The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP, 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)-45EP, are grinding, cutting, and polishing work in dental oral use.

AI/ML Overview

Based on the provided document, here's an analysis of the acceptance criteria and the study conducted for the TRAUS ENDO device:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., specific sensitivity, specificity, accuracy targets). Instead, the study's acceptance was based on conformity to established medical device standards and demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing.

Acceptance Criterion (Implicit)	Reported Device Performance (TRAUS ENDO)
Compliance with IEC 60601-1 (medical electrical safety)	Conforms
Compliance with IEC 60601-1-2 (electromagnetic compatibility)	Conforms
Compliance with ISO 14457 (dentistry-handpieces and motors)	Conforms
Compliance with ISO 17665-1 (sterilization of healthcare products-moist heat)	Conforms
Compliance with ISO 1797-1 (shanks for rotary instrument)	Conforms
Compliance with ISO 10993-1 (biological evaluation of medical devices)	Conforms
Technical Characteristics Substantially Equivalent to Predicates	Demonstrated through comparison table and bench testing
No new clinical risks compared to similar market devices	Evaluated based on literature research (non-clinical)

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing for the TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP.

Sample Size for Test Set: The document states "TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP samples were compliant." It does not specify the exact number of samples tested for each model or for each test. It implies that a sufficient number of samples were tested to demonstrate compliance.
Data Provenance: The data is from bench testing conducted by Saeshin Precision Co., Ltd. (Republic of Korea), the manufacturer. It is prospective in the sense that these tests were performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study involved bench testing against engineering and safety standards, not a clinical study with a ground truth established by medical experts. The "ground truth" was the specifications and requirements of the referenced international standards.

4. Adjudication Method for the Test Set

This is not applicable in the context of this submission. Adjudication methods are typically used in clinical trials to resolve discrepancies among expert readers. Here, the "test set" involves physical device performance measurements evaluated against pre-defined standard requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The TRAUS ENDO is a dental handpiece, a mechanical device, and its performance evaluation does not involve human interpretation of output in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the TRAUS ENDO device. The device is a physical instrument, not an algorithm. Its performance is inherent to its design and manufacturing.

7. Type of Ground Truth Used

The "ground truth" used for this study was the requirements and specifications outlined in the referenced international standards (IEC 60601-1, IEC 60601-1-2, ISO 14457, ISO 17665-1, ISO 1797-1, ISO 10993-1). Device performance was measured and compared directly to these established standards.

8. Sample Size for the Training Set

This is not applicable. The TRAUS ENDO is a mechanical dental handpiece, not an AI or machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.

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

June 29, 2015

Saeshin Precision Co., Ltd. Mr. Sae Kwan Choi QA Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 711-814 REPUBLIC OF KOREA

Re: K143411 Trade/Device Name: TRAUS ENDO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: May 26, 2015 Received: May 28, 2015

Dear Mr. Choi:

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 devicerelated 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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) K143411

Device Name

TRAUS ENDO

Indications for Use (Describe)

The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP, 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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Image /page/3/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric design. The contact information includes the address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea, and the telephone and fax numbers: Tel: +82 53 587 2341/ Fax: +82 53 580 0999.

K143411 510(k) Summary

[As required by 21 CFR 807.92] This 510(k) summary is prepared in accordance with 21 CFR807.92

1. Date Prepared [21 CFR 807.92(a)(1)]

6/26/2015

2. Submitter's Information [21 CFR807.92(a)(1)]

Name of Sponsor: Saeshin Precision Co., Ltd. .
- Address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, -Daegu, 711-814, Republic of Korea
Contact Name: Sae Kwan, Choi (Mr.) / Quality Manager .
- Telephone No. : +82 53 587 2341 -
- Fax No. : +82 53 580 0999 -
- Email Address : ksqc@saeshin.com -
. Registration Number: 3007958831
. Name of Manufacturer: Same as Sponsor
- Address: Same as Sponsor -

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

. Trade Name: TRAUS ENDO
Common Name: Dental Handpieces
. Classification Name: Dental Handpiece and Accessories
. Classification Panel: Dental
. Classification Regulation: 21 CFR 872.4200
EKX . Product Code:
Device Class: |

General Information

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Image /page/4/Picture/0 description: The image contains the logo for SAESHIN, along with their address and contact information. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The telephone number is +82 53 587 2341, and the fax number is +82 53 580 0999.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follows:

. 510(k) Number: K123582
●

Applicant:

Saeyang Microtech Co., Ltd.
Common Name: Dental Handpieces ●
. Device Name: Endo a class
. 510(k) Number: K111616
Applicant: Saeshin Precision Co., Ltd
Dental Handpieces Common Name: ●
Device Name: E-CUBE

K123582 is the primary predicate and K111616 is the reference predicate. There are no significant differences between the TRAUS ENDO dental handpieces and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in device design, composition of materials and technical specifications.

5. Description of the Device [21 CFR 807.92(a)(4)]

Intended Use [21 CFR 807.92(a)(5)] 6.

The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

7. Technological Characteristics [21 CFR 807.92(a)(6)]

Model Nos. ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP ●
Gear Ratio: 20:1, 16:1, 32:1
Dimensions: Ø 16.7 X 63 mm, Ø 16.7 X 63 mm and Ø 16.7 X 63 mm .
Weight: 34.8 g
Charger: AC 100 - 240 V, 50 /60 Hz, DC 4.5V

One difference noted between the TRAUS ENDO and its predicates is its slower rotational speed, as a result of the 32:1 gear reduction ratio. However, equivalence to predicates has been demonstrated through bench testing and this difference raises no new concerns.

