(149 days)
Not Found
No
The description details a microprocessor controlling functional parameters and an automatic frequency sweep to locate resonance, which are standard control system functions, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The device is described as an "ultrasonic surgical system" used for "osteotomy, osteoplasty and drilling" in various surgical procedures, which are therapeutic interventions.
No
The device is an ultrasonic surgical system used for cutting, drilling, and shaping bone during various surgical procedures. It is a therapeutic device that performs an intervention, not a device that provides diagnostic information about a patient's condition.
No
The device is a surgical system that includes a control unit, handpieces, pumps, tubing, tips, wrenches, and a foot-pedal, all of which are hardware components. While it contains software for control and supervision, it is not solely software.
Based on the provided information, the Piezosurgery® Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an ultrasonic surgical system for osteotomy, osteoplasty, and drilling in various surgical procedures performed on the patient. IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical system with handpieces, tips, and a control unit designed to perform mechanical cutting of bone using ultrasonic energy. This is a direct surgical intervention, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
The Piezosurgery® Plus is a surgical device used directly on the patient's body during a procedure.
N/A
Intended Use / Indications for Use
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- Otolaryngology
- Oral/maxillofacial
- Hand and foot
- Neurosurgery
- Spine
- Plastic/reconstructive, and
- Orthopedic surgery.
The device may also be used with endoscopic visual assistance to perform the above listed procedures.
Product codes (comma separated list FDA assigned to the subject device)
JDX, DZI, ERL, HBE, HWE
Device Description
The Piezosurgery Plus device 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.
The Piezosurgery Plus system consists of a control unit which provides control and power functions, two different detachable surgical handpieces which provide the ultrasonic mechanical energy, two peristaltic irrigation pumps, two irrigation tubing systems, a range of single use insert tips, torque wrenches, and a foot-pedal.
The control unit has a color LCD touch screen user interface for the selection/visualization of device functional parameters. Inside the control unit are located two ultrasonic generators which drive the two handpieces, the electrical power supply modules and the microprocessor electronic board that controls and supervises the functional parameters of the device.
The two piezoelectric ultrasonic handpieces available for the Piezosurgery Plus are identified as 'Piezosurgery Medical' and 'Piezosurgery Medical +'. The handpieces are reusable and capable of being reprocessed by autoclaving.
The handpiece labeled 'Piezosurgery Medical +', uses identical technology to the 'Piezosurgery Medica' handpiece but differs from it as it contains larger piezoceramic rings in its transducer, allowing more efficient cutting of thick bony structures, and also use with extended reach for minimally invasive bone surgery in long narrow access path, in small cavities and other hard to reach areas.
The two peristaltic pumps, which provide, through the two single-use irrigation tubing sets, sterile fluid to the surgical site, are mounted on the two lateral panels of the control unit.
The control unit includes connectors for the handpieces and for the foot-pedal. Each handpiece receives the functional drive signals from the control unit.
Each irrigation tubing set connects each handpiece irrigation connector to a sterile fluid bag (not supplied with the device) via the associated peristaltic pump.
The user may select either of the two handpieces for activation from the LCD touch-screen. Ultrasonic power and irrigation flow are simultaneously activated for the selected handpiece by pressing the foot-pedal.
The ultrasonic generator(s) provides electrical energy at a specific range of frequency. The generator must drive the transducer at or near its anti-resonance frequency for optimal operation. A key function of the generator is to locate the anti-resonant frequency and drive the output at this frequency.
In particular, the generator conducts an automatic frequency sweep across a frequency interval of 36 kHz - 24 kHz to locate and lock the electrical resonance frequency of the transducer/insert system. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The PiezosurgeryPlus handpieces transducers and family of inserts are designed to resonate in this range of frequencies.
The ultrasonic signal can be modulated in amplitude, generating a sinusoidal signal with alternative amplitudes of high and low value that creates a hammer effect that enhances cutting and minimizes insert stalling.
