(197 days)
No
The description focuses on the mechanical and electronic aspects of ultrasonic vibration and frequency tuning, with no mention of AI or ML algorithms for data analysis, decision making, or image processing.
Yes
Explanation: The device is intended for various oral surgical procedures including implantology, periodontal therapy, and endodontics, which are medical treatments.
No
This device is designed for various oral surgical and dental procedures that involve physical intervention (e.g., cutting, drilling, scaling, cleaning), not for diagnosing conditions.
No
The device description clearly outlines hardware components including a table-top unit (console), handpiece, foot-pedal, and insert tips, all of which are physical components generating ultrasonic energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's oral tissues (bone cutting, scaling, root canal treatments, etc.). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system that generates ultrasonic energy for mechanical action on the patient's tissues. It does not describe any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on the device's mechanical performance (tuning frequency, vibration amplitude), reprocessing effectiveness, and biocompatibility with tissues. These are typical evaluations for surgical or dental devices, not IVDs.
The device is a surgical/dental device used for direct treatment and procedures within the oral cavity.
N/A
Intended Use / Indications for Use
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- Scaling applications, including:
- 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
- Scaling applications, including:
- 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Product codes (comma separated list FDA assigned to the subject device)
DZI, ELC
Device Description
The Piezosurgery Touch and Piezosurgery White use ultrasonic energy to generate mechanical microvibrations of the available tip inserts to perform the dental procedures defined in its intended use.
They consist of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. They also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.
The table-top units use piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the insert tip attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.
The ultrasonic generator electronics searches and locates the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the insert tip in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz.
Each of the insert tips is available separately.
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
Prescription Use
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)
Comparative performance bench testing:
This test compares the performances of the subject inserts (SLC, SLO-H, SLS, SLE1 and SLE2) to their predicate inserts (OP3, OT1, EL2, EL2 and EL3) in terms of tuning frequency and vibration amplitude in order to establish their substantial equivalence, concluding that:
- The tuning frequency of the new inserts and of their predicate inserts is between 24 and 36 kHz, which is the range of the device functional ultrasonic frequency.
- The vibration amplitude of the new inserts and of their predicate inserts have comparable values.
Reprocessing:
Separate cleaning and sterilization test have been carried out on a typical worst case reprocessed insert tip in order to successfully validate the reprocessing instructions provided with the reusable insert tips.
Biocompatibility:
A cytotoxicity growth inhibition test in 1929 mouse fibroblasts, in accordance with ISO 10993-5:2009, was also carried out to demonstrate that a typical worst case reprocessed insert tip had "no cytotoxic effects in all extracts in the growth inhibition test with L929 mouse fibroblasts".
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.
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
January 11, 2018
Mectron SPA % Roger Gray VP, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 It
Re: K171958
Trade/Device Name: Piezosurgery Touch, Piezosurgery White Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: December 7, 2017 Received: December 13, 2017
Dear 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171958
Device Name
Piezosurgery Touch and Piezosurgery White
Indications for Use (Describe)
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- · Scaling applications, including:
- · 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tor: · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
· Scaling applications, including:
-
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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
| 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. Underneath the word is a gray line with five gray circles of varying sizes along the line. The circles are evenly spaced, with the largest circle in the middle and the smallest circles on the ends.
510(k) Summary in accordance with 21 CFR 807.92
ADMINISTRATIVE INFORMATION 1.
| 510(k) submission number | K171958 |
|---|---|
| Submission date: | 28 November 2017 |
| 510(k) Owner and Submitter: | MECTRON S.p.a |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Phone: +39 0185 35 361 | |
| Fax: +39 0185 351 374 | |
| 510(k) Submission Correspondent: | 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 | |
| 2. | |
| DEVICE | |
| Trade name of the device: | Piezosurgery Touch and Piezosurgery White |
| Common Name/Regulation Description: | Bone cutting instrument and accessories |
| Classification Regulation: | 21 CFR 872.4120 |
| FDA Panel: | Dental |
| Product Code: | DZI, ELC |
| Classification: | Class II |
4
3. IDENTIFICATION OF PREDICATE DEVICES
The substantial equivalence of the subject device is based on the following legally marketed primary predicate devices:
| Trade name | Manufacturer | Product Codes | 510(k) Number | Decision Date |
|---|---|---|---|---|
| Piezosurgery White | Mectron S.p.a | DZI, ELC | K151248 | 4 September 2015 |
In addition, two reference devices are cited in this submission, these being:
| Trade name | Manufacturer | Product Codes | 510(k) Number | Decision Date |
|---|---|---|---|---|
| Piezosurgery Touch | Mectron S.p.a | DZI, ELC | K122322 | 6 December 2012 |
| Piezosurgery Device | Mectron S.p.a | DZI | K043408 | 8 June 2005 |
DEVICE DESCRIPTION 4.
