(116 days)
Not Found
No
The device description focuses on microprocessor-based control of ultrasonic parameters and does not mention any AI or ML capabilities. The performance studies are standard electrical, software, and sterilization validations, not AI/ML model performance evaluations.
Yes
The device is intended for various dental procedures, including periodontal therapy and debridement for periodontal diseases, which are therapeutic interventions.
No
Explanation: The Piezosurgery White is described as a piezoelectric ultrasonic device intended for various oral surgical procedures and applications like bone cutting, scaling, and endodontics. Its function involves using ultrasonic energy for mechanical action (cutting, cleaning, reaming), not for diagnosing conditions or diseases.
No
The device description clearly outlines hardware components including a console, handpiece, foot-pedal, and insert tips. While it contains software, it is integral to the operation of the physical device.
Based on the provided information, the Piezosurgery White is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient (bone cutting, scaling, endodontics, etc.) within the oral cavity. IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- Device Description: The device description details a system that generates ultrasonic energy and applies it mechanically to tissues. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, sample handling, analytical methods for biological samples, or any other typical features of an IVD device.
Therefore, the Piezosurgery White is a surgical device used for direct treatment of patients, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Piezosurgery White 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
The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use. The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. The device also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use. Inside the console are located the ultrasonic generator, the electrical power supply module and the microprocessor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the footswitch. One external peristaltic pump, intended for delivery of saline solution to the point of use, is attached to the console. The console is equipped with a keyboard that allows the surgeon to set/control the functions of the device. The keyboard also provides monitoring information, by means icons, in case of malfunction of the device. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch. The ultrasonic generator of the Piezosurgery White is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece. The touch panel of the console allows setting of the following treatment/operative parameters: Six different types of treatment (IMPLANT, CORTICAL, CANCELLOUS, SPECIAL, PERIO, ENDO): Seven different levels of irrigation (from 0 to 6); . The "pump/flush" function. The Piezosurgery White uses piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the tip insert attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip. The ultrasonic generator electronics and locates the resonant frequency of the transducer/insert combination, which varies according to the geometry/morphology of the tip insert in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery White handpiece transducer and family of inserts are designed to resonate in this range of frequencies. The Piezosurgery White complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed on the Piezosurgery White and associated inserts to support the claims of substantial equivalence, including:
- Testing to confirm compliance with safety requirements of IEC 60601-1.
- Testing to confirm compliance with EMC requirements of IEC 60601-1-2.
- Testing to confirm compliance with the safety requirements of IEC 80601-2-60.
- Software documentation, verification and validation in accordance with FDA quidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 May 2005.
- Sterilization validation in accordance with ISO 17665-1 and ISO 14937.
- Bench tests to demonstrate substantial equivalence to the predicate device, including:
- Current to the handpiece.
- Working frequency range.
- Leakage current.
- Ultrasonic transduction power.
- Ultrasonic frequency range and amplitude of vibration for inserts PR1 and PR2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
MECTRON S.p.A. c/o Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome ITALY
Re: K151248
Trade/Device Name: Piezosurgery White Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: II Product Code: DZI, ELC Dated: June 4, 2015 Received: June 8, 2015
Dear Mr. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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
Page 2 - Mr. Roger Gray
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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)
Device Name PIEZOSURGERY WHITE
Indications for Use (Describe)
The Piezosurgery White 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 word "mectron" in orange font. Below the word is a gray line with a series of gray circles of increasing size along the line. The circles are evenly spaced and appear to be part of a logo or branding element.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
medical technology
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
510(k) Summary in accordance with 21 CFR 807.92
ADMINISTRATIVE INFORMATION 1.
