(324 days)
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.
The Ki-20 is designed to use in dental surgery. It consists of an E-type motor (DC 28V Operation Motor), handpieces, a control box, a foot switch and other accessories. It is designed that the speed and direction of the handpiece can be controlled by the control box and the foot switch. The irrigation tube and the pump are used to supply the cooling water for the successful surgery.
The provided set of documents is a 510(k) summary for the SAEYANG MICROTECH CO., LTD. Ki-20 dental handpiece. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness is not available within these documents.
However, based on the provided text, I can extract information about the types of tests performed and the general conclusion.
Here's a breakdown of the available information and why other requested details are missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets and corresponding device performance results. Instead, it lists various international standards that the device was tested against. The "reported device performance" is summarized as compliance with these standards.
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance (Summary) |
|---|---|
| Dental Handpieces Coupling dimensions | Complied with ISO 3964:2014 |
| Dentistry Dental units - General requirements | Complied with ISO 7494-1:2004 |
| Dentistry Handpieces and motors | Complied with ISO 14457:2012 |
| Electrical safety and EMC | Complied with IEC 60601-1, IEC 60601-1-2, IEC61000-3-2, IEC61000-3-3 |
| Sterilization validation | Complied with ISO 11135-1, ISO 11138-1, ISO 11138-3, ISO 11607-1, ISO 17664, ISO 17665-1, and ISO 17665-2 |
| Software validation | Complied with FDA Guidance, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" |
| Usability | Complied with EN60601-1-6, EN 62366 and IEC 62366 |
| Temperature rise | Performed (no specific standard or result provided, but implied to be acceptable) |
| Overall Conclusion | No testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes used for any of the non-clinical bench tests. The nature of these tests (e.g., electrical safety, mechanical coupling) often involves testing a limited number of units to ensure compliance with specifications inherent in the standards.
- Data Provenance: The manufacturing company, Saeyang Microtech Co., Ltd., is located in the Republic of Korea. It can be inferred that the testing data originated from tests conducted in relation to this manufacturing location, likely by the manufacturer itself or a certified testing facility they employed. The tests are non-clinical bench tests, meaning they are not performed on patients and are effectively "prospective" in the sense that they are conducted to evaluate the device before widespread marketing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and not provided. The device is a dental handpiece, and the tests performed are primarily engineering and safety compliance tests against established international standards. There is no concept of "ground truth" established by human experts in the context of these non-clinical, objective performance tests. For example, validating coupling dimensions or electrical safety does not rely on expert consensus or interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretations (e.g., imaging diagnostics) where multiple readers are involved and their disagreements need to be resolved to establish a robust ground truth. For the non-clinical, objective nature of the tests listed (e.g., checking if dimensions meet ISO standards), such an adjudication method is irrelevant.
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 is not applicable and not provided. The Ki-20 is a dental handpiece, a physical medical device. It does not incorporate Artificial Intelligence (AI) and is not a diagnostic device that would involve human readers interpreting data. Therefore, an MRMC study or an assessment of AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. Similar to point 5, the Ki-20 is a mechanical/electrical dental handpiece, not an algorithm or software-only device. There is no "standalone algorithm" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the traditional sense. For the non-clinical bench tests, the "ground truth" implicitly comes from the specifications and requirements defined within the international standards (e.g., ISO, IEC) listed in the document. The device's performance is compared against these objective, predefined technical criteria rather than against clinical outcomes or expert interpretations.
8. The sample size for the training set
This is not applicable and not provided. The Ki-20 is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable and not provided for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2015
SAEYANG MICROTECH CO., LTD. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave., Suite 110 Fullerton, CA 92831
Re: K141482 Trade/Device Name: Ki-20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 20, 2015 Received: March 23, 2015
Dear Ms. 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K141482
Device Name
Ki-20
Indications for Use (Describe)
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (K141482)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Apr 24, 2015
1. 510K Applicant / Submitter:
Saeyang Microtech Co., Ltd. 348, Seongseo-ro, Dalseo-gu, Daegu 704-900 REPUBLIC OF KOREA Tel: +82-53-582-9000~2 Fax: +82-53-581-9003
2. Submission Contact Person
LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Proprietary Name: Ki-20
- Common Name: Dental Handpiece and Accessories ●
- Classification Name: Controller, Foot, Handpiece and Cord .
- Regulatory Class: Class I ●
- Product Code: EBW ●
- Classification Regulation: 21 CFR 872.4200 .
4. Predicate Device
Primary Predicate Device: . Endo E Class by Saeyang Microtech Co., Ltd. (K123608)
Reference Predicate Devices: . TRAUS SIP10 by Saeshin Precision Co., Ltd. (K123695) X-CUBE by Saeshin Precision Co., Ltd. (K092758)
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5. Description:
The Ki-20 is designed to use in dental surgery. It consists of an E-type motor (DC 28V Operation Motor), handpieces, a control box, a foot switch and other accessories. It is designed that the speed and direction of the handpiece can be controlled by the control box and the foot switch. The irrigation tube and the pump are used to supply the cooling water for the successful surgery.
8. Indications for Use
For use in a wide range of dental procedures including: endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.
9. Substantial Equivalence Discussion:
Ki-20 is substantially equivalent to Endo E Class (K123608), TRAUS SIP10 (K123695) and X-CUBE (K092758). The following comparison table is presented to demonstrate substantial equivalence.
Ki-20 does not have a new intended use and it shows equivalent specifications with the predicate devices in most of parameters. The handpiece rotation speed of the subject device encompasses the subject device as well.
Torque setting range applied to the motor of the subject device is different from the predicate device; however, it is within what was cleared in the reference devices.
| CandidateDevice | PrimaryPredicateDevice | ReferencePredicateDevice | ReferencePredicateDevice | Micromotordrive | as drilling intothe tooth canal,and generaldentistry, suchas removingcarious materialfrom the dentin.Electricmicromotordrive | as drilling intothe tooth canal,and generaldentistry, suchas removingcarious materialfrom the dentin.Electricmicromotordrive | surgery andendodontics fortreatment ofdental hardtissue andmechanicalrotating rootcanalpreparationElectricmicromotordrive | endodontics fortreatment ofdental hardtissue andmechanicalrotating rootcanalpreparationElectricmicromotordrive | |
|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | K141482 | K123608 | K123695 | K092758 | Packagecontents | Power cord,Control unit,Irrigation tube,Y-tube, Tubeholder, Coolanthanger, Footcontrol,handpiecestand, E-typemotor&Motorcord, Foothanger, Contraangle,E-type spraynozzle,External spraynozzle, Nozzleclamp, Internalspray nozzle | Control Unit,E-type Motor &Motor Cord, E-typeHandpiece, footswitch,Handpiecestand, PowerCord,AutoclavingPlugs, Manual | Hanger, Footcontroller,Control box,Power cord,Motor stand,Irrigation tube,Internal spraynozzle, Motorcap forautoclave,Anglehandpiece,BLDC motor,Tube holder,Tube clamp, Y-tube, Foothanger, Foothanger jointcap, InstructionManual | Hanger, Footcontroller,Control box,Power cord,Motor stand,Irrigation tube,Internal spraynozzle, Motorcap forautoclave,Anglehandpiece,BLDC motor,Tube holder,Tube clamp, Y-tube, Foothanger |
| Device Name | Ki-20 | Endo E Class | TRAUS SIP10 | X-CUBE | PatientContactingPart's Material | Stainless Steel& BSBM | Stainless Steel& BSBM | Stainless Steel& BSBM | Stainless Steel& BSBM |
| Common Name | DentalHandpiece andaccessories | DentalHandpiece andaccessories | DentalHandpiece andaccessories | Surgical motorunit forimplantologyand maxillasurgery | Handpiecechuck | Push button &handle type | Push button &handle type | Push button &handle type | Push button &handle type |