The Piezosurgery Plus 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
bone or other materials
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)
Electrical safety and electromagnetic compatibility: The subject device was tested to confirm compliance of the subject device to IEC 60601-1:2005 + AMD1:2012 and IEC 60601-1-2:2007.
Software verification and validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 May 2005. The software for this device was considered as a 'major' level of concern.
Biocompatibility: The Piezosurgery Plus components that come into direct contact with patients during surgical procedures are the tip inserts, which are supplied for single use only. According to ISO 10993-1, these components are classified as 'external communicating devices', in contact with 'tissue/bone/dentin' with 'limited' contact duration
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Mectron Spa % Roger Gray VP, Quality And Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 IT
Re: K153743
Trade/Device Name: Piezosurgery Plus Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic Surgical Instrument And Accessories/Attachments Regulatory Class: Class II Product Code: JDX, DZI, ERL, HBE, HWE Dated: April 21, 2016 Received: April 25, 2016
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.
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
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153743
Device Name
PIEZOSURGERY PLUS
Indications for Use (Describe)
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- Otolaryngology
- Oral/maxillofacial
- Hand and foot
- Neurosurgery
- Spine
- Plastic/reconstructive, and
- Orthopedic surgery.
The device may also be used with endoscopic visual assistance to perform the above listed procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Mectron S.p.A., a medical technology company. The word "mectron" is written in orange, with the words "medical technology" in gray to the right. Below the logo is the text "Mectron S.p.A.".
Via Loreto, 15/A - 16042 Carasco – GE (Italy)
510(k) Summary in accordance with 21 CFR 807.92
ADMINISTRATIVE INFORMATION 1.
| Type of 510(k) submission: | Traditional |
|---|---|
| Submission date: | December 22, 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 | |
| Proprietary Name: | Piezosurgery Plus |
| Regulation Number: | 21 CFR 888.4580 |
| Device Classification Name: | Sonic surgical instrument and accessories/attachments. |
| Regulation Identification: | A sonic surgical instrument is a hand-held device with various accessories or |
| attachments, such as a cutting tip that vibrates at high frequencies, and is | |
| intended for medical purposes to cut bone or other materials, such as acrylic. | |
| Regulation Medical Specialty: | Orthopedic |
| Classification product codes: | JDX |
| DZI, ERL, HBE, HWE |
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Image /page/4/Picture/0 description: The image shows the logo for Mectron S.p.A, a medical technology company. The logo features the word "mectron" in orange, with the words "medical technology" in gray to the right. Below the logo is the company's address: Via Loreto, 15/A - 16042 Carasco - GE (Italy).
3. IDENTIFICATION OF PREDICATE DEVICES
The substantial equivalence of the subject device is based on the following legally marketed predicate devices
| Table 1: Identification of Predicate Devices | |||||
|---|---|---|---|---|---|
| Trade Name | Manufacturer | Product Code | 510(k) Number | Decision Date | |
| Piezosurgery Flex | MECTRON Spa | JDX, DZI, ERL, HBE, HWE | K132848 | 29 November 2013 | |
| Alliger Ultrasonic Surgical | |||||
| System Model AUSS-7 | MISONIX INC | LFL | K070313 | 11 May 2007 |
DEVICE DESCRIPTION AND TECHNOLOGICAL CHARACTERISTICS 4.
The Piezosurgery Plus device 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.
The Piezosurgery Plus system consists of a control unit which provides control and power functions, two different detachable surgical handpieces which provide the ultrasonic mechanical energy, two peristaltic irrigation pumps, two irrigation tubing systems, a range of single use insert tips, torque wrenches, and a foot-pedal.
The control unit has a color LCD touch screen user interface for the selection/visualization of device functional parameters. Inside the control unit are located two ultrasonic generators which drive the two handpieces, the electrical power supply modules and the microprocessor electronic board that controls and supervises the functional parameters of the device.
