(290 days)
The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.
PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.
The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).
The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.
The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.
The provided text is a 510(k) Summary for the PIEZOTOME CUBE, an ultrasonic surgical system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for clinical efficacy. Therefore, much of the requested information regarding an acceptance criteria table, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, and specific ground truth types for a clinical performance study cannot be found or directly inferred from the provided text.
The document primarily relies on comparisons of technical characteristics and performance testing to the predicate device, PIEZOTOME SOLO.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding performance results for clinical efficacy. Instead, it compares the technical characteristics and performance of the PIEZOTOME CUBE to its predicate device, PIEZOTOME SOLO, arguing that the differences have no impact on safety or effectiveness.
Below is a summary of the technical performance comparisons, which serve as the "reported device performance" in the context of demonstrating substantial equivalence, effectively meeting the "acceptance criteria" of being similar to the predicate.
| Feature / Characteristic | PIEZOTOME CUBE (New Device) | PIEZOTOME SOLO (Predicate Device #1 - K112188) | Impact of the differences on Safety / Effectiveness |
|---|---|---|---|
| Indications for Use | Consistent with predicate | The intended use of the SATELEC PIEZOTOME SOLO... is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. | Similar to PD#1 - No Impact |
| Intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology. | The PIEZOTOME SOLO is a device designed to perform dental surgery including osteotomies, osteoplasties, periodontal and implant surgery. | Similar to PD#1 - No Impact | |
| Principle of Operation | An electrical signal supplied to the dental piezo-ultrasonic Handpiece, comprising a piezoelectric ceramic transducer converting electrical signal into ultrasonic vibrations. | Identical (Principle is described, assumed identical as "No Impact" stated for this category) | Identical to PD#1 - No Impact |
| Dimensions (Console) | Height: 160 mm, Depth: 271 mm, Width: 251 mm, Weight: 3.5 kg | Height: 136 mm, Depth: 306 mm, Width: 378 mm, Weight: 3.7 kg | No Impact |
| Power Supply | 100-230 VAC, 50/60 Hz, 150 VA | 100-230 VAC, 50/60 Hz, 150 VA | Identical to PD#1 - No Impact |
| Electrical Safety | Class 1, BF Type | Class 1, BF Type | Identical to PD#1 - No Impact |
| Piezoelectric Performances (Output Ultrasonic frequency) | 28 to 36 kHz | 28 to 36 kHz | Identical to PD#1 - No Impact |
| Available Modes | D1/ D2 / D3 / D4 | D1/ D2 / D3 / D4 | Identical to PD#1 - No Impact |
| Nominal Output Current (D1, D2, D3, D4 modes) | 215.3 mA, 171.2 mA, 123.9 mA, 120.8 mA | 215.3 mA, 171.2 mA, 123.9 mA, 120.8 mA | Identical to PD#1 - No Impact |
| Frequency Modulation (D1-D3) | 60 Hz | 60 Hz | Identical to PD#1 - No Impact |
| Frequency Modulation (D4) | 30 Hz | 30 Hz | Identical to PD#1 - No Impact |
| Irrigation Performances (Pump, Off, Min, Max Flow Rate) | 1 pump, 0 ml/min, 10 ml/min, 120 ml/min | 1 pump, 0 ml/min, 10 ml/min, 120 ml/min | Identical to PD#1 - No Impact |
| User Interface for Setting | Sensitive areas on front panel (LED) | Keys on front panel (Monochrome LCD) | No Impact (considered a minor change with no impact on safety/effectiveness) |
| Environmental (Storage Temperature) | 0 to +50 °C | -20 to +70 °C | No Impact |
| Handpieces | CUBE LED Handpiece | PIEZOTOME SOLO Handpiece | No Impact (difference in specific handpiece model, but technology and function are similar) |
| Biocompatibility Material (Handpiece) | Polyphenylsulfone (PPSU) used in Medical Application | Polyphenylsulfone (PPSU) used in Medical Application | Identical to PD#1 - No Impact |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Identical to PD#1 - No Impact |
| Sterilization Validation | Per ISO 17665-1, ISO 17665-2, AAMI ST55, AAMI TIR 30 | N/A (implied met by predicate) | Validated for new device |
| Cleaning Validation | Per FDA Guidance "Reprocessing Medical Devices..." | N/A (implied met by predicate) | Validated for new device |
| Software V&V | Per "Guidance for Industry and FDA Staff..." | N/A (implied met by predicate) | Validated for new device |
The acceptance criterion, in essence, is that the new device's performance is either identical to the predicate or that any differences have no impact on safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Performance Testing bench" and various validation tests (Electrical Safety, EMC, Software V&V, Sterilization, Cleaning, Biocompatibility). These are bench tests or validation processes, not clinical studies with human patient data or specific "test sets" in the context of AI/ML performance evaluation. Therefore, sample size and data provenance (country, retrospective/prospective) in the clinical sense are not applicable here.
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)
This information is not provided. The device is a physical ultrasonic surgical system, not an AI/ML diagnostic tool that requires ground truth established by medical experts for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to expert consensus for ground truth establishment in studies involving interpretation, which is not the case for this device.
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
No such study was mentioned or performed, as the PIEZOTOME CUBE is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is an ultrasonic surgical system, not an algorithm. Performance testing was primarily bench testing and direct comparison to a predicate device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the context of this submission refers to the established technical specifications and performance characteristics of the predicate device, as well as compliance with recognized standards (e.g., IEC 60601-1, ISO 10993-1). For the validation tests performed (sterilization, cleaning, biocompatibility), the "ground truth" would be the successful adherence to the requirements of the specified standards and guidance documents. There is no mention of clinical outcome data or pathology reports for ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Satelec - Acteon Group Argie Zoubroulis Quality Manager 124 Gaither Drive Suite # 140 Mt. Laurel, New Jersey 08054 April 3, 2018
Re: K172137
Trade/Device Name: PIEZOTOME CUBE Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: March 23, 2018 Received: April 3, 2018
Dear Argie 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 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172137
Device Name PIEZOTOME CUBE
Indications for Use (Describe)
The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
| 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) |
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510(k) Summary [As Required by 21 CFR 807.92.c] K172137
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 Fax: philippe.girard@acteongroup.com email:
01.b. Contact Person:
Argie ZOUBROULIS SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext. 390 Telephone: 856-222-4726 Fax: argie.zoubroulis@acteongroup.com Email:
8044015 1.c. Establishment Registration Number: 1.d. Date Prepared: May 2, 2018
- 1.e. Type of 510(k) submission:
- II DEVICE
02.a. Trade Name of Device:
02.b. Common Name of Device:
02.c. Classification Regulation:
02.d. Regulation Identification: Traditional 510(k) Submission.
PIEZOTOME CUBE
Piezoelectric Handpiece and Console
Classification Name : Bone Cutting Instrument and Accessories (21 CFR 872.4120)
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting Handpiece, and ACpowered bone saw.
02.e. Medical Device Class: ll
Image /page/3/Picture/20 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in a bold, sans-serif font. The letters are dark gray. A blue curved line is below the word, starting from the left and extending upwards, partially encircling the word.
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| 02.f. | Panel: | Dental |
|---|---|---|
| 02.g. | Product Code: | DZI |
| 02-h. | Subsequent Product Codes: | Not Applicable |
III - PREDICATE DEVICES
The Substantial Equivalence (SE) of PIEZOTOME CUBE is based on the Predicate Device identified in the Table 01.
| Trade Name | Manufacturer | Product Code | 510(k) number | Date Cleared |
|---|---|---|---|---|
| PIEZOTOME SOLOPIEZOTOME SOLO LED | SATELEC | DZI | K112188 | Feb 03, 2012 |
Table 01 Identification of I egally Marketed Predicate Devices
IV -DEVICE DESCRIPTION
SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.
PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.
The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).
The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.
Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.
The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.
Image /page/4/Picture/12 description: The image shows the logo for ACTEON. The logo is composed of the company name in a bold, sans-serif font, with the letters in a dark gray color. A curved, light blue line extends from the bottom left of the image, arching upwards and towards the left of the word ACTEON. The overall design is simple and modern.
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V - INDICATION FOR USE
The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
VI - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE (SUBSTANTIAL EQUIVALENCE)
A comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device is present in Table 02.
