For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

Device Description

The motor turned by the power converted into DC24V by controller delivers its turning power to the bur through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

AI/ML Overview

The provided text describes a 510(k) summary for the Saeyang Microtech ENDO e class device, which is a dental handpiece and accessories. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that a clinical study would typically assess. Instead, the "acceptance criteria" for this 510(k) revolve around compliance with established safety and performance standards for dental devices and demonstrating substantial equivalence to legally marketed predicate devices.

The "reported device performance" is essentially a description of the device's features and its compliance with relevant standards.

Acceptance Criterion (Implicit in 510(k))	Reported Device Performance
Compliance with IEC 60601-1: 1988 +A1 1991,+A2 1995 (Medical Electrical Equipment)	Complied
Compliance with ANSI/AAMI/IEC 60601-1-2: 2007 (Electromagnetic Compatibility)	Complied
Compliance with ISO 3964:1982 (Dental Handpieces - Connections)	Complied
Compliance with ISO 7494-1:2004 (Dental Units - Part 1: General Requirements)	Complied
Compliance with ISO 7785-2:1995 (Dental Handpieces - Part 2: Dental Low-Speed Handpieces)	Complied
Compliance with ISO 11498:1997 (Dentistry - Torque measurement for endodontic handpieces)	Complied
Sterilization Validation Passed	Validation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Software Validation Passed	Validation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Speed Accuracy Testing Passed	Testing performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Temperature Rise Testing Passed	Testing performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Substantial Equivalence to Predicate Devices	The ENDO e class has similar characteristics and intended use as previously cleared devices (AEU-26L, TCM Endo V, ATR TECNIKA). The subject device is substantially equivalent to the predicate devices in intended use, operation, safety and function across key features like motor speed, torque setting, reciprocating drive, foot pedal control, and programmable presets.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the sense of patient data. The "tests" were non-clinical bench tests and compliance with standards. The data provenance would be from manufacturing and engineering tests conducted by Saeyang Microtech in Korea.

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)

Not applicable, as no clinical testing with patient data or expert-adjudicated ground truth was performed or required for this type of 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no test set requiring ground truth adjudication from experts was used.

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

Not applicable. This device is a dental handpiece (a physical tool), not an AI-powered diagnostic or assistive software. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" was derived from the specifications and requirements of the international and national standards (e.g., IEC 60601-1, ISO 3964) and the performance characteristics of the predicate devices for comparison. For example, for speed accuracy testing, the ground truth would be the expected or specified speed, and the device's measured speed would be compared against that.

8. The sample size for the training set

Not applicable, as this is a physical device and not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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MARAT SAEYANG MICROTECH

Image /page/0/Picture/1 description: The image contains two different symbols. The symbol on the left is a circle with a checkmark inside, surrounded by some text. The symbol on the right is the CE marking followed by the number 0120 below it.

100-39. GALSAN-DONG, DALSEO-GU, DAEGU, KOREA. Tel. +82-53-582-9000~2, Fax. +82-53-581-9003 http://www.saeyang.com, e-mail:marathon@saeyang.com

Section 3: 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. 510(k): 123608

1. Submitter's Identification:

Saeyang Microtech Co., Ltd. 100-39 Galsan-Dong, Dalseo-Gu, Daegu, Korea Phone: 82-53-582-9000-2 Fax: 82-53-581-9003 Contact - Kim San-ghoon

AUG 1 6 2013

Date Summary Prepared: July 12, 2013

2. Name of Device:

Trade/Proprietary Name: ENDO e class

Classification Name:

Controller, Foot, Handpiece And Cord

Class in which Device has been placed:

The Dental panel has classified this device as Class I, 21 CFR Part 872.4200, Product Code EBW.

Predicate Device Information: 3.

1. K111078 Aseptico, Inc's AEU-26L Electronic Endodontic System
1. K042822 Nouvag Ag's TCM Endo V, Model 1534
1. K000547 A.T.R.'S TECNIKA

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4. Device Description:

5. Indication for Use:

For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

6. Substantial Equivalence:

The ENDO e class has similar characteristics and intended use as previously cleared devices. The subject device is substantially equivalent to the predicate devices.

