(148 days)
Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.
PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.
PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips.
The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values).
The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.
The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.
The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.
The provided document is a 510(k) Premarket Notification for a medical device called PIEZOTOME M+, issued by the FDA. It declares the device to be "substantially equivalent" to legally marketed predicate devices.
This document describes a medical device (PIEZOTOME M+, an ultrasonic surgical system) and its performance data to demonstrate substantial equivalence to existing devices. Therefore, the questions related to acceptance criteria and study design for an AI/algorithm-based device (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this document.
The "performance data" discussed in the document refers to typical engineering and safety tests for a physical medical device, not an AI/algorithmic system. The information provided is about electrical safety, electromagnetic compatibility, software verification (specifically stating the software is identical to a predicate device, not a new algorithm), and performance testing bench (meaning physical tests to confirm the device functions as intended, not AI model performance).
Here's how the provided information relates to the request, focusing on what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical format for an AI/algorithm where specific metrics (e.g., accuracy, sensitivity, specificity) and thresholds are defined. Instead, it demonstrates equivalency through a comparison of technological characteristics and verification against established electrical and safety standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), including USA and Canadian Deviations. | "The Electrical Safety Tests have been performed according to IEC 60601-1:2005... included USA and Canadian Deviations." |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests). | "The Electromagnetic Compatibility Tests have been performed according to IEC 60601-1-2:2007..." |
| Software Verification & Validation: Adherence to "Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). | "Software Verification activities were conducted and documented according to the document named 'Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' dated May 11, 2005. Moreover, the Software System included in PIEZOTOME M+ is strictly the same Software as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009)." |
| Performance (Physical Device Function): Similar technical characteristics for bone surgery and dental applications (piezoelectric and irrigation performance) to predicate devices. | "The Technical Characteristics for Bone Surgery Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Devices Piezoelectric System (K100410, cleared April 28, 2010) and PIEZOTOME 2 (K091331, cleared December 11, 2009). The Technical Characteristics for Dental Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009)." |
| Sterilization Validation: Compliance with applicable standards for reusable and single-use accessories. | "The Sterilizability Tests have been performed according to applicable Standards for Re-Usable accessories and Single Use Accessories provided under Sterile State." |
| Biocompatibility Validation: Compliance with ISO 10993-1 and 510(k) Memorandum - #G95-1 Table 1 requirements for body contact. | "The Biocompatibility Tests have been performed according to applicable Standards for Accessories in contact to the Patient. Tests were conducted according to the ISO 10993-1 Standard and 510(k) Memorandum - #G95-1 Table 1 'Initial Evaluation Tests for Consideration requirements (Body Contact: External communicating Device - Type of Tissue / Bone Dentin Communicating - Contact Duration: A limited less than 24 hours)." |
| Similarity to Predicate Devices: Overall technological characteristics being similar or identical to predicate devices. | A comprehensive comparison table (Table 02 on pages 5-9) is provided, detailing numerous identical or substantially equivalent characteristics across various categories (intended use, product codes, dimensions, power supply, safety classifications, internal/external constitution, software, piezoelectric performance, irrigation performance, user interface, footswitch, environmental conditions, handpieces, tips, sterilization, biocompatibility, safety/EMC standards). Minor differences (e.g., footswitch actuators, storage temperature range, specific tip designs, handpiece color) are explicitly stated to have "no impact" on substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document pertains to a physical medical device. The "performance data" refers to engineering and safety tests of the device itself and its components (e.g., electrical safety, EMC, sterilization, biocompatibility), not an AI/algorithm dataset. There is no mention of a "test set" in the context of data used for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document does not describe an AI/algorithm that requires expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted diagnostic or clinical decision support device. It's an ultrasonic surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no standalone algorithm. The "software" mentioned is identical to a predicate device's software, suggesting a control system for the physical device, not an analytical algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., IEC, ISO) and benchmarks against predicate devices' physical characteristics and function.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 19, 2017
SATELEC % Ms. Argie Zoubroulis Quality Manager ACTEON, Inc. 124 Gaither Drive, Suite #140 Mt. Laurel, New Jersey 08054
Re: K163610
Trade/Device Name: PIEZOTOME M+, PIEZOTOME M+ Handpiece Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic Surgical Instrument and Accessories/Attachments Regulatory Class: Class II Product Code: JDX, HWE, DZI, ERL, HBE Dated: April 19, 2017 Received: April 21, 2017
Dear Ms. Zoubroulis :
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 Actinclude 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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Sincerelv.