| New Device | Predicate Device #1(PD#1) | Impact of the differenceson Safety /Effectiveness | |
|---|---|---|---|
| Trade /Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Indication for Use | The PIEZOTOME CUBEis an ultrasonic surgicalsystem that supplyutilities to and serve as abase for dental tips. ThePIEZOTOME CUBEconsist of a control unitand handpiece intendedfor use in intraoralsurgery procedures,including osteotomy,osteoplasty, periodonticsand implantology. | The intended use of theSATELEC PIEZOTOMESOLO (or PIEZOTOMESOLO LED available inoption) is to supplyutilities to and serve as abase for dental tools andaccessories for use byqualified dentalpractitioners. | Similar to PD#1 - No Impact |
| Intended Use | The intended use of theSATELEC PIEZOTOMECUBE is to supply utilitiesand to serve as a base fordental tools andaccessories for use byqualified dentalpractitioners. | The intended use of thePIEZOTOME SOLO is tosupply utilities to andserve as a base fordental tools andaccessories for use byqualified dentalpractitioners.ThePIEZOTOME SOLO is adevice designed toperform dental surgeryincluding osteotomies,osteoplasties,periodontaland implantsurgery. | Similar to PD#1 - No Impact |
| Code Product | DZI | DZI | Identical to PD#1 - No Impact |
| Subsequent product | / | / | Identical to PD#1 - No Impact |
| Part | 872 - Dental devices | 872 - Dental devices | Identical to PD#1 - No Impact |
| Regulation Number | 21 CFR 872.4120 | 21 CFR 872.4120 | Identical to PD#1 - No Impact |
Table 02 – Comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device
Image /page/5/Picture/6 description: The image shows the word "ACTEON" in a bold, sans-serif font. The letters are dark gray, almost black. A curved, light blue line extends from the bottom left of the image, arching upwards and to the right, partially surrounding the word. The line adds a sense of motion or energy to the logo.
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006 – 510(k) Summary (SMDA Requirements) S001 Additional Inform natio n
| Regulation Identification | A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The | A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a | Identical to PD#1 - No Impact |
|---|---|---|---|
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------- |
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| New Device | Predicate Device #1(PD#1) | Impact of the differences onSafety / Effectiveness | |
|---|---|---|---|
| Trade /Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| device includes themanual bone drill andwire driver, poweredbone drill, rotary bonecutting handpiece, andAC-powered bone saw | wire, pin, or screw. Thedevice includes themanual bone drill andwire driver, poweredbone drill, rotary bonecutting handpiece, andAC-powered bone saw | ||
| Regulation Name | Bone Cutting Instrumentand Accessories | Bone Cutting Instrumentand Accessories | Identical to PD#1 - No Impact |
| Regulatory Class | II | II | Identical to PD#1 - No Impact |
| Principle of operation | |||
| Principle | An electrical signal emitted by the medical device issupplied to the dental piezo-ultrasonic Handpiece. Itcomprises a piezoelectric ceramic transducer, whichconverts the electrical signal into ultrasonicvibrations. Mechanical vibrations are transmitted to atip attached to the end of the ultrasonic Handpiece | Identical to PD#1 - No Impact | |
| Dimensions of the Console | |||
| Height (mm) | 160 | 136 | No Impact |
| Depth (mm) | 271 | 306 | No Impact |
| Width (mm) | 251 | 378 | No Impact |
| Weight (kg) | 3.5 | 3.7 | No Impact |
| Mounting Unit | Table Top | Table Top | Identical to PD#1 - No Impact |
| Power Supply | |||
| Supply Voltage (VAC) | 100 VAC to 230 VAC | 100 VAC to 230 VAC | Identical to PD#1 - No Impact |
| Frequency (Hz) | 50 Hz / 60 Hz | 50 Hz / 60 Hz | Identical to PD#1 - No Impact |
| Power Consumption (VA) | 150 | 150 | Identical to PD#1 - No Impact |
| Electrical Safety Classification | |||
| Equipment Classification | Class 1 | Class 1 | Identical to PD#1 - No Impact |
| Electrical Type | BF Type | BF Type | Identical to PD#1 - No Impact |
| Applied Parts on the Console | |||
| Quantity of connectors forApplied Parts | 1 | 1 | Identical to PD#1 - No Impact |
| Localization | Front Panel of theDevice | Front Panel of theDevice | Identical to PD#1 - No Impact |
| Internal constitution of the Console | |||
| Power supply | Switch Power Supply | Switch Power Supply | Identical to PD#1 - No Impact |
| Mother Board Fire aspects | UL94-V0 (self-extinguishing material) | UL94-V0 (self-extinguishing material) | Identical to PD#1 - No Impact |
| Display Board Fireaspects | UL94-V0 (self-extinguishing material) | UL94-V0 (self-extinguishing material) | Identical to PD#1 - No Impact |
