(337 days)
Piezomed is a piezoelectric ultrasonic device, consisting of handpieces and associated instruments, 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:
- o Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- o Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation;
- o Restorative and Prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.
Piezomed SA-320 is an ultrasonic drive unit intended for the treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics.
The device consists of the control unit, the foot control, the piezo handpiece incl. cable, an irrigation tubing set, the instrument set "Bone" and the corresponding instrument changer, and various accessories such as the stand and a motor rest.
The unit provides an instrument (tip) detection, choosing automatically the power class fixed for the attached instrument (tip). Within certain limits the user can change the pre-adjusted power settings manually. Furthermore, the user can choose between three adjustable working modes (Power, Basic, Smooth). A boost function enables a short-term power increase by 20 %. A LED lighting ring provides illumination of the surgical site.
This document is a 510(k) submission summary for a medical device and thus does not include the detailed study protocols, criteria, or results that would be found in a clinical trial report. The information provided is primarily to demonstrate substantial equivalence to a predicate device, not to prove defined acceptance criteria through a specific study in the way typically found for an AI/ML device.
However, based on the provided text, I can extract information related to performance testing that served to demonstrate the device met regulatory requirements for substantial equivalence.
Here's an interpretation based on the provided document:
Acceptance Criteria and Reported Device Performance
The document describes the Piezomed SA-320 as a revised and improved version of a predicate device (Piezosurgery Touch, K122322). The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device by meeting relevant performance standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety (compliance with IEC 60601-1:2005) | Compliant: Electrical Safety Tests according to IEC 60601-1:2005 were performed. |
| Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2:2007) | Compliant: Electromagnetic Compatibility Test according to IEC 60601-1-2:2007 was performed. |
| Mechanical Strength (compliance with ANSI/AAMI ES 60601-1:2005) | Compliant: Mechanical strength test according to ANSI/AAMI ES 60601-1:2005 was performed. |
| Dental Handpiece Performance (compliance with ISO 22374:2005) | Compliant: Type testing according to ISO 22374:2005: Dentistry -- Dental handpieces -- Electrical-powered scalers and scaler tips was performed. |
| Software Validation (compliance with IEC 62304:2006) | Validated: Software validation according to IEC 62304:2006: Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software was performed. |
| Usability Validation (compliance with IEC 62366:2007) | Validated: Usability validation according to IEC 62366:2007 was performed. |
| Thermal Safety (compliance with IEC 62471:2006) | Compliant: Thermal safety according to the standard IEC 62471:2006: Photobiological safety of lamps and lamp systems was performed. |
| Performance Parameters (Flow Rate, Biocompatibility, Sterilizability, Functionality, Lifecycle) | Demonstrated: Flow rate testing, evaluation of biocompatibility and sterilizability, various functionality and lifecycle tests as well as further bench tests were performed to demonstrate substantial equivalence. Specific parameters include: - Mains supply: 100 – 240 V / 50-60Hz (matches predicate)- Max. power consumption: 90 VA (vs. 120 VA for predicate)- Operating frequency: Automatic scan, from 24 KHz to 32 KHz (vs. 24 KHz to 36 KHz for predicate)- Coolant flow rate: at least 50 ml (vs. max. 75 ml for predicate)- LED system: 4 LEDs (vs. 1 LED for predicate)- Cleaning/Sterilization: Thermo washer disinfection approved, Steam sterilization at 132°C (270°F) (matches predicate)- Autoclaveability: Handpiece and blank/polished instruments/tips 132°C (270°F) for 4 minutes with drying time (matches predicate). Diamond coated instruments/tips: Single-use only (matches predicate).- Range of instruments/tips: 24 variants (vs. 31 for predicate)- Materials of the instruments/tips: Stainless steel – polished or diamond-coated (matches predicate) |
Study Details:
-
Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of data for an AI/ML algorithm. The performance testing described refers to physical device testing according to established standards. For these tests, the sample size would typically refer to the number of devices or components tested. This information is not provided in the summary.