| Type of 510(k) submission: | Traditional |
|---|---|
| Submission date: | 27 August 2015 |
| 510(k) Submitter: | MECTRON S.p.a |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Phone: +39 0185 35 361 | |
| Fax: +39 0185 351 374 | |
| 510(k) Contact Person: | Roger Gray |
| VP, Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania, 10 | |
| 00153 Rome, Italy | |
| Phone: +39 06 578 2665 | |
| Fax: +39 06 574 3786 | |
| email: rgray@donawa.com | |
| Manufacturer: | MECTRON S.p.a |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Establishment Registration Number: 3003933619 | |
| 2. | DEVICE |
| Trade name of the device: | Piezosurgery White |
| Common Name/Regulation Description: | Bone cutting instrument and accessories |
| Classification Regulation: | 21 CFR 872.4120 |
| FDA Panel: | Dental |
| Product Code: | DZI ELC |
| Classification: | Class II |
3. IDENTIFICATION OF THE PREDICATE DEVICE
The substantial equivalence of the subject device is based on the following legally marketed predicate device
| Trade name | Manufacturer | Product Codes | 510(k) Number | Decision Date |
|---|---|---|---|---|
| Piezosurgery Touch | Mectron S.p.a | DZI, ELC | K122322 | 12/06/2012 |
DEVICE DESCRIPTION 4.
The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.
4
Image /page/4/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with several gray circles on it. The circles are evenly spaced along the line.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
medical technology
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. The device also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.
Inside the console are located the ultrasonic generator, the electrical power supply module and the microprocessor electronic board that controls and supervises the functional parameters of the device.
The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the footswitch. One external peristaltic pump, intended for delivery of saline solution to the point of use, is attached to the console.
The console is equipped with a keyboard that allows the surgeon to set/control the functions of the device. The keyboard also provides monitoring information, by means icons, in case of malfunction of the device. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch.
The ultrasonic generator of the Piezosurgery White is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.
The touch panel of the console allows setting of the following treatment/operative parameters:
- Six different types of treatment (IMPLANT, CORTICAL, CANCELLOUS, SPECIAL, PERIO, . ENDO):
- Seven different levels of irrigation (from 0 to 6); .
- . The "pump/flush" function.
The Piezosurgery White uses piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the tip insert attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.
The ultrasonic generator electronics and locates the resonant frequency of the transducer/insert combination, which varies according to the geometry/morphology of the tip insert in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery White handpiece transducer and family of inserts are designed to resonate in this range of frequencies.
The Piezosurgery White complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
INTENDED USE/INDICATIONS FOR USE 5.
Piezosurgery White 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.
5
Image /page/5/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with five gray circles of varying sizes along the line. The circles are evenly spaced, with the smallest circle on the left and the largest circle on the right.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
medical technology
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.
Piezoelectric ultrasonic technology is used both by the subject and the predicate device to generate mechanical micro-vibrations of the insert connected to the handpiece. The subject device and predicate device share many characteristics, including identical piezoelectric transducers and ultrasonic generators, as shown in the following comparison table.
| Item | Subject Device
Piezosurgery White | Predicate Device
Piezosurgery Touch | Equivalence |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | MECTRON SPA
Via Loreto 15
16042 Carasco - Italy | MECTRON SPA
Via Loreto 15
16042 Carasco - Italy | N/A |
| 510(k) Number | Subject of this submission | K122322 | N/A |
| FDA Panel | Dental | Dental | Same |
| Regulation Number
and name | 872.4120 - Bone cutting instrument and
accessories | 872.4120 - Bone cutting instrument and
accessories
872.4850 - Ultrasonic Scaler | Same |
| Product Code | DZI, ELC | DZI, ELC | Same |
| Regulatory Class | Class II | Class II | Same |
| 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. | Same |
| Device type | Table top device | Table top device | Same |
| Indications for Use /
Intended Use | Piezosurgery White 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,
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. | 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 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. | Same |
| Item | Subject Device
Piezosurgery White | Predicate Device
Piezosurgery Touch | Equivalence |
| Main device
components | Control unit with integrated irrigation peristaltic pump, electric power supply and ultrasonic generator. Piezoelectric ultrasonic handpiece and cord. Torque wrench to tighten the inserts on the hand piece. Footswitch with cord. Bracket/s for irrigation solution bag. Power supply cord. Range of insert tips to be used according to the dental applications defined by the intended use. Other accessories/attachments. | Control unit with integrated irrigation peristaltic pump, electric power supply and ultrasonic generator. Piezoelectric ultrasonic handpiece and cord. Torque wrench to tighten the inserts on the hand piece. Footswitch with cord. Bracket/s for irrigation solution bag. Power supply cord. Range of insert tips to be used according to the dental applications defined by the intended use. Other accessories and attachments. | Same |
| Transducer
technological
characteristics | Piezoelectric:
The transducer uses four hard
piezoceramic disks to convert the
generator's electrical signal to ultrasonic
vibration of the insert tip. | Piezoelectric:
The transducer uses four hard
piezoceramic disks to convert the
generator's electrical signal to ultrasonic
vibration of the insert tip. | Same |
| Automatic
resonance frequency
tuning | Electronics with automatic frequency
tuning. | Electronics with automatic frequency
tuning. | Same |
| Modulated amplitude
of the ultrasonic
signal mode | Yes | Yes | Same |
| Output performance
specification | Operational Vibration frequency:
24 kHz to ~ 36 kHz.
