(149 days)
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 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 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.
The provided text describes the Mectron Piezosurgery Plus device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device numerically meets specific criteria as typically seen in AI/ML device submissions.
This document is a 510(k) summary for a traditional surgical instrument, not an AI/ML powered device. The "performance testing" section focuses on demonstrating the device's functionality, safety, and equivalence to predicate devices based on well-established non-AI engineering principles and physical testing.
Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts, MRMC studies, standalone performance, ground truth types for training/test sets, training set size) are not applicable to this type of device and submission.
Here's a breakdown of the information that can be extracted from the document, acknowledging the non-AI nature:
Acceptance Criteria and Device Performance (Non-AI Device)
Since this is a traditional surgical instrument, the "acceptance criteria" are generally framed around demonstrating functional equivalence to predicate devices and compliance with relevant safety standards, rather than numerical performance against a specific metric (like sensitivity/specificity for AI). The "reported device performance" refers to the results of engineering tests confirming these aspects.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary from Text) |
|---|---|
| Electrical Safety Compliance | Complies with IEC 60601-1:2005 + AMD1:2012 |
| Electromagnetic Compatibility (EMC) Compliance | Complies with IEC 60601-1-2:2007 |
| Software Verification & Validation | Conducted and documentation provided per FDA Guidance for Medical Device Software (May 11, 2005). Software classified as 'major' level of concern. |
| Biocompatibility of Patient-Contacting Components | Tip inserts (single-use) classified as 'external communicating devices' in contact with 'tissue/bone/dentin' with 'limited' contact duration. Materials (stainless steel, titanium alloy, PEEK) are identical to or in accordance with predicate device/standards, with PEEK data provided. |
| Osteotomy/Osteoplasty Efficiency (Comparative) | Able to efficiently carry out osteoplasty and osteotomy with results at least equivalent to the identified predicate device with equivalent inserts. (Evaluated by measuring cutting speed for osteotomy and bone volume removed for osteoplasty). |
| Bone Safety (Prevention of Necrosis) | No evidence of bone necrosis recorded on any bone sample obtained using 'worst case' tip inserts during comparative testing. (Evaluated by microscopic inspection at 40x magnification on cow femur/rib samples). |
| Device Safety (Prevention of Insert Breakage) | No insert breakages noted during stress tests. ('Worst case' inserts subjected to 600 mechanical stress cycles, 5 samples per insert type, simulating clinical usage). |
| Sterility Assurance Level (SAL) | Components supplied sterile (irrigation tube set, insert tips) meet SAL = 10-6. Recommended steam sterilization for reusable parts (handpieces, torque wrenches) at 132°C (270°F) for 4 min achieves SAL = 10-6. |
| Substantial Equivalence to Predicate Devices | The device's technological characteristics, intended use, and performance testing demonstrate substantial equivalence to the Piezosurgery Flex (K132848) and/or Alliger Ultrasonic Surgical System Model AUSS-7 (K070313), with differences evaluated and determined not to raise new questions of safety or effectiveness. |
Information Regarding the Study (or lack thereof for AI/ML specific aspects):
-
Sample size used for the test set and the data provenance:
- Test Type 1 (Osteotomy/Osteoplasty Efficiency): "cow femur or rib samples" were used. No specific number of samples is provided.
- Test Type 2 (Bone Safety): Performed on "bone surfaces derived from the above test type 1." Same samples, no specific count.
- Test Type 3 (Device Safety - Insert Breakage): "Five samples were tested for each investigated insert type."
- Data Provenance: In vitro testing (cow bone), not human data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this engineering performance testing. "Ground truth" was established by direct measurement (cutting speed, volume removed) or visual inspection (microscope for necrosis). The document does not mention external experts for ground truth establishment.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic or prognostic study requiring multi-reader adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This is a traditional surgical instrument, not an AI-assisted device for diagnostic or prognostic purposes.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a console and handpiece system, always used with a human operator. The performance testing describes the device's physical capabilities.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" was direct physical measurement and observation:
- Cutting speed measurement.
- Volume of bone removed measurement.
- Microscopic visual inspection for bone necrosis.
- Observation of insert integrity after stress cycles.
- For safety and software, it was compliance with recognized standards and guidance.
- For mechanical testing, the "ground truth" was direct physical measurement and observation:
-
The sample size for the training set:
- Not applicable; this is not an AI/ML device that requires a training set. The software mentioned is for device control and functionality, validated through traditional software V&V.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set mentioned for an AI/ML algorithm.
