(111 days)
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.
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.
This document describes the Mectron Compact Piezo LED, an ultrasonic scaler device. However, it does not contain a study that establishes acceptance criteria and proves the device meets them in the context of clinical performance or diagnostic efficacy.
The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices. This type of submission primarily focuses on comparing the new device's technological characteristics and safety with existing, cleared devices, rather than conducting new clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.
Here's a breakdown of the information provided, specifically addressing the points in your request:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in terms of diagnostic or clinical efficacy (e.g., sensitivity, specificity, accuracy for a disease detection task). The device is an ultrasonic scaler, a therapeutic and dental hygiene tool, not a diagnostic imaging or AI-driven diagnostic device.
The "performance" discussed relates to technical specifications and compliance with safety and electromagnetic compatibility standards, which are:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Complies |
| Compliance with IEC 60601-1-2 (EMC Requirements) | Complies |
| Compliance with IEC 80601-2-60 (Safety Requirements) | Complies |
| Software Verification and Validation | Validated in accordance with FDA Guidelines |
| Functional testing (current, working frequency, leakage, ultrasonic transducer power) | Confirmed |
| Photobiological safety of LED illumination (IEC 62471:2006) | Found to be in compliance |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is not a study evaluating a diagnostic device with a test set of patient data. The "testing" mentioned is non-clinical, focusing on engineering, electrical safety, and regulatory compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. There is no concept of "ground truth" as typically understood in diagnostic AI/imaging studies, as this is a dental scaling device undergoing technical and safety evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasonic scaler, a physical tool used by dentists. It is not an AI diagnostic tool and does not involve "human readers" or AI assistance in the interpretation of information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no standalone algorithm performance as this is a hardware device. The device has software that controls its functions, and this software was verified and validated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As explained, the device is not being evaluated against a diagnostic "ground truth." The "truth" in this context refers to compliance with established engineering standards and functional specifications.
8. The sample size for the training set
Not applicable. This refers to a manufactured device and its components, not a machine learning model that undergoes training on a dataset.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
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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
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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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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.aVia Loreto 1516042 Carasco - (GE) - ITALYPhone: +39 0185 35 361Fax: +39 0185 351 374 |
| 510(k) Contact Person: | Roger GrayVP, Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania, 1000153 Rome, ItalyPhone: +39 06 578 2665Fax: +39 06 574 3786email: rgray@donawa.com |
| Manufacturer: | MECTRON S.p.aVia Loreto 1516042 Carasco - (GE) - 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 |
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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.
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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 DeviceCompact Piezo Led | Predicate Device 1 (PD1)Compact Piezo P2KPrimary Predicate | Predicate Device 2 (PD2)MultipiezoReference Predicate | Explanation ofdifferencesSE# |
|---|---|---|---|---|
| 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 |
| TechnologicalCharacteristics(mechanism ofaction) | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibration ofthe insert tips. The piezoelectrictransducer uses piezoceramicdisks to convert the generator'selectrical signal to ultrasonicvibration of the insert tip. | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibration ofthe insert tips. The piezoelectrictransducer uses piezoceramicdisks to convert the generator'selectrical signal to ultrasonicvibration of the insert tip. | Piezoelectric ultrasonictechnology that generatesmechanical micro-vibration ofthe insert tips. The piezoelectrictransducer uses piezoceramicdisks to convert the generator'selectrical signal to ultrasonicvibration of the insert tip. | Identical to PD1 &PD2 |
| Device type | Sub-assembly device intendedto be incorporated into a dentalunit and/or table top device | Sub-assembly device intendedto be incorporated into a dentalunit and/or table top device | Table top device | Identical to PD1.SE#1 |
| Description | Subject DeviceCompact Piezo Led | Predicate Device 1 (PD1)Compact Piezo P2KPrimary Predicate | Predicate Device 2 (PD2)MultipiezoReference Predicate | Explanation ofdifferencesSE# |
| Indications foruse/Intendeduse | The Compact Piezo Led is anultrasonic scaler intended foruse, with the appropriateassociated insert tips, in thefollowing dental applications:· Scaling: Procedures forremoval of supragingival/subgingival and interdentalcalculus/plaque deposits;· Periodontology: Periodontaltherapy and debridement forperiodontal diseases,including periodontal pocketirrigation and cleaning;Endodontics: Treatments forroot canal reaming irrigation,revision, filling, gutta-perchacondensation andretrograde preparation;· Restorative and Prosthetics:Restorative proceduresincluding cavity preparation,removal of prostheses,amalgam condensation,finishing of crownpreparations, inlay/onlaycondensation andimplants/restorationscleaning. | The Compact Piezo P2K deviceis an ultrasonic scaler intendedfor use with the appropriateassociated insert tips, in thefollowing dental applications:· Scaling: All general scalingapplications includingremoval of supra/subgingival/ interdentalcalculus/plaque deposits;· Periodontology: Periodontaltherapy and debridement forall types of periodontaldiseases, includingperiodontal pocket irrigationand