Max. Output: 25 Watt | Operational Vibration frequency:
24 kHz to ~ 36 kHz.
Max. Output: 25 Watt | Same |
| Supply Voltage | 100 - 240 VAC | 100 - 240 VAC | Same |
| Output Modes | Six output modes identified as Endo,
Perio, Special, Cancellous, Cortical and
Implant on the touch panel. | Six output modes identified as Endo,
Perio, Special, Cancellous, Cortical and
Implant on the touch panel. | Same |
| Activation | Footswitch connected to the control
console by means of a cord. | Footswitch connected to the control
console by means of a cord. | Same |
| Irrigation system | Irrigation bag connected to a peristaltic
pump. Adjustable irrigation flow rate. | Irrigation bag connected to a peristaltic
pump. Adjustable irrigation flow rate. | Same |
| Adjustable irrigation
flow rate. | Seven irrigation flow rates, from
0 to 75 ml/min | Seven irrigation flow rates, from
0 to 75 ml/min | Same |
| Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Same |
| Electromagnetic
Compatibility | Complies with IEC 60601-1-2 | Complies with EN 60601-1-2 which is
equivalent to IEC 60601-1-2 | Same |
| Does the device
contain software? | Yes | Yes | Same |
| Software Validation | In accordance with FDA Guidance:
"Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices" | In accordance with FDA Guidance:
"Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices" | Same |
| Parts need to be
sterilized | Yes | Yes | Same |
| Recommended
sterilization method | Autoclaving (Steam Sterilization) | Autoclaving (Steam Sterilization) | Same |
| Single use parts | Diamond coated inserts | Diamond coated inserts | Same |
| Item | Subject Device
Piezosurgery White | Predicate Device
Piezosurgery Touch | Equivalence |
| Tip Inserts | Material: Stainless steel
The insert tips are secured to the
handpiece by a thread, using a torque
wrench. | Material: Stainless steel
The insert tips are secured to the
handpiece by a thread, using a torque
wrench. | Same |
| Console Dimensions | Width: 298,5 mm
Height: 84 mm
Depth: 245 mm | Width: 300 mm
Height: 95 mm
Depth: 250 mm | Very similar |
6
Image /page/6/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with several gray circles of varying sizes along the line. The circles are evenly spaced.
medical technology
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361
Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
7
Image /page/7/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with several gray circles of varying sizes along the line. The circles are evenly spaced.
medical technology
Mectron S.p.A Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
SUBSTANTIAL EQUIVALENCE DISCUSSION 7.
The Piezosurgery White and the predicate device, Piezosurgery Touch, share identical indications for use / intended use.
Both devices combine the functions of a bone cutting instrument and of an ultrasonic dental scaler.
Piezosurgery White uses the same fundamental technology as the predicate device, utilizing the same piezoelectric ultrasonic technology to generate mechanical micro-vibration of the insert tips fitted onto the handpiece.
The ultrasonic generator of the Piezosurgery White. which generates and controls the appropriate drive signal (power and frequency) to the transducer, is identical in design, manufacture and function to the ultrasonic generator used in the predicate device, Piezosurgery Touch, including the availability of a low frequency burst mode.