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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
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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
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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)
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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.aVia Loreto 1516042 Carasco - (GE) - ITALYPhone: +39 0185 35 361Fax: +39 0185 351 374 |
| 510(k) Contact Person: | Roger GrayVP, Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania, 1000153 Rome, ItalyPhone: +39 06 578 2665Fax: +39 06 574 3786email: rgray@donawa.com |
| Manufacturer: | MECTRON S.p.aVia Loreto 1516042 Carasco - (GE) - ITALYEstablishment 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 orattachments, such as a cutting tip that vibrates at high frequencies, and isintended for medical purposes to cut bone or other materials, such as acrylic. |
| Regulation Medical Specialty: | Orthopedic |
| Classification product codes: | JDXDZI, 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 SurgicalSystem 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
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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 PlusSubject Device | Piezosurgery FlexPrimary Predicate Device(PD1) | Alliger Ultrasonic SurgicalSystem Model AUSS-7Secondary Predicate Device(PD2) | Equivalence |
|---|---|---|---|---|
| Manufacturer | MECTRON SPAVia Loreto 1516042 CarascoItaly | MECTRON SPAVia Loreto 1516042 CarascoITALY | MISONIX INC.1938 New HighwayFarmingdale, NY 11736USA | N/A |
| 510(k) Number | Subject of this submission | K132848 | K070313 | N/A |
| RegulationNumber | 888.4580 | 888.4580 | Unclassified | Identical to PD1 |
| Regulation Name | Sonic surgical instrument andaccessories/attachments | Sonic surgical instrument andaccessories/attachments | Instrument, UltrasonicSurgical | Identical to PD1 |
| Common/UsualName | Bone cutting instruments andaccessories | Bone cutting instruments andaccessories | Ultrasonic Surgical SystemUltrasonic 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 PlusSubject Device | Piezosurgery FlexPrimary Predicate Device(PD1) | Alliger Ultrasonic SurgicalSystem Model AUSS-7Secondary Predicate Device(PD2) | Equivalence |
| Intended Use /Indications for Use | The Piezosurgery® Plus isan ultrasonic surgical systemconsisting of handpieces andassociated tips forosteotomy, osteoplasty anddrilling in a variety of surgicalprocedures, including but notlimited to:• Otolaryngology• Oral/maxillofacial• Hand and foot• Neurosurgery• Spine• Plastic/reconstructive, and• Orthopedic surgeryThe device may also be usedwith endoscopic visualassistance to perform theabove listed procedures. | The PIEZOSURGERY FLEXis an ultrasonic surgicalsystem consisting ofhandpieces and associatedtips for cutting bone,osteotomy, osteoplasty, anddrilling in a variety of surgicalprocedures, including but notlimited to:• Otolaryngological,• Oral/maxillofacial,• Hand and Foot,• Neurosurgical,• Spine,• Plastic reconstructivesurgery.It may also be used withendoscopic visual assistanceto perform the above listedprocedures. | The AUSS-7 ULTRASONICSURGICAL SYSTEM isindicated for use in thefragmentation and aspirationof both soft and hard (e.g.bone) tissue in the followingsurgical specialties:• Neurosurgery• Gastrointestinal andaffiliated organ surgery• Urological surgery• Orthopedic surgery• Gynecology• Thoracic surgery• Wound care | Substantiallyequivalent |
| Technologicalcharacteristics(mechanism ofaction) | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibrationof the insert tips. | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibrationof the insert tips. | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibrationof the insert tips. | Identical to PD1 & PD2 |
| TransducerTechnologicalcharacteristics | Piezoelectric UltrasonicTechnology:The transducer usespiezoceramic disks thatconvert the electrical inputsignal from the generator toultrasonic vibration of theinsert | Piezoelectric UltrasonicTechnology:The transducer usespiezoceramic disks thatconvert the electrical inputsignal from the generator toultrasonic vibration of theinsert | Piezoelectric UltrasonicTechnology:The transducer usespiezoceramic disks thatconvert the electrical inputsignal from the generator toultrasonic vibration of theinsert | Identical to PD1 & PD2 |
| Operatingfrequency range | 24 kHz to ~ 36 kHz | 24 kHz to ~ 36 kHz | 22.5 kHz | Identical to PD1 |
| Electrical powerinput | 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 WApproximately: 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 parametersare displayed and controlledthrough a 12.1 inch LCDColor Touch Screen. | The functional parametersare displayed and controlledthrough a console with touchpanel | The functional parametersare displayed on a color LCDScreen on the deviceconsole | Substantiallyequivalent |