Jennifer R. Stevenson -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163610
Device Name PIEZOTOME M+
Indications for Use (Describe)
Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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."
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Additional Information - February 17, 2017
Summary of Safety And Effectiveness [As Required by 21 CFR 807.92.c]
I - SUBMITTER
01.a. 510(k) Submitter:
SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex France 011-33-556-340-607 Telephone: 011-33-556-349-292 email: philippe.girard@acteongroup.com
01.b. Contact Person:
Argie ZOUBROULIS SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800-289-6367 Ext. 390 856-222-4726 Fax: Email: argie.zoubroulis@acteongroup.com
| 01.c. Establishment Registration Number: | 8044015 |
|---|---|
| 01.d. Date Prepared: | November 29, 2016 |
| 01.e. Type of 510(k) submission: | Traditional 510(k) Submission. |
II - DEVICE
| 02.a. Trade Name of Device: | PIEZOTOME M+ |
|---|---|
| 02.b. Common Name of Device: | Sonic surgical instrument and accessories / attachments |
| 02.c. Classification Regulation: | 21 CFR 888.4580 |
| 02.d. 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 |
| 02.e. Medical Device Class: | II |
| 02.f. Panel: | Orthopedic |
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/3/Picture/10 description: The image shows the logo for ACTEON. The logo consists of the word "ACTEON" in a dark gray, sans-serif font. A light blue curved line is located to the left of the word, starting below the "A" and extending upwards and to the left. The logo is simple and modern.
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Additional Information - February 17, 2017
JDX 02.g. Product Code:
HWE, DZI, ERL, HBE 02-h. Subsequent Product Codes:
III - PREDICATE DEVICES
The Substantial Equivalence (SE) of PIEZOTOME M+ is based on the Predicate Devices identified in the Table 01.
| Trade Name | Manufacturer | Product Code | 510(k) number | Date Cleared |
|---|---|---|---|---|
| Piezoelectric System | SATELEC | JDX, DZI, ERL,HBE, HWE | K100410 | April 28, 2010 |
| PIEZOTOME 2 | SATELEC | DZI | K091331 | Dec 11, 2009 |
|--|
SATELEC Piezoelectric System Predicate Device has not been subject to a design-related recall. SATELEC PIEZOTOME 2 Predicate Device has not been subject to a design-related recall.
IV - DEVICE DESCRIPTION
PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.
PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips,
The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values)
The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.
The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.
The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/4/Picture/18 description: The image shows the logo for ACTEON. The logo is in a dark gray color and is in all caps. There is a blue swoosh that starts at the bottom left of the logo and curves up and around the left side of the word.
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Additional Information - February 17, 2017
V - INDICATION FOR USE
Piezotome® M+ is an ultrasonic system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.
Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
VI - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES (SUBSTANTIAL EQUIVALENCE)
A comparison Between PIEZOTOME M+ et The Predicate Devices is present in Table 02.
