(111 days)
No
The description mentions a microprocessor and electronics to control frequency, but no mention of AI or ML algorithms for learning or adaptation beyond finding the resonant frequency.
Yes
The device is described as an ultrasonic scaler for various dental applications including scaling, periodontology, endodontics, restorative and prosthetics, all of which are considered therapeutic interventions for dental conditions.
No
The device is an ultrasonic scaler used for therapeutic dental applications like scaling, periodontology, endodontics, and restorative/prosthetic procedures, not for diagnosis.
No
The device description explicitly lists multiple hardware components including an ultrasonic generator, handpiece/cord, insert tips, torque wrench, and wiring connection kits. While it contains software, it is not solely software.
Based on the provided information, the Compact Piezo Led is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient within the mouth (scaling, periodontology, endodontics, restorative and prosthetics). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The device description details a device that generates ultrasonic energy for mechanical action on teeth and surrounding tissues. This is a therapeutic and procedural device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD testing.
Therefore, the Compact Piezo Led is a dental therapeutic/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:
· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:
· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:
· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;
· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
Product codes
ELC
Device Description
The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.
The Compact Piezo Led uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.
The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.
The range of tip inserts, handpiece and torque wrench are autoclavable.
The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.
The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted through the dental unit's controls.
The ultrasonic generator of the Compact Piezo Led is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.
The ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the tip insert in use.
The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.
The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing of the subject device includes:
- Testing to confirm compliance of the Compact Piezo Led with the safety requirements of standard IEC 60601-1.
- Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2.
- Testing to confirm compliance with the safety requirements of standard IEC 80601-2-60.
- Software Verification and Validation.
- Functional testing to confirm: current delivered to the handpiece, working frequency range, leakage currents, ultrasonic transducer power.
- Direct comparison of functional test results with the predicate devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Mectron Spa c/o Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, 00153 ITALY
Re: K151023
Trade/Device Name: Compact Piezo LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: May 4, 2015 Received: May 7, 2015
Dear Mr. Roger Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 (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); 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. 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) K151023
Device Name COMPACT PIEZO LED
Indications for Use (Describe)
The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:
· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:
· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:
· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;
· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with five gray circles of varying sizes along the line. The circles are evenly spaced and increase in size from left to right.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
510(k) Summary in accordance with 21 CFR 807.92 for Mectron Compact Piezo Led
1. ADMINISTRATIVE INFORMATION
| Type of 510(K) submission: | Traditional 510(k) Submission |
|---|---|
| Submission date: | 4 August 2015 |
| 510(k) Submitter: | MECTRON S.p.a |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Phone: +39 0185 35 361 | |
| Fax: +39 0185 351 374 | |
| 510(k) Contact Person: | Roger Gray |
| VP, Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania, 10 | |
| 00153 Rome, Italy | |
| Phone: +39 06 578 2665 | |
| Fax: +39 06 574 3786 | |
| email: rgray@donawa.com | |
| Manufacturer: | MECTRON S.p.a |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Establishment Registration Number: 3003933619 | |
| Trade name of the device: | Compact Piezo Led |
| Common Name / Regulation Description: | Ultrasonic scaler |
| Regulation Number: | 21 CFR 872.4850 |
| Classification: | Class II |
| FDA Panel: | Dental |
| Product Code: | ELC |
4
Image /page/4/Picture/0 description: The image shows the logo for Mectron. The word "mectron" is written in orange, with the letters all connected. Below the word is a gray line with five gray circles of varying sizes along the line.
Mectron S Via Loreto, 15/A 16042 Carasco - GE (Italy) +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
3. PREDICATE DEVICES
The substantial equivalence of the Compact Piezo Led is based on the legally marketed predicate devices identified in Table 1:
Table 1: Predicate Devices
| Trade name | Predicate reference | Manufacturer | Product Code | 510(k) Number | Decision Date |
|---|---|---|---|---|---|
| Compact Piezo P2k | PD1 (primary) | Mectron S.p.a | ELC | K102218 | 01/24/2011 |
| Multipiezo | PD2 (reference) | Mectron S.p.a | ELC | K140965 | 08/20/2014 |
● The piezoelectric ultrasonic handpiece and the ultrasonic generator that are supplied with the subject device are identical/very similar to those described in the 510(k) submissions for these predicate devices.
