Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

Device Description

The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:

Model	Transmission gear ratio	Maximum speed
X-SG93L	1:3 Increasing	120,000 min-1
X-SG93	1:3 Increasing	120,000 min-1
X-SG25L	1:1 Direct Drive	40,000 min-1
The handpieces are manufactured using titanium and stainless steel and feature a push-button chuck mechanism. They are designed for use with surgical motors with an ISO 3964 (EN ISO 3964) type coupling system. The handpieces are designed for use with surgical burs, as follows:

X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm)
X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).
The Oral Surgery Contra handpieces are a prescription-only device.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Oral Surgery Contra" device. It is a submission for substantial equivalence based on comparisons to predicate and reference devices, and no clinical studies were conducted that prove device meets acceptance criteria.

Here's an analysis based on the provided text:

No clinical studies were performed. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Oral Surgery Contra." Therefore, there is no information in the provided text regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria through clinical data.

The "Summary of Performance Testing" section mentions "verification/validation testing to internal functional specifications" and conformance to various ISO standards (AAMI/ANSI/ISO 17665-1:2006 for sterilization, ISO 14457:2012 for handpieces and motors, and AAMI/ANSI/ISO 10993-1: 2018 for biocompatibility). These are bench tests and evaluations, not clinical studies involving patients or expert review of clinical images/data.

Therefore, since no clinical study was performed, the following requested information cannot be provided from the text:

A table of acceptance criteria and the reported device performance: Not applicable for clinical performance.
Sample sized used for the test set and the data provenance: Not applicable as there was no test set from a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 mechanical handpiece, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical handpiece, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this document describes a regulatory submission relying on substantial equivalence to predicate devices and bench testing, rather than novel clinical performance studies.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2021

Nakanishi Inc. % Yulia Nikova Regulatory Project Manager Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson. Texas 75081

Re: K211584

Trade/Device Name: Oral Surgery Contra Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: KMW Dated: May 21, 2021 Received: May 24, 2021

Dear Yulia Nikova:

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

510(k) Number (if known) K211584

Device Name Oral Surgery Contra

Indications for Use (Describe)

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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K211584 Submitter: NAKANISHI INC. 700 Shimohinata Kanuma, Tochigi 322-8666 Japan Contact Person: Mr. Masaaki Kikuchi General Manager, Regulatory Affairs Dept. TEL: +81-289-64-7277 FAX: +81-289-62-9738 email: m-kikuchi@nsk-nakanishi.co.jp Date Prepared: August 16, 2021 Submission Type: Traditional 510(k) Subject Device: Manufacturer: NAKANISHI INC. Trade Name: Oral Surgery Contra Common Name: Handpiece, Rotary Bone Cutting Regulatory Class: Class II Product Code: KMW Regulation: 21 CFR 872.4120, Bone cutting instrument and accessories Predicate Device: K173905 dated June 19, 2018 Clearance: Manufacturer: NAKANISHI INC. Trade Name: Surgic Pro, Surgic Pro+ Common Name: Controller, Foot, Handpiece and Cord Regulatory Class: Class I Dental Handpiece and Accessories Classification Name: Product Code(s) -EBW Primary: Product Code(s) -EGS Subsequent KMW Regulation: 21 CFR 872.4200, Dental handpiece and accessories K161957 dated November 23, 2016 Reference Device: Clearance: Manufacturer: W&H Dentalwerk Burmoos GmbH Trade Name: Implantmed SI-1015 incl. Accessories Common Name: Controller, Foot, Handpiece and Cord Regulatory Class: Class I Classification Name: Dental Handpiece and Accessories Product Code: EBW 21 CFR 872.4200, Dental handpiece and accessories Regulation: Device The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-Description: SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The

Page 1 of 5 NAKANISHI INC

maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for

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Model	Transmission gear ratio	Maximum speed
X-SG93L	1:3 Increasing	120,000 min-1
X-SG93	1:3 Increasing	120,000 min-1
X-SG25L	1:1 Direct Drive	40,000 min-1

the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:

The handpieces are manufactured using titanium and stainless steel and feature a push-button chuck mechanism. They are designed for use with surgical motors with an ISO 3964 (EN ISO 3964) type coupling system.

The handpieces are designed for use with surgical burs, as follows:

X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm) - X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).

The Oral Surgery Contra handpieces are a prescription-only device.

Indications for Oral Surgery Contra is for oral surgery. This device is driven by an electronic Use: micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

Summary of Comparison with the predicate device shows the characteristics of the subject Technological device to be substantially equivalent to the predicate device. As such, the Oral Characteristics: Surgery Contra handpieces and the predicate device have the same technological characteristics:

Intended use
Method of operation
Push-button autochuck
Lubrication requirements
Autoclavable ●

The following technological differences exist between the subject device and the predicate:

. Transmission gear ratios
Compatible burs

These differences do not raise different questions of safety and effectiveness. Additionally, the reference device has the similar transmission ratios and is compatible with the same types of burs as the subject device.

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The following table summarizes the comparison of the subject Oral Surgery Contra handpieces with the primary predicate and reference devices for indications for use and technological characteristics.