| New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | ||
|---|---|---|---|---|
| Trade /Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| Intended Use | Piezotome® M+ is anultrasonic surgicalsystem consisting ofhandpiecesandassociated tips, forcutting bone, bonesubstitutes and metal.The system can beused for osteotomy,osteoplasty,decorticating, drilling,shaping,andsmoothing of bonesand teeth, in a varietyof surgicalprocedures, includinggeneral orthopaedic,otolaryngological,maxillofacial,oral,hand,foot,neurosurgicalspine,andplastic/reconstructivesurgery.Piezotome® M+ is tosupply utilities to andserve as a base fordental tools such asultrasonicscaler,bonecuttinginstrumentandaccessories for use byqualifieddentalpractitionersinperiodontics | The PiezoelectricSystem, distributed bySynthes, is anultrasonic surgicalsystem consisting ofhandpieces andassociated tips, forcutting bone, bonesubstitutes and metal.The system can beused for osteotomy,osteoplasty,decorticating, drilling,shaping, andsmoothing of bonesand teeth, in a varietyof surgicalprocedures, includinggeneral orthopaedic,otolaryngological,maxillofacial, oral,hand, foot,neurosurgical spine,andplastic/reconstructivesurgery. | The intended use ofthe SATELECPIEZOTOME 2 is tosupply utilities to andserve as a base fordental tools such asultrasonic scaler,bone cuttinginstrument andaccessories for use byqualified dental | Substantiallyequivalent toPD#1 for BoneSurgery clinicalapplication - Noimpact.Substantiallyequivalent toPD#2 for Dentalclinicalapplication - Noimpact |
| New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | Equivalence | |
| Trade /Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | |
| Knumber | Unknownendodontics, scaling,prosthesis and oralsurgery. | K100410 | K091331practitioners inperiodontics,endodontics, scaling,prosthesis and oralsurgery. | |
| Code Product | JDX | JDX | DZI | Identical toPD#1 |
| Subsequent productCodes | DZI, ERL, HBE, HWE | DZI, ERL, HBE, HWE | / | Identical toPD#1 |
| Part | 888 - OrthopedicDevice | 888 - OrthopedicDevice | 872 - Dental devices | Identical toPD#1 |
| Regulation Number | 21 CFR 888.4580 | 21 CFR 888.4580 | 21 CFR 872.4120 | Identical toPD#1 |
| RegulationIdentification | A sonic surgicalinstrument is a hand-held device withvarious accessories orattachments, such asa cutting tip thatvibrates at highfrequencies, and isintended for medicalpurposes to cut boneor other materials,such as acrylic | A sonic surgicalinstrument is a hand-held device withvarious accessories orattachments, such asa cutting tip thatvibrates at highfrequencies, and isintended for medicalpurposes to cut boneor other materials,such as acrylic | A bone cuttinginstrument andaccessories is a metaldevice intended foruse in reconstructiveoral surgery to drill orcut into the upper orlower jaw and may beused to prepare boneto insert a wire, pin, orscrew. The deviceincludes the manualbone drill and wiredriver, powered bonedrill, rotary bonecutting handpiece,and AC-poweredbone saw | Identical toPD#1 |
| Regulation Name | Sonic surgicalinstrument andaccessoriesattachments | Sonic surgicalinstrument andaccessoriesattachments | Bone CuttingInstrument andAccessories | Identical toPD#1 |
| Regulatory Class | II | II | II | Identical toPD#1 and PD#2 |
| Principle of operation | ||||
