The Impla-NX (Model: ISE-270M) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Device Description

As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.

With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance with specific metrics like sensitivity, specificity, or AUC, nor does it detail a study proving the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the document is a 510(k) summary for a dental handpiece and accessories, Impla-NX (Model: ISE-270M), demonstrating substantial equivalence to a predicate device (Surgic Pro by NSK Nakanishi, Inc.). The performance testing mentioned is primarily non-clinical bench testing against various ISO and IEC standards related to dental equipment, electrical safety, EMC, photobiological safety, and sterilization validation.

Therefore, most of the requested information cannot be extracted from this document as it pertains to clinical performance studies and AI/human reader assessments, which are not relevant to this device's regulatory submission as presented.

However, I can provide information based on the type of performance tests conducted and the general conclusion:

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

The document lists various international standards that the device was tested against. The "acceptance criteria" would be compliance with these standards, and the "reported device performance" is that these tests were conducted and found to be compliant. Specific numerical performance metrics for each standard are not provided in this summary.

Acceptance Criteria (Standards Compliance)	Reported Device Performance
ISO 3964 Dental Handpieces Coupling dimensions	Testing conducted, no violations of requirements.
ISO 7494-1 Dentistry - Dental units -Part 1: General requirements and test methods	Testing conducted, no violations of requirements.
ISO 14457:2017 Dentistry Handpieces and motors	Testing conducted, no violations of requirements.
ISO 17665-1, 2 Steam Sterilization Validation	Sterilization validation conducted, no violations of requirements.
IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC	Electrical safety and EMC testing conducted, no violations of requirements.
IEC 80601-2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment	Testing conducted, no violations of requirements.
IEC 62471 Photobiological safety of lamps and lamp systems	Testing conducted, no violations of requirements.
Software Validation	Software validation conducted, no violations of requirements.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical bench testing against standards, not a clinical study with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 surgical engine, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the respective ISO and IEC standards.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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May 21, 2021

MICRO-NX Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620

Re: K201192

Trade/Device Name: Impla-NX (Model: ISE-270M) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: May 14, 2021 Received: May 19, 2021

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

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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 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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

Device Name Impla-NX (Model: ISE-270M)

Indications for Use (Describe)

The Impla-NX (Model: ISE-270M) is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

(K201192)

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

Date: May 3, 2021

1. 510K 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

1. Submission Contact Person

LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

2. Device

Proprietary Name Impla-NX (Model: ISE-270M)
Common Name Implant Surgical Engine .
. Classification Name - Dental handpiece and accessories
Classification 21CFR 872.4200 (Product Code: EBW) .

3. Predicate Device

Surgic Pro by NSK Nakanishi, Inc (K173905)

4. Description:

As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.

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8. Indications for Use

9. Substantial Equivalence Discussion:

The Impla-NX (Model: ISE-270M) is substantially equivalent to Surgic pro( K173905) in the indications for use and the technological characteristics. The following comparison table is presented to demonstrate substantial equivalence.

The Impla-NX (Model: ISE-270M) does not have new Indications for Use: it is the same as the predicate device's indications for use. It shows equivalent specifications with the predicate devices in most of parameters.

The difference between the subject device and the predicate device is the number of memory set but this does not affect the performance as it is just for user convenience. The user can always adjust the setting parameters as needed.

Another difference is the torque of motor that the subject device has a slightly lower max torque than the predicate device. However, the max torque of 70Ncm is more than enough to be used in the clinical setting for the Indications for Use and it is covered by the max value of the predicate device; therefore, it would not raise a question in safety.

We conclude that the subject device is substantially equivalent to the predicate device.

	Subject Device	Predicate Device	Comparison
510(k) Number	K201192	K173905	-
Device Name	Impla-NX (Model:ISE-270M)	Surgic Pro	-
Common Name	Controller, Foot,Handpiece and cord	Controller, Foot,Handpiece AndCord	-
Manufacturer	MICRO-NX Co.,Ltd.	NSK Nakanishi,Inc	-
Indications for Use	The Impla-NX(Model: ISE-270M)is intended for usein dental oralsurgery and dental	The Surgic Pro+ /Surgic Pro isintended for use indental oral surgeryand dental implant.	Same
	implant. The mainunit is designed tobe used with aspecific dentalmicromotor thatdrives dentalhandpieces fittedwith appropriatetools to cut hardtissues in the mouth.Electric	The main unit isdesigned to be usedwith a specificdental micromotorthat drives dentalhandpieces fittedwith appropriatetools to cut hardtissues in themouth.Electric
Micromotor drive	Micromotor drive	Micromotor drive	Same
Package contents	Control UnitMicromotorFoot switch(wired)Irrigation TubeOperation Manual	Control UnitMicromotorFoot ControllerHandpieceIrrigation tubeOperation Manual	Different- The subjectdevice does notincludehandpieces.
	Optic	Yes	Yes	Same
	Memory	■ 6 Pre-set implantsystems■ 9 user defined of9 steps each	■ 8 Pre-set implantsystems■ 8 user defined of8 steps each	Different
		Torque on the motor	Max.70Ncm	Max.80Ncm	Same- It is within thecontrol range ofthe predicateproduct.
		Speed on the motor	200-40,000 rpm	200-40,000 rpm	Same.

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10. Performance Tests (Non-clinical)

Non-clinical bench tests were performed as followings:

ISO 3964 Dental Handpieces Coupling dimensions

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ISO 7494-1 Dentistry - Dental units -Part 1: General requirements and test methods
ISO 14457:2017 Dentistry Handpieces and motors
ISO 17665-1, 2 Steam Sterilization Validation
IEC 60601-1, IEC 60601-1-2: Electrical safety and EMC
IEC 80601-2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
IEC 62471 Photobiological safety of lamps and lamp systems

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

10. Conclusions:

Based on the information provided in this premarket notification, MICRO-NX Co., Ltd. concludes that the Impla-NX (Model: ISE-270M) is substantially equivalent to the predicate device as described herein in safety and effectiveness.

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.