(245 days)
Not Found
No
The document describes a device using piezoelectric ultrasonic technology for mechanical vibrations and scaling, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is used for dental applications such as bone cutting, calculus removal, and scaling, which are therapeutic interventions.
No
Explanation: The device description and intended use indicate that this device is used for surgical procedures like bone cutting and for dental hygiene procedures such as scaling and root planing, not for diagnosing medical conditions.
No
The device description explicitly states it uses "piezoelectric ultrasonic technology to generate mechanical microvibrations" and is supplied with "insert tips," indicating it is a hardware device that utilizes software for control, but is not solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The OSSTEMPiezo and Piezosurgery 3 devices are described as using piezoelectric ultrasonic technology for mechanical actions like bone cutting, scaling, and root planing. These are surgical and dental procedures performed directly on the patient, not tests on samples outside the body.
- Intended Use: The listed intended uses are all related to direct dental and oral surgical interventions.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on laboratory results.
Therefore, the OSSTEMPiezo and Piezosurgery 3 are therapeutic and surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OSSTEMPiezo is intended for use in the following dental applications:
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
The Piezosurgery 3 is intended for use in the following dental applications: - Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
Product codes (comma separated list FDA assigned to the subject device)
DZI, ELC
Device Description
The OSSTEMPiezo uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
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)
The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling. The insert tip microvibration results in a safe and effective cut, preserving the osteotomized surfaces, surgical tactile control, reduction of risk of adjacent tissue damage, reduction of tissue heating, and improved post-operative healing. The evaluations demonstrated precisely delineated incisions and the need for limited pressure on the handpiece to achieve the desired cutting action, which improves surgical control and reduces the possibility of trauma to soft tissue.
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.
0
PIEZOSURGERY®
162
Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter: Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:+39 0185 450863, Fax:+39 0185 42799 E-mail: piezosurgery@piezosurgery.com
DEC 2 9 2009
510(k) Summary
- Mectron S.p.A. Submitter's information Via Loreto 15/A 16042 Carasco (GE), Italy Tel. +39 0185 35361 Fax +39 0185 351374 E-mail: mectron@mectron.com
- 510(k) Contact person 2.
Enrico Perfler Executive Manager, Regulatory & Quality Assurance Meditrial s.r.l. Via Aldo Moro, 20 - 25124 Brescia, Italy +39 0185 474 847 Tel: +39 0185 394 904 Fax: +39 347 074 7145 Cell: Email: e.perfler@meditrial.eu
Summary's date 3.
- Device name and classification
| a. Trade/device name
b. Classification name | OSSTEMPiezo
Bone cutting instrument and accessories
(per 21 CFR section 872.4120)
Ultrasonic scaler
(per 21 CFR section 872.4850) |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| c. Classification panel
d. Regulatory class
e. Product code | Dental
Class II
DZI, ELC |
3 April 2009
Device description ട്.
The OSSTEMPiezo uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
Intendend use/Indications for use 6.
The OSSTEMPiezo is intended for use in the following dental applications:
- Bone cutting for use in oral surgery •
- Removing supra and subgingival calculus deposits and stains from teeth -
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing -
- Retrograde preparation of root canals -
1
PIEZOSURGERY®
६०१२
Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter: Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:+39 0185 450863, Fax:+39 0185 42799 E-mail: piezosurgery@piezosurgery.com
7. Predicate device
Piezosurgery® device (K052518).
8. Performance evaluations
The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling. The insert tip microvibration results in a safe and effective cut, preserving the osteotomized surfaces, surgical tactile control, reduction of risk of adjacent tissue damage, reduction of tissue heating, and improved post-operative healing. The evaluations demonstrated precisely delineated incisions and the need for limited pressure on the handpiece to achieve the desired cutting action, which improves surgical control and reduces the possibility of trauma to soft tissue.
Conclusion 9.
We believe the information provided in this premarket notification support a finding of substantial equivalence between the OSSTEMPiezo and the predicate device Piezosurgery currently marketed.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
FEB 2 2 2010
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Piezosurgery S.R.L. C/O Mr. Ing. Enrico Perfler Executive Manager. Regulatory and Quality Assurance Meditrial S.R.L. Via Aldo Moro 20 - 25124 Brescia ITALY
Re: K091227
Trade/Device Name: Piezosurgery 3, OSSTEMPiezo Regulation Number: 21CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: December 17, 2009 Received: December 22, 2009
Dear Mr. Perfler:
This letter corrects our substantially equivalent letter of December 29, 2009.
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 (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.
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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Piezosurgery 3
Indications for Use: The Piezosurgery 3 is intended for use in the following dental applications:
6417
Indications for Use
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
RS. Betz DNS for Dr. K.P. Mulky (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K09/227
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
13