| Principle | An electrical signal emitted by the medical device is supplied to the dentalpiezo-ultrasonic Handpiece. It comprises a piezoelectric ceramictransducer, which converts the electrical signal into ultrasonic vibrations.Mechanical vibrations are transmitted to a tip attached to the end of theultrasonic Handpiece | Identical toPD#1 and PD#2 | ||
| Dimensions of the Console | ||||
| Height / Depth /Witdh (mm) | 149.5 / 339.9 / 472.9 | 149.5 / 339.9 / 472.9 | 149.5 / 339.9 / 472.9 | Identical toPD#1 and PD#2 |
| Power Supply | ||||
| Supply Voltage(VAC) | 100 to 230 | 100 to 230 | 100 to 230 | Identical toPD#1 and PD#2 |
| Frequency (Hz) | 50 to 60 | 50 to 60 | 50 to 60 | Identical toPD#1 and PD#2 |
| Power Consumption(VA) | 150 | 150 | 150 | Identical toPD#1 and PD#2 |
| New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | ||
| Trade /Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| Electrical Safety Classification | ||||
| EquipmentClassification | Class 1 | Class 1 | Class 1 | Identical toPD#1 and PD#2 |
| Electrical Type | BF Type | BF Type | BF Type | Identical toPD#1 and PD#2 |
| Additional earth | Equipotential plug | Equipotential plug | Equipotential plug | Identical toPD#1 and PD#2 |
| Applied Parts on the Console | ||||
| ofQuantityconnectorsforApplied Parts | 2 | 2 | 2 | Identical toPD#1 and PD#2 |
| Localization | Right and left of thefront panel | Right and left of thefront panel | Right and left of thefront panel | Identical toPD#1 and PD#2 |
| Internal constitution of the Console | ||||
| Power supply | Power SwitchingSupply (PSU) | Power SwitchingSupply (PSU) | Power SwitchingSupply (PSU) | Identical toPD#1 and PD#2 |
| Mother Board | Same Mother board | Same Mother board | Same Mother board | Identical toPD#1 and PD#2 |
| Display Board | Same Display Board | Same Display Board | Same Display Board | Identical toPD#1 and PD#2 |
| Display Board andMother Board Fireaspects | UL94 Printed CircuitBoard | UL94 Printed CircuitBoard | UL94 Printed CircuitBoard | Identical toPD#1 and PD#2 |
| Software Constitution | ||||
| MotherBoardSoftware | BO209034 | BO209034 | BO209034 | Identical toPD#1 and PD#2 |
| DisplayBoardSoftware | BO209284 | BO209274 | BO209284 | Identical toPD#2 |
| External constitution of the Console | ||||
| Fireaspects(forCasing) | UL 94 V0ThermoplasticMaterial | UL 94 V0ThermoplasticMaterial | UL 94 V0ThermoplasticMaterial | Identical toPD#1 and PD#2 |
| Pictures | Image: [device] | Image: [device] | Image: [device] | Difference ofcolors -Identical Shape- No Impact |
| Piezoelectric Performances for Bone Surgery | ||||
| OutputUltrasonicfrequency | Min 28 kHz | Min 28 kHz | Min 28 kHz | Identical toPD#1 and PD#2 |
| MaximumHandpiececurrentrange | 270 mA | 270 mA | 270 mA | Identical toPD#1 and PD#2 |
| Available modes | D1, D2, D3, D4 | D1, D2, D3, D4 | D1, D2, D3, D4 | Identical toPD#1 and PD#2 |
| FrequencyModulation for D1,D2, D3 | 60 Hz | 60 Hz | 60 Hz | Identical toPD#1 and PD#2 |
| FrequencyModulation for D4 | 30 Hz | 30 Hz | 30 Hz | Identical toPD#1 and PD#2 |
| Piezoelectric Performances for Dental Application | ||||
| OutputUltrasonicfrequency | Min 28 kHz | - | Min 28 kHz | Identical toPD#2 |
| New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | ||
| Trade /Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| MaximumHandpiece currentrange | 100 mA | - | 100 mA | Identical toPD#2 |
| Available modes | SOFT / MEDIUM /HIGH / BOOST | - | SOFT / MEDIUM /HIGH / BOOST | Identical toPD#2 |
| Irrigation Performances | ||||
