(261 days)
Not Found
No
The description focuses on the device's ultrasonic energy generation and transmission, with automatic frequency tuning. There is no mention of AI or ML algorithms for decision-making, image analysis, or other complex tasks.
Yes
The device is used for surgical procedures (osteotomy and osteoplasty) in dentistry, which are forms of medical treatment. The description explicitly states it is an "Ultrasonic Surgical Unit" and an "ultrasound generator for use in dental surgery," indicating its role in treating medical conditions.
No
Explanation: The device description states it is an ultrasonic surgical unit used for bone surgery, specifically ostcotomy and ostcoplasty techniques, and mechanical ultrasound treatment in prophylaxis, periodontics, or endodontics. These are interventional/surgical procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as an ultrasound generator, handpiece, and tips, and describes the transformation of ultrasonic energy to kinetic energy, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details an "ultrasound generator for use in dental surgery" that transforms energy and transmits it to a tip for surgical procedures. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Ultrasonic Surgical Unit described is a surgical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ultrasonic Surgical Unit is a piezoelectric device for bone surgery that enables osteotomy and osteoplasty techniques to be applied to in dental use.
Product codes
DZI
Device Description
Sonic Surgeon 300is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics.
The tips can easily be changed during the treatment and can also be cleaned and autoclaved
Material for sonic surgeon 300 are as follows
| Component | material |
|---|---|
| Enclosure (Generator Unit, Foot Switch) | PC ABS |
| Hose, and seals | Silicone |
| Enclosure (Handpiece) | PES |
| Tip | SUS |
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 Ultrasonic Surgical Unit has been manufactured and tested to meet the safety requirements of IEC. The Ultrasonic Surgical Unit complies with IEC 60601-1Medical electrical equipment - Part 1: Generalrequirements for safety and IEC 60601-1-2:2001, Medical electrical equipment - Part 1: Generalrequirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
The performance tests demonstrated thatUltrasonic Surgical Unitperforms in a substantially equivalent manner to the predicate device
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
21108
5. 510(k) Summary
A. Applicant:
[as required by 807.92(c)]
-Company name: DONG IL TECHNOLOGY LTD.
-Address:215-6, Bugyang-dong, Hwaseong-si, Gyeonggi-do, 445-040, Republic of Korea -Tel : +82(31)356-7114 Fax : +82(31)357-261http://www.dongiltech.co.kr
-Contact person: Peter Chung 412-687-3976
-Date: Mar 16,2011
B. Proprietary and Established Names:
Trade Name:Sonic Surgeon 300
Common Name: Bone cutting instrument and accessories
Regulation Name: Sonic surgical instrument and accessories/attachments
Regulatory Classification: 2, Dental,
Product Code: DZI
C. legally marketed predicate devices : Piezosurgery(K043408)
D. Device Description,
Sonic Surgeon 300is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics.
The tips can easily be changed during the treatment and can also be cleaned and autoclaved
Material for sonic surgeon 300 are as follows
| Component | material |
|---|---|
| Enclosure (Generator Unit, Foot Switch) | PC ABS |
| Hose, and seals | Silicone |
| Enclosure (Handpiece) | PES |
| Tip | SUS |
E. Intended use
Ultrasonic Surgical.Unitis a piezoelectric device for bone surgery that enables osteotomy and osteoplasty techniques to be applied to in dental use
1
F.Technological Characteristics:
a).Ultrasonic Surgical Unit has the following features
The Ultrasonic Surgical Unittransforms generated ultrasonic(26±3kHz) energy to the kinetic energy and transmitsit to the tip.
The generator of the Ultrasonic Surgical Unit performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece.
This feature makes it possible to bone cutting, grinding and drilling action.
- b).Our device is very similar with predicate device, Piezosurgery(K043408), because Sonic Surgeon 300 has the following identical characteristics ; intended use, sterilization method used material , electronic input power , frequency, and power output
G. Performance (Safety and Effectiveness Information)
TheUltrasonic Surgical Unit has been manufactured and tested to meet the safety requirements of IEC. The Ultrasonic Surgical Unit complies with IEC 60601-1Medical electrical equipment - Part 1: Generalrequirements for safety and IEC 60601-1-2:2001, Medical electrical equipment - Part 1: Generalrequirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
I.Conclusion:
The performance tests demonstrated thatUltrasonic Surgical Unitperforms in a substantially equivalent manner to the predicate device
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 graphic of three human figures connected at the shoulders, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the graphic. The text is in all caps and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dong IL Technology Limited C/O Mr. Peter Chung Submission Correspondent 300 Atwood Pittsburgh, Pennsylvania 15213
DEC 1 6 2011
Re: K110881
Trade/Device Name: Ultrasonic Surgical Unit Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 14, 2011 Received: December 13, 2011
Dear Mr. Chung:
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.
3
Page 2 - Mr. Chung
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 (OS) 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 /ucm 1 1 5809 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 vours.
Nh 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
- Indications for Use Statement
Indications for Use
510(k) Number (if known): K II088I.
Device Name: Ultrasonic Surgical Unit
Indications For Use: Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110881