(343 days)
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.
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.
The provided text is a 510(k) summary for a medical device called "Piezosurgery White." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.
The device in question ("Piezosurgery White") is a surgical instrument that uses ultrasonic energy for bone cutting and other dental procedures. It is not an AI-powered diagnostic or assistive device that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC), human reader performance, ground truth establishment by experts, or MRMC studies that are common for AI/ML medical devices.
The "Performance Data" section states:
"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."
This indicates that a bench test was performed to ensure the new inserts (W1-W6) met specific performance criteria (tuning frequency and vibration amplitude) to demonstrate substantial equivalence to existing inserts for a physical surgical device.
Therefore, I cannot extract the requested information from the provided text because the device and the nature of its evaluation are different from what the prompt is asking about (which seems to be tailored towards AI/ML device performance studies).
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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 1516042 Carasco - (GE) - ITALYPhone: +39 0185 35 361Fax: +39 0185 351 374 |
| Sponsor Contact: | Franco Zunino |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 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, ProductCodes: | Bone cutting instrument and accessories, 872.4120, DZI andUltrasonic scaler, 872.4850, ELC |
| Submission Purpose: | To add the W1 - W6 inserts to the currently cleared Piezosurgery insertsoffering. |
| Device Description: | The Piezosurgery White uses ultrasonic energy to generate mechanicalmicro-vibration of the available insert tips designed with differentmorphologies/shapes to perform the dental procedures defined in itsintended use.The Piezosurgery White consists of a table-top unit (console) containing theirrigation delivery system, the internal electric power supply, the ultrasonicgenerator, and the control keyboard. |
| Indications for Use: | The Piezosurgery White is a piezoelectric ultrasonic device, consisting ofhandpieces and associated tip inserts, intended for:• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oralsurgical procedures, including implantology, periodontal surgery, surgicalorthodontic, and surgical endodontic procedures;• Scaling applications, including:– Scaling: All general procedures for removal ofsupragingival and interdental calculus & plaque deposits;– Periodontology: Periodontal therapy and debridement for alltypes of periodontal diseases, including periodontal pocket irrigationand cleaning;– Endodontics: All treatments for root canal reaming, irrigation,revision, filling, gutta-percha condensation and retrogradepreparation;– Restorative and Prosthetics: Cavity preparation, removal ofprostheses, amalgam condensation, finishing of crown preparationsand inlay/onlay condensation. |
| Materials: | The Piezosurgery insert components are manufactured from stainlesssteels (ASTM F899). |
| Primary Predicate: | Piezosurgery White (MECTRON S.p.A - K151248) |
| Performance Data: | A features comparison and risk analysis of the modified devices wasperformed. The results demonstrate that the modifications do not alter theoperating principle or mechanism of action of the inserts.The tuning frequency and vibration amplitude of each insert was evaluatedvia performance bench testing. The results demonstrated that the W1-W6met the stipulated acceptance criteria and so are substantially equivalent tothe predicate inserts. |
| TechnologicalCharacteristics: | The new Piezosurgery insert tips possess the same technologicalcharacteristics 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 inserttips is the same as previously cleared device. |
| Conclusion: | The Piezosurgery White possesses the same intended use andtechnological characteristics as the predicate devices. ThereforePiezosurgery White is substantially equivalent for its intended use. |
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§ 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.