- Data Provenance: Not applicable, as this is related to physical device testing, not data-driven algorithm validation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a traditional medical device (piezoelectric ultrasonic device), not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the objective measurements from the standards and physical properties.
-
Adjudication method for the test set:
- Not applicable for the same reasons as above. Testing involved adherence to published international standards for medical devices.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is not an AI/ML enabled device designed to assist human readers or clinicians in interpreting images or data. It is a surgical tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical, human-operated medical tool, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing cited is adherence to objective criteria and methodologies outlined in recognized international standards (e.g., IEC 60601-1, ISO 22374). This is physical and electrical property testing against defined limits, not expert judgment on medical data.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
-
How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, composed of three overlapping silhouettes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the face. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
W & H DENTALWERK BÜRMOOS GMBH Mag. Anja Lindner Manage Regulatory Affairs Iqnaz-Glaser-Strasse 53 A - 5111 Bürmoos AUSTRIA
Re: K133488
Trade/Device Name: Piezomed SA 320 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: II Product Code: DZI Dated: September 09, 2014 Received: September 09, 2014
Dear Ms. Lindner:
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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Page 2 - Ms. Lindner
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,
Susan Runno DDS, MA
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
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Image /page/2/Picture/0 description: The image shows a logo with the letters 'W&H' inside of a rounded hexagon. The letters are in a bold, sans-serif font. The logo is black and white. The logo is simple and modern.
Indications for Use
510(k) number:
Device Name:
Piezomed SA-320
Indication for Use:
Piezomed is a piezoelectric ultrasonic device, consisting of handpieces and associated instruments, 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:
- o Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- o Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde preparation;
- o Restorative and Prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows a logo with the letters 'W&H' inside of a rounded hexagon. The letters are in a bold, sans-serif font and are arranged horizontally. The ampersand symbol '&' is placed between the 'W' and the 'H'. The logo is black and white.
510(k) SUMMARY
| Applicant andOwner | W & H DENTALWERK BÜRMOOS GMBHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaTel.: 0043 -6274 / 6236 -397Fax: 0043 -6274 / 6236 -55 |
|---|---|
| RegistrationNumber | 9681479 |
| ContactPerson | Mag. Anja LINDNER |
| Date ofSubmission | November 7th, 2013 |
| Device Name | Piezomed SA-320 |
| ClassificationName | Drill, Bone, Powered |
| RegulationNumber | 21 CFR 872.4120 |
| Product Code | DZI |
| PredicateDevices | "Piezosurgery Touch", Mectron S.P.A. / Italy, K122322 |
| DeviceDescription | Piezomed SA-320 is an ultrasonic drive unit intended for the treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics.The device consists of the control unit, the foot control, the piezo handpiece incl. cable, an irrigation tubing set, the instrument set "Bone" and the corresponding instrument changer, and various accessories such as the stand and a motor rest.The unit provides an instrument (tip) detection, choosing automatically the power class fixed for the attached instrument (tip). Within certain limits the user can change the pre-adjusted power settings manually. Furthermore, the user can choose between three adjustable working modes (Power, Basic, Smooth). A boost function enables a short-term power increase by 20 %. A LED lighting ring provides illumination of the surgical site. |
|---|---|
| ----------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Image: W&H logo | 510(k)Piezomed SA-320 | Page 2 of 4 | ||
|---|---|---|---|---|