The two piezoelectric ultrasonic handpieces available for the Piezosurgery Plus are identified as 'Piezosurgery Medical' and 'Piezosurgery Medical +'. The handpieces are reusable and capable of being reprocessed by autoclaving.
The handpiece labeled 'Piezosurgery Medical +', uses identical technology to the 'Piezosurgery Medica' handpiece but differs from it as it contains larger piezoceramic rings in its transducer, allowing more efficient cutting of thick bony structures, and also use with extended reach for minimally invasive bone surgery in long narrow access path, in small cavities and other hard to reach areas.
The two peristaltic pumps, which provide, through the two single-use irrigation tubing sets, sterile fluid to the surgical site, are mounted on the two lateral panels of the control unit.
The control unit includes connectors for the handpieces and for the foot-pedal. Each handpiece receives the functional drive signals from the control unit.
Each irrigation tubing set connects each handpiece irrigation connector to a sterile fluid bag (not supplied with the device) via the associated peristaltic pump.
The user may select either of the two handpieces for activation from the LCD touch-screen. Ultrasonic power and irrigation flow are simultaneously activated for the selected handpiece by pressing the foot-pedal.
The ultrasonic generator(s) provides electrical energy at a specific range of frequency. The generator must drive the transducer at or near its anti-resonance frequency for optimal operation. A key function of the generator is to locate the anti-resonant frequency and drive the output at this frequency.
In particular, the generator conducts an automatic frequency sweep across a frequency interval of 36 kHz - 24 kHz to locate and lock the electrical resonance frequency of the transducer/insert system. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery
5
Image /page/5/Picture/0 description: The image shows the logo for Mectron, a medical technology company. The logo features the word "mectron" in orange, with the words "medical technology" in gray to the right. Below the logo is the company's name, Mectron S.p.A., and address, Via Loreto, 15/A - 16042 Carasco - GE (Italy).
Plus handpieces transducers and family of inserts are designed to resonate in this range of frequencies.
The ultrasonic signal can be modulated in amplitude, generating a sinusoidal signal with alternative amplitudes of high and low value that creates a hammer effect that enhances cutting and minimizes insert stalling.
The Piezosurgery Plus 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.
The Piezosurgery® Plus is an ultrasonic system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- Otolaryngology
- Oral/maxillofacial
- Hand and foot
- · Neurosurgery
- · Spine
- · Plastic/reconstructive, and
- · Orthopedic surgery
The device may also be used with endoscopic visual assistance to perform the above listed procedures.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Piezoelectric ultrasonic technology is used by the subject device and both the predicate devices to generate mechanical micro-vibrations of the insert connected to the handpiece. The subject device and predicate devices share many technological characteristics, as identified in the following section.
SUBSTANTIAL EQUIVALENCE 7.
A comparison of the subject device with the predicate devices is shown in Table 2.
| Feature | Piezosurgery Plus
Subject Device | Piezosurgery Flex
Primary Predicate Device
(PD1) | Alliger Ultrasonic Surgical
System Model AUSS-7
Secondary Predicate Device
(PD2) | Equivalence |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Manufacturer | MECTRON SPA
Via Loreto 15
16042 Carasco
Italy | MECTRON SPA
Via Loreto 15
16042 Carasco
ITALY | MISONIX INC.