The Piezosurgery Touch and Piezosurgery White use ultrasonic energy to generate mechanical microvibrations of the available tip inserts to perform the dental procedures defined in its intended use.
They consist of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. They also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.
The table-top units use piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the insert tip attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.
The ultrasonic generator electronics searches and locates the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the insert tip in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz.
Each of the insert tips is available separately.
The purpose of this 510(k) is to add additional insert tip designs to the PIEZOSURGERY TOUCH and PIEZOSURGERY WHITE to extend the number of insert tips already cleared for sale in the US under K122322 and K151248.
5
5. INDICATIONS FOR USE
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
- Scaling applications, including:
- Scaling: All general procedures for removal of supragingival and interdental calculus & plaque ı deposits;
- i Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- i Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- ı Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
- Scaling applications, including:
- 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
These indications for use statements are identical to those for the original unmodified (predicate) devices, as cleared under K122322 and K151248.
6. NEW INSERT TIPS:
The new insert tips are similar in design to tips already cleared with the PIEZOSURGERY TOUCH and PIEZSURGERY WHITE. The following are the model references of the insert tips being introduced by this submission:
- റ്റ്C: Osteoplasty insert SLO-H: Micrometric osteotomy insert ડાર: Sinus membrane separator insert tip ટાEJ: Sinus membrane elevator insert tip SLE2: Sinus membrane elevator insert tip PL1: Osteotomy/osteoplasty insert
- PL2: Osteotomy/osteoplasty insert
- ы 3: Osteotomy/osteoplasty insert
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Image /page/6/Picture/1 description: The image contains the word "mectron" in orange font. Below the word is a horizontal line with five circles of increasing size along the line. The circles are gray.
7. SUBSTANTIAL EQUIVALENCE
The new insert tips are substantially equivalent to insert tips already FDA-cleared for use with the Predicate Devices or the Reference Device, as follows:
| Subject Insert Tip | Predicate Insert Tip | Predicate/Reference Device 510(k) # |
|---|---|---|
| SLC | OP3 | K043408 |
| SLO-H | OT1 | K043408 |
| SLS | EL1 | K043408 |
| SLE-1 | EL2 | K043408 |
| SLE-2 | EL3 | K043408 |
| PL1 | OT5 | K043408 |
| PL2 | OT9 | K043408 |
| PL3 | OT11 | K151248 |
Finite Element Analysis (FEA) was utilized in the design of the new insert tips to ensure that the resonant ultrasonic frequency of the inserts was within the functional ultrasonic frequency range of the Piezosurgery Touch and Piezosurgery White.
The new insert tips share the same intended uses as the identified predicate insert tips, have very similar operative part shapes, and functional testing has demonstrated compliance with specifications, thus no new issues of safety and effectiveness are raised.
NON-CLINICAL TESTING 8.
The following non-clinical performance tests were completed.
Comparative performance bench testing:
This test compares the performances of the subject inserts (SLC, SLO-H, SLS, SLE1 and SLE2) to their predicate inserts (OP3, OT1, EL2, EL2 and EL3) in terms of tuning frequency and vibration amplitude in order to establish their substantial equivalence, concluding that:
- The tuning frequency of the new inserts and of their predicate inserts is between 24 and 36 kHz, which is the range of the device functional ultrasonic frequency.
- The vibration amplitude of the new inserts and of their predicate inserts have comparable values.
Reprocessing:
Separate cleaning and sterilization test have been carried out on a typical worst case reprocessed insert tip in order to successfully validate the reprocessing instructions provided with the reusable insert tips.
Biocompatibility:
A cytotoxicity growth inhibition test in 1929 mouse fibroblasts, in accordance with ISO 10993-5:2009, was also carried out to demonstrate that a typical worst case reprocessed insert tip had "no cytotoxic effects in all extracts in the growth inhibition test with L929 mouse fibroblasts".
7
Image /page/7/Picture/0 description: The image shows the word "mectron" in orange font. Underneath the word is a gray line with five gray circles of varying sizes along the line. The circles are spaced out along the line, with the largest circle on the right and the smallest circle on the left.
9. CONCLUSION
Based on the information contained within this submission, the additional insert tips that are the subject of this submission, are substantially equivalent to the predicate device insert tips with of the Piezosurgery Touch and Piezosurgery White devices. It is concluded that the Piezosurgery Touch and Piezosurgery White devices that have been modified by the introduction of these new insert tips are substantially equivalent to the identified predicate devices cleared under K122322 and K151248, which are already in interstate commerce within the USA.