(261 days)
Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.
Sonic Surgeon 300 is 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. The Ultrasonic Surgical Unit transforms generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it 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 document describes the safety and effectiveness information of the Sonic Surgeon 300 / Ultrasonic Surgical Unit.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria for performance benchmarks like accuracy, precision, or sensitivity. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety Conformity: Adherence to recognized medical electrical equipment safety standards. | The Ultrasonic Surgical Unit has been manufactured and tested to meet the safety requirements of IEC. The Ultrasonic Surgical Unit complies with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and IEC 60601-1-2:2001 (Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests). |
| Substantial Equivalence: Demonstrated similarity in intended use, technological characteristics, and performance to a legally marketed predicate device. | The device is deemed "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." "The performance tests demonstrated that Ultrasonic Surgical Unit performs in a substantially equivalent manner to the predicate device." |
| Intended Use Conformity: The device performs its stated "Indications for Use." | The device is described as "a piezoelectric device for bone surgery that enables osteotomy and osteoplasty techniques to be applied to in dental use." This intended use is consistent with the general description of its function. |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size or test set in the context of a formal clinical or performance study involving patients or a dataset for evaluating an AI model. The "performance tests" mentioned are likely technical evaluations against standards rather than a study on a specific number of cases/patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided. The document describes a device for surgical use and its technical compliance, not an AI or diagnostic tool that requires ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. The "performance tests" likely refer to engineering and electrical safety testing, not clinical performance evaluation with adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable or provided. The device is an ultrasonic surgical unit, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case study evaluating human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable or provided. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable or explicitly stated as ground truth is typically associated with diagnostic or AI performance evaluation. The "ground truth" in this context would be the specifications and requirements of the safety standards (IEC 60601-1, IEC 60601-1-2) and the operational characteristics of the predicate device (Piezosurgery, K043408). The device's performance is measured against these established technical specifications and the functionality of the predicate.
8. The sample size for the training set:
This information is not applicable or provided. The document describes a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable or provided for the same reasons as above.
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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
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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
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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.
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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
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- 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
§ 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.