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Image /page/5/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a stylized blue cube. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The telephone number is +82 53 587 2341 and the fax number is +82 53 580 0999.

Clinical Tests

A non-clinical evaluation, based on literature research, has been done. The evaluation of the applicable market data showed that TRAUS ENDO Dental handpieces, ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP, do not pose known or new clinical risks than similar medical devices currently on the market. Based on those results clinical test have not been executed.

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Image /page/6/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 711-814, Korea. The telephone number is +82 53 587 2341 and the fax number is +82 53 580 0999.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

When compared to the predicate devices (K123582 and K111616), the subject device TRAUS ENDO has nearly identical:

Intended Use .
Device Design .
Composition of materials .
· Technical Specifications

The TRAUS ENDO is similar to other commercially available products based on the intended use, the claims, the material composition employed. The following tables outlines and differences between the TRAUS ENDO and the predicate devices.

Parameter	ProposedTRAUS ENDO	PredicateENDO a class	PredicateE-CUBE
510(k) Number	K143411	K123582	K111616
Manufacturer	Saeshin Precision Co., Ltd	Saeyang Microtech Co., Ltd.	Saeshin Precision Co., Ltd
Intended Use	TRAUS ENDO, ACL(B)-41EP,ACL(B)-42EP, and ACL(B)- 45EP are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills(Gates- Glidden).	ENDO a class is indicated for application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in mechanical and rotary preparation of root canals.	E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates- Glidden).
Device DesignComponents	Contra-Angle HandpieceMotor Handpiece Charging StationPower Cord	Contra-Angle HandpieceMotor HandpieceCharging StandMotor Handpiece CapPower CordOil Guide	Contra BoxMicro MotorContra-Angle HandpieceFoot-Control PedalAdapter
Parameter	ProposedTRAUS ENDO	PredicateENDO a class	PredicateE-CUBE
Operational Mode	AC power and Gear driven	AC power and Gear driven	AC power and Gear driven
Reduction Ratio	16:1, 20:1, 32:1	4:1, 10:1, 16:1 and 20:1	1:1, 4:1, 10:1, 16:1, 20:1
Coupling Dimension	N/A	ISO 3964 connection	ISO 3964 connection
Chuck Type	Latch Type	Latch Type	Latch Type
Shank Type	Type 1	Type 1	Type 1
Composition of Materials
Gear	Stainless steel (SUS420F)	Not Known	Stainless steel (SUS420F)
Shank	Stainless steel (BiodurTrimtite)		Stainless steel (BiodurTrimtite)
Head	Brass (C3604BD-F)		Brass (C3604BD-F)
Chuck	Stainless steel (SUS420F)		Stainless steel (SUS420F)
Handle	Aluminum (AL6061)		Aluminum (AL6061)
Patient-Contacting	Chuck, Head		Chuck, Head
Operator-Contacting	Handle, Head		Handle, Head
Technical Specification
Supply Voltage	100-240 V AC 50/60 Hz	100-240 V	100-240 V AC 50/60 Hz
Operational Voltage	DC 4.5 V	DC 2.4 V	DC 4.5 V, 0.4 VA
Gear ratio	16:1, 20:1 and 32:1	4:1, 10:1, 16:1 and 20:1	1:1, 4:1, 10:1, 16:1 and 20:1
Torque	1 -4 Ncm	0.1 - 4.0 Ncm	0.6 – 5.2 Ncm
Motor Speed	100 – 12,000 rpm	140 - 500 rpm	1,000 - 13,000 rpm
Lubricant
Chemical Composition	N/A	N/A	K073353 (DO-ALL Dentalhandpiece Lubricant/ProDriveSystems Inc.)
510k#
BiocompatibleDelivery system
Sterilization	Contra-angle at 132 °C for 4minutes in Autoclave.	Contra-angle at 121 °C for 20minutes or 132 °C for 15minutes in Autoclave.	Contra-angle at 134 °C for 4minutes in Autoclave.

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Image /page/7/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric design. The contact information includes the address '# 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea' and the telephone number '+82 53 587 2341' and fax number '+82 53 580 0999'.

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Parameter	ProposedTRAUS ENDO	PredicateENDO a class	PredicateE-CUBE
Performance Standards	IEC60601-1	Conform	Conform	Conform
	IEC60601-1-2	Conform	Conform	Conform
	ISO14457	Conform	Conform	Conform

9. Bench Testing

The following bench tests were performed on the TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-42EP, to verify conformity to standards and demonstrate substantial equivalence to the predicates:

IEC 60601-1: Medical Electrical Equipment Part 1 (2005/(R)2012 AND a1:2012) .
IEC 60601-1-2: Medical Electrical Equipment Part 1-2 (2007-03) .
ISO 14457: Dentistry-Handpieces and Motors (2012-09-15) .
ISO 17665-1: Sterilization of health care products-Moist heat Part1 (2006-08-15) .
. ISO 1797-1: Shanks for rotary instrument - Part1 (1st edition Amendment)
ISO 10993-1: Biological Evaluation of Medical Devices Part 1 (4th Edition) .

TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP samples were compliant with standards and demonstrated substantial equivalence to the predicates.

10. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Presicion Co., Ltd., we conclude that the TRAUS ENDO has been determined to the predicate devices as described herein.

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.