This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

Device Description

The motor turned by the power converted into DC2.4V by controller delivers its turning power to the file 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 Saeyang Microtech's ENDO a class device, a cordless endodontic handpiece. The 510(k) summary (K123582) details its intended use, substantial equivalence to predicate devices, and the non-clinical tests performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through compliance with established international standards and a comparison of technical specifications with predicate devices to establish substantial equivalence.

Based on the provided information, the acceptance criteria relate to compliance with regulatory standards and functional equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance
Regulatory Compliance & Safety
IEC 60601-1: 1988 +A1 1991,+A2 1995 (Medical electrical equipment)	Complied
ANSI/AAMI/IEC 60601-1-2: 2007 (Electromagnetic compatibility)	Complied
ISO3964:1982	Complied
ISO7494-1:2004	Complied
ISO7785-2:1995	Complied
ISO11498:1997	Complied
Sterilization Validation	Complied
Software Validation	Complied
Speed Accuracy Testing	Complied
Temperature Rise Testing	Complied
General Safety Hazards	None demonstrated that violated requirements or resulted in hazards.
Functional Equivalence to Predicate Devices
Intended Use	Substantially equivalent to predicate devices (Endodontic procedures using a root canal instrument for mechanical and rotary preparation).
Operation	Substantially equivalent to predicate devices.
Speed Adjustment Range	140-500 rpm (Predicate devices: 125-625 rpm, 280 rpm, 300 rpm) - Comparable range
Torque Adjustment Range	0.1-4.0 Ncm (Predicate devices: 1.0-5.0 Ncm, Low/High mode, 0.5-4.0 Ncm) - Comparable range
Gear Ratio Selection	4:1, 10:1, 16:1, 20:1 (Predicate devices: 17:1, 32:1, 16:1) - Offers more options or overlaps with predicates
Forward/Auto Reverse Drive	YES (Matches predicate devices)
Reciprocation Drive	YES (Matches predicate devices)
User-defined Presets (Speed/Torque)	YES (Matches predicate devices)
Auto Power Off	YES (Matches predicate devices)
Product Material	Comparable to predicate devices (ABS, silicon, SUS)
Principle of Operation	Substantially equivalent to predicate devices (motorized handpiece for punching, cutting, removing functions in root canals).
Rechargeable Battery	Ni_Mh 1.2V2 (Comparable to predicate Li_ion 3.7V, Ni_Mh 1.2V3)
Motor Voltage	DC2.4V (Comparable to predicate DC3.6V, DC3.6V, DC2V)
Physical Dimensions & Weight	Comparable to predicate devices.

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

The document describes non-clinical bench tests performed to ensure compliance with relevant ISO and IEC standards. These tests typically do not involve "test sets" in the sense of patient data. Instead, they involve testing of physical devices or components against specified technical requirements and protocols.

Sample Size: Not explicitly stated as a number of devices, but the testing would have been conducted on a representative sample of the ENDO a class device.
Data Provenance: The tests were conducted internally by Saeyang Microtech in Korea, with results being "Complied" for each standard. Given the nature of bench testing for regulatory submission, this would be considered prospective testing for the purpose of demonstrating compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this submission. The device is a direct drive, AC-powered handpiece for endodontic procedures, not an AI or diagnostic imaging device that requires expert-established ground truth from clinical data. The "ground truth" here is the adherence to engineering and safety standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy involving multiple human readers, which is not relevant for this device. The non-clinical tests involved verifying physical and functional specifications against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a dental handpiece. The device is a mechanical tool, and the submission explicitly states: "No clinical testing was conducted."

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

This question is not applicable. The ENDO a class is a physical device, a dental handpiece, not an algorithm or AI system.

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

The "ground truth" in this context refers to compliance with established international standards (ISO, IEC) for medical devices, specifically dental handpieces, and the functional specifications of the device meeting pre-defined thresholds or being comparable to predicate devices. It is based on engineering and performance testing protocols.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI or machine learning device.

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

This question is not applicable. There is no "training set."

Summary

{0}------------------------------------------------

MARA SAEYANG MICROTECH

Image /page/0/Picture/1 description: The image contains two logos. The first logo on the left is a circular logo with a checkmark in the center. The second logo on the right contains the letters "CE" stacked on top of the number "0120". These logos are often found on products to indicate compliance with certain standards or regulations.

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.

510k: K123582

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 a class

Classification Name: Handpiece, direct drive, ac-powered

Class in which Device has been placed:

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

3. Predicate Device Information:

1. K092833 Dentamerica Inc Cordless Endodontic Handpiece
1. K970339 J. Morita USA, Inc Tri Auto Zx

{1}------------------------------------------------

1. 090931 W & H Dentalwerk GMBH Cordless ENDO handpiece ENTRAN

4. Device Description:

5. Indication for Use:

This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

e. Substantial Equivalence:

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

	Device	Predicate 1	Predicate 2	Predicate 3
510(k) Number		K092833	K970339	K090931
Device Name	ENDO a Class	Endo-max	Tri Auto ZX	ENTRAN & S5ENDO Motor
Common Name	CordlessEndodonticHandpiece	CordlessEndodonticHandpiece	cordlessendodontictreatmentmotorizedhandpiecewithrootcanalmeasurement	Cordless ENDO-Handpiece"ENTRAN"
Manufacturer	SaeyangMicrotech	DentamericaInc.	J.Morita USAInc.,	W&H
Intended Use	This applicationarea extends toendodontic	Thisapplicationarea extends toendodontic	TheTRIAUTOZXdevice is a	Modular electricalsystem formechanical
	proceduresusing a rootcanalinstrumentwhich isintended by themanufacturerfor use in themechanical androtarypreparation ofroot canals.	to endodonticproceduresusing a rootcanalinstrumentwhich isintended bythemanufacturerfor use in themechanicaland rotarypreparation ofroot canals.	cordlessendodontictreatmentmotorizedhandpiecewith rootcanalmeasurementcapability. Itcan be usedto enlargecanals whilemonitoringthe positionof the file tipinside thecanal. It canbe used tomeasure thelength of thecanal, and itcan be usedas a lowspeedmotorizedhandpiece.	preparation of theroot canal, usinga special rootcanalinstrument(ENDO file), which isintended by themanufacturer foruse in themechanical androtarypreparation of theroot canal.
Allows adjustment ofthe motor speed	140~500rpm	125~625rpm	280rpm	300rpm
Allows setting thetorque applied to themotor in Ncm	0.1-4.0 Ncm	1.0-5.0 Ncm	Low mode orHigh mode	0.5~4.0 Ncm
Allows selection ofgear ratios for differentgeared E-typehandpieces	4:1, 10:1,16:1, 20:1	17:1	32:1	16:1
Allows selection offorward or Autoreverse drive rotation	YES	YES	YES	YES

{2}------------------------------------------------

. .

{3}------------------------------------------------

Allows reciprocationdrive(forward/reversecycling)	Allows the user todefine their ownpresets for speed andtorque	Auto Power Off	Product material	Principle of Operation		by handling ofthe controller	by handling ofThe controller	by handling ofthe controller	by handling ofthe controller
YES	YES	YES	-InjectionMolding(ABS)-Screw cap & o-ring(silicon)-machinework(Kind ofSUS)	The motorturned by thepowerconverted intoDC2.4V bycontrollerdelivers itsturning powerto the filethrough spin toperformpunching,cutting andremovingfunctions.The hand-piececan beoperated,stopped andset/adjustedon/in its speed,torque andturning direction	Input voltage(charger)	AC100V~240V	AC100V~240V, 50-60Hz	AC110V or220V, 50-60Hz	AC100V~240V,50-60Hz
YES	YES	YES	-InjectionMolding(ABS)-Screw cap &o-ring(silicon)-machinework(Kind ofSUS)	The motorturned by thepowerconverted intoDC3.6V bycontrollerdelivers itsturning powerto the filethrough spin toperformpunching,cutting andremovingfunctions.The hand-piece can beoperated,stopped andset/adjustedon/in itsspeed, torqueand turning	Rechageble Battery	Ni_Mh 1.2V*2	Li_ion 3.7V	Ni_Mh 1.2V*3	Li_ion 3.7V
YES	YES	YES	-InjectionMolding(ABS)-Screw cap &o-ring(silicon)-machinework(Kind ofSUS)	The motorturned by thepowerconvertedinto DC3.6Vbycontrollerdeliversturning powerto thefilethrough spintoperformpunching,cutting andremovingfunctions.Thehand-piece can beoperated,stoppedandset/adjustedon/inspeed, torqueandturning	Motor Voltage	DC2.4V	DC3.6V	DC3.6V	DC2V
YES	YES	YES	-InjectionMolding(ABS)-Screw cap & o-ring(silicon)-machinework(Kind ofSUS)	The motor turnedby the powerconvertedintoDC2Vbycontroller deliversits turning powerto the file throughspin to performpunching, cuttingand removingfunctions.The hand-piececan be operated,stoppedandset/adjusted on/inits speed, torqueandturningdirectionbyhandling of thecontroller	Motor Size	$13 \phi * 31.5(L)$	$13 \phi * 31.5(L)$	$13 \phi * 31.5(L)$	$13 \phi * 31.5(L)$
Demensions(Handpiece)	192(L) X 27(W)X 28(H)	192(L) X26(W) X29(H)	193(L) X30(W) X37(H)	187(L) X 28(W) X26(H)
Weight(Handpiece)	138g	150g	130g	120g
Demensions(chargingstation)	115(L) X 98(W)X 60(H)	105(L) X85(W) X59(H)	123(L) X88(W) X55(H)	160(L) X 95(W) X62(H)

{4}------------------------------------------------

Discussion of Non-Clinical Tests Performed for Determination of 7. 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:

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.

{5}------------------------------------------------

Discussion of Clinical Tests Performed: 7.

No clinical testing was conducted.

8. Conclusions:

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

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a sphere, which is meant to represent the department's mission of protecting the health of all Americans.

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

August 16, 2013

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

Re: K123582

Trade/Device Name: ENDO a Class Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX 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, 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.

{7}------------------------------------------------

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/ResourcesforYou/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/ReportalProblem/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,

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

{8}------------------------------------------------

HON SAEYANG MICROTECH

Image /page/8/Picture/1 description: The image shows two logos. The logo on the left is a circle with a checkmark inside and the letters "SGS" below. The logo on the right is the letters "CE" stacked on top of the number "0120".

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 of 1

510(k) Number (if known): K123582

Device Name: ENDO a class

Indications For Use:

This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

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. Greens 2013.08.16 09:23:32 -04'00' tor M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K123582

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.