1938 New Highway
Farmingdale, NY 11736
USA | N/A |
| 510(k) Number | Subject of this submission | K132848 | K070313 | N/A |
| Regulation
Number | 888.4580 | 888.4580 | Unclassified | Identical to PD1 |
| Regulation Name | Sonic surgical instrument and
accessories/attachments | Sonic surgical instrument and
accessories/attachments | Instrument, Ultrasonic
Surgical | Identical to PD1 |
| Common/Usual
Name | Bone cutting instruments and
accessories | Bone cutting instruments and
accessories | Ultrasonic Surgical System
Ultrasonic Surgical Aspirator | Identical to PD1 |
| Regulation Panel | Orthopedic | Orthopedic | General & Plastic Surgery | Identical to PD1 |
| Product Code | JDX, DZI, ERL, HBE, HWE | JDX, DZI, ERL, HBE, HWE | LFL | Identical to PD1 |
| Regulatory Class | Class II | Class II | Unclassified | Identical to PD1 |
| Feature | Piezosurgery Plus
Subject Device | Piezosurgery Flex
Primary Predicate Device
(PD1) | Alliger Ultrasonic Surgical
System Model AUSS-7
Secondary Predicate Device
(PD2) | Equivalence |
| Intended Use /
Indications for Use | The Piezosurgery® Plus is
an ultrasonic surgical system
consisting of handpieces and
associated tips for
osteotomy, osteoplasty and
drilling in a variety of surgical
procedures, including but not
limited to:
• Otolaryngology
• Oral/maxillofacial
• Hand and foot
• Neurosurgery
• Spine
• Plastic/reconstructive, and
• Orthopedic surgery
The device may also be used
with endoscopic visual
assistance to perform the
above listed procedures. | The PIEZOSURGERY FLEX
is an ultrasonic surgical
system consisting of
handpieces and associated
tips for cutting bone,
osteotomy, osteoplasty, and
drilling in a variety of surgical
procedures, including but not
limited to:
• Otolaryngological,
• Oral/maxillofacial,
• Hand and Foot,
• Neurosurgical,
• Spine,
• Plastic reconstructive
surgery.
It may also be used with
endoscopic visual assistance
to perform the above listed
procedures. | The AUSS-7 ULTRASONIC
SURGICAL SYSTEM is
indicated for use in the
fragmentation and aspiration
of both soft and hard (e.g.
bone) tissue in the following
surgical specialties:
• Neurosurgery
• Gastrointestinal and
affiliated organ surgery
• Urological surgery
• Orthopedic surgery
• Gynecology
• Thoracic surgery
• Wound care | Substantially
equivalent |
| Technological
characteristics
(mechanism of
action) | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration
of the insert tips. | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration
of the insert tips. | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration
of the insert tips. | Identical to PD1 & PD2 |
| Transducer
Technological
characteristics | Piezoelectric Ultrasonic
Technology:
The transducer uses
piezoceramic disks that
convert the electrical input
signal from the generator to
ultrasonic vibration of the
insert | Piezoelectric Ultrasonic
Technology:
The transducer uses
piezoceramic disks that
convert the electrical input
signal from the generator to
ultrasonic vibration of the
insert | Piezoelectric Ultrasonic
Technology:
The transducer uses
piezoceramic disks that
convert the electrical input
signal from the generator to
ultrasonic vibration of the
insert | Identical to PD1 & PD2 |
| Operating
frequency range | 24 kHz to ~ 36 kHz | 24 kHz to ~ 36 kHz | 22.5 kHz | Identical to PD1 |
| Electrical power
input | 100 - 240 VAC - 50/60 Hz. | 100 - 240 VAC - 50/60 Hz. | 120 VAC - 60 Hz | Identical to PD1 |
| Output power | Two handpieces:
Approximately: 24 W
Approximately: 75 W | One handpiece:
Approximately 24 W | One handpiece:
130 Watt (max.) | See note SE#2 |
| Device type | Table top device | Table top device | Table top device | Identical to PD1 & PD2 |
| User Interface | The functional parameters
are displayed and controlled
through a 12.1 inch LCD
Color Touch Screen. | The functional parameters
are displayed and controlled
through a console with touch
panel | The functional parameters
are displayed on a color LCD
Screen on the device
console | Substantially
equivalent |
| Operation | The device has two separate
piezoelectric ultrasonic
handpieces: the operator may
choose either of the two
handpieces by selection from
the LCD touch-screen. | The device has one
piezoelectric ultrasonic
handpiece. | The device has one
piezoelectric ultrasonic
handpiece. | Substantially
equivalent |
| Ultrasonic
vibration activation | Foot-pedal connected to the
