(343 days)
Not Found
No
The summary describes a piezoelectric ultrasonic device for dental procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on mechanical properties and equivalence to a predicate device.
Yes
The device is described for a variety of surgical and therapeutic procedures, including periodontal therapy and endodontic treatments.
No
The device is described as a piezoelectric ultrasonic device intended for various surgical and dental procedures (e.g., bone cutting, scaling, root canal treatment). Its function involves generating mechanical micro-vibration for therapeutic or procedural purposes, not for diagnosing conditions.
No
The device description clearly states it is a piezoelectric ultrasonic device consisting of a table-top unit (console) with hardware components like an irrigation delivery system, power supply, ultrasonic generator, and control keyboard, in addition to handpieces and tip inserts. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The Piezosurgery White is a surgical device that uses ultrasonic energy to perform procedures directly on the patient's tissues (bone, teeth, etc.) within the oral cavity. It is an in vivo device, not an in vitro device.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient, not laboratory testing of specimens.
Therefore, based on the provided information, the Piezosurgery White is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The 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, revision, 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 White uses ultrasonic energy to generate mechanical micro-vibration of the available insert tips designed with different morphologies/shapes to perform the dental procedures defined in its intended use.
The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard.
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)
A features comparison and risk analysis of the modified devices was performed. The results demonstrate that the modifications do not alter the operating principle or mechanism of action of the inserts. The tuning frequency and vibration amplitude of each insert was evaluated via performance bench testing. The results demonstrated that the W1-W6 met the stipulated acceptance criteria and so are substantially equivalent to the predicate inserts.
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.
Piezosurgery White (MECTRON S.p.A - K151248)
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
§ 872.4120 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
April 13, 2018
Mectron S.p.a % Karen Warden Representative/Consultant BackRoads Consulting, Inc PO Box 566 Chesterland, Ohio 44026-0566
Re: K171326
Trade/Device Name: Piezosurgery White Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: March 12, 2018 Received: March 13, 2018
Dear Karen Warden:
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);
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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
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
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Indications for Use
510(k) Number (if known) K171326
Device Name Piezosurgery White
Indications for Use (Describe)
The 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for K171326
| Date: | 12 April 2018 |
|---|---|
| Sponsor: | MECTRON S.p.A. |
| Via Loreto 15 | |
| 16042 Carasco - (GE) - ITALY | |
| Phone: +39 0185 35 361 | |
| Fax: +39 0185 351 374 | |
| Sponsor Contact: | Franco Zunino |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | Piezosurgery White |
| Common Name: | Powered bone drill with tip inserts and ultrasonic scaler |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | |
| Codes: | Bone cutting instrument and accessories, 872.4120, DZI and |
| Ultrasonic scaler, 872.4850, ELC | |
| Submission Purpose: | To add the W1 - W6 inserts to the currently cleared Piezosurgery inserts |
| offering. | |
| Device Description: | The Piezosurgery White uses ultrasonic energy to generate mechanical |
| micro-vibration of the available insert tips designed with different | |
| morphologies/shapes to perform the dental procedures defined in its | |
| intended use. | |
| The Piezosurgery White consists of a table-top unit (console) containing the | |
| irrigation delivery system, the internal electric power supply, the ultrasonic | |
| generator, and the control keyboard. | |
| Indications for Use: | The 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, | |
| revision, 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. | |
| Materials: | The Piezosurgery insert components are manufactured from stainless |
| steels (ASTM F899). | |
| Primary Predicate: | Piezosurgery White (MECTRON S.p.A - K151248) |
| Performance Data: | A features comparison and risk analysis of the modified devices was |
| performed. The results demonstrate that the modifications do not alter the | |
| operating principle or mechanism of action of the inserts. | |
| The tuning frequency and vibration amplitude of each insert was evaluated | |
| via performance bench testing. The results demonstrated that the W1-W6 | |
| met the stipulated acceptance criteria and so are substantially equivalent to | |
| the predicate inserts. | |
| Technological | |
| Characteristics: | The new Piezosurgery insert tips possess the same technological |
| characteristics as the predicate device. These include: | |
| intended use (as described above) basic design (bone cutting accessories), and material (medical grade stainless steel) The fundamental scientific technology of the additional Piezosurgery insert | |
| tips is the same as previously cleared device. | |
| Conclusion: | The Piezosurgery White possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore | |
| Piezosurgery White is substantially equivalent for its intended use. |
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