PIEZOMED

K133488 · W&H Dentalwerk Buermoos GmbH · DZI · Oct 16, 2014 · Dental

Device Facts

• Record ID: K133488
• Device Name: PIEZOMED
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: DZI · Dental
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Piezomed SA-320 is an ultrasonic drive unit for dental surgery; implantology; maxillofacial surgery; periodontics. System includes control unit; foot control; piezo handpiece; irrigation tubing; instrument set; accessories. Device uses piezo-ceramic oscillating system to transform electrical energy into mechanical ultrasonic vibrations for tissue treatment. Features automatic instrument/tip detection to set power class; manual power adjustment; three working modes (Power, Basic, Smooth); 20% boost function; LED illumination ring. Operated by dental professionals in clinical settings. Output is mechanical vibration at surgical site; irrigation fluid delivery. Benefits include precise bone/tissue cutting; calculus removal; root canal preparation; cavity preparation. Healthcare provider uses visual/tactile feedback to guide instrument; output facilitates surgical/dental procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), performance testing (ISO 22374), software validation (IEC 62304), usability validation (IEC 62366), photobiological safety (IEC 62471), flow rate testing, biocompatibility, and sterilization validation.

Technological Characteristics

Piezo-ceramic oscillating system; 100-240V power supply; 24-32 kHz operating frequency; 4 LED illumination; stainless steel instruments (polished or diamond-coated). Connectivity: foot control. Sterilization: thermo washer disinfection and steam sterilization at 132°C. Software validation per IEC 62304.

Indications for Use

Indicated for patients requiring oral surgical procedures including bone cutting, osteotomy, osteoplasty, drilling, scaling, periodontal therapy, endodontic treatments, and restorative/prosthetic preparations.

Regulatory Classification

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.

Predicate Devices

• Piezosurgery Touch, Mectron S.P.A. / Italy (K122322)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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## Indications for Use

510(k) number:

K133488

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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## 510(k) SUMMARY

| Applicant and<br>Owner | W & H DENTALWERK BÜRMOOS GMBH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Bürmoos<br>Austria<br>Tel.: [phone]<br>Fax: [phone] / 6236 -55 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration<br>Number | 9681479 |
| Contact<br>Person | Mag. Anja LINDNER |
| Date of<br>Submission | November 7th, 2013 |
| Device Name | Piezomed SA-320 |
| Classification<br>Name | Drill, Bone, Powered |
| Regulation<br>Number | 21 CFR 872.4120 |
| Product Code | DZI |
| Predicate<br>Devices | "Piezosurgery Touch", Mectron S.P.A. / Italy, K122322 |

| Device<br>Description | 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.<br><br>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.<br><br>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)<br>Piezomed SA-320 | Page 2 of 4 |
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| Intended Use: | Piezomed is a piezoelectric ultrasonic device, consisting of handpieces<br>and associated instruments, intended for:<br>- Bone Cutting, osteotomy, osteoplasty and drilling in a variety of<br>oral surgical procedures, including implantology, periodontal<br>surgery, surgical orthodontic, and surgical endodontic<br>procedures;<br>- Scaling applications, including:<br>o Scaling: All general procedures for removal of<br>supragingival and interdental calculus & plaque deposits;<br>o Periodontology: Periodontal therapy and debridement for<br>all types of periodontal diseases, including periodontal<br>pocket irrigation and cleaning;<br>o Endodontic: All treatments for root canal reaming,<br>irrigation, revision, filling, gutta-percha-condensation and<br>retrograde preparation;<br>o Restorative and Prosthetics: Cavity preparation, removal of<br>prostheses, finishing of crown preparations. | | | |
| | | W&H's Piezomed SA-320 represents a revised and improved version of<br>the predicate device.<br>The technical principle is the same as within the predicate device<br>(piezo-electric principle).<br>The main technological characteristics are the same or, at least, quite<br>similar to those of the comparable product. | | |
| Technological<br>Characteristics | | Technological<br>Characteristic | Subject device | Predicate Device<br>(K122322) |
| | | User Interface | Consisting of: control unit,<br>foot control, handpiece,<br>instruments/tips | Consisting of: control unit,<br>foot control, handpiece,<br>inserts |
| | | Mains supply | 100 – 240 V / 50-60Hz | 100-240 V / 50-60 Hz |
| | | Max. power<br>consumption | 90 VA | 120 VA |
| | | Operating frequency | Automatic scan,<br>from 24 KHz to 32 KHz | Automatic scan,<br>from 24 KHz to 36 KHz |
| | | Energy source | Piezo-ceramic oscillating<br>system | Piezo-ceramic oscillating<br>system |
| | | 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 disinfection<br>approved, Steam sterilization<br>at 132°C (270°F) | Thermo washer disinfection<br>approved, Steam<br>sterilization at 132°C<br>(270°F) |
| | | 510(k)<br>Piezomed SA-320 | | Page 3 of 4 |
| | Autoclaveability | Handpiece:<br>Dynamic air removal<br>sterilizer,<br>132°C (270°F) for 4 minutes,<br>Drying time: 20 - 30 min<br><br>Blank, polished<br>instruments/tips:<br>Dynamic air removal<br>sterilizer,<br>132°C (270°F) for 4 minutes,<br>Drying time: 20 - 30 min<br><br>Diamond coated<br>instruments/tips:<br>Single-use only | Handpiece:<br>Dynamic air removal<br>sterilizer,<br>132°C (270°F) for 4 minutes<br>Drying time: 20 min<br><br>Blank, polished inserts /<br>tips:<br>Dynamic air removal<br>sterilizer,<br>132°C (270°F) for 4 minutes,<br>Drying time: 20 min<br><br>Diamond coated inserts /<br>tips:<br>Single-use only | |
| | Range of instruments / tips | 24 variants for various<br>applications | 31 variants for various<br>applications | |
| | Materials of the<br>instruments / tips | Stainless steel –<br>polished or diamond-coated | Stainless steel –<br>polished or diamond-coated | |
| Comparison of<br>the device to<br>the predicate<br>device | The target field of application, the intended use, functions and<br>technological features, performance parameter and material are the<br>same or, at least, quite similar to those of the predicate device.<br>The product comparison did not raise new or different questions<br>regarding safety and efficacy.<br>The new device is substantially equivalent to the predicate device. | | | |
| Performance<br>Testing | Electrical Safety Tests according to IEC 60601-1:2005, Medical<br>electrical equipment - Part 1: General requirements for basic safety and<br>essential performance.<br><br>Electromagnetic Compatibility Test according to IEC 60601-1-2:2007:<br>General requirement for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility - Requirements and<br>tests<br><br>Type testing according to ISO 22374:2005: Dentistry -- Dental<br>handpieces -- Electrical-powered scalers and scaler tips<br><br>Software validation according to IEC 62304:2006: Medical device<br>software -- Part 1: Guidance on the application of ISO 14971 to medical<br>device software | | | |
| Image: W&H logo | | 510(k)<br>Piezomed SA-320 | Page 4 of 4 | |
| | | Mechanical strength test according ANSI/AAMI ES 60601-1:2005<br>Usability validation according to IEC 62366:2007<br>Thermal safety according to the standard IEC 62471:2006:<br>Photobiological safety of lamps and lamp systems<br>Flow rate testing, evaluation of biocompatibility and sterilizability,<br>various functionality and lifecycle tests as well as further bench tests demonstrate substantial equivalence. | | |
| Clinical<br>Testing | Clinical data were not needed for this new product. | | | |

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