| Irrigation Pumps | 2 | 2 | 2 | Identical toPD#1 and PD#2 |
| Minimum IrrigationFlow Rate (nominal) | 10 ml/min | 10 ml/min | 10 ml/min | Identical toPD#1 and PD#2 |
| Maximum IrrigationFlow Rate (nominal) | 120 ml/min | 120 ml/min | 120 ml/min | Identical toPD#1 and PD#2 |
| User Interface for setting | ||||
| User interfaceforSetting | 5.1" color touchscreen LCD on frontpanel | 5.1" color touchscreen LCD on frontpanel | 5.1" color touchscreen LCD on frontpanel | Identical toPD#1 and PD#2 |
| UltrasonicPowerSetting | Accessible on 5.1"color touch screenLCD on front panel | Accessible on 5.1"color touch screenLCD on front panel | Accessible on 5.1"color touch screenLCD on front panel | Identical toPD#1 and PD#2 |
| IrrigationFlowSetting | Accessible on 5.1"color touch screenLCD on front panel | Accessible on 5.1"color touch screenLCD on front panel | Accessible on 5.1"color touch screenLCD on front panel | Identical toPD#1 and PD#2 |
| Footswitch | ||||
| Type of Footswitch | Multifunction | Multifunction | Multifunction | IdenticaltoPD#1 and PD#2 |
| Number of actuatorson Footswitch | 3 | 5 | 5 | No impact |
| Environmental | ||||
| Where used | Operating Theatre | Operating Theatre | Dental office | Identical toPD#1 |
| OperatingTemperature | +10°C to +30°C | +10°C to +30°C | +10°C to +40°C | Identical toPD#1 |
| StorageTemperature | 0°C to +50°C | -20°C to +70°C | -20°C to +70°C | No impact |
| Anatomical site | GeneralOral Sphere | General | Oral sphere | SubstantiallyequivalenttoPD#2 for Dentalclinicalapplication - NoimpactSubstantiallyequivalenttoPD#1 for BoneSurgery clinicalapplication - Noimpact. |
| Handpieces | ||||
| Bone SurgeryHandpiece | PIEZOTOME M+Handpiece (greycolor) | PiezoelectricHandpiece(black color) | PIEZOTOMEHandpiece(grey color) | SubstantiallyEquivalent - NoImpact |
| Dental Handpiece | NEWTRONHandpiece | - | NEWTRONHandpiece | Identical toPD#2 |
| Type of Applied Part | Ultrasonic Handpiece | Ultrasonic Handpiece | Ultrasonic Handpiece | Identical toPD#1 and PD#2 |
| Trade /Device Name | New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | Equivalence |
| Knumber | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | |
| Technology used forHandpieces | Unknown | K100410 | K091331 | |
| Piezoelectrictechnology | Piezoelectrictechnology | Piezoelectrictechnology | Identical toPD#1 and PD#2 | |
| Dimensions of the Bone Surgery Handpieces | ||||
| Length (mm) | 130 | 130 | 130 | Identical toPD#1 and PD#2 |
| Maximum Diameter(mm) | 23 | 23 | 23 | Identical toPD#1 and PD#2 |
| Dimensions of the Dental Handpieces | ||||
| Length (mm) | 112 | 112 | Identical toPD#2 | |
| Maximum Diameter(mm) | 21 | 21 | Identical toPD#2 | |
| Irrigation Tubing | ||||
| Length (mm) | 3550 | 3550 | 2550 | Identical toPD#1 |
| Principle of irrigation | Peristaltic tape | Peristaltic tape | Peristaltic tape | Identical toPD#1 and PD#2 |
| Dimensions of the Footswitch | ||||
| Width / Height /Depth (mm) | 311 / 181 / 209 | 311 / 181 / 209 | 311 / 181 / 209 | Identical toPD#1 and PD#2 |
| Bone Ultrasonic Tips | ||||
| Tips dedicated forOsteotomy,osteoplasty,shaping, andsmoothingof bonesand teeth | BS1L | Saw 20.1 x 21.4 x 4.0x 0.6 mm -03.000.402S | - | SubstantiallyEquivalent - NoImpact |
| BS4 | Scalpel Rnd 22.45 x12.6 x 3.9 mm dia x0.7 mm -03.000.405S | - | ||
| SL1 | Diamond 24.6 x 12.85x 2.6 x 0.6 mm -03.000.409S | - | ||
| SL2 | Diamond Rnd 21.9 x12.4 x 1.8 mm -03.000.410S | - | ||
| BS1 XXL | Saw Slim 104 mm -03.000.412S | - | ||
| BS2L XL | Saw L Long -03.000.418S | - | ||
| BS2R XL | Saw R Long -03.000.419S | - | ||
| BS6 XXL | Scalpel Flat 15° 129mm - 03.000.421S -03.000.411S | - | ||
| BS1 RD | Saw 20 mm -03.000.424S | - | ||
| Tips dedicated forDecorticating | SL3 | Sinus Lift 22.9 x 10.1x 5 dia x 0.4 mm -03.000.411S | ||
| Cleaning, Disinfection | ||||
| DentalUltrasonicTips | Re-usable, | Re-usable, | Identical toPD#2 | |
| Cleanable, | Cleanable, | |||
| Disinfectable | Disinfectable | |||
| New Device | Predicate Device #1(PD#1) | Predicate Device #2(PD#2) | ||
| Trade /Device Name | PIEZOTOME M+ | Piezoelectric System | PIEZOTOME 2 | Equivalence |
| Knumber | Unknown | K100410 | K091331 | |
| BoneUltrasonicTips | Single Use | Single Use | Re-usable,Cleanable,Disinfectable | Identical toPD#1 |
| DentalUltrasonicHandpiece | Re-usable,Cleanable,Disinfectable | - | Re-usable,Cleanable,Disinfectable | Identical toPD#2 |
| BoneUltrasonicHandpiece | Re-usable,Cleanable,Disinfectable | Re-usable,Cleanable,Disinfectable | Re-usable,Cleanable,Disinfectable | Identical toPD#1 and PD#2 |
| Sterilization / Sterile State | ||||
| DentalUltrasonicTips | Sterilizable 132°C / 4 min - Re-usable | - | Sterilizable 132°C / 4 min - Re-usable | Identical toPD#2 |
| BoneUltrasonicTips | Provided underSterile StateSingle Use | Provided underSterile StateSingle Use | Sterilizable 132°C / 4 minRe-usable | Identical toPD#1 |
| DentalUltrasonicHandpiece | Sterilizable 132°C / 4 min | - | Sterilizable 132°C / 4 min | Identical toPD#1 |
| BoneUltrasonicHandpiece | Sterilizable 132°C / 4 min | Sterilizable 132°C / 4 min | Sterilizable 132°C / 4 min | Identical toPD#1 and PD#2 |
| Irrigation Tubing | Provided underSterile State - Single Use | Provided underSterile State - Single Use | Provided underSterile StateSingle Use | Identical toPD#1 and PD#2 |
| Biocompatibility | ||||
| Tipmaterial incontact to thePatient | Stainless Steel orMedical Material usedin Medical Application | Stainless Steel orMedical Material usedin Medical Application | Stainless Steel orMedical Material usedin Medical Application | Identical toPD#1 and PD#2 |
| UltrasonicHandpiece materialin contact to Patient | Polyphenylsulfone(PPSU) used inMedical Application | Polyphenylsulfone(PPSU) used inMedical Application | Polyphenylsulfone(PPSU) used inMedical Application | Identical toPD#1 and PD#2 |
| Safety / EMC and Additional Safety Mark for USA and CANADA | ||||
| Safety andEMCStandard | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Identical toPD#1 and PD#2 |
| USElectricalStandard | ANSI/AAMI ES60601-1:2005/(R)2012 | UL 60601-1: 2003 | No impact |
Table 02 - Comparison Between PIEZOTOME M+ et the Predicate Devices
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/5/Picture/10 description: The image shows the logo for ACTEON. The logo is in a dark gray color and is in all capital letters. There is a blue curved line that starts on the left side of the logo and goes up and over the top of the letters.
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Additional Information – February 17, 2017
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/6/Picture/4 description: The image shows the logo for ACTEON. The logo is in a dark gray color and features a stylized letter "A" with a curved line extending from the bottom left of the "A" and wrapping around the word. The word "ACTEON" is written in all capital letters.
