(137 days)
Not Found
No
The description focuses on the device's ultrasonic bone-cutting mechanism and control systems, with no mention of AI or ML technologies.
Yes
The device is described as an "ultrasonic bone-cutting instrument for use in surgical dentistry," indicating a direct medical intervention.
No
Explanation: The device description states it is an "ultrasonic bone-cutting instrument" used for surgical procedures, not for identifying or investigating a disease, injury, or other condition.
No
The device description explicitly details hardware components such as a main chassis, irrigation delivery system, internal electric power supply, control panel, ultrasonic generator, footswitch, and handpiece. This indicates it is a hardware device with integrated software for control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an ultrasonic bone-cutting instrument for use in surgical dentistry." This describes a surgical tool used directly on a patient's tissue (bone), not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a surgical instrument with a handpiece, footswitch, and internal components for generating ultrasonic energy for cutting. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EMS Piezon Master Surgery is a surgical instrument used for a therapeutic procedure (bone cutting).
N/A
Intended Use / Indications for Use
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.
Product codes
DZI
Device Description
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument designed for use in surgical dentistry. The device generates piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments used in surgical dentistry, including oral surgery, implantology, periodontal surgery, and maxillary surgery.
The EMS Piezon Master Surgery device consists of a main chassis containing an irrigation delivery system, an internal electric power supply, a control panel with lightemitting diode (LED) displays, and ultrasonic generator. A one-step footswitch is connected to the main chassis by a footswitch cord and a handpiece containing cutting and non-cutting instruments is connected directly to the main chassis.
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
surgical dentistry
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)
Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA EMS Piezon Master Surgery
SPONSOR
E.M.S. ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
| Contact Person: | Suzanne Fassio-Hardy |
|---|---|
| Telephone: | 022 994 47 00 |
| DEC 1 8 2007 |
Date Prepared: August 2, 2007
DEVICE NAME 2.
| Proprietary Name: | EMS Piezon Master Surgery |
|---|---|
| Common/Usual Name: | Bone-cutting instrument and accessories |
| Classification Name: | Drill, Bone, Powered |
3. PREDICATE DEVICES
4. INTENDED USE
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.
న. DEVICE DESCRIPTION
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument designed for use in surgical dentistry. The device generates piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments used in surgical dentistry, including oral surgery, implantology, periodontal surgery, and maxillary surgery.
1
The EMS Piezon Master Surgery device consists of a main chassis containing an irrigation delivery system, an internal electric power supply, a control panel with lightemitting diode (LED) displays, and ultrasonic generator. A one-step footswitch is connected to the main chassis by a footswitch cord and a handpiece containing cutting and non-cutting instruments is connected directly to the main chassis.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The EMS Piezon Master Surgery and the predicate devices Piezosurgery s.r.l. Piezosurgery and SATELEC Piezotome™ generate piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments and are indicated for use in surgical dentistry. Differences between the proposed EMS Piezon Master Surgery and the predicate ultrasonic bone-cutting instruments are limited to design differences in the control panel, irrigation delivery system, and accessories available with each device. Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry.
The similarities in intended use, technical specifications, and functional performance between the EMS Piezon Master Surgery, Piezosurgery® and Piezotome™ leads to a conclusion of substantial equivalence between the proposed and predicate devices.
TRO MEDICAL SYSTEMS SA 510(k) S Piezon Master Surgery
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and welfare.
DEC 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
E.M.S. Electro Medical Systems S.A. C/O Ms. Susan M. Bonapace Regulatory Associate Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K072146
Trade/Device Name: EMS Piezon Master Surgerv Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: December 13, 2007 Received: December 14, 2007
Dear Ms. Bonapace:
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 such 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 - Ms. Bonapace
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
EMS Piezon Master Surgefy
Indications for Use:
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.
escription Use Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C) CTON
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division use only)
meral Respital mist in it
510(k) Number K072146
Page 1 of 1
DICAL SYSTEMS SA 510(k) Master Surgery
August 2, 2007