(15 days)
No
The summary describes a mechanical device for dental procedures with no mention of AI or ML capabilities.
Yes
The TRAUS SIP10 is intended for the "treatment of dental hard tissue and mechanical rotating root canal preparation," which directly indicates therapeutic use in dental surgery.
No
The device description states it is used for "treatment of dental hard tissue and mechanical rotating root canal preparation," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is an AC-powered device that includes hardware components such as a hand-held motor, controller, contra angle handpiece, and foot controller.
Based on the provided information, the TRAUS SIP10 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in dental surgery, implantology, maxilla-facial surgery, and endodontics for treating dental hard tissue and mechanical rotating root canal preparation. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a motor, controller, handpiece, and foot controller, all components used for mechanical procedures within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVD devices are designed to perform tests on these samples to diagnose diseases or conditions.
Therefore, the TRAUS SIP10 is a surgical/dental device used for treatment, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
Product codes
EKY
Device Description
The TRAUS SIP10 is an AC-powered device that includes a hand-held motor, controller, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue
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 biocompatibility of the patient contact parts has been demonstrated through the cytotoxicity, sensitization and irritation testing by ISO 10993-1 Biological evaluation of medical devices - Part1 Evaluation and Testing within a risk management process.
The TRAUS SIP10 conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/1 description: The image shows the logo for SAESHIN. The logo consists of a stylized letter "G" on the left and the word "SAESHIN" on the right. The letter "G" is formed by a black circle with a white crescent shape cut out of it. The word "SAESHIN" is written in a bold, sans-serif font.
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
510(k) Summary
DEC 1 8 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: December 26, 2011
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | Saeshin Precision Co., Ltd. |
| Address | #93-15, Paho-dong, Dalseo-Gu, Daegu, 704- |
| 220, Republic of Korea | |
| Phone | |
| Fax | |
| Contact | +82 53-587-2345 |
| +82 53-587-2347 | |
| Y. S. Lee |
-
- Device:
Proprietary Name - TRAUS SIP10 Common Name - Dental handpiece and accessories Classification Name - Controller, Foot, Handpiece And Cord
- Device:
-
- Classifications Names & Citations: EBW, EGS, 21CFR872.4200
-
- Description:
The TRAUS SIP10 is an AC-powered device that includes a hand-held motor, controller, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.
-
- Indication for use:
The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
- Indication for use:
-
- Review:
The TRAUS SIP10 has the same device characteristics as the predicate device;
- Review:
1
Image /page/1/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a stylized letter "S" inside of a circle on the left, followed by the word "SAESHIN" in bold, sans-serif font. The logo is black and white.
indication for use, material, design and use concept are similar.
The biocompatibility of the patient contact parts has been demonstrated through the cytotoxicity, sensitization and irritation testing by ISO 10993-1 Biological evaluation of medical devices - Part1 Evaluation and Testing within a risk management process.
The TRAUS SIP10 conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
Based on the comparison of intended use and technical features, the TRAUS SIP10 is substantially equivalent to the predicate device.
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Precision Co., Ltd. concludes that the TRAUS SIP10 are safe and effective and substantially equivalent to predicate devices as described herein.
-
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three parallel lines forming its body and wings. The eagle faces right and is positioned to the right of the text that forms a circular border around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
December 18, 2012
Saeshin Precision Company, Limited C/O Mr. Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Incorporated 12 Laboratory Drive RESEARCH TRIANGLE NC 27709
Re: K123695
Trade/Device Name: TRAUS SIP 10 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKY Dated: October 31, 2012 Received: December 3, 2012
Dear Mr. Rongero:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
3
Page 2 - Mr. Rongero
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 devicerelated 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 vours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
510(k) Number K 423 095
Device Name: TRAUS SIP10
Indication for use:
The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
Prescription Use_ (Per 21CFR801 Subpart D) Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.18 Susan Runner DDS, MA -11:50:08 -05'00'
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number;
SAESHIN PRECISION CO., LTD.