A-dec NLZ Electric Motor System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 11, 2017 Nakanishi, Inc. % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 1130033 JAPAN Re: K163131 Trade/Device Name: A-dec NLZ Electric Motor System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW Dated: April 24, 2017 Received: April 25, 2017 Dear Izumi Maruo: 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 {1}------------------------------------------------ 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. # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163131 Device Name A-dec NLZ electric motor system #### Indications for Use (Describe) The A-dec NLZ electric motor system is control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, prophylaxis and endodontic treatment, with use of a straight, right-angle ISO E-tvpe handpiece attachment of equal, gear-reducing, or gearincreasing speed. 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 Druq 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white text on a blue background. A white line is above the text. ### 510(k) Summary #### Owner/Company name, address a. NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan ### b. Contact Kimihiko Satoh General Manager, Regulatory Affairs Department NAKANISHI INC. 700 Shimohinata, Kanuma-shi, Tochigi, 322-8666, Japan +81-289-64-4325 Phone: Fax: --+81-289-62-6665 k-satoh@nsk-nakanishi.co.jp Email: ### c. Application Correspondent Izumi Maruo Senior Consultant MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan Phone: +81-3-3818-8577 Fax: +81-3-3818-8573 maruo@mici.co.jp Email: #### d. Date prepared May 10, 2017 ### e. Name of device Trade Name: Classification Name: Regulation Name: Regulatory Class: Product Code: A-dec NLZ Electric Motor System Controller, Foot, Handpiece and Cord Dental handpiece and accessories Class I EBW Image /page/3/Picture/14 description: The image shows a hand holding a blue object that resembles a pen or stylus. The hand is light-skinned and appears to be wearing a glove. The blue object has a unique design with sharp angles and lines. Below the hand and object, the words "Powerful Partners" are written in a small, light-colored font. {4}------------------------------------------------ Image /page/4/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 a curved line above the letters. #### f. Predicate devices The A-dec NLZ electric motor system is substantially equivalent to the following legally marketed device: 510(k): K133776 A-dec/W&H Electric Motor, Model EA-53 Trade name: Product code: EBW ## g. Description of the device The A-dec NLZ electric motor system is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. Control Unit, Motor and Motor Tubing are constituents of the A-dec NLZ electric motor system under this 510(k) application. The A-dec NLZ electric motor system is intended for use only with the A-dec 300 (K082985) or A-dec 500 (K032756) delivery system. The A-dec 300 (K082985) or A-dec 500 (K032756) delivery system offers operation modes for use with the A-dec NLZ electric motor system. The Control Unit of the A-dec NLZ electric motor system is contained within the control head of the A-dec 300 (K082985) or A-dec 500 (K032756). The subject device acquires +24 VAC electrical power from the delivery system to the Control Unit. User can control the motor system through Touch Pad and Foot Controller of the delivery system. The control unit receives instructions such as motor rotation/stop, speed setting value, torque setting value, and LED turning ON/OFF from Touch Pad and Foot Controller. The Control Unit drives the Motor using instructed rotation speed and torque via Motor Tubing. The delivery system provides standard mode (range of rotation speed is 1,000 - 40,000 rpm) and endo mode (range of rotation speed is 100 - 5,000 rpm). The Motor Tubing is connected to the Control Unit via a lead wire and air/water supply via tubing inside the control head of the delivery system. The other side of the Motor Tubing is attached to the Motor. Image /page/4/Picture/9 description: The image shows a hand holding a blue object that resembles a pen or stylus. The hand is light-skinned and appears to be in a writing or drawing position. The blue object has a stylized design, possibly representing a logo or symbol. Below the hand and object, the words "Powerful Partners" are written in a smaller font, suggesting a brand name or slogan. {5}------------------------------------------------ # h. Indications for Use The A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. #### i. Statement of substantial equivalence The Indications for Use of the A-dec NLZ electric motor system is similar to the predicate. Other features of the subject device are similar to the predicate. Following table is comparison between the A-dec NLZ electric motor system and the predicate. | | A-dec NLZ electric motor<br>system | A-dec/W&H Electric Motor,<br>Model EA-53 (K133776) | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The A-dec NLZ electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. | The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right- angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed. | | Drive | Electronic-micromotor | Electronic-micromotor | | Components | Motor controller, Electric micromotor, Motor tubing | Motor controller, Electric micromotor, Motor tubing | | Size | | | | -Motor controller | D78.5 x W148.0 x H43.0<br>(Protruding parts not included.) | D60 x W120 x H44<br>(Protruding parts not included.) | Table 1. Comparison table between the A-dec NLZ electric motor system and the predicate Image /page/5/Picture/8 description: The image shows the text "510(k) Summary Page 3 of 5". The text is centered and in a simple font. The image appears to be a header or footer from a document. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is in blue and white. The letters "NSK" are in a bold, sans-serif font, with a white line above the letters. | -Motor | Length : 31 mm<br>Diameter : Φ20.1(Front)<br>Φ22.1(Rear) | Length : 31 mm<br>Diameter : Φ20.7(Front)<br>Φ21.3(Rear) | |---------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------| | -Motor tubing | Length of tubing<br>NLZ CDAS: 1600 mm<br>NLZ CDAL: 2080 mm | Length of tubing<br>2080 mm | | Material of Motor exterior | Titanium | Stainless steel | | Light | LED | LED | | Range of rotation speed (rