The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

Device Description

The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "TRAUS ENDO," which is a dental handpiece. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific performance acceptance criteria through clinical trials or algorithm performance evaluations.

Therefore, the information requested about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment, training set details), and specific performance metrics (like effect size or standard performance values) for proving the device meets acceptance criteria cannot be found in this document.

This type of 510(k) submission generally relies on demonstrating the new device is as safe and effective as a legally marketed predicate device, often through:

Comparison of technological characteristics: Showing similarities in design, materials, and operating principles.
Performance testing to standards: Demonstrating compliance with relevant electrical safety, biocompatibility, and sterilization standards (as listed in Section 12). These are typically engineering tests, not clinical studies involving human or animal subjects for performance evaluation.
Verification/Validation: Ensuring the device design meets specified requirements and user needs.

Based on the provided text, I can extract the following information related to "performance data" (which in this context refers to engineering and quality assurance tests, not clinical performance):

1. A table of acceptance criteria and the reported device performance:

The document states that "The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria." However, it does not explicitly list the specific quantitative acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Software Verification/Validation (EN 62304)	Device passed based on predetermined Pass/Fail criteria.
Temperature Test (ISO 14457, IEC 80601-2-60)	Device passed based on predetermined Pass/Fail criteria.
Eccentricity Test (ISO 14457)	Device passed based on predetermined Pass/Fail criteria.

Note: The document also references assessments for Biocompatibility (ISO 10993) and Reprocessing Validation (cleaning, sterilization per ISO 17665-1) that were performed on previously cleared predicate devices with the same materials and processes.

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

Sample Size: Not specified. The tests mentioned (Software, Temperature, Eccentricity) are typically performed on a limited number of manufactured units or prototypes to demonstrate compliance with standards, not on a "test set" in the context of a large-scale clinical performance study.
Data Provenance: Not explicitly stated, but these are likely internal lab tests performed by the manufacturer (Saeshin Precision Co., Ltd.) to engineering standards. There is no mention of country of origin for any "data" beyond the manufacturing location. The study is not a retrospective or prospective clinical study.

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

This information is not applicable to the "performance data" presented in this 510(k) summary. The tests performed are engineering and quality assurance tests that do not involve human expert interpretation for ground truth establishment.

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

This information is not applicable as the "performance data" refers to technical-compliance testing, not human-read interpretation of data requiring adjudication.

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. The device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness study was conducted or reported in this document.

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

This is not applicable. The device is hardware (a dental handpiece) and its accompanying components. It is not an algorithm, and its performance is not measured in a standalone computational manner.

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

The concept of "ground truth" as typically applied to diagnostic AI models is not applicable here. The "ground truth" for the engineering performance tests (Temperature, Eccentricity) would be the specific quantitative limits defined by the ISO/IEC standards (e.g., maximum allowable temperature, maximum allowable eccentricity), and the "truth" of the software passing would be its adherence to specified functional requirements.

8. The sample size for the training set:

This is not applicable. The device is not an AI model requiring a training set.

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

This is not applicable. The device is not an AI model.

In summary, the provided document is a regulatory submission for a Class I medical device based on substantial equivalence, which primarily relies on demonstrating compliance with recognized standards and similarity to predicate devices rather than comprehensive clinical performance studies involving large datasets or AI components.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

June 24, 2022

Saeshin Precision Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612

Re: K212043

Trade/Device Name: TRAUS ENDO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: May 16, 2022 Received: May 26, 2022

Dear Priscilla 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212043

Device Name TRAUS ENDO

Indications for Use (Describe)

The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

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 (K212043)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Date: 6/23/2022

2. Applicant / Submitter

Saeshin Precision Co., Ltd. # 52, Secheon-ro 1-gil, Dasa-eup Dalseonggun, Daegu, 711-814, Korea Tel: +82 53 587 2345 / Fax:+82 53 580 0918

3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com

4. Trade/Proprietary Name:

TRAUS ENDO

5. Common Name:

Dental Handpiece

6. Classification:

Handpiece, Direct Drive, Ac-Powered (21CFR 872.4200, Product code EKX, Class I, Dental)

7. Device Description:

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8. Indication for use:

The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

9. Primary Predicate Device:

. TRAUS ENDO (K143411) by Saeshin Precision Co., Ltd.