cleaning;Endodontics: All endodonticsprocedures includingtreatments for root canalreaming, irrigation, revision,filling, gutta-perchacondensation andretrograde preparation;· Restorative and Prosthetics:All general restorativeprocedures including cavitypreparation, removal ofprostheses, amalgam,condensation and finishingof crown preparation andinlay/onlay condensation. | The Multipiezo Pro andMultipiezo are piezoelectricultrasonic dental scalersintended for use, with theappropriate associated tipinserts, in the following dentalapplications:· Scaling: All generalprocedures for removal ofsupragingival/subgingivaland interdentalcalculus/plaque deposits;· Periodontology: Periodontaltherapy and debridement forall types of periodontaldiseases, includingperiodontal pocket irrigationand cleaning;· Endodontics: All treatmentsfor root canal reaming,irrigation, revision, filling,gutta-percha condensationand retrograde preparation;Restorative and Prosthetics:All general restorativeprocedures including cavitypreparation, removal ofprostheses, amalgamcondensation, finishing ofcrown preparations,inlay/onlay condensation,implants/restorationscleaning. | Very similar to PD1& PD2 |
| TransducerTechnologicalcharacteristics | Piezoelectric: The transduceruses four piezoceramic disks toconvert the generator'selectrical signal to ultrasonicvibration of the insert tip | Piezoelectric: The transduceruses four piezoceramic disks toconvert the generator'selectrical signal to ultrasonicvibration of the insert tip | Piezoelectric: The transduceruses four piezoceramic disks toconvert the generator'selectrical signal to ultrasonicvibration of the insert tip | Identical to PD1 &PD2 |
| Automaticresonantfrequency tuning | Electronics with automaticfrequency tuning | Electronics with automaticfrequency tuning | Electronics with automaticfrequency tuning | Identical to PD1 &PD2 |
| Led systemincorporatedinside thehandpiece toprovideillumination ofthe operativesite. | Yes | No | Yes | Identical to PD2.SE#2 |
| Irrigation supplysource | Through irrigation line of thedental unit where the CompactPiezo Led is mounted. | Through irrigation line of thedental unit where the CompactPiezo P2K is mounted. | Two irrigation sources:A refillable irrigation bottlemounted on the consoleconnected to peristaltic pump,or alternatively external watersupply by means of an optionalaccessory. | Identical to PD1.SE#3 |
| Description | Subject DeviceCompact Piezo Led | Predicate Device 1 (PD1)Compact Piezo P2KPrimary Predicate | Predicate Device 2 (PD2)MultipiezoReference Predicate | Explanation ofdifferencesSE# |
| Irrigation flowrate adjustment | Through the flow regulator ofthe dental unit | Through the flow regulator ofthe dental unit | Flow rate adjustable through thetouch panel of the console | Identical to PD1.SE#4 |
| Feedbacksystem control | The power is automaticallyadjusted as a function of theresistance encountered by theinsert tip during the treatment. | The power is automaticallyadjusted as a function of theresistance encountered by theinsert tip during the treatment. | The power is automaticallyadjusted as a function of theresistance encountered by theinsert tip during the treatment. | Identical to PD1 &PD2 |
| Supply Voltage | Powered through the dentalunit: 24 VAC ± 10% or 32 VDC± 10%. | Powered through the dentalunit: 24 VAC ± 10% or 32 VDC± 10%. | 100 - 240 VAC - 50/60 Hz | Identical to PD1.SE#5 |
| Outputperformancespecifications | Output: 15 WattFrequency range: 24 kHz to ~36kHz | Output: 15 WattFrequency range: 24 kHz to~36 kHz | Output: 15 WattFrequency range: 24 kHz to ~36kHz | Identical to PD1 &PD2 |
| Power Activation | Activation through the dentalunit | Activation through the dentalunit | Foot-pedal connected to thecontrol console by means of acord | 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 |
| ElectromagneticCompatibility | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Complies IEC 60601-1-2 | Identical to PD1 &PD2 |
| Does the devicecontainsoftware? | Yes | Yes | Yes | Identical to PD1 &PD2 |
| Differences inSoftware | Software controls deviceintegrated with third party dentalunit, including Led illuminationat tip | Software controls deviceintegrated with third party dentalunit. | Software control stand-aloneunit, including Led illuminationof tip | Different from PD1& PD2SE#7 |
| SoftwareDocumentation | In accordance with FDAGuidance: 'Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices' | In accordance with FDAGuidance: 'Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices' | In accordance with FDAGuidance: 'Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices' | Identical to PD1 &PD2 |
| Parts need to besterilized beforeuse? | Yes | Yes | Yes | Identical to PD1 &PD2 |
| Recommendedsterilizationmethod | Autoclaving (SteamSterilization) | Autoclaving (SteamSterilization) | Autoclaving (SteamSterilization) | Identical to PD1 &PD2 |
| Parts suppliedsterile? | 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 tothe handpiece by a thread,using a torque wrench. | Raw Material: Stainless steel.The insert tips are secured tothe handpiece by a thread,using a torque wrench. | Raw Material: Stainless steel.The insert tips are secured tothe 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
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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
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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 thehandpiece, the footswitch and the power supply cord. The subject device is intended to be integrated inside a dental unitmanufactured 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 theoperative site. Testing was carried out by third party test laboratory according to IEC 62471:2006 – 'Photobiological safety oflamps 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 forirrigation 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 fluidsupply.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 ledillumination 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 ofelements that the subject device does not have, ie. touch screen, peristaltic pump, etc. The software for PD2 includes control ofthe 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 betweenthe 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 electroniccomponents to be incorporated into PD2, because all functional signals are generated internally, rather than some beingreceived 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.
§ 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.