(324 days)
No
The device description and performance studies focus on mechanical and electrical components and standard safety/performance testing, with no mention of AI/ML terms or data-driven functionalities.
Yes
The device is used for dental procedures like drilling into the tooth canal and removing carious material, which are therapeutic interventions.
No
The device description and intended use clearly state that it is for dental surgical procedures, such as drilling and removing material, which are therapeutic rather than diagnostic actions.
No
The device description explicitly lists multiple hardware components including an E-type motor, handpieces, a control box, a foot switch, irrigation tube, and pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures within the mouth (drilling into tooth canals, removing carious material). This is a direct intervention on the patient's body.
- Device Description: The description details a surgical motor, handpieces, control box, and irrigation system. These are components of a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions based on the examination of these samples.
Therefore, the Ki-20 is a dental surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth canal, dentin
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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
2
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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3
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)
4
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.
| | Candidate
Device | Primary
Predicate
Device | Reference
Predicate
Device | Reference
Predicate
Device | Micromotor
drive | as drilling into
the tooth canal,
and general
dentistry, such
as removing
carious material
from the dentin.
Electric
micromotor
drive | as drilling into
the tooth canal,
and general
dentistry, such
as removing
carious material
from the dentin.
Electric
micromotor
drive | surgery and
endodontics for
treatment of
dental hard
tissue and
mechanical
rotating root
canal
preparation
Electric
micromotor
drive | endodontics for
treatment of
dental hard
tissue and
mechanical
rotating root
canal
preparation
Electric
micromotor
drive |
|------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K141482 | K123608 | K123695 | K092758 | Package
contents | Power cord,
Control unit,
Irrigation tube,
Y-tube, Tube
holder, Coolant
hanger, Foot
control,
handpiece
stand, E-type
motor&Motor
cord, Foot
hanger, Contra
angle,
E-type spray
nozzle,
External spray
nozzle, Nozzle
clamp, Internal
spray nozzle | Control Unit,
E-type Motor &
Motor Cord, E-
type
Handpiece, foot
switch,
Handpiece
stand, Power
Cord,
Autoclaving
Plugs, Manual | Hanger, Foot
controller,
Control box,
Power cord,
Motor stand,
Irrigation tube,
Internal spray
nozzle, Motor
cap for
autoclave,
Angle
handpiece,
BLDC motor,
Tube holder,
Tube clamp, Y-
tube, Foot
hanger, Foot
hanger joint
cap, Instruction
Manual | Hanger, Foot
controller,
Control box,
Power cord,
Motor stand,
Irrigation tube,
Internal spray
nozzle, Motor
cap for
autoclave,
Angle
handpiece,
BLDC motor,
Tube holder,
Tube clamp, Y-
tube, Foot
hanger |
| Device Name | Ki-20 | Endo E Class | TRAUS SIP10 | X-CUBE | Patient
Contacting
Part's Material | Stainless Steel
& BSBM | Stainless Steel
& BSBM | Stainless Steel
& BSBM | Stainless Steel
& BSBM |
| Common Name | Dental
Handpiece and
accessories | Dental
Handpiece and
accessories | Dental
Handpiece and
accessories | Surgical motor
unit for
implantology
and maxilla
surgery | Handpiece
chuck | Push button &
handle type | Push button &
handle type | Push button &
handle type | Push button &
handle type |
| Manufacturer | Saeyang
Microtech Co.,
Ltd. | Saeyang
Microtech Co.,
Ltd. | Saeshin
Precision Co.,
Ltd. | Saeshin
Precision Co.,
Ltd. | Coolant Motor | DC motor | No | DC motor | DC motor |
| Intended Use | For use in a
wide range of
dental
procedures
including;
endodontic
surgeries, such | For use in a
wide range of
dental
procedures
including;
endodontic
surgeries, such | The TRAUS
SIP 10 is
intended for use
in dental
surgery,
implantology,
maxilla-facial | The X-CUBE is
intended for use
in dental
surgery,
implantology,
maxilla-facial
surgery and | Shank length &
Type | Shank length :
11mm(Type 1
Shank) | Shank length :
11mm(Type 1
Shank) | Shank length :
11mm(Type 1
Shank) | Shank length :
11mm(Type 1
Shank) |
| Operation
Principle | Speed control,
Torque control,
Program
Memory | Speed control,
Torque control,
Program
Memory | Speed control,
Torque control,
Program
Memory | Speed control,
Torque control,
Program
Memory | | | | | |
5
6
| Motor speed
range | 60040,000rpm | 2017500rpm | 040,000 rpm | 60050,000
rpm |
|--------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| Handpiece rpm
range | 20 ~ 80,000 rpm | 2017,500rpm | 10200,000rpm | 10200,000rpm |65Ncm | 0.1
| Torque setting
range applied to
the motor in
Ncm | 59.9Ncm | 565Ncm | 565Ncm |120V,
| Allows
reciprocating
drive
(forward/reverse
cycling) | Yes | Yes | Yes | Yes |
| Allows selection
of gear ratios for
different geared
E-type
handpieces | 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 selection
of forward or
Auto reverse
drive rotation | Yes | Yes | Yes | Yes |
| Allows selection
of Auto stop | Yes | Yes | Yes | Yes |
| Allows use of a
foot switch
control to
operate the
attached
handpiece motor | Yes
Electronic foot
control | Yes
Electronic foot
control | Yes
Electronic foot
control | Yes
Electronic foot
control |
| Allows the user
to define their
own presets for
speed and
torque | Yes | Yes | Yes | Yes |
| Allows
programmable
doctor's choice | Yes | Yes | Yes | Yes |
| | AC100V
50/60Hz
AC220V240V,120V,
50/60Hz | AC100V
50/60Hz
AC220V240V,120V,
50/60Hz | AC100V
50/60Hz
AC220V240V,120V,
50/60Hz | AC100V
50/60Hz
AC220V~240V,
50/60Hz |
| Input
voltage(charger) | | | | |
| Handpiece
Coupling type | E-type | E-type | E-type | E-type |
| Lubricant | NSK PANA
SPRAY PLUS | NSK PANA
SPRAY PLUS | Information not
available | Information not
available |
7
| (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.