| External constitution of the Console | |||
| Fire aspects (for Casing) | UL94-V0 (self-extinguishing material) | UL94-V0 (self-extinguishing material) | Identical to PD#1 - No Impact |
| Pictures | |||
| Picture of the Console | Image: Picture of the Console | Image: Picture of the Console | No impact |
| New Device | Predicate Device #1(PD#1) | Impact of the differences onSafety / Effectiveness | |
| Trade /Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Picture of the Footswitch | Image: footswitch | Image: footswitch | Identical to PD#1 - No Impact |
| Piezoelectric Performances for Dental Bone Surgery | |||
| Technology | SATELEC PIEZOTOMEtopology | SATELEC PIEZOTOMEtopology | Identical to PD#1 - No Impact |
| OutputUltrasonicfrequency (kHz) | 28 to 36 | 28 to 36 | Identical to PD#1 - No Impact |
| Available modes | D1/ D2 / D3 / D4 | D1/ D2 / D3 / D4 | Identical to PD#1 - No Impact |
| Nominal specification forOutput Current Value inD1 mode (mA) | 215.3 | 215.3 | Identical to PD#1 - No Impact |
| Nominal specification forOutput Current Value inD2 mode (mA) | 171.2 | 171.2 | Identical to PD#1 - No Impact |
| Nominal specification forOutput Current Value inD3 mode (mA) | 123.9 | 123.9 | Identical to PD#1 - No Impact |
| Nominal specification forOutput Current Value inD4 mode (mA) | 120.8 | 120.8 | Identical to PD#1 - No Impact |
| Frequency Modulation forD1 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation forD2 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation forD3 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation forD4 mode (Hz) | 30 | 30 | Identical to PD#1 - No Impact |
| Irrigation Performances | |||
| Irrigation Pump(s) | 1 | 1 | Identical to PD#1 - No Impact |
| Off Irrigation (ml/min) | 0 | 0 | Identical to PD#1 - No Impact |
| Minimum Irrigation FlowRate (nominal) (ml/min) | 10 | 10 | Identical to PD#1 - No Impact |
| Maximum Irrigation FlowRate (nominal) (ml/min) | 120 | 120 | Identical to PD#1 - No Impact |
| Localization of the Mains Power Switch | |||
| Power-On / Power-Off | Mains switch localized atthe rear of the Device | Mains switch localizedat the rear of the Device | Identical to PD#1 - No Impact |
| User Interface for setting | |||
| User interface forinformation on settings | LED (Light EmittedDiode) | Monochrome LCD | No Impact |
| Ultrasonic Power Settingkeys | Sensitive areas on frontpanel | Keys on front panel | No Impact |
| Irrigation Flow Settingkeys | Sensitive areas on frontpanel | Keys on front panel | No Impact |
| Footswitch | |||
| Type of Footswitch | Multifunction | Multifunction | Identical to PD#1 - No Impact |
| Number of actuators onFootswitch | 2 Functions | 2 Functions | Identical to PD#1 - No Impact |
| Environmental | |||
| New Device | Predicate Device #1(PD#1) | Impact of the differences onSafety / Effectiveness | |
| Trade /Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Where used | Usable in all medicalpremisesExcept Operatingtheater / outdoor | Usable in all medicalpremisesExcept Operatingtheater / outdoor | Identical to PD#1 - No Impact |
| OperatingTemperature(°C) | +10 to +30 | +10 to +30 | Identical to PD#1 - No Impact |
| Storage Temperature (°C) | 0 to +50 | -20 to +70 | No Impact |
| MaximumOperatingAltitude (m) | 2000 | 2000 | Identical to PD#1 - No Impact |
| Anatomical site | Bones in the oral sphere | Bones in the oralsphere | Identical to PD#1 - No Impact |
| Handpieces | |||
| DentalBoneSurgeryHandpiece | CUBE LED Handpiece | PIEZOTOME SOLOHandpiece | No Impact |
| Type of Applied Part | Ultrasonic Handpiece | Ultrasonic Handpiece | Identical to PD#1 - No Impact |
| TechnologyusedforHandpieces | Piezoelectric technology | Piezoelectric technology | Identical to PD#1 - No Impact |
| Dimensions of the Dental Bone Surgery Handpieces | |||
| Length (mm) | 130 | 130 | Identical to PD#1 - No Impact |
| Maximum Diameter (mm) | 23 | 23 | Identical to PD#1 - No Impact |
| Irrigation Tubing | |||
| Length (mm) | 2550 | 2550 | Identical to PD#1 - No Impact |
| Principle of irrigation | Peristaltic tape | Peristaltic tape | Identical to PD#1 - No Impact |
| Dimensions of the Footswitch | |||
| Width (mm) | 173 | 173 | Identical to PD#1 - No Impact |
| Height (mm) | 140 | 140 | Identical to PD#1 - No Impact |
| Depth (mm) | 176 | 176 | Identical to PD#1 - No Impact |
| Ingress Protection Rating(IPxx) | IPX1 | IPX1 | Identical to PD#1 - No Impact |
| Cleaning | |||
| DentalBoneUltrasonicHandpiece | Re-usable, Cleanable | Re-usable, Cleanable | Identical to PD#1 - No Impact |
| Unit Casing | Re-usable, Cleanable | Re-usable, Cleanable | Identical to PD#1 - No Impact |
| Sterilization / Sterile State | |||
| DentalBoneUltrasonicHandpiece | Sterilizable132°C / 4 min | Sterilizable132°C / 4 min | Identical to PD#1 - No Impact |
| Irrigation Tubing | Provided under SterileState - Single Use | Provided under SterileState - Single Use | Identical to PD#1 - No Impact |
| Biocompatibility | |||
| UltrasonicHandpiecematerialincontacttoPatient | Polyphenylsulfone(PPSU) used in MedicalApplication | Polyphenylsulfone(PPSU) used in MedicalApplication | Identical to PD#1 - No Impact |
| Standards | |||
| Safety Standard | IEC 60601-1 | IEC 60601-1 | Identical to PD#1 - No Impact |
| EMC Standard | IEC 60601-1-2 | IEC 60601-1-2 | Identical to PD#1 - No Impact |
| Summary of Major Changes | |||
| Major Changes - User Interface for setting | |||
| User interface for Setting | Sensitive areas withLight Emitted Diode(LED) | Monochrome LCD | No Impact |
| Ultrasonic Power Setting | Accessible on Sensitivearea on front panel | Accessible on Keyboardon front panel | No Impact |
| New Device | Predicate Device #1(PD#1) | ||
| Trade /Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | Impact of the differences onSafety / Effectiveness |
| Knumber | K172137 | K112188 | |
| Irrigation Flow Setting | Accessible on Sensitivearea on front panel | Accessible on Keyboardon front panel | No Impact |
| Handpieces | |||
| Dental Bone SurgeryHandpiece | CUBE LED Handpiece | PIEZOTOME SOLOHandpiece | |
| Pictures of Dental BoneSurgery Handpieces | Image: CUBE LED Handpiece | Image: PIEZOTOME SOLO Handpiece | No Impact |
Image /page/7/Picture/1 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 light blue swoosh that starts below the A and goes up and over the top of the letters.
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Image /page/8/Picture/1 description: The image shows the word "ACTEON" in a bold, sans-serif font. The letters are dark gray, almost black. A curved, light blue line appears below and to the left of the word, adding a visual element to the logo.
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Image /page/9/Picture/1 description: The image shows the logo for ACTEON. The text "ACTEON" is written in a bold, sans-serif font and is dark gray. A blue swoosh design is located to the left and below the text, adding a visual element to the logo.
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A lot of features and characteristics of PIEZOTOME CUBE are identical to the Predicate Device #1. The ldentified differences have no impact on the Substantial Equivalence. Moreover, the identified Major Changes have no impact on the Substantial Equivalence.
VII - PERFORMANCE DATA
Electromagnetic Compatibility Test: The Electromagnetic Compatibility Tests have been performed according to IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -- requirements and tests (Recognition Number 19-12).
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.
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.
Performance Testing bench: The comparison of performances between PIEZOTOME CUBE and Predicate Device has been performed. The Technical Characteristics for PIEZOTOME CUBE (Piezoelectric Performances, Frequency Modulations and Irrigation Performances) are similar as the Predicate Device PIEZOTOME SOLO (K112188, cleared February 03, 2012).
Sterilization Validation: The Sterilizability Tests of SATELEC CUBE LED Handpiece have been performed according to applicable Standards for Re-Usable accessories (i.e., ISO 17665-1, ISO 17665-2, AAMI ST55, and AAMI TIR 30).
Cleaning Validation: Cleaning validation of the PIEZOTOME CUBE was conducted per the FDA Guidance Document entitled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 17, 2015.
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
Image /page/10/Picture/10 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 on the left side of the word. The word is in a dark gray color.
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requirements (Body Contact: External communicating Device – Type of Tissues: Tissue / Bone Dentin Communicating - Contact Duration: A limited less than 24 hours), SATELEC CUBE LED Handpiece is the same as SATELEC PIEZOTOME SOLO Handpiece used with the Predicate Device PIEZOTOME SOLO (K112188, cleared February 03, 2012).
VIII -CONCLUSION
Following all information contained in this Pre-Market Notification Submission File, we can declare that the SATELEC PIEZOTOME CUBE is Substantially Equivalent (SE) to the SATELEC Predicate Device PIEZOTOME SOLO (K112188, cleared February 03, 2012).
End of Section (No other information after this line expect Appendix if applicable)
Image /page/11/Picture/4 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 placed below and to the left of the word. The color of the text is a dark gray.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.