| Operation | The device has two separatepiezoelectric ultrasonichandpieces: the operator maychoose either of the twohandpieces by selection fromthe LCD touch-screen. | The device has onepiezoelectric ultrasonichandpiece. | The device has onepiezoelectric ultrasonichandpiece. | Substantiallyequivalent |
| Ultrasonicvibration activation | Foot-pedal connected to thedevice control unit by meansof a cord. | Foot-pedal connected to thedevice control unit by meansof a cord. | Foot-pedal connected to thedevice control unit by meansof a cord. | Identical to PD1 & PD2 |
| Automaticresonancefrequency tuning | Electronics with automatictuning of the resonancefrequency | Electronics with automatictuning of the resonancefrequency. | Unknown. | Identical to PD1 |
| Modulatedultrasonic signal | Yes | Yes | Unknown | Identical to PD1 |
| Table 2: Substantial Equivalence Comparison between Piezosurgery Plus and the Predicate Devices | ||||
| Feature | Piezosurgery PlusSubject Device | Piezosurgery FlexPrimary Predicate Device(PD1) | Alliger Ultrasonic SurgicalSystem Model AUSS-7Secondary Predicate Device(PD2) | Equivalence |
| Irrigation system | External irrigation tubingconnecting the handpiece tothe irrigation bag via aperistaltic pump. | External irrigation tubingconnecting the handpiece tothe irrigation bag via aperistaltic pump. | External irrigation tubingconnecting the handpiece tothe irrigation bag via aperistaltic pump. | Identical to PD1 & PD2 |
| Irrigation flow rateadjustment | Flow rate adjustable throughthe LCD touch screen of thecontrol unit.Flow rate adjustable from 4ml/min to approx. 81 ml/min. | Flow rate adjustable throughthe touch panel of the controlunit.Flow rate adjustable from 8ml/min to approx. 65 ml/min | Flow rate adjustable throughthe front panel of the controlunit.Max flow approx 67 ml/min | Substantiallyequivalent |
| Irrigant fluid | Physiological sterile salinesolution or sterile water | Physiological sterile salinesolution or sterile water | Physiological sterile salinesolution. | 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 |
| ElectromagneticCompatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to PD1 & PD2 |
| Device containssoftware? | Yes | Yes | Yes | Identical to PD1 & PD2 |
| SoftwareValidation | In accordance with FDAGuidance:"Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices" | In accordance with FDAGuidance:"Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices" | Unknown | Identical to PD1 |
| Parts suppliedsterile | Yes:Irrigation tube set and theinsert tips/extensions/protective sleeves aresupplied sterile for single useonly. | Yes:Irrigation tube set and theinsert tips are supplied sterilefor single use only. | Yes:Irrigation tube set and theinsert tips are supplied sterilefor single use only. | Identical to PD1 & PD2 |
| Sterilizationmethod | Ethylene Oxide (EtO)Sterilization Process | Ethylene Oxide (EtO)Sterilization Process | Unknown | Identical to PD1 |
| Parts need to besterilized | Yes:Ultrasonic handpieces, torquewrenches and other minoraccessories are reusable andmust be sterilized prior toreuse. | Yes:Ultrasonic handpiece, torquewrench and other minoraccessories are reusable andmust be sterilized prior toreuse. | Yes:Ultrasonic handpiece,torque wrench and otherminor accessories arereusable and must besterilized prior toreuse. | Identical to PD1 & PD2 |
| Recommendedsterilizationmethod | Steam Sterilization (Pre-vacuum)SterilizationTemperature:132°C (270°F).Minimum Exposure Time:4 min. | Steam Sterilization (Pre-vacuum)SterilizationTemperature:132°C (270°F).Minimum Exposure Time:4 min. | Steam Sterilization (Pre-vacuum)SterilizationTemperature:132°C (270°F).Minimum Exposure Time:4 min. | Identical to PD1 & PD2 |
| Sterility AssuranceLevel | SAL = 10-6 | SAL = 10-6 | SAL = 10-6 | Identical to PD1 & PD2 |
| Tip Inserts thatcome into directcontact withpatients | Raw Material: Stainless steel.The insert tips are secured tothe handpiece by a thread,using a torque wrench. | Raw Material: Stainless steel.The insert tips are secured tothe handpiece by a thread,using a torque wrench. | Information not available.The insert tips are secured tothe handpiece by a thread,using a torque wrench | Identical to PD1 |
| Control unitdimensions | Width: 410 mmHeight: 310 mmDepth: 380mm | Width: 300 mmHeight: 95 mmDepth: 250mm | Width: 410 mmHeight: 180 mmDepth: 485mm | Differences have noimpact on safety andeffectiveness |
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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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 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.
§ 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.