Who is the manufacturer of PIEZOSURGERY PLUS?

Mectron S.P.A. filed the 510(k) submission for PIEZOSURGERY PLUS (K153743).

What is the FDA product code for PIEZOSURGERY PLUS?

JDX. It is classified under 21 CFR 888.4580 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PIEZOSURGERY PLUS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PIEZOSURGERY PLUS?

Piezosurgery Flex (K132848); Alliger Ultrasonic Surgical System Model AUSS-7 (K070313).

Who can help prepare an FDA 510(k) submission like PIEZOSURGERY PLUS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PIEZOSURGERY PLUS

K153743 · Mectron S.P.A. · JDX · May 25, 2016 · Orthopedic

Device Facts

Record ID	K153743
Device Name	PIEZOSURGERY PLUS
Applicant	Mectron S.P.A.
Product Code	JDX · Orthopedic
Decision Date	May 25, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.4580
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Piezosurgery Plus is an ultrasonic surgical system for bone cutting; osteotomy; osteoplasty; drilling. System comprises control unit with LCD touch screen; two detachable piezoelectric handpieces; peristaltic irrigation pumps; single-use insert tips; foot-pedal. Control unit houses ultrasonic generators and microprocessor board. Generator performs automatic frequency sweep (24-36 kHz) to lock onto transducer resonance frequency. Ultrasonic signal amplitude modulation creates 'hammer effect' to enhance cutting and prevent stalling. Used in OR by surgeons. Irrigation system delivers sterile saline/water to surgical site. Device provides mechanical micro-vibrations to inserts for precise bone removal. Benefits include efficient bone cutting with minimized risk of necrosis and insert breakage. Output parameters (power, flow) controlled via touch screen; activation via foot-pedal.

Clinical Evidence

Bench testing only. No clinical or animal data. Testing included: 1) Osteotomy/osteoplasty comparative tests on cow femur/rib samples measuring cutting speed and bone volume removal; 2) Bone safety evaluation via 40x magnification microscopy showing no necrosis; 3) Device safety stress testing (600 cycles) on 'worst case' inserts showing no breakage.

Technological Characteristics

Piezoelectric ultrasonic system; 24-36 kHz frequency range. Materials: Stainless steel (AISI 316/316L), titanium alloy, PEEK. Control unit: 12.1-inch LCD touch screen. Irrigation: Peristaltic pumps (4-81 ml/min). Connectivity: Foot-pedal. Sterilization: EtO for single-use parts; steam (132°C, 4 min) for reusable handpieces. Compliance: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring osteotomy, osteoplasty, or drilling during surgical procedures in otolaryngology, oral/maxillofacial, hand and foot, neurosurgery, spine, plastic/reconstructive, and orthopedic surgery. May be used with endoscopic visual assistance.

Regulatory Classification

Identification

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Predicate Devices

Piezosurgery Flex (K132848)
Alliger Ultrasonic Surgical System Model AUSS-7 (K070313)

Related Devices

K132848 — PIEZOSURGERY FLEX · Mectron S.P.A. · Nov 29, 2013
K172464 — XD880A Ultrasonic Osteotomy Surgical System · Morley Research Consortium · Apr 24, 2018
K083284 — PIEZOSURGERY MEDICAL · Piezosurgery S.R.L. · Apr 8, 2009
K122322 — PIEZOSURGERY TOUCH · Mectron S.P.A. · Dec 6, 2012
K201274 — Ultrasonic Osteotomy Surgical System · Smtp Technology Co., Ltd. · Feb 19, 2021

Submission Summary (Full Text)

{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. 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 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 | {4}------------------------------------------------ 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 {6}------------------------------------------------ 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) {7}------------------------------------------------ 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 {8}------------------------------------------------ Image /page/8/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. A gray line with circles runs underneath the word "mectron". The text "Mectron S.p.A." is located below the logo. Via Loreto, 15/A - 16042 Carasco - GE (Italy) 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 s…