| Manufacturer | SaeyangMicrotech Co.,Ltd. | SaeyangMicrotech Co.,Ltd. | SaeshinPrecision Co.,Ltd. | SaeshinPrecision Co.,Ltd. | Coolant Motor | DC motor | No | DC motor | DC motor |
| Intended Use | For use in awide range ofdentalproceduresincluding;endodonticsurgeries, such | For use in awide range ofdentalproceduresincluding;endodonticsurgeries, such | The TRAUSSIP 10 isintended for usein dentalsurgery,implantology,maxilla-facial | The X-CUBE isintended for usein dentalsurgery,implantology,maxilla-facialsurgery and | Shank length &Type | Shank length :11mm(Type 1Shank) | Shank length :11mm(Type 1Shank) | Shank length :11mm(Type 1Shank) | Shank length :11mm(Type 1Shank) |
| OperationPrinciple | Speed control,Torque control,ProgramMemory | Speed control,Torque control,ProgramMemory | Speed control,Torque control,ProgramMemory | Speed control,Torque control,ProgramMemory |
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| Motor speedrange | 600~40,000rpm | 20~17500rpm | 0~40,000 rpm | 600~50,000rpm |
|---|---|---|---|---|
| Handpiece rpmrange | 20 ~ 80,000 rpm | 20~17,500rpm | 10~200,000rpm | 10~200,000rpm |
| Torque settingrange applied tothe motor inNcm | 5~65Ncm | 0.1~9.9Ncm | 5~65Ncm | 5~65Ncm |
| Allowsreciprocatingdrive(forward/reversecycling) | Yes | Yes | Yes | Yes |
| Allows selectionof gear ratios fordifferent gearedE-typehandpieces | 1:1, 1:2,20:1, 32:1 | 1:1, 4:1, 6:1,8:1, 10:1, 16:1,20:1, 64:1 | 1:5, 1:4, 1:1,16:1, 20:1,27:1, 32:1, 64:1 | 1:5, 1:4, 1:1,16:1, 20:1,27:1, 32:1, 64:1 |
| Allows selectionof forward orAuto reversedrive rotation | Yes | Yes | Yes | Yes |
| Allows selectionof Auto stop | Yes | Yes | Yes | Yes |
| Allows use of afoot switchcontrol tooperate theattachedhandpiece motor | YesElectronic footcontrol | YesElectronic footcontrol | YesElectronic footcontrol | YesElectronic footcontrol |
| Allows the userto define theirown presets forspeed andtorque | Yes | Yes | Yes | Yes |
| Allowsprogrammabledoctor's choice | Yes | Yes | Yes | Yes |
| AC100V | AC100V | AC100V | AC100V | |
| Inputvoltage(charger) | ||||
| HandpieceCoupling type | E-type | E-type | E-type | E-type |
| Lubricant | NSK PANASPRAY PLUS | NSK PANASPRAY PLUS | Information notavailable | Information notavailable |
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| (K131014) | (K131014) |
|---|---|
| ----------- | ----------- |
10. Performance Tests (Non-clinical)
Non-clinical bench tests were performed as followings:
- ISO 3964:2014 Dental Handpieces Coupling dimensions ●
- ISO 7494-1:2004 Dentistry Dental units -Part 1: General requirements and test methods ●
- ISO 14457:2012 Dentistry Handpieces and motors ●
- IEC 60601-1, IEC 60601-1-2, IEC61000-3-2, IEC61000-3-3: Electrical safety and EMC ●
Along with the above tests, the following tests were performed:
- Sterilization validation in accordance with ISO 11135-1, ISO 11138-1, ISO 11138-3, ISO ● 11607-1, ISO 17664, ISO 17665-1, and ISO 17665-2
- Software validation in accordance with the FDA Guidance, "General Principles of ● Software Validation; Final Guidance for Industry and FDA Staff"
- Usability test EN60601-1-6, EN 62366 and IEC 62366
- . Temperature rise testing
None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.
11. Conclusions:
Based on the information provided in this premarket notification, Saeyang Microtech Co., Ltd. concludes that the Ki-20 is substantially equivalent to the predicate device as described herein in.
§ 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.