device containssoftware? | YES | YES | Similar to Predicate DeviceThis difference does not impact safety or clinicalperformance |
| 25 | User interface | Touch screen (monitor) | Touch screen (keypad) | Similar to Predicate DeviceOptimized user interface. This difference does notimpact safety or clinical performance |
| 26 | Connectivity | Wireless | No connection | Optimization of the device with the introduction of IoTboard (ESP32) for wireless connection. The FW/SWthat 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-BoneSubject Device | PIEZOSURGERY TOUCHPredicate Device - K122322 | Identical / Different | |
| The connection does not impact safety, clinicalperformance, basic performance, or the intendedpurpose of the medical device. | ||||
| 27 | FW/SW -Device management | C | Assembler | Similar to Predicate:A porting from Assembler to C was performedmaintaining the same management and the same workmode.This difference does not impact safety or clinicalperformance |
| 28 | FW/SW -UI management | Qt e C++ | C | Similar to Predicate:This difference does not impact safety or clinicalperformance. They are consequences of the Userinterface optimization. |
| 29 | FW/SW -Internalcommunicationsmanagementcommunicationprotocol. | SSTP-EVO Protocol | SPI Communication | Optimization of the device. Communication betweenmicroprocessors is enhanced with the new proprietaryThis difference does not impact safety or clinicalperformance. |
| 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 havedimensions and weights consistent with the tabletopuse. |
| Weight (approx) | 4,7kg | 3,2 Kg |
Electronic Submission Template And Resource (eSTAR) — MT-Bone Rev.03
{7}------------------------------------------------
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)
{10}------------------------------------------------
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 performancetesting 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 forelectrical 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 guidanceUse of International Standard ISO 10993-1.Biological evaluation was done on the device system with identification of thecritical devices and components. The Biological Evaluation Plan and Reportsummarizes 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 arebiocompatible. |
| Reprocessing | The reusable device and components (handpiece, torque wrench and insert) werevalidated in terms of cleaning (both manual and automated) and for sterilizationprocesses.All tests passed successfully.The testing showed the efficacy of the reprocessing procedures applied to therelevant parts of the subject devices. |
| Software and Firmware | The software used in the various modules embedded within the devices wasdeveloped and positively validated according to:IEC 62304+A1. The FDA guidance " Content of Premarket Submissions for DeviceSoftware Functions" The requirements of clause 14 of IEC/EN 60601-1 third edition |
| Bench performancetesting 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 isstill valid. | |
| Performance Testing –Bench | A series of tests evaluated the efficacy and safety of reusable inserts, providingvaluable insights into their performance and ensuring the highest standards ofquality 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 inaccordance with the user manual. | |
| - Understanding of the graphical interface relating to functional screens andsupport screens. | |
| - clinical procedures evaluation on implant site preparation, osteotomy andosteoplasty. | |
| The usability tests passed successfully. Analyzing all the KOLs feedback andevaluations, the usability of the device, considering in particular all the newaspects (GUI, PIEZOSURGERY MT and PIEZODRILL MT handpieces, K11torque wrench, PD inserts) results validated according to the test objectives. | |
| Furthermore, the validation in terms of clinical procedures highlights a wellperceived increase of the performance of the most representative inserts used forosteotomy, osteoplasty and pilot hole preparation. | |
| Cadaver Lab | The cadaver lab confirmed the requirements on performance, safety, benefits andusability. The evaluation process conducted by clinicians in the cadaver lab hasbeen comparative between the new device MT-Bone and its predicatePIEZOSURGERY touch. |
| By comparing the MT-Bone system with the predicate device, clinicians haveassessed its improvements, advantages, or potential limitations in clinicalapplications for which it is intended. | |
| This comparative analysis has also collected data to demonstrate the equivalenceof the MT-Bone device to its predicate legacy PIEZOSURGERY touch device andthe compliance to the relevant general safety and performance requirements. | |
| Distribution testing | Transport simulation (according to ASTM D4169), verification of the sterile barriermaintenance of the single use components and electrical safety verification on thedevice after transport simulation were done on the device system configuration. |
| The verification of the sterile barrier maintenance of the single use componentspassed all the performed tests. | |
| All the controls on the components after the tests performed in externallaboratories were conducted and all the items worked properly. | |
| Electrical safety tests, done internally by V&V department, resultedin | |
| Bench performancetesting category | Test description |
| To conclude, all tests in this report are considered successfully passed, so thepackaging of the device is compliant with all relative standards that specify thetransportation rules. |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the word "mectron" in orange font. Below the word "mectron" are three gray circles. The circles are evenly spaced and appear to be part of the logo.
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
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "mectron" in orange color. The letters are in lowercase and have a rounded sans-serif font. Below the word "mectron" are three gray circles. The circles are arranged horizontally and are of the same size.
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.
§ 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.