. The tip inserts intended for use with the subject device were previously cleared by FDA within the 510(k)s of these predicate devices.
4. DEVICE DESCRIPTION
The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.
The Compact Piezo Led uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.
The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.
The range of tip inserts, handpiece and torque wrench are autoclavable.
The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.
The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted through the dental unit's controls.
The ultrasonic generator of the Compact Piezo Led is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece.
The ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the tip insert in use.
The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.
The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
5
Image /page/5/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with a series of gray circles of increasing size along the line. The circles are evenly spaced and appear to be part of the logo.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
5. INTENDED USE/INDICATIONS FOR USE
The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:
- . Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits;
- . Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning;
- . Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;
- . Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
Piezoelectric ultrasonic technology is used both by the subject and the predicate to generate mechanical micro-vibrations of the insert connected to the handpiece. The subject device and predicate devices share the same piezoelectric transducers, very similar ultrasonic generators, and same insert tips. Similarities and differences between the subject device and the predicate devices are summarized in Table 2.
| Description | Subject Device
Compact Piezo Led | Predicate Device 1 (PD1)
Compact Piezo P2K
Primary Predicate | Predicate Device 2 (PD2)
Multipiezo
Reference Predicate | Explanation of
differences
SE# |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| FDA panel | Dental | Dental | Dental | Identical to PD1 &
PD2 |
| Regulation #
and name | 872.4850 - Ultrasonic Scaler | 872.4850 - Ultrasonic Scaler | 872.4850 - Ultrasonic Scaler | Identical to PD1 &
PD2 |
| Product Code | ELC | ELC | ELC | Identical to PD1 &
PD2 |
| Classification | Class II | Class II | Class II | Identical to PD1 &
PD2 |
| Technological
Characteristics
(mechanism of
action) | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration of
the insert tips. The piezoelectric
transducer uses piezoceramic
disks to convert the generator's
electrical signal to ultrasonic
vibration of the insert tip. | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration of
the insert tips. The piezoelectric
transducer uses piezoceramic
disks to convert the generator's
electrical signal to ultrasonic
vibration of the insert tip. | Piezoelectric ultrasonic
technology that generates
mechanical micro-vibration of
the insert tips. The piezoelectric
transducer uses piezoceramic
disks to convert the generator's
electrical signal to ultrasonic
vibration of the insert tip. | Identical to PD1 &
PD2 |
| Device type | Sub-assembly device intended
to be incorporated into a dental
unit and/or table top device | Sub-assembly device intended
to be incorporated into a dental
unit and/or table top device | Table top device | Identical to PD1.