device control unit by means
of a cord. | Foot-pedal connected to the
device control unit by means
of a cord. | Foot-pedal connected to the
device control unit by means
of a cord. | Identical to PD1 & PD2 |
| Automatic
resonance
frequency tuning | Electronics with automatic
tuning of the resonance
frequency | Electronics with automatic
tuning of the resonance
frequency. | Unknown. | Identical to PD1 |
| Modulated
ultrasonic signal | Yes | Yes | Unknown | Identical to PD1 |
| Table 2: Substantial Equivalence Comparison between Piezosurgery Plus and the Predicate Devices | | | | |
| Feature | Piezosurgery Plus
Subject Device | Piezosurgery Flex
Primary Predicate Device
(PD1) | Alliger Ultrasonic Surgical
System Model AUSS-7
Secondary Predicate Device
(PD2) | Equivalence |
| Irrigation system | External irrigation tubing
connecting the handpiece to
the irrigation bag via a
peristaltic pump. | External irrigation tubing
connecting the handpiece to
the irrigation bag via a
peristaltic pump. | External irrigation tubing
connecting the handpiece to
the irrigation bag via a
peristaltic pump. | Identical to PD1 & PD2 |
| Irrigation flow rate
adjustment | Flow rate adjustable through
the LCD touch screen of the
control unit.
Flow rate adjustable from 4
ml/min to approx. 81 ml/min. | Flow rate adjustable through
the touch panel of the control
unit.
Flow rate adjustable from 8
ml/min to approx. 65 ml/min | Flow rate adjustable through
the front panel of the control
unit.
Max flow approx 67 ml/min | Substantially
equivalent |
| Irrigant fluid | Physiological sterile saline
solution or sterile water | Physiological sterile saline
solution or sterile water | Physiological sterile saline
solution. | Identical to PD1 & PD2 |
| Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to PD1 & PD2 |
| Electromagnetic
Compatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to PD1 & PD2 |
| Device contains
software? | Yes | Yes | Yes | Identical to PD1 & PD2 |
| 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" | Unknown | Identical to PD1 |
| Parts supplied
sterile | Yes:
Irrigation tube set and the
insert tips/extensions/
protective sleeves are
supplied sterile for single use
only. | Yes:
Irrigation tube set and the
insert tips are supplied sterile
for single use only. | Yes:
Irrigation tube set and the
insert tips are supplied sterile
for single use only. | Identical to PD1 & PD2 |
| Sterilization
method | Ethylene Oxide (EtO)
Sterilization Process | Ethylene Oxide (EtO)
Sterilization Process | Unknown | Identical to PD1 |
| Parts need to be
sterilized | Yes:
Ultrasonic handpieces, torque
wrenches and other minor
accessories are reusable and
must be sterilized prior to
reuse. | Yes:
Ultrasonic handpiece, torque
wrench and other minor
accessories are reusable and
must be sterilized prior to
reuse. | Yes:
Ultrasonic handpiece,
torque wrench and other
minor accessories are
reusable and must be
sterilized prior to
reuse. | Identical to PD1 & PD2 |
| Recommended
sterilization
method | Steam Sterilization (Pre-
vacuum)
Sterilization
Temperature:132°C (270°F).
Minimum Exposure Time:
4 min. | Steam Sterilization (Pre-
vacuum)
Sterilization
Temperature:132°C (270°F).
Minimum Exposure Time:
4 min. | Steam Sterilization (Pre-
vacuum)
Sterilization
Temperature:132°C (270°F).
Minimum Exposure Time:
4 min. | Identical to PD1 & PD2 |
| Sterility Assurance
Level | SAL = 10-6 | SAL = 10-6 | SAL = 10-6 | Identical to PD1 & PD2 |
| Tip Inserts that
come into direct
contact with
patients | Raw Material: Stainless steel.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench. | Raw Material: Stainless steel.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench. | Information not available.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench | Identical to PD1 |
| Control unit
dimensions | Width: 410 mm
Height: 310 mm
Depth: 380mm | Width: 300 mm
Height: 95 mm
Depth: 250mm | Width: 410 mm
Height: 180 mm
Depth: 485mm | Differences have no
impact on safety and
effectiveness |
Table 2: Substantial Equivalence Comparison between Piezosurgery Plus and the Predicate Devices
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Image /page/6/Picture/0 description: The image contains the word "mectron" in orange font. The font is sans-serif and appears to be bolded. The word is horizontally oriented and centered in the image.
medical technology
Mectron S.p.A.
