Oral Surgery Contra

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211584 Device Name Oral Surgery Contra #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ | 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. {5}------------------------------------------------ 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 Surgery<br>Contra | Surgic Pro, Surgic<br>Pro+ | Implantmed SI-<br>1015 incl.<br>Accessories | | 510(k) Submitter<br>[Number] | NAKANISHI INC.<br>[K211584] | NAKANISHI INC.<br>[K173905] | W&H Dentalwerk<br>Bürmoos GmbH<br>[K161957] | | Product Code(s) -<br>Primary | KMW | EBW | EBW | | Product Code(s) -<br>Subsequent | n/a | KMW<br>EGS | n/a | | Indications for Use | Oral Surgery Contra<br>is for oral surgery.<br>This device is driven<br>by an electronic<br>micromotor for oral<br>surgery and dental<br>implant. This device<br>aims to transfer the<br>rotation of the power<br>source with various<br>gear ratios, and<br>moves instruments<br>such as a surgical bur<br>to cut the<br>maxillary/mandibular<br>bone during oral<br>surgery treatment. | Surgic Pro+ / Surgic<br>Pro<br>The Surgic Pro+ /<br>Surgic Pro is<br>intended for use in<br>dental oral surgery<br>and dental implant.<br>The main unit is<br>designed to be used<br>with a specific<br>dental micromotor<br>that drives dental<br>handpieces fitted<br>with appropriate<br>tools to cut hard<br>tissues in the mouth.<br>SG20/ X-SG20L<br>This medical device<br>is for oral surgery<br>and dental implant<br>operation. This<br>device is driven by<br>an electronic<br>micromotor for oral<br>surgery and dental<br>implant. The device<br>is intended to<br>transmit the rotation<br>of the power source<br>at different gear<br>ratios, thereby<br>moving instruments<br>such as surgical burs<br>or surgical drills to<br>cut the maxilla /<br>mandible during oral<br>surgery and dental<br>implant. | Mechanical drive<br>unit with coolant<br>supply for<br>transmission<br>instruments with<br>ISO 3964<br>(DIN13940)<br>compatible coupling<br>system, for use in<br>dental surgery,<br>implantology and<br>maxillofacial<br>surgery (CMF) for<br>treatment of dental<br>hard tissue. | | Application | Dental Oral Surgery<br>Preparation for<br>Dental Implants | Dental Oral Surgery<br>Dental Implants | Dental Surgery<br>Implantology<br>Maxillofacial<br>Surgery (CMF) | | | | | | | Model Numbers | X-SG25L<br>X-SG93<br>X-SG93L | SG20<br>X-SG20L | WS-56 L<br>WS-75 L<br>WS-91 L<br>WS-92 L<br>S-11 L | | Power Source | Electrical<br>Micromotor | Electrical<br>Micromotor | Electrical<br>Micromotor | | Handpiece<br>Chuck<br>Mechanism | Push-button | Push-button | Push-button | | Burs | ISO 1797<br>Type 1 CA<br>X-SG25L<br>ISO 1797<br>Type 3 FG<br>X-SG93<br>X-SG93L | ISO 1797-1 (Type 1) | ISO 1797-1 Type 1<br>WS-56 L<br>WS-75 L<br>ISO 1797-1 Type 3<br>WS-91 L<br>WS-92 L<br>ISO 1797-1 Type 2<br>S-11 L | | Handpiece<br>Coupling | ISO 3964 (EN ISO<br>3964) | ISO 3964 (EN ISO<br>3964) | ISO 3964 (EN ISO<br>3964) | | Transmission ratio | X-SG93L = 1:3<br>Increasing<br>X-SG93 = 1:3<br>Increasing<br>X-SG25L = 1:1<br>Direct Drive | SG20 = 20:1<br>Reduction<br>X-SG20L = 20:1<br>Reduction | WS-56 L = 1:1<br>WS-75 L = 20:1<br>WS-91 L = 1:2.7<br>WS-92 L = 1:2.7<br>S-11 L = 1:1 | | Materials<br>Composition<br>(Handpiece and<br>Exterior Coating) | Pure<br>Ti(MIM)+MRK-T | SG20: Stainless<br>Steel + CrN<br>X-SG20L: Pure<br>Ti(MIM)+MRK-T) | Chromium coated<br>steel and<br>chromium coated<br>brass | | Cleaning | Automatic Cleaning<br>(Washer-Disinfector)<br>Or<br>Manual Cleaning | Automatic Cleaning<br>(Washer-<br>Disinfector)<br>Or<br>Manual Cleaning | Automatic Cleaning<br>(Washer-<br>Disinfector)<br>Or<br>Manual Cleaning | | Sterilization | Pre-Vacuum<br>(Dynamic Air<br>Removal)<br>132°C, 4 min.<br>Drying Time: 30 min.<br>Gravity Displacement<br>132°C, 15 min<br>Drying Time: 30 min | Pre-Vacuum<br>(Dynamic Air<br>Removal)<br>132°C, 4 min.<br>Drying Time: 30 min.<br>Gravity Displacement<br>132°C, 15 min<br>Drying Time: 30 min | Pre-Vacuum<br>(Dynamic Air<br>Removal)<br>132°C, 4 min<br>Drying Time: 30 min.<br>Gravity Displacement<br>132°C, 15 min<br>Drying Time: 30 min | # Page 3 of 5 NAKANISHI INC. {6}------------------------------------------------ #### 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 {7}------------------------------------------------ | 510(k) SUMMARY | is substantially equivalent. Sterilization has been validated in conformance to<br>the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006;<br>"Sterilization of Health Care Products – Moist Heat - Part 1: Requirements for<br>the Development, Validation, and Routine Control of a Sterilization Process for<br>Medical Devices." Documentation was provided demonstrating that the Oral<br>Surgery Contra complies with the FDA requirements stated in Guidance for the<br>Reprocessing Medical Devices in Health Care Settings: Validation Methods<br>and Labeling - Guidance for Industry and Food and Drug Administration Staff.<br>In addition, testing for conformity to ISO 14457:2012; "Dentistry – Handpieces<br>and Motors" has been conducted. | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility<br>Testing: | Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO<br>10993-1: 2018 "Biological evaluation of medical devices – Part 1: Evaluation and<br>testing" and FDA Guidance “Use on International Standard ISO 10993,<br>“Biological evaluation of medical devices – Part 1: Evaluation and Testing” and<br>included:<br>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 the<br>Clinical Tests: | Clinical testing was not required for a determination of substantial equivalence of<br>the Oral Surgery Contra. | | Conclusion: | NAKANISHI INC. considers the Oral Surgery Contra handpieces to be<br>substantially equivalent to the predicate and reference devices listed above. This<br>conclusion is based on the similarities in primary intended use, principles of<br>operation, functional design and established medical use. |