This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

Device Description

This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction (forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.

AI/ML Overview

This application describes the MEG-TORQ device, a cordless motor handpiece system for tightening and loosening abutment screws on dental implants. The FDA's 510(k) clearance (K161500) is based on the device being substantially equivalent to the predicate device, ISD900 (K110278), manufactured by NAKANISHI Co., Ltd.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" as a set of quantified thresholds for performance metrics. Instead, "performance data" describes tests performed to affirm the device's safety and functionality in relation to established standards and its predicate device. The conclusion of these tests is that the device meets these standards and is therefore "substantially equivalent."

Performance Aspect	Standard/Test Performed	Reported Device Performance
Functional Performance	ISO 14457:2012 Dentistry Handpieces and motors	All test results support substantial equivalence to the predicate devices.
Sterilization Validation	ANSI/AAMI ST79, ISO17665-1, ISO 17665-2, ISO 11138-1, and ISO11138-3	All test results support substantial equivalence to the predicate devices.
Electrical Safety & EMC	IEC 60601-1, IEC 60601-1-6, EN 60601-1-2, EN 61000-3-2, EN 61000-3-3	All test results support substantial equivalence to the predicate devices.
Abutment Screw Shear (due to higher RPM)	Maximum speed and torque test	The test results showed that this difference does not raise a concern in this regard (i.e., higher RPM does not shear off the abutment screw).

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

The document does not specify a sample size for the non-clinical performance tests. The testing appears to be primarily laboratory-based engineering and performance verification against standards and the predicate device's specifications. The data provenance is implied to be from the manufacturer, MICRO-NX Co., Ltd. (REPUBLIC OF KOREA), as they conducted and submitted the tests. The tests performed are retrospective in the sense that they are conducted on the final device design to demonstrate compliance, rather than during an iterative development process.

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

This information is not provided. The "ground truth" here is compliance with technical standards and the functional performance outlined in the predicate device's specifications. These are established through recognized testing methodologies rather than human expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting images or data, and disagreements need to be resolved to establish ground truth. The tests described are objective engineering and performance tests against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was provided in the submission." This type of study would involve human readers (e.g., dentists) using the device and evaluating its effectiveness compared to alternatives, potentially with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The MEG-TORQ is a physical medical device (a dental handpiece), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.

7. Type of Ground Truth Used:

The ground truth used for demonstrating substantial equivalence is based on:

Standards Compliance: Meeting the requirements of recognized international and national standards (ISO 14457, ANSI/AAMI ST79, ISO17665-1/2, ISO 11138-1/3, IEC 60601-1/1-6, EN 60601-1-2, EN 61000-3-2/3-3).
Predicate Device Specifications: The functional and safety characteristics of the legally marketed predicate device (ISD900, K110278).
Engineering Verification: Direct measurement of physical performance (e.g., torque output, speed, "abutment screw shear" test) against expected values or parameters to ensure safe and effective operation within the intended use.

8. Sample Size for the Training Set:

Not applicable/provided. As this is a mechanical device, there is no "training set" in the context of an AI algorithm or model. The device development would involve engineering design and testing prototypes, but not a data-driven training set.

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

Not applicable/provided. See point 8.

Summary

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

February 22, 2017

MICRO-NX Co., Ltd % Ms. Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine. California 92606

Re: K161500 Trade/Device Name: MEG - TORQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: January 24, 2017 Received: January 25, 2017

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.

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

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the quality systems (OS) 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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)

K161500

Device Name

MEG-TORQ

Indications for Use (Describe)

This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K161500)

Date: Feb 14, 2017

1. Applicant / Submitter:

MICRO-NX Co., Ltd. 37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun, Daegu 711-891 REPUBLIC OF KOREA Tel: +82-53-611-0071 Fax:+82-53-611-0074

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	MEG-TORQ
Common Name:	Dental Implant Torque Driver
Classification Name:	Handpiece, Direct Drive, AC-powered
Classification:	Class I, 21 CFR 872.4200
Classification Product Code:	EKX

4. Predicate Device:

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 by NAKANISHI Co., Ltd. (K110278)

5. Device Description:

This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction

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(forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.

6. Indications for Use:

This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

7. Performance Data(Non-Clinical):

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

Performance test in accordance with ISO 14457:2012 Dentistry Handpieces and motors
. Sterilization validation testing in accordance with ANSVAAMI ST79, ISO17665-1, ISO 17665-2, ISO 11138-1, and ISO11138-3
· Electrical safety and EMC test in accordance with IEC 60601-1, IEC 60601-1-6, EN 606011-1-2, EN 61000-3-2, EN 61000-3-3

Performance Data(Clinical): 8.

No clinical performance testing was provided in the submission.

9. Substantial Equivalence

MEG-TORQ is substantially equivalent to ISD900 (K110278). The following comparison table is presented to demonstrate substantial equivalence.

The intended use of the subject device is the same as the predicate device. The subject device is also similar to the predicate device in terms of operational modes, type of chuck, patient contacting part, and shank type which confirms to ISO1797-1. The differences between the subject device and the predicate devices are device dimensions, speed in rpm, and torque options. However, the non-clinical performance test results provided in this submission support that the subject device is substantially equivalent to the predicate device. Especially, the maximum speed and torque test was performed to verify that the use of the subject device with the highest rpm does not shear off the abutment screw. The test results showed that this difference does not raise a concern in this regard.

	Submission Device	Predicate Device
510(k) Number	K161500	K110278
Device Name	Meg-Torque	CORDLESS PROSTHODONTICSCREWDRIVER WITH TORQUECALIBRATION SYSTEM, MODELISD900

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Common Name	Handpiece, Direct Drive, AC-Powered	Handpiece, Direct Drive, AC-Powered
Manufacturer	MICRO-NX Co., Ltd	NAKANISHI Co., Ltd.
Intended Use	This product is a cordless motorhandpiece system intended fortightening and loosening anabutment screw to fix and removethe abutment on a dental implant inprosthodontic treatment.	This product is a cordless motorhandpiece system intended fortightening and loosening an abutmentscrew to fix and remove the abutmenton a dental implant in prosthodontictreatment.
Operational modes	Speed control, Torque control,Rotate both forward/reverseoperation, Calibration	Speed control, Torque control, Rotateboth forward/reverse operation,Calibration
Air/water ports	N/A	N/A
Fiberoptics	N/A	N/A
Dimensions	30×28×200(mm)(Width×Length×Height)	27×29×207(mm)(Width×Length×Height)
Type of chuck	Push Button Chuck	Push Button Chuck
Coupling dimensions	N/A	N/A
Chemicalcomposition of thewaterlines	N/A	N/A
The patient-contacting portionsof the device	The rotary instrument.	The rotary instrument.
Light intensity	N/A	N/A
Bur extraction force	N/A	N/A
Maximum air/waterpressure	N/A	N/A
Speed in rpms	15, 30, 45, 60 rpm	15, 20, 25rpm
Torque	5,15,20,25,30,35Ncm	10-40Ncm in 1 or 5 Ncm increments
Conformance withstandards for shanks	Screwdriver shank ø2.35mmISO1797-1 Type1	Screwdriver shank ø2.35mmISO1797-1 Type1
Coupling dimensions	N/A	N/A
Hose connections	N/A	N/A

10. Conclusion:

Based on the performance testing results, comparison of technology, and the indications for use, contained in the submission, MICRO-NX Co., Ltd. concludes that the MEG-TORQ 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.