(337 days)
Not Found
No
The description focuses on the device's ultrasonic technology, instrument detection, power settings, and working modes, with no mention of AI or ML capabilities.
Yes
The device is described as an ultrasonic device intended for various dental, oral, and maxillofacial surgical procedures, including bone cutting, scaling, periodontology, and endodontics, all of which are considered therapeutic applications aimed at treating conditions or diseases.
No
The device description and intended use clearly state that it is for "Bone Cutting, osteotomy, osteoplasty and drilling," "Scaling applications," and "treatment of organic hard and soft tissue." These are all therapeutic and surgical procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as a control unit, foot control, handpiece, irrigation tubing set, instrument set, and accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures, scaling, and other treatments performed directly on the patient's tissues (bone, teeth, root canals). This is a therapeutic and surgical function, not a diagnostic one.
- Device Description: The description details a physical device with handpieces, instruments, and a control unit used for mechanical manipulation of tissue. This aligns with a surgical or therapeutic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform physical procedures on the patient.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DZI
Device 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.
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.
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)
Electrical Safety Tests according to IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility Test according to IEC 60601-1-2:2007: General requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Type testing according to ISO 22374:2005: Dentistry -- Dental handpieces -- Electrical-powered scalers and scaler tips
Software validation according to IEC 62304:2006: Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
Mechanical strength test according ANSI/AAMI ES 60601-1:2005
Usability validation according to IEC 62366:2007
Thermal safety according to the standard IEC 62471:2006: Photobiological safety of lamps and lamp systems
Flow rate testing, evaluation of biocompatibility and sterilizability, various functionality and lifecycle tests as well as further bench tests demonstrate substantial equivalence.
Clinical data were not needed for this new product.
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.
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/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 and
Owner | W & H DENTALWERK BÜRMOOS GMBH
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -397
Fax: 0043 -6274 / 6236 -55 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration
Number | 9681479 |
| Contact
Person | Mag. Anja LINDNER |
| Date of
Submission | November 7th, 2013 |
| Device Name | Piezomed SA-320 |
| Classification
Name | Drill, Bone, Powered |
| Regulation
Number | 21 CFR 872.4120 |
| Product Code | DZI |
| Predicate
Devices | "Piezosurgery Touch", Mectron S.P.A. / Italy, K122322 |
| Device
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.
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 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. | | | |
| | | W&H's Piezomed SA-320 represents a revised and improved version of
the 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, quite
similar to those of the comparable product. | | |
| Technological
Characteristics | | Technological
Characteristic | 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. power
consumption | 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 oscillating
system | Piezo-ceramic oscillating
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
approved, Steam sterilization
at 132°C (270°F) | Thermo washer disinfection
approved, Steam
sterilization at 132°C
(270°F) |
| | | 510(k)
Piezomed SA-320 | | Page 3 of 4 |
| | Autoclaveability | Handpiece:
Dynamic air removal
sterilizer,
132°C (270°F) for 4 minutes,
Drying time: 20 - 30 min
Blank, polished
instruments/tips:
Dynamic air removal
sterilizer,
132°C (270°F) for 4 minutes,
Drying time: 20 - 30 min
Diamond coated
instruments/tips:
Single-use only | Handpiece:
Dynamic air removal
sterilizer,
132°C (270°F) for 4 minutes
Drying time: 20 min
Blank, polished inserts /
tips:
Dynamic air removal
sterilizer,
132°C (270°F) for 4 minutes,
Drying time: 20 min
Diamond coated inserts /
tips:
Single-use only | |
| | Range of instruments / tips | 24 variants for various
applications | 31 variants for various
applications | |
| | Materials of the
instruments / tips | Stainless steel –
polished or diamond-coated | Stainless steel –
polished or diamond-coated | |
| Comparison of
the device to
the predicate
device | The target field of application, the intended use, functions and
technological features, performance parameter and material are the
same or, at least, quite similar to those of the predicate device.
The product comparison did not raise new or different questions
regarding safety and efficacy.
The new device is substantially equivalent to the predicate device. | | | |
| Performance
Testing | Electrical Safety Tests according to IEC 60601-1:2005, Medical
electrical equipment - Part 1: General requirements for basic safety and
essential performance.
Electromagnetic Compatibility Test according to IEC 60601-1-2:2007:
General requirement for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and
tests
Type testing according to ISO 22374:2005: Dentistry -- Dental
handpieces -- Electrical-powered scalers and scaler tips
Software validation according to IEC 62304:2006: Medical device
software -- Part 1: Guidance on the application of ISO 14971 to medical
device software | | | |
| Image: W&H logo | | 510(k)
Piezomed SA-320 | Page 4 of 4 | |
| | | Mechanical strength test according ANSI/AAMI ES 60601-1:2005
Usability validation according to IEC 62366:2007
Thermal safety according to the standard IEC 62471:2006:
Photobiological safety of lamps and lamp systems
Flow rate testing, evaluation of biocompatibility and sterilizability,
various functionality and lifecycle tests as well as further bench tests demonstrate substantial equivalence. | | |
| Clinical
Testing | Clinical data were not needed for this new product. | | | |
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