(127 days)
Not Found
No
The device description focuses on standard ultrasonic technology, a microprocessor for generating and controlling the drive signal, and a touch screen for parameter setting. There is no mention of AI, ML, or any features that would suggest learning or adaptive capabilities based on data.
Yes
The device is described as an ultrasonic dental scaler used for various dental applications including scaling, periodontology, endodontics, restorative and prosthetics, all of which are therapeutic procedures.
No
The document describes a dental scaler used for procedures like scaling, periodontology, endodontics, and restorative work, which are all treatment procedures, not diagnostic ones.
No
The device description clearly outlines physical hardware components including a base control unit, peristaltic pumps, handpieces, connecting cords, and a footswitch. While it contains a microprocessor-based ultrasonic generator, it is integrated into the physical console and controls the hardware components.
Based on the provided text, the Multipiezo Pro and Multipiezo devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for dental procedures performed directly on a patient (scaling, periodontology, endodontics, restorative and prosthetics). These are clinical treatments, not tests performed on samples taken from the body.
- Device Description: The description details a device that generates ultrasonic energy and delivers irrigation fluid for use in the mouth. This aligns with a therapeutic or procedural device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
- Measuring analytes
In summary, the Multipiezo Pro and Multipiezo are dental devices used for performing procedures within the oral cavity, not for diagnosing conditions by testing samples outside the body.
N/A
Intended Use / Indications for Use
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 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Multipiezo Pro and Multipiezo devices are dental piezoelectic ultrasonic devices that use ultrasonic energy to generate mechanical micro-vibration of the inserts to perform the dental procedures defined in their intended use.
The Multipiezo Pro consists of a base control unit (console) with two integrated peristaltic pumps which deliver irrigation liquid, contained in two independent detachable 500 ml bottles, to two sterilizable ultrasonic handpieces with connecting cords. The selection of the irrigation fluid occurs automatically when the operator removes the handpiece from the support associated with the tank containing the liquid that the dentist wants to use for the treatment. Only one handpiece can be used at a time.
The Multipiezo device consists of a base control unit with a single integrated peristaltic pump which delivers the irrigation liquid contained in one detachable tank to one single ultrasonic handpiece with connecting cord.
The consoles of both devices are connected to mains power by an electrical cord, and include connectors for the hand piece/s and for the footswitch. The consoles incorporate peristaltic pump/s which provide/s the irrigation fluid contained in the tank/s to the operation site.
The handpiece contains a piezoelectric ultrasonic transducer which is connected to the ultrasonic generator (inside the console) by a cable at one end and to which tip inserts are attached at the other end.
The ultrasonic generator, identical in both devices, is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the transducer in the handpiece. A touch screen on the console of both devices allows the setting of treatment parameters, as follows:
- Four type of functions (Endo, Perio/Scaler, Restorative, Soft Mode) that can be adjusted through 6 power levels
- . Seven different levels of irrigation (from 0 to 6)
- . Insert tip illumination (on, off or auto)
- Flush function.
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:
The Multipiezo Pro and Multipiezo devices comply with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
Bench testing of the subject devices includes:
- Testing to confirm compliance with the safety requirements of standard IEC 60601-1
- Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2014
Mectron Spa C/O Mr. Roger Gray VP, Quality and Regulatory Donawa Lifescience Consulting Piazzz Albania, 10. 00153 Rome. Italy
Re: K140965
Trade/Device Name: Multipiezo Pro, Multipiezo Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 20, 2014 Received: May 23, 2014
Dear Mr. 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
Page 2 - Mr. Gray
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,
Mary S. Runner -S
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 Statement
510(k) Number (if known): K140965
Device Name: Mectron Multipiezo Pro and Multipiezo Dental Scalers
Indications for Use: 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 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, 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.
| Prescription Use
(Part 21 CFR 801 Subpart
D) | X | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ---------------------------------------------------- | ---------- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
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.
medical technology
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 1.400.000 i.v. mectron@mectron.com
510(k) Summary in accordance with 21 CFR 807.92
| Device Name: | Multipiezo Pro
Multipiezo |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | April 9, 2014 |
| Manufacturer: | Mectron Spa
Via Loreto, 15, 16042 Carasco - (GE)
Italy |
| FDA Registration Number: | 3003933619 |
| 510(k) Owner: | Mectron Spa
Via Loreto, 15, 16042 Carasco - (GE)
Italy |
| 510(k) Contact: | Roger Gray
VP, Quality and Requlatory
Donawa Lifescience Consulting
Piazza Albania, 10, 00153 Rome, Italy
Tel: +39 06 578 2665
Fax: +39 06 574 3786 |
| Common Name/Regulation Description: | Scaler, ultrasonic |
| Classification Regulation: | 21 CFR 872.4850 |
| FDA Panel: | Dental |
| Product Code: | ELC |
| Class: | Class II |
Two devices, Multipiezo Pro and Multipiezo, have been bundled in this single 510(k) submission. The devices share the following identical functional/technical characteristics:
- Same Intended Use/Indications for Use ●
- Same Technological Characteristics (mechanism of action) .