	Subject Device	Predicate Device	Reference Device
Trade Name	Oral SurgeryContra	Surgic Pro, SurgicPro+	Implantmed SI-1015 incl.Accessories
510(k) Submitter[Number]	NAKANISHI INC.[K211584]	NAKANISHI INC.[K173905]	W&H DentalwerkBürmoos GmbH[K161957]
Product Code(s) -Primary	KMW	EBW	EBW
Product Code(s) -Subsequent	n/a	KMWEGS	n/a
Indications for Use	Oral Surgery Contrais for oral surgery.This device is drivenby an electronicmicromotor for oralsurgery and dentalimplant. This deviceaims to transfer therotation of the powersource with variousgear ratios, andmoves instrumentssuch as a surgical burto cut themaxillary/mandibularbone during oralsurgery treatment.	Surgic Pro+ / SurgicProThe Surgic Pro+ /Surgic Pro isintended for use indental oral surgeryand dental implant.The main unit isdesigned to be usedwith a specificdental micromotorthat drives dentalhandpieces fittedwith appropriatetools to cut hardtissues in the mouth.SG20/ X-SG20LThis medical deviceis for oral surgeryand dental implantoperation. Thisdevice is driven byan electronicmicromotor for oralsurgery and dentalimplant. The deviceis intended totransmit the rotationof the power sourceat different gearratios, therebymoving instrumentssuch as surgical bursor surgical drills tocut the maxilla /mandible during oralsurgery and dentalimplant.	Mechanical driveunit with coolantsupply fortransmissioninstruments withISO 3964(DIN13940)compatible couplingsystem, for use indental surgery,implantology andmaxillofacialsurgery (CMF) fortreatment of dentalhard tissue.
Application	Dental Oral SurgeryPreparation forDental Implants	Dental Oral SurgeryDental Implants	Dental SurgeryImplantologyMaxillofacialSurgery (CMF)

Model Numbers	X-SG25LX-SG93X-SG93L	SG20X-SG20L	WS-56 LWS-75 LWS-91 LWS-92 LS-11 L
Power Source	ElectricalMicromotor	ElectricalMicromotor	ElectricalMicromotor
HandpieceChuckMechanism	Push-button	Push-button	Push-button
Burs	ISO 1797Type 1 CAX-SG25LISO 1797Type 3 FGX-SG93X-SG93L	ISO 1797-1 (Type 1)	ISO 1797-1 Type 1WS-56 LWS-75 LISO 1797-1 Type 3WS-91 LWS-92 LISO 1797-1 Type 2S-11 L
HandpieceCoupling	ISO 3964 (EN ISO3964)	ISO 3964 (EN ISO3964)	ISO 3964 (EN ISO3964)
Transmission ratio	X-SG93L = 1:3IncreasingX-SG93 = 1:3IncreasingX-SG25L = 1:1Direct Drive	SG20 = 20:1ReductionX-SG20L = 20:1Reduction	WS-56 L = 1:1WS-75 L = 20:1WS-91 L = 1:2.7WS-92 L = 1:2.7S-11 L = 1:1
MaterialsComposition(Handpiece andExterior Coating)	PureTi(MIM)+MRK-T	SG20: StainlessSteel + CrNX-SG20L: PureTi(MIM)+MRK-T)	Chromium coatedsteel andchromium coatedbrass
Cleaning	Automatic Cleaning(Washer-Disinfector)OrManual Cleaning	Automatic Cleaning(Washer-Disinfector)OrManual Cleaning	Automatic Cleaning(Washer-Disinfector)OrManual Cleaning
Sterilization	Pre-Vacuum(Dynamic AirRemoval)132°C, 4 min.Drying Time: 30 min.Gravity Displacement132°C, 15 minDrying Time: 30 min	Pre-Vacuum(Dynamic AirRemoval)132°C, 4 min.Drying Time: 30 min.Gravity Displacement132°C, 15 minDrying Time: 30 min	Pre-Vacuum(Dynamic AirRemoval)132°C, 4 minDrying Time: 30 min.Gravity Displacement132°C, 15 minDrying Time: 30 min

Page 3 of 5 NAKANISHI INC.

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Summary of Performance Testing:

The Oral Surgery Contra handpieces are developed and produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing.

Tests were performed on the subject device including verification/validation testing to internal functional specifications which demonstrated that the device

Page 4 of 5

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510(k) SUMMARY	is substantially equivalent. Sterilization has been validated in conformance tothe FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006;"Sterilization of Health Care Products – Moist Heat - Part 1: Requirements forthe Development, Validation, and Routine Control of a Sterilization Process forMedical Devices." Documentation was provided demonstrating that the OralSurgery Contra complies with the FDA requirements stated in Guidance for theReprocessing Medical Devices in Health Care Settings: Validation Methodsand Labeling - Guidance for Industry and Food and Drug Administration Staff.In addition, testing for conformity to ISO 14457:2012; "Dentistry – Handpiecesand Motors" has been conducted.
BiocompatibilityTesting:	Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO10993-1: 2018 "Biological evaluation of medical devices – Part 1: Evaluation andtesting" and FDA Guidance “Use on International Standard ISO 10993,“Biological evaluation of medical devices – Part 1: Evaluation and Testing” andincluded:Cytotoxicity per ISO 10993-5 Sensitization per ISO 10993-10 Irritation per ISO 10993-10 Acute Systemic Toxicity per ISO 10993-11 Pyrogenicity per ISO 10993-11
Discussion of theClinical Tests:	Clinical testing was not required for a determination of substantial equivalence ofthe Oral Surgery Contra.
Conclusion:	NAKANISHI INC. considers the Oral Surgery Contra handpieces to besubstantially equivalent to the predicate and reference devices listed above. Thisconclusion is based on the similarities in primary intended use, principles ofoperation, functional design and established medical use.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.