| Intended Use: | Piezomed is a piezoelectric ultrasonic device, consisting of handpiecesand associated instruments, intended for:- Bone Cutting, osteotomy, osteoplasty and drilling in a variety oforal surgical procedures, including implantology, periodontalsurgery, surgical orthodontic, and surgical endodonticprocedures;- Scaling applications, including:o Scaling: All general procedures for removal ofsupragingival and interdental calculus & plaque deposits;o Periodontology: Periodontal therapy and debridement forall types of periodontal diseases, including periodontalpocket irrigation and cleaning;o Endodontic: All treatments for root canal reaming,irrigation, revision, filling, gutta-percha-condensation andretrograde preparation;o Restorative and Prosthetics: Cavity preparation, removal ofprostheses, finishing of crown preparations. | |||
| W&H's Piezomed SA-320 represents a revised and improved version ofthe predicate device.The technical principle is the same as within the predicate device(piezo-electric principle).The main technological characteristics are the same or, at least, quitesimilar to those of the comparable product. | ||||
| TechnologicalCharacteristics | TechnologicalCharacteristic | Subject device | Predicate Device(K122322) | |
| User Interface | Consisting of: control unit,foot control, handpiece,instruments/tips | Consisting of: control unit,foot control, handpiece,inserts | ||
| Mains supply | 100 – 240 V / 50-60Hz | 100-240 V / 50-60 Hz | ||
| Max. powerconsumption | 90 VA | 120 VA | ||
| Operating frequency | Automatic scan,from 24 KHz to 32 KHz | Automatic scan,from 24 KHz to 36 KHz | ||
| Energy source | Piezo-ceramic oscillatingsystem | Piezo-ceramic oscillatingsystem | ||
| Coolant flow rate | at least 50 ml | max. 75 ml | ||
| LED system | 4 LEDs | 1 LED | ||
| Activation of device | Mains switch on control unit | Mains switch on control unit | ||
| Cleaning/Sterilization | Thermo washer disinfectionapproved, Steam sterilizationat 132°C (270°F) | Thermo washer disinfectionapproved, Steamsterilization at 132°C(270°F) | ||
| 510(k)Piezomed SA-320 | Page 3 of 4 | |||
| Autoclaveability | Handpiece:Dynamic air removalsterilizer,132°C (270°F) for 4 minutes,Drying time: 20 - 30 minBlank, polishedinstruments/tips:Dynamic air removalsterilizer,132°C (270°F) for 4 minutes,Drying time: 20 - 30 minDiamond coatedinstruments/tips:Single-use only | Handpiece:Dynamic air removalsterilizer,132°C (270°F) for 4 minutesDrying time: 20 minBlank, polished inserts /tips:Dynamic air removalsterilizer,132°C (270°F) for 4 minutes,Drying time: 20 minDiamond coated inserts /tips:Single-use only | ||
| Range of instruments / tips | 24 variants for variousapplications | 31 variants for variousapplications | ||
| Materials of theinstruments / tips | Stainless steel –polished or diamond-coated | Stainless steel –polished or diamond-coated | ||
| Comparison ofthe device tothe predicatedevice | The target field of application, the intended use, functions andtechnological features, performance parameter and material are thesame or, at least, quite similar to those of the predicate device.The product comparison did not raise new or different questionsregarding safety and efficacy.The new device is substantially equivalent to the predicate device. | |||
| PerformanceTesting | Electrical Safety Tests according to IEC 60601-1:2005, Medicalelectrical equipment - Part 1: General requirements for basic safety andessential performance.Electromagnetic Compatibility Test according to IEC 60601-1-2:2007:General requirement for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements andtestsType testing according to ISO 22374:2005: Dentistry -- Dentalhandpieces -- Electrical-powered scalers and scaler tipsSoftware validation according to IEC 62304:2006: Medical devicesoftware -- Part 1: Guidance on the application of ISO 14971 to medicaldevice software | |||
| Image: W&H logo | 510(k)Piezomed SA-320 | Page 4 of 4 | ||
| Mechanical strength test according ANSI/AAMI ES 60601-1:2005Usability validation according to IEC 62366:2007Thermal safety according to the standard IEC 62471:2006:Photobiological safety of lamps and lamp systemsFlow rate testing, evaluation of biocompatibility and sterilizability,various functionality and lifecycle tests as well as further bench tests demonstrate substantial equivalence. | ||||
| ClinicalTesting | Clinical data were not needed for this new product. |
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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.