Via Loreto, 15/A - 16042 Carasco – GE (Italy)
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Image /page/7/Picture/0 description: The image shows the word "mectron" in orange color. The font is sans-serif and appears to be bold. The word is presented in a simple and clean style.
medical technology
7
Mectron S.p.A. Via Loreto, 15/A - 16042 Carasco – GE (Italy)
Many of the features and characteristics of the subject device are identical to those of the primary predicate device (PD1), and where there are differences, the subject device is substantially equivalent to the secondary predicate device (PD2).
Some differences clearly have no impact on safety or effectiveness, such as dimensional differences, and the number of operator-usable handpieces, while other differences, such as user interface design and
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minimum/maximum irrigation flow rates, provide for improved flexibility of use. Justification is provided in this submission for substantial equivalence for more significant differences, including indications for use/intended use, and output power.
8. PERFORMANCE TESTING
Electrical safety and electromagnetic compatibility: The subject device was tested to confirm compliance of the subject device to IEC 60601-1:2005 + AMD1:2012 and IEC 60601-1-2:2007.
Software verification and validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 May 2005. The software for this device was considered as a 'major' level of concern.
Biocompatibility: The Piezosurgery Plus components that come into direct contact with patients during surgical procedures are the tip inserts, which are supplied for single use only. According to ISO 10993-1, these components are classified as 'external communicating devices', in contact with 'tissue/bone/dentin' with 'limited' contact duration ≤ 24 h.
The materials with which the Piezosurgery Plus insert tips are identical to the insert tip materials cleared with the predicate device Piezosurgery Flex (K132848). Materials not used in this predicate device are titanium alloy and stainless steel AISI 316/316L, which are in accordance with relevant standards for surgical use, and PEEK, for which biocompatibility data is provided.
Mechanical testing: Three types of mechanical performance tests have been carried out:
Test type 1: Osteotomylosty comparative test. The objective of these tests was to provide evidence that the subject device tip inserts are able to efficiently carry out the surgical procedures of osteoplasty and osteotomy with results at least equivalent to the identified predicate device with equivalent inserts.
The tests were conducted using cow femur or rib samples. Osteotomy efficiency was evaluated by measuring the cutting speed of the insert. Osteoplasty efficiency was evaluated by measuring the volume of bone removed. The test results demonstrate the subject device osteotomy/osteoplasty tip inserts are able to carry out osteoplasty and osteotomy in a manner at least equivalent to the applicable predicate device/tip combination, without raising any new questions of safety and effectiveness.
Test type 2: Bone safety. The objective of this test was to demonstrate the ability of the subject device to cut/remove bone without causing bone necrosis. To evaluate the presence of necrosis, pictures of the bone surfaces derived from the above test type 1 were taken using a Veho Discovery USB microscope at 40x magnification. No evidence of bone necrosis was recorded on any bone sample obtained by using 'worst case' tip inserts.
Test type 3: Device safety. The object of this test was to demonstrate the bone cutting ability of the subject inserts without insert breakage. To carry out this test, the 'worst case' inserts were subjected to stress tests, being subjected to a number of mechanical stress cycles (600 working cycles), to simulate clinical usage. Five samples were tested for each investigated insert type. No insert breakages were noted during these tests.
No animal or clinical performance tests have been carried out.
CONCLUSION 9.
Based on the information contained within this submission, it is concluded that the Mectron Piezosurgery Plus is substantially equivalent to the identified predicate devices which are already in commercial distribution in the United States.