(290 days)
No
The summary describes a standard ultrasonic surgical system with a control unit, handpiece, and tips. There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on electrical safety, software validation (standard for medical devices), and performance comparison to a predicate device, not AI/ML model performance.
Yes.
The device is an ultrasonic surgical system intended for intraoral surgery procedures, which involve treating or curing conditions, thus classifying it as a therapeutic device.
No
The device is described as an "ultrasonic surgical system" and its intended use is for "intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology." These are all surgical or therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a console, handpiece, footswitch, and tips. It also mentions hardware-specific testing like electrical safety and sterilization validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PIEZOTOME CUBE is an ultrasonic surgical system for intraoral surgery procedures such as osteotomy, osteoplasty, periodontics, and implantology. These are surgical interventions performed directly on the patient's body.
- Device Description: The description details a surgical tool that uses ultrasonic vibrations to perform procedures on bone and tissue. It involves a handpiece, tips that contact the patient, and irrigation for cooling and rinsing.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The PIEZOTOME CUBE is a surgical device used for direct treatment and manipulation of tissues within the oral cavity, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes
DZI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
Bones in the oral sphere
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental practitioners. Usable in all medical premises Except Operating theater / outdoor
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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);
1
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
2
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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3
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.
4
| 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 SOLO | ||||
| PIEZOTOME 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.
5
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 differences
on Safety /
Effectiveness |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Trade /
Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| 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. | The intended use of the
SATELEC PIEZOTOME
SOLO (or PIEZOTOME
SOLO LED available in
option) 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 Use | The intended use of the
SATELEC PIEZOTOME
CUBE is to supply utilities
and to serve as a base for
dental tools and
accessories for use by
qualified dental
practitioners. | The intended use of the
PIEZOTOME SOLO is to
supply utilities to and
serve as a base for
dental tools and
accessories for use by
qualified dental
practitioners.
The
PIEZOTOME SOLO is a
device designed to
perform dental surgery
including osteotomies,
osteoplasties,
periodontal
and implant
surgery. | 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.
6
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 |
|---|---|---|---|
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------- |
7
| | New Device | Predicate Device #1
(PD#1) | Impact of the differences on
Safety / Effectiveness |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Trade /
Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| | device includes the
manual bone drill and
wire driver, powered
bone drill, rotary bone
cutting handpiece, and
AC-powered bone saw | 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 | |
| Regulation Name | Bone Cutting Instrument
and Accessories | Bone Cutting Instrument
and 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 is
supplied to the dental piezo-ultrasonic Handpiece. It
comprises a piezoelectric ceramic transducer, which
converts the electrical signal into ultrasonic
vibrations. Mechanical vibrations are transmitted to a
tip 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 for
Applied Parts | 1 | 1 | Identical to PD#1 - No Impact |
| Localization | Front Panel of the
Device | Front Panel of the
Device | 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 Fire
aspects | 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 on
Safety / 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 PIEZOTOME
topology | SATELEC PIEZOTOME
topology | Identical to PD#1 - No Impact |
| Output
Ultrasonic
frequency (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 for
Output Current Value in
D1 mode (mA) | 215.3 | 215.3 | Identical to PD#1 - No Impact |
| Nominal specification for
Output Current Value in
D2 mode (mA) | 171.2 | 171.2 | Identical to PD#1 - No Impact |
| Nominal specification for
Output Current Value in
D3 mode (mA) | 123.9 | 123.9 | Identical to PD#1 - No Impact |
| Nominal specification for
Output Current Value in
D4 mode (mA) | 120.8 | 120.8 | Identical to PD#1 - No Impact |
| Frequency Modulation for
D1 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for
D2 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for
D3 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for
D4 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 Flow
Rate (nominal) (ml/min) | 10 | 10 | Identical to PD#1 - No Impact |
| Maximum Irrigation Flow
Rate (nominal) (ml/min) | 120 | 120 | Identical to PD#1 - No Impact |
| Localization of the Mains Power Switch | | | |
| Power-On / Power-Off | Mains switch localized at
the rear of the Device | Mains switch localized
at the rear of the Device | Identical to PD#1 - No Impact |
| User Interface for setting | | | |
| User interface for
information on settings | LED (Light Emitted
Diode) | Monochrome LCD | No Impact |
| Ultrasonic Power Setting
keys | Sensitive areas on front
panel | Keys on front panel | No Impact |
| Irrigation Flow Setting
keys | Sensitive areas on front
panel | Keys on front panel | No Impact |
| Footswitch | | | |
| Type of Footswitch | Multifunction | Multifunction | Identical to PD#1 - No Impact |
| Number of actuators on
Footswitch | 2 Functions | 2 Functions | Identical to PD#1 - No Impact |
| Environmental | | | |
| | New Device | Predicate Device #1
(PD#1) | Impact of the differences on
Safety / Effectiveness |
| Trade /
Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Where used | Usable in all medical
premises
Except Operating
theater / outdoor | Usable in all medical
premises
Except Operating
theater / outdoor | Identical to PD#1 - No Impact |
| Operating
Temperature
(°C) | +10 to +30 | +10 to +30 | Identical to PD#1 - No Impact |
| Storage Temperature (°C) | 0 to +50 | -20 to +70 | No Impact |
| Maximum
Operating
Altitude (m) | 2000 | 2000 | Identical to PD#1 - No Impact |
| Anatomical site | Bones in the oral sphere | Bones in the oral
sphere | Identical to PD#1 - No Impact |
| | | Handpieces | |
| Dental
Bone
Surgery
Handpiece | CUBE LED Handpiece | PIEZOTOME SOLO
Handpiece | No Impact |
| Type of Applied Part | Ultrasonic Handpiece | Ultrasonic Handpiece | Identical to PD#1 - No Impact |
| Technology
used
for
Handpieces | 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 | |
| Dental
Bone
Ultrasonic
Handpiece | 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 | |
| Dental
Bone
Ultrasonic
Handpiece | Sterilizable
132°C / 4 min | Sterilizable
132°C / 4 min | Identical to PD#1 - No Impact |
| Irrigation Tubing | Provided under Sterile
State - Single Use | Provided under Sterile
State - Single Use | Identical to PD#1 - No Impact |
| Biocompatibility | | | |
| Ultrasonic
Handpiece
material
in
contact
to
Patient | Polyphenylsulfone
(PPSU) used in Medical
Application | Polyphenylsulfone
(PPSU) used in Medical
Application | 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 with
Light Emitted Diode
(LED) | Monochrome LCD | No Impact |
| Ultrasonic Power Setting | Accessible on Sensitive
area on front panel | Accessible on Keyboard
on front panel | No Impact |
| | New Device | Predicate Device #1
(PD#1) | |
| Trade /
Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | Impact of the differences on
Safety / Effectiveness |
| Knumber | K172137 | K112188 | |
| Irrigation Flow Setting | Accessible on Sensitive
area on front panel | Accessible on Keyboard
on front panel | No Impact |
| Handpieces | | | |
| Dental Bone Surgery
Handpiece | CUBE LED Handpiece | PIEZOTOME SOLO
Handpiece | |
| Pictures of Dental Bone
Surgery 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.