- . Same accessories (insert tips, etc.)
- Same operative modes/signal information .
- Same parts to be sterilized and sterilization methods ●
- . Same performance
4
Image /page/4/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 increase in size from left to right.
medical technology
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 1.400.000 i.v. mectron@mectron.com
Intended Use/Indications for use
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 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, 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.
Device Description and Technological Characteristics:
The Multipiezo Pro and Multipiezo devices are dental piezoelectic ultrasonic devices that use ultrasonic energy to generate mechanical micro-vibration of the inserts to perform the dental procedures defined in their intended use.
The Multipiezo Pro consists of a base control unit (console) with two integrated peristaltic pumps which deliver irrigation liquid, contained in two independent detachable 500 ml bottles, to two sterilizable ultrasonic handpieces with connecting cords. The selection of the irrigation fluid occurs automatically when the operator removes the handpiece from the support associated with the tank containing the liquid that the dentist wants to use for the treatment. Only one handpiece can be used at a time.
The Multipiezo device consists of a base control unit with a single integrated peristaltic pump which delivers the irrigation liquid contained in one detachable tank to one single ultrasonic handpiece with connecting cord.
The consoles of both devices are connected to mains power by an electrical cord, and include connectors for the hand piece/s and for the footswitch. The consoles incorporate peristaltic pump/s which provide/s the irrigation fluid contained in the tank/s to the operation site.
The handpiece contains a piezoelectric ultrasonic transducer which is connected to the ultrasonic generator (inside the console) by a cable at one end and to which tip inserts are attached at the other end.
The ultrasonic generator, identical in both devices, is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the transducer in the handpiece. A touch screen on the console of both devices allows the setting of treatment parameters, as follows:
- Four type of functions (Endo, Perio/Scaler, Restorative, Soft Mode) that can be adjusted through 6 power levels
- . Seven different levels of irrigation (from 0 to 6)
- . Insert tip illumination (on, off or auto)
- Flush function. .
Non clinical testing
The Multipiezo Pro and Multipiezo devices comply with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.
Bench testing of the subject devices includes:
- Testing to confirm compliance with the safety requirements of standard IEC 60601-1 .
- Testing to confirm compliance with EMC requirements of standard 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 several gray circles of varying sizes along the line. The circles are evenly spaced and appear to be part of the logo. The background is white.
medical technology
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 1.400.000 i.v. mectron@mectron.com
Substantial Equivalence
The substantial equivalence of the subject devices is based on the following predicate devices:
- . EMS Piezon Master 600, manufactured by Electro Medical System SA, 510(k) reference K022328, cleared on 13 August 2002.
- Compact Piezo P2K, manufactured by Mectron Spa, 510(k) reference K102218, cleared on 24 January . 2011.
The technological characteristics and operating parameters of the Multipiezo are identical or very similar to those of the predicate devices. With respect to the functional aspects, the Multipiezo Pro and Multipiezo use the same fundamental technology as the two predicate devices.
Both the subject devices and the predicate devices use same piezoelectric technology to generate mechanical micro-vibration to the inserts to perform the dental ultrasound treatments according to their intended use.
Both the subject devices and the two predicate devices have the ultrasonic transducers housed in the respective handpieces. The transducers of the Multipiezo and of the predicate devices are formed by piezoceramic disks which convert the input electrical power to mechanical vibration of the insert.
Any differences between the subject device and one or other of the predicate devices is not significant with regard to device safety or effectiveness
Conclusion
The Multipiezo pro and Multipiezo and the predicate devices share the same general intended use and technology.
The differences existing between the subject devices and the predicate devices relating to technical specifications, performance and intended use are minor and do not affect safety and effectiveness.
The data presented in this submission demonstrate the similarities in the intended use/indications of use and technology existing between the Multipiezo Pro and Multipiezo devices and the referenced predicate devices. and thus supports a finding of substantial equivalence between the subject device and the predicate devices which are already in commercial distribution in the United States.