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Additional Information – February 17, 2017
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/7/Picture/4 description: The image shows the logo for ACTEON. The logo is in black and has a blue swoosh underneath it. The text is in all caps and is a sans-serif font.
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Additional Information – February 17, 2017
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/8/Picture/4 description: The image shows the logo for ACTEON. The logo is in a dark gray color and is in all caps. There is a blue swoosh underneath the logo.
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Additional Information – February 17, 2017
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/9/Picture/4 description: The image shows the logo for ACTEON. The logo consists of the word "ACTEON" in bold, sans-serif font. A blue curved line is located to the left of the word, starting below the "A" and extending upwards and to the left. The word "ACTEON" is in a dark gray color.
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Additional Information - February 17, 2017
A lot of features and characteristics of PIEZOTOME M+ are identical to the Predicate Device #1 and Predicate Device #2. The Identified differences have no impact on the Substantial Equivalence.
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document – April 10, 2017 - Version 02
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Image /page/10/Picture/5 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in a bold, sans-serif font. A blue curved line is below the word, starting from the left and extending upwards, partially encircling the word. The logo is simple and modern.
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Additional Information - February 17, 2017
VII - PERFORMANCE DATA
Electromagnetic Compatibility Test: The Electromagnetic Compatibility Tests have been performed according to IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3). (Recognition Number 5-64).
Electrical Safety Tests: The Electrical Safety Tests have been performed according to IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (General). (Recognition Number 5-71) included USA and Canadian Deviations.
Additional Safety Mark: PIEZOTOME M+ is in accordance with ANSI / AAMI ES 60601-1: 2005 / (R) 2012 and bears the *c BVS **us marking, related to the file number GSAA.
Software Verification and Validation: Software Verification activities were conducted and documented according to the document named "Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. Moreover, the Software System included in PIEZOTOME M+ is strictly the same Software as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009).
Performance Testing bench: The comparison of performances between PIEZOTOME M+ and Predicate Devices has been performed.
The Technical Characteristics for Bone Surgery Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Devices Piezoelectric System (K100410, cleared April 28, 2010) and PIEZOTOME 2 (K091331, cleared December 11, 2009). The Technical Characteristics for Dental Application of PIEZOTOME M+ (Piezoelectric Performances and Irrigation Performances) are similar as the Predicate Device PIEZOTOME 2 (K091331, cleared December 11, 2009). The Bone Surgery Tips for PIEZOTOME M+ are similar as the Bone Surgery Tips of the Predicate Device Piezoelectric System (K100410, cleared April 28, 2010).
Sterilization Validation: The Sterilizability Tests have been performed according to applicable Standards for Re-Usable accessories and Single Use Accessories provided under Sterile State.
Biocompatibility Validation: The Biocompatibility Tests have been performed according to applicable Standards for Accessories in contact to the Patient. Tests were conducted according to the ISO 10993-1 Standard and 510(k) Memorandum - #G95-1 Table 1 "Initial Evaluation Tests for Consideration requirements (Body Contact: External communicating Device - Type of Tissue / Bone Dentin Communicating - Contact Duration: A limited less than 24 hours).
VIII - CONCLUSION
Following all information contained in this Pre-Market Notification File, we can declare that the SATELEC PIEZOTOME M+ is Substantially Equivalent (SE) to the SATELEC Predicate Devices Piezoelectric System (K100410, cleared April 28, 2010) and PIEZOTOME 2 (K091331, cleared December 11, 2009).
End of Section (No other information after this line expect Appendix if applicable)
Pre-Market Notification 510(k) Submission for PIEZOTOME M+ By SATELEC K163610 - Traditional 510(k) - Confidential Document - April 10, 2017 - Version 02
Image /page/11/Picture/15 description: The image shows the logo for ACTEON. The logo is in a dark gray color and is in all caps. There is a blue swoosh that goes from the bottom left of the image to the top left.
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§ 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.