(220 days)
Not Found
No
The 510(k) summary describes a dental operative unit that supplies utilities to tools and does not mention any AI or ML capabilities.
No.
The device acts as a base and supplies utilities to dental tools, but it is not itself a tool used to treat a condition or disease.
No
The device is described as a base for dental tools used in various dental procedures, not for identifying or diagnosing conditions.
No
The device description clearly states it is a "dental operative unit that supplies utilities to and serves as a base for dental tools," indicating it is a hardware device with physical components.
Based on the provided information, the Satelec PIEZOTOME 2 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states its use is to "supply utilities to and serve as a base for dental tools" used directly on patients during dental procedures (periodontics, endodontics, scaling, prosthesis, and oral surgery).
- Device Description: It's described as a "dental operative unit" that supports dental tools used in clinical settings.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Satelec PIEZOTOME 2 is a device used for performing procedures on the patient.
N/A
Intended Use / Indications for Use
The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
Product codes (comma separated list FDA assigned to the subject device)
DZI
Device Description
The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
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
qualified dental practitioners
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)
Not Found
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
Ko9133
510(k) Pre-Market Notification for Satelec PIEZOTOME 2
DEC 1 1 2009
SMDA Summary of Safety and Effectiveness – "510 (k) Summary" ത
- A. Submitter Information SATELEC - ACTEON Group 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANCE
- S
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact Person:
Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 Email: rick rosati@us acteongroup.com
May 1st, 2009 Date Prepared:
- B. Device Identification
Common Usual Name: Bone cutting instrument and accessories
Proprietary Name: PIEZOTOME 2
C. Identification of the Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| PIEZOTOME | Satelec | K060274 | May 1, 2006 |
The Satelec PIEZOTOME 2 is substantially equivalent to the predicate device by Satelec, the PIEZOTOME (K060274) previously cleared by the FDA and currently marketed.
Indications for Use: The intended use of the Satelec PIEZOTOME 2 is to D. supply utilities to and serve as a base for dental tools such as ultrasonic scaler,
1
510(k) Pre-Market Notification for Satelec PIEZOTOME 2
bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
E. Device Description
The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
F Substantial Equivalence
The PIEZOTOME 2 and the predicate device, PIEZOTOME (K060274) are both dental operative units that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K091331
Trade/Device Name: Piezotome 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 23, 2009 Received: November 24, 2009
Dear Mr. Rosati:
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.
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
Page 2- Mr. Rosati
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Rh for
Ánthony 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
Indications for Use
1691231 510(k) Number:
PIEZOTOME 2 Device Name:
Indications for Use:
The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Marley for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091331