Apart from the minor cosmetic differences existing between the external designs of the subject and predicate device cases, both the subject device and the predicate device consist essentially of a table-top unit with incorporated touch keyboard, peristaltic pump, footswitch, ultrasonic handpiece/s, hoses/connectors, a variety of tips for bone cutting, and a torque wrench for attaching the tips to the handpiece.
Compared to predicate device, Piezosurgery White presents the same operational characteristics and user interface, including identical, operating parameters, which can be selected/adjusted by the operator through the keyboard, specifically: Six output modes, seven pre-set flow rates of the irrigation fluid, and a 'Pump/Flush' function that allows the operator to prime the entire irrigation circuit
The touch keyboard of the predicate device Piezosurgery Touch has the additional function "Light" that allows the operator to manage the LED illumination of the handpiece, whereas on the subject device, when a handpiece incorporating an LED light is used, it is switched on by pressing the foot-pedal.
Except for ten new inserts, introduced with this submission, whose minimal differences compared to predicate inserts and/or to equivalent manual instruments do not raise new questions of safety or performance, all the inserts intended for use with the Piezosurgery White have been previously cleared by FDA for use with the predicate device.
Inserts PR1 and PR2, introduced in this submission, have shapes and intended use similar to existing manual periosteal elevators, having a frontal semi-circular profile with a radius of 2 mm and 5 mm respectively. The shape and dimensions of these inserts are suitable for generating ultrasonic longitudinal vibrational behaviour that mimics use of manual periosteal elevators to allow periosteum detachment by following the anatomical profile.
Inserts PR1 and PR2 have very similar shapes and designs to already-cleared inserts OP3 and EL3, having circular flat geometry of the operative part. Insert EL3 also has a very similar use to inserts PR1 and PR2, being intended for detaching/separating the sinus membrane.
Finite Element Analysis (FEA) was utilized in the design of inserts PR1 and PR2 to ensure that the resonant ultrasonic frequency of the inserts was within the functional ultrasonic frequency range of the
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Mectron S.p.A Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
medical technology
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
Piezosurgery White. Functional bench tests conducted on inserts PR1 and PR2 when attached to the Piezosurgery White handpiece verify that the operative resonant frequency of the inserts is within the functional ultrasonic frequency range of the Piezosurgery White.
Inserts PR1 and PR2 share the same intended use as manual periosteal elevators, have very similar operative part shapes, and functional testing has demonstrated compliance with specifications, thus no new issues of safety and effectiveness are raised.
8. SUMMARY OF NON-CLINICAL TESTING
Non-clinical testing was performed on the Piezosurgery White and associated inserts to support the claims of substantial equivalence, including:
- Testing to confirm compliance with safety requirements of IEC 60601-1.
- Testing to confirm compliance with EMC requirements of IEC 60601-1-2.
- Testing to confirm compliance with the safety requirements of IEC 80601-2-60.
- . Software documentation, verification and validation in accordance with FDA quidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 May 2005.
- Sterilization validation in accordance with ISO 17665-1 and ISO 14937.
- Bench tests to demonstrate substantial equivalence to the predicate device, including:
- Current to the handpiece. o
- Working frequency range. O
- Leakage current. O
- Ultrasonic transduction power. O
- Ultrasonic frequency range and amplitude of vibration for inserts PR1 and PR2. O
CONCLUSION 9.
The subject device, Piezosurgery White, and the predicate device, Piezosurgery Touch, share the same intended use, principle of operation, technological characteristics to generate ultrasonic mechanical vibrations of the associated tip inserts, and range of available insert tips, with no differences that raise new questions of safety and effectiveness.
The majority of tip inserts included in this submission for use with the subject device are identical to those cleared within the 510(k) submission of the predicate device. The new tip inserts introduced within this submission are manufactured from the same materials, with similar morphologies, and sterilized by the same methods as those cleared previously by FDA with the predicate device.
Based on the information contained within this submission, it is concluded that the Mectron Piezosurgery White is substantially equivalent to the identified predicate device already in interstate commerce within the USA.