10. Additional Predicate/Reference Device:

. STRONG Dental Handpieces (K181129) by Saeshin Precision Co., Ltd.
ENDO a class (K123582) by Saeyang Microtech Co., Ltd. ●

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11. Substantial Equivalence:

	Subject Device	Primary PredicateDevice	Predicate Device	Reference Device
Manufacturer	Saeshin Precision Co.,Ltd.	Saeshin Precision Co.,Ltd.	Saeshin Precision Co.,Ltd.	Saeyang Microtech Co.,Ltd.
Device Name	TRAUS ENDO	TRAUS ENDO	STRONG DentalHandpieces	ENDO a class
510(k) Number	K212043	K143411	K181129	K123582
DeviceClassification Name	Handpiece, direct drive,AC-powered	Handpiece, direct drive,AC-powered	Handpiece, direct drive,AC-powered	Handpiece, direct drive,AC-powered
ClassificationProduct Code	EKX	EKX	EGS	EKX
Device Class	I	I	I	I
Regulation Number	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200
Indication for Use	The TRAUS ENDO,ACL(B)-41EP, ACL(B)-42EP, ACL(B)-46EP, areindicated for use bydentists in standardendodontic proceduresusing rotary files androtary endodontic drills(Gates-Glidden).	The TRAUS ENDO,ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP,are indicated for use bydentists in standardendodontic proceduresusing rotary files androtary endodontic drills(Gates- Glidden).	The Strong DentalHandpiece, ACL(B)-46EP is intended for widerange of dentalprocedures, including:A. Implant placement,including1. Preparation of theosteotomy site2. Bone contouring,osteoplastyB. Periodontal surgeries1. Bone contouring &alveoplasty around livingteeth2. Removal of exostosisC. Bone grafting1.Preparation of the donorsite (for e.g. symphysisand ascending rames etc.)2. Harvesting autogenliving boneSinus elevation &grafting of alveolarsockets3. D. Removal andsectioning of teeth andteeth bone for e.g.impacted third molars andcomplicated extractions.	This application areaextends to endodonticprocedures using a rootcanal instrument which isintended by themanufacturer for use inthe mechanical androtary preparation of rootcanals.
Components	Contra-Angle HandpieceMotor Handpiece BatteryChargerPower Cord	Contra-Angle HandpieceMotor Handpiece BatteryChargerPower Cord	Contra-Angle Handpiece	Contra-Angle HandpieceMotor Handpiece BatteryChargerPower Cord
Gear	10:116:120:1	16:120:132:1	10:1	4:110:116:120:1

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Chuck TypeShank Type	Latch TypeType 1	Latch TypeType 1	Latch TypeType 1	Latch TypeType 1
Composition ofMaterial	Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum	Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum	Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum	Stainless Steel
Supply voltage	100-240V AC 50/60Hz	100-240V AC 50/60Hz	-	100-240V AC 50/60Hz
Operational voltage	DC 4.5V	DV 4.5V	-	-
Torque moto speed	1-4 Ncm	1-4 Ncm	2 Ncm	1-4 Ncm
Sterilization	Contra-angle at 132°C for 4 minutes in Autoclaveconforms IEC 60601-1IEC 60601-1-2ISO 14457	Contra-angle at 132°C for 4 minutes in Autoclaveconforms IEC 60601-1IEC 60601-1-2ISO 14457	Contra-angle at 132°C for 4 minutes in Autoclaveconforms ISO 14457	conforms IEC 60601-1IEC 60601-1-2
Electrical safety
Allows selection offorward or Autoreverse drive rotation	Yes	Yes	-	Yes
Allows reciprocation drive	Yes	No	-	Yes

The indications for use and the technological characteristics of the subject device is the same as the predicate device, the unmodified devices. The ACL(B)-41EP and the ACL(B)-42EP are cleared under K143411 and the ACL(B)-46EP is cleared under K181129. The modification is adding reciprocation mode and we identified a reference device (K123582) which offers the same mode.

We performed risk analysis and verification/validation tests per modifications, and the test results support that the modification raises no new safety and effectiveness questions.

12. Performance Data:

The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria.

· Software Verification/Validation (EN 62304).
· Temperature Test (ISO 14457, IEC 80601-2-60)
· Eccentricity Test (ISO 14457)

We also referenced the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" while preparing the software documentation.

Biocompatibility Testing per ISO 10993 was assessed under K143411, the previous cleared device, which has the same patient contacting material and manufacturing processes as the subject device.

Reprocessing Validation (i.e., Cleaning, Sterilization per ISO 17665-1) was assessed under K143411 and K181129, the previously cleared devices.

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13. Conclusion:

The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The subject device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.

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.