SE#1 |
| Description | Subject Device
Compact Piezo Led | Predicate Device 1 (PD1)
Compact Piezo P2K
Primary Predicate | Predicate Device 2 (PD2)
Multipiezo
Reference Predicate | Explanation of
differences
SE# |
| Indications for
use/Intended
use | The Compact Piezo Led is an
ultrasonic scaler intended for
use, with the appropriate
associated insert tips, in the
following dental applications:
· Scaling: Procedures for
removal of supragingival/
subgingival and interdental
calculus/plaque deposits;
· Periodontology: Periodontal
therapy and debridement for
periodontal diseases,
including periodontal pocket
irrigation and cleaning;
Endodontics: Treatments for
root canal reaming irrigation,
revision, filling, gutta-percha
condensation and
retrograde preparation;
· Restorative and Prosthetics:
Restorative procedures
including cavity preparation,
removal of prostheses,
amalgam condensation,
finishing of crown
preparations, inlay/onlay
condensation and
implants/restorations
cleaning. | The Compact Piezo P2K device
is an ultrasonic scaler intended
for use with the appropriate
associated insert tips, in the
following dental applications:
· Scaling: All general scaling
applications including
removal of supra/sub
gingival/ interdental
calculus/plaque deposits;
· Periodontology: Periodontal
therapy and debridement for
all types of periodontal
diseases, including
periodontal pocket irrigation
and cleaning;
Endodontics: All endodontics
procedures including
treatments for root canal
reaming, irrigation, revision,
filling, gutta-percha
condensation and
retrograde preparation;
· Restorative and Prosthetics:
All general restorative
procedures including cavity
preparation, removal of
prostheses, amalgam,
condensation and finishing
of crown preparation and
inlay/onlay condensation. | The Multipiezo Pro and
Multipiezo are piezoelectric
ultrasonic dental scalers
intended for use, with the
appropriate associated tip
inserts, in the following dental
applications:
· Scaling: All general
procedures for removal of
supragingival/subgingival
and interdental
calculus/plaque deposits;
· Periodontology: Periodontal
therapy and debridement for
all types of periodontal
diseases, including
periodontal pocket irrigation
and cleaning;
· Endodontics: All treatments
for root canal reaming,
irrigation, revision, filling,
gutta-percha condensation
and retrograde preparation;
Restorative and Prosthetics:
All general restorative
procedures including cavity
preparation, removal of
prostheses, amalgam
condensation, finishing of
crown preparations,
inlay/onlay condensation,
implants/restorations
cleaning. | Very similar to PD1
& PD2 |
| Transducer
Technological
characteristics | Piezoelectric: The transducer
uses four piezoceramic disks to
convert the generator's
electrical signal to ultrasonic
vibration of the insert tip | Piezoelectric: The transducer
uses four piezoceramic disks to
convert the generator's
electrical signal to ultrasonic
vibration of the insert tip | Piezoelectric: The transducer
uses four piezoceramic disks to
convert the generator's
electrical signal to ultrasonic
vibration of the insert tip | Identical to PD1 &
PD2 |
| Automatic
resonant
frequency tuning | Electronics with automatic
frequency tuning | Electronics with automatic
frequency tuning | Electronics with automatic
frequency tuning | Identical to PD1 &
PD2 |
| Led system
incorporated
inside the
handpiece to
provide
illumination of
the operative
site. | Yes | No | Yes | Identical to PD2.
SE#2 |
| Irrigation supply
source | Through irrigation line of the
dental unit where the Compact
Piezo Led is mounted. | Through irrigation line of the
dental unit where the Compact
Piezo P2K is mounted. | Two irrigation sources:
A refillable irrigation bottle
mounted on the console
connected to peristaltic pump,
or alternatively external water
supply by means of an optional
accessory. | Identical to PD1.
SE#3 |
| Description | Subject Device
Compact Piezo Led | Predicate Device 1 (PD1)
Compact Piezo P2K
Primary Predicate | Predicate Device 2 (PD2)
Multipiezo
Reference Predicate | Explanation of
differences
SE# |
| Irrigation flow
rate adjustment | Through the flow regulator of
the dental unit | Through the flow regulator of
the dental unit | Flow rate adjustable through the
touch panel of the console | Identical to PD1.
SE#4 |
| Feedback
system control | The power is automatically
adjusted as a function of the
resistance encountered by the
insert tip during the treatment. | The power is automatically
adjusted as a function of the
resistance encountered by the
insert tip during the treatment. | The power is automatically
adjusted as a function of the
resistance encountered by the
insert tip during the treatment. | Identical to PD1 &
PD2 |
| Supply Voltage | Powered through the dental
unit: 24 VAC ± 10% or 32 VDC
± 10%. | Powered through the dental
unit: 24 VAC ± 10% or 32 VDC
± 10%. | 100 - 240 VAC - 50/60 Hz | Identical to PD1.