	Subject Device	Predicate 1	Predicate 2	Predicate 3		through spin toperform	through spin toperform	spin to performpunching.cutting andremovingfunctions.	set/adjusted on/in itsspeed, torque and turningdirection by handling ofthe controller
510(k) Number	K123608	K111078	K000547	K042822		punching,cutting andremovingfunctions.The hand-piececan beoperated,stopped andset/adjustedon/in itsspeed, torqueand turningdirection byhandling of thecontroller	punching,cutting andremovingfunctions.The hand-piececan beoperated,stopped andset/adjustedon/in itsspeed, torqueand turningdirection byhandling ofThe controller	The hand-piececan beoperated,stopped andset/adjustedon/in its torqueand turning directionby handling ofthe controller
Device Name	ENDO E Class	AEU-26L	ATR TECNIKA	TCM ENDO V	Allowsadjustment ofthe motor speed	20~17500rpm	300~30000rpm	1600~12800rpm	1200~16000rpm
Common Name	DentalHandpiece andaccessories	DentalHandpiece andaccessories	DentalHandpiece andAccessories	Endodontic Device withApex locator	Torque settingrange applied tothe motor inNmm	1~99Nmm	7~98Nmm	1~99Nmm	2~50Nmm
Manufacturer	SaeyangMicrotech	ASEPTICO	AdvancedTechnologyResearch	NOUVAG AG	Allowsreciproatingdrive(forward/reversecycling)	Yes	Yes	Yes	Yes
Intended Use	For use in awide range ofdentalproceduresincluding:endodonticsurgeries,such as drillingin to the	For use in awide range ofdentalproceduresincluding:endodonticsurgeries, suchas drilling into the tooth	The ATRTecnika isintended fordental drillingand tighteningof various typeof screw indentalimplantation	The TCM Endo V is adental root canalmeasurement andtreatment device that canmeasure the length of theroot canal and enlargethe root canal whilemonitoring the position ofthe file tip inside the	Allows settingthe torqueapplied to themotor ingram/cm	Units not ingram/cm.Torque isconfigurablefrom 1 to 99	YesTorqueaccuracy	Units not ingram/cm.Torque isconfigurablefrom 1 to 99	Yes
	tooth canal,and generaldentistry, suchas removingcariousmaterial fromthe dentin.	canal, andgeneraldentistry, suchas removingcariousmaterial fromthe dentin.	and inmicrosurgery	canal.	Allows selectionof gear ratiosfor differentgeared E-type	1:1, 4:1, 6:1,8:1, 10:1,16:1, 20:1,64:1	1:5, 1:1, 8:1,16:1	15:1. 16:1,18:1, 20:1	8:1
Micromotordrive	electricMicromotordrive	electricMicromotordrive	electricMicromotordrive	electric Micromotor drive
Packagecontents	Control Unit.E-type Motor& Motor Cord,E-typeHandpiece,foot switch,Handpiecestand, PowerCord,* AutoclavingPlugs, Manual	ElectronicControlConsole, E-typeMicromotor &Motor Cord, E-typeHandpiece,foot switch,Handpiecestand, PowerCord, Manual	control unit,foot-pedal, E-typemicromotor,handpiecestand, autoclaveplug, powercord, Manual.	Control Unit. Endo micro-motor, foot switch,Handpiece stand. Lipconnector cable. Manual
Product material	-InjectionMolding(ABS)-Screw cap &o-ring(silicon)-machinework(Kind ofSUS)	-InjectionMolding(ABS)-Screw cap &o-ring(silicon)-machinework(Kind ofSUS)	-InjectionMolding(ABS)-Screw cap &o-ring(silicon)-machinework(Kind ofSUS)	-Injection Molding(ABS)-Screw cap & o-ring(silicon)-machine work(Kind ofSUS)
Principle ofOperation	The motorturned by thepowerconverted intoDC Voltage bycontrollerdelivers itsturning powerto the file	The motorturned by thepowerconverted intoDC Voltageby controllerdelivers itsturning powerto the file	The motorturned by thepowerconverted intoDC Voltage bycontrollerdelivers itsturning power tothe file through	The motor turned by thepower converted into DCVoltage by controllerdelivers its turning powerto the file through spin toperform punching, cuttingand removing functions.The hand-piece can beoperated, stopped and

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handpieces
Allows selectionof forward orAuto reversedrive rotation	YES	YES	YES	YES
Allows selectionof Auto stop	YES	NO	NO	YES
Allows use of afoot pedalcontrol tooperate theattachedhandpiecemotor	YESelectronic footcontrol	YESelectronic footcontrol	YESelectronic footcontrol	YESelectronic foot control
Allows the userto define theirown presets forspeed andtorque	YES	YES	YES	YES
Allowsprogrammabledoctor's choice	YES	YES	YES	NO
Inputvoltage(charger)	AC100V~~120V,50/60HzAC220V~~240v,50/60Hz	AC100V~240V,50-60Hz	AC110V orAC220V.50/60Hz	100V~/115V~/230V~,50-60Hz
handpieceCoupling type	E-type	E-type	E-type	NOUVAG AG only

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing that was conducted in accordance with IEC 60601-1: 1988 +A1 1991,+A2 1995; ANSI/AAMI/IEC 60601-1-2: 2007; Non-clinical Bench Test performed as following:

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Test Standards	Result
ISO3964:1982
ISO7494-1:2004	Complied
ISO7785-2:1995
ISO11498:1997

Along with the above tests, sterilization validation, software validation, speed accuracy testing, and temperature rise testing were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.

8. Discussion of Clinical Tests Performed:

No clinical testing was conducted.

9. Conclusions:

The ENDO e class is substantially equivalent to the predicate devices in intended use, operation, safety and function.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2013

Saeyang Microtech Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard GREAT NECK NY 11021

Re: K123608

Trade/Device Name: ENDO e class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: July 12, 2013 Received: July 18, 2013

Dear Mr. Shah:

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. Ilsting 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. Shah

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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SAEYANG MICROTECH

Image /page/8/Picture/1 description: The image shows two certification logos. The logo on the left is a circle with a checkmark inside and the letters "STS" below it. The logo on the right is the CE marking followed by the number "0120". These logos are often found on products to indicate that they meet certain safety and quality standards.

100-39. GALSAN-DONG, DALSEO-GU, DAEGU, KOREA. Tel. +82-53-582-9000~2. Fax. +82-53-581-9003 http://www.saeyang.com. e-mail:marathon@saeyang.com

Section 2: Indications for Use

Page 1 of 1

510(k) Number (if known): 123608

Device Name: ENDO e class

Indications For Use:

For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

Prescription Use_ × (Per 21 CFR 801 Subpart D)

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)

Sheena A. Green - S 2013.08.16 13:06:48-04.00

for M. Susan Runner, DDS, MA

ivision Sign-Off) vision of Anesthesiology, General Hospital tection Control, Dental Devices

10(k) Number: K 123(008

2-1

Regulation Number and Section

§ 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.