Surgical Angle Handpiece, Surgical Straight Handpiece

K171155 · Nakanishi, Inc. · KMW · Nov 21, 2017 · Dental

Device Facts

• Record ID: K171155
• Device Name: Surgical Angle Handpiece, Surgical Straight Handpiece
• Applicant: Nakanishi, Inc.
• Product Code: KMW · Dental
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).

Device Story

Surgical Straight/Angle Handpiece series; manual dental/oral surgical instrument. Connects to air or electronic motors (ISO 3964 compliant); accepts friction grip burs (ISO 1797-1). Used by licensed dental professionals in clinical settings for bone cutting, tooth sectioning, and implant site preparation. Device features Bur Lock Ring Chuck Design; external water irrigation nozzle. Non-sterile; requires steam sterilization before use. Provides mechanical rotation to burs for precise bone/tooth manipulation; assists clinicians in surgical access and site preparation; improves procedural efficiency in oral surgery.

Clinical Evidence

Bench testing only. Verification and validation testing performed against internal functional specifications and international standards (ISO 14457, ISO 1797-1, ISO 3964). Sterilization validated per AAMI/ANSI/ISO 17665-1:2006. Biocompatibility evaluated per AAMI/ANSI/ISO 10993-1.

Technological Characteristics

Materials: Stainless steel (including SUS304T water lines) and aluminum. Interface: ISO 3964 motor coupling; ISO 1797-1 Type 2 friction grip burs. Max motor speed: 40,000 min-1. Gear ratios: 1:1 (direct) and 1:2 (increasing). Form factor: Straight and 20-degree angle models; 108.7mm-135mm length. Sterilization: Steam (moist heat). Non-optic.

Indications for Use

Indicated for licensed professionals performing oral surgical and dental procedures, including wisdom tooth sectioning/removal, root tip resection, bone removal/shaping, and implant drilling in the maxilla and mandible.

Regulatory Classification

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.

Predicate Devices

• MontBlanc Surgical Contra-Angle Handpiece and Straight Handpiece (K111532)
• E-Type Speed Reducer Contra Angle (K970953)

Submission Summary (Full Text)

{0}------------------------------------------------

November 21, 2017

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".

Nakanishi Inc. c/o Belia Juarez Regulatory Project Manager Ken Block Consulting 1201 Richardson Dr. Richardson, Texas 75080

Re: K171155

Trade/Device Name: Surgical Straight/Angle Handpiece Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: KMW, EGS Dated: October 20, 2017 Received: October 23, 2017

Dear Belia Juarez:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner -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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K171155

Device Name Surgical Straight/Angle Handpiece

#### Indications for Use (Describe)

The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).

Type of Use (Select one or both, as applicable)

2 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)

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}------------------------------------------------

# NSI

K171155

## ←5. 510(k) SUMMARY

| Submitter: | NAKANISHI INC.<br>700 Shimohinata<br>Kanuma-Shi, Tochigi-Ken Japan 322-8666 | | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | NAKANISHI INC.<br>Mr. Kimihiko Satoh<br>General Manager, Regulatory Affairs Dept<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | | |
| Date Prepared: | November 20, 2017 | | |
| Trade Name: | Surgical Straight/Angle Handpiece | | |
| Common Name: | Handpiece, Rotary Bone Cutting<br>Handpiece, Contra-and Right-Angle Attachment, Dental | | |
| Classification Name: | Bone Cutting Instrument and Accessories | | |
| Regulation: | 21 CFR 872.4120<br>Class II | | |
| Product Code: | KMW and EGS | | |
| Predicate Devices: | Primary: K111532 Anthogyr SAS | MontBlanc Surgical Contra-Angle Handpiece and Straight Handpiece<br>Secondary: K970953 NAKANISHI INC.<br>E-Type Speed Reducer Contra Angle | |
| Device<br>Description: | The Surgical Straight/Angle Handpiece features an allowable maximum motor speed<br>at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed<br>with an angle appearance and a straight appearance. Models are available to be<br>connected directly onto motors compliant to ISO 3964. All the devices are<br>manufactured using stainless steel with some aluminum, and use a Bur Lock Ring<br>Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight<br>(1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-<br>E2G, SGA-E2S. | | |
| Indications<br>for Use: | The Surgical Straight/Angle Handpiece Series is intended for use by licensed<br>professionals for oral surgical and dental use. Typical uses include sectioning and<br>removal of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, bone<br>removal, bone shaping) and implant treatment (such as drilling the maxilla and<br>mandible). | | |
| Summary of<br>Technological<br>Characteristics: | As with the predicate devices referenced above, the Surgical Straight/Angle<br>handpieces are intended for oral surgical and dental use. The handpieces are powered<br>by either an air-motor or electronic micro motors compliant to ISO 14457 with<br>couplings compliant to [ISO 3964 (EN ISO 3964)]. Friction Grip Burs that conform to<br>standard ISO 1797-1 (EN ISO 1797) are to be used with the Surgical Straight/Angle<br>Handpieces. The allowable maximum motor speed rotation for the handpieces should<br>be set at 40,000min-1. The handpieces are provided non-optic. Overall dimensions,<br>weight, angle, and gear ratio vary due to the differences in the device's compatibility. | | |

Image /page/3/Picture/6 description: In the image, a hand wearing a white glove is holding a blue plastic tool. The tool appears to be designed for a specific purpose, possibly related to crafting or assembly. The hand is positioned in a way that suggests the tool is being used or demonstrated. The text "Powerful Partners" is visible at the bottom of the image.

{4}------------------------------------------------

The handpieces overall length varies between 108.7mm-135mm depending on the model. The handpieces feature a Bur Lock Ring Chuck Design. The Surgical Straight/Angle Handpieces are provided non-sterile, so it must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization). All models feature an external water supply irrigation nozzle that is provided with the handpiece. The handpieces are composed of Stainless Steel and Aluminum and the water lines are composed of Stainless Steel (Grade SUS304T.)

The proposed device shares technological characteristics with the predicate devices. The proposed device also has some differences in technological characteristics from those of the predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and does not impact the substantial equivalence of the device.

| | Proposed: NAKANISHI INC.<br>K171155 | Predicate: ANTHOGYR SAS<br>[K111532] |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Surgical Straight/Angle Handpiece | MontBlanc Surgical Contra-Angle<br>Handpiece and Straight Handpiece |
| Models | SGA-E, SGA-ES, SGA-E2G, SGA-E2S<br>SGS-E, SGS-ES, SGS-E2G, SGS-E2S | 12200X, 12200XL, 12200XLED, 12400X,<br>12400XLED |
| Indication for Use | The Surgical Straight/Angle Handpiece<br>Series is intended for use by licensed<br>professionals for oral surgical and dental<br>use. Typical uses include sectioning and<br>removal of wisdom teeth, cutting teeth,<br>oral surgery (such as root tip resection,<br>bone removal, bone shaping...) and<br>implant treatment (such as drilling the<br>maxilla and mandible). | Indications are very widespread in the<br>field of implantology and surgery. The<br>mentioned handpieces have been<br>developed especially for the following<br>applications:<br>-MontBlac Surgical Contra-angle<br>handpiece: for e.g. hemisection, wisdom<br>tooth extraction.<br>-MontBlac Surgical Straight handpiece:<br>for e.g. application in the area of the<br>front teeth, root tip, resection, bone<br>removal, osteotomy on the upper and<br>lower jaw, preprosthetic surgical<br>osteoplasty, sequestrum removal,<br>fenestration on the alveolar appendix,<br>opical ventilation, bone osteoplasty,<br>bone smoothing |
| Handpiece Type | Straight, 20° Angle | Straight, Contra Angle |
| Operational Mode(s)<br>Motor Connection | ISO 3964 motor connection | ISO 3964 motor connection |
| Weight | 59.5g to 103.5g | 125g straight<br>98g contra-angle |
| Coupling Type | ISO 3964 Coupling | ISO 3964 Coupling |
| Burs | ISO 1797-1<br>Type 2 | EN ISO 1797-1<br>Contra: Type 3 Straight: Type 1 or 2 |
| Max Rotation Speed<br>(motor) | $40,000min^{-1}$ | $40,000min^{-1}$ |
| Max rotation speed<br>(handpiece) | $40,000min^{-1} to 80,000min^{-1}$ | $40,000min^{-1}to 120,000min^{-1}$ |
| Gear Ratio | 1:1 Direct Drive, 1:2 Increasing | 1:1 Direct Drive, 1:3 Increasing |

Summary of Performance Testing:

The Surgical Straight/Angle Handpiece was developed and is 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 handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006; "Sterilization of Health Care Products -

Image /page/4/Picture/6 description: In this image, a hand wearing a white glove is holding a blue medical device. The device appears to be some type of surgical instrument, possibly a clamp or forceps. The hand is positioned as if it is in the process of using the device. The text "Powerful Partners" is visible at the bottom of the image.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a blue background. The letters "NSK" are in a bold, sans-serif font, with the "N" and "S" connected by a curved line.

Moist Heat - Part 1: Requirements for the Development. Validation, and Routine Control of a Sterilization Process for Medical Devices." Documentation was provided demonstrating that the Surgical Straight/Angle Handpiece complies with the FDA requirements stated in Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use on International Standard ISO 10993, "Biological evaluation of medical devices - Part 1: Evaluation and Testing". In addition, testing for electrical safety was performed in accordance with ISO 14457.

Conclusion: NAKANISHI INC. considers the Surgical Straight/Angle Handpiece to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

Section 5: Page 3 of 3

Image /page/5/Picture/3 description: The image shows a hand wearing a white glove holding a blue surgical instrument. The instrument appears to be a type of surgical dissector or similar tool, with a pointed tip and a handle designed for precise manipulation. The text "Powerful Partners" is visible at the bottom of the image, suggesting the instrument is part of a medical product line or partnership.