SE#5 |
| Output
performance
specifications | Output: 15 Watt
Frequency range: 24 kHz to ~36
kHz | Output: 15 Watt
Frequency range: 24 kHz to
~36 kHz | Output: 15 Watt
Frequency range: 24 kHz to ~36
kHz | Identical to PD1 &
PD2 |
| Power Activation | Activation through the dental
unit | Activation through the dental
unit | Foot-pedal connected to the
control console by means of a
cord | Identical to PD1.
SE#6 |
| lectrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to PD1 &
PD2 |
| Electromagnetic
Compatibility | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Identical to PD1 &
PD2 |
| Does the device
contain
software? | Yes | Yes | Yes | Identical to PD1 &
PD2 |
| Differences in
Software | Software controls device
integrated with third party dental
unit, including Led illumination
at tip | Software controls device
integrated with third party dental
unit. | Software control stand-alone
unit, including Led illumination
of tip | Different from PD1
& PD2
SE#7 |
| Software
Documentation | In accordance with FDA
Guidance: 'Guidance for the
Content of Premarket
Submissions for Software
Contained in Medical Devices' | In accordance with FDA
Guidance: 'Guidance for the
Content of Premarket
Submissions for Software
Contained in Medical Devices' | In accordance with FDA
Guidance: 'Guidance for the
Content of Premarket
Submissions for Software
Contained in Medical Devices' | Identical to PD1 &
PD2 |
| Parts need to be
sterilized before
use? | Yes | Yes | Yes | Identical to PD1 &
PD2 |
| Recommended
sterilization
method | Autoclaving (Steam
Sterilization) | Autoclaving (Steam
Sterilization) | Autoclaving (Steam
Sterilization) | Identical to PD1 &
PD2 |
| Parts supplied
sterile? | No | No | No | Identical to PD1 &
PD2 |
| ingle use parts | Diamond coated inserts | Diamond coated inserts | Diamond coated inserts | Identical to PD1 &
PD2 |
| ip Inserts | Raw Material: Stainless steel.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench. | Raw Material: Stainless steel.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench. | Raw Material: Stainless steel.
The insert tips are secured to
the handpiece by a thread,
using a torque wrench. | Identical to PD1 &
PD2 |
| imensions | 46 x 71 x 34 mm
(ultrasonic generator module) | 46 x 71 x 34 mm
(ultrasonic generator module) | 440 x 230 x 145 mm
(table top device console | Identical to PD1.
SE#8 |
Table 2: Predicate Device Comparison Table
6
Image /page/6/Picture/0 description: The image shows the word "mectron" in orange font. Below the word is a gray line with several gray circles of varying sizes along the line. The circles are evenly spaced and appear to be connected to the line.
Mectron S.p.A. Via Loreto, 15/A
16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
medical technology
P.IVA IT00177110996
N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
7
Image /page/7/Picture/0 description: The image shows the word "mectron" in orange font. Underneath the word is a gray line with circles of varying sizes along the line. The circles increase in size from left to right. The logo is simple and modern.
Mectron S.p.A. Via Loreto, 15/A
16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996
N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
8
Image /page/8/Picture/0 description: The image shows the logo for Mectron. The word "mectron" is written in orange, with a line underneath it. The line has several gray circles of varying sizes along it.
Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
7. SUBSTANTIAL EQUIVALENCE DISCUSSION
With specific reference to the SE#s identified in Table 1 related to differences between one or both of the predicate devices and the subject device, Table 2 provides an explanation of the differences.
Table 2: Discussion of differences between predicates and subject device.
| SE# | SE Discussion |
|---|---|
| SE #1 | PD 1 is identical to the subject device. |
| PD 2 is a stand-alone table top ultrasonic scaler device, comprising a console with a panel control to which are connected to the | |
| handpiece, the footswitch and the power supply cord. The subject device is intended to be integrated inside a dental unit | |
| manufactured by a third party, whereas PD 2 is a stand-alone table top device. | |
| This difference between the subject device and PD 2 does not raise any new or different questions . | |
| SE #2 | PD 2 is identical to the subject device. |
| Compared with PD 1, the hand piece of the subject device incorporates Led illumination in order to improve visibility of the | |
| operative site. Testing was carried out by third party test laboratory according to IEC 62471:2006 – 'Photobiological safety of | |
| lamps and lamp systems' and found to be in compliance. | |
| The Led system incorporated in the handpiece of the subject device does not raise any new or different questions . | |
| SE #3 | PD 1 is identical to the subject device. |
| The subject device is intended to be assembled inside a dental unit, receiving functional drive signals, including those for | |
| irrigation supply, from the dental unit. | |
| PD 2 is a stand-alone table top unit which has the irrigation system integrated in its console. | |
| Therefore with the subject device, the operator adjusts irrigation flow by means of the dental unit's control panel, while with PD 2, | |
| irrigation flow is adjusted by means of the integrated control panel, from either an attached fluid bottle or from an external fluid | |
| supply. | |
| This difference does not raise any new or different questions. | |
| SE #4 | See above point SE 3 |
| SE #5 | PD 1 is identical to the subject device. |
| The subject device is intended to be assembled inside a dental unit and powered from a power source internal to the dental unit. | |
| The proposed device receives the functional drive signals, including electrical power, from the dental unit. | |
| PD 2 is a stand-alone table top device connected to mains power. | |
| This difference does not raise any new or different questions. | |
| SE #6 | PD 1 is identical to the subject device. |
| The subject device is intended to be assembled inside a dental unit and to receive its functional signals from the dental unit. | |
| PD 2 is a stand-alone table top device connected to mains power, with its functional signals being generated internally. | |
| This difference does not raise any new or different questions . | |
| SE #7 | Compared to PD1 the software of the subject device has been modified to allow the generator module to drive the led |
| illumination on the handpiece, together with a modification to allow use of a 'soft' operative mode. | |
| Compared to PD2 the software of the subject device is different because the PD2 is a table top device which includes control of | |
| elements that the subject device does not have, ie. touch screen, peristaltic pump, etc. The software for PD2 includes control of | |
| the led illumination and use of 'soft' mode, however. | |
| Since the software of the subject device has been validated in accordance with FDA Guidelines, the differences existing between | |
| the subject device and predicate device software do not raise any new or different questions . | |
| SE #8 | PD 1 is identical to the subject device. |
| The dimensional differences between the subject device and PD2 are as a result of the need for the additional electronic | |
| components to be incorporated into PD2, because all functional signals are generated internally, rather than some being | |
| received from an external source. | |
| This difference does not raise any new or different questions . |
8. SUMMARY OF NON-CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The Compact Piezo Led complies with the electrical safety and electromagnetic compatibility established by standards IEC 60601-1, IEC 60601-1-2 and IEC 80601-2-60.
Non-clinical testing of the subject device includes:
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Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc.: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 4.286.000 i.v. mectron@mectron.com
- Testing to confirm compliance of the Compact Piezo Led with the safety requirements of standard IEC 60601-1.
- · Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2.
- Testing to confirm compliance with the safety requirements of standard IEC 80601-2-60. ●
- · Software Verification and Validation.
- . Functional testing to confirm: current delivered to the handpiece, working frequency range, leakage currents, ultrasonic transducer power.
- . Direct comparison of functional test results with the predicate devices
9. CONCLUSION
The subject device, Compact Piezo Led, and the predicate devices, Compact Piezo P2K and Multipiezo, share the same intended uses, principles of operation, technological characteristics to generate ultrasonic mechanical vibrations of the associated tip inserts, and range of available insert tips, with no differences that raise new questions.
The tip inserts included in this submission are identical to those cleared within the 510(k) submissions of the predicate devices.
Based on the information contained within this submission, it is concluded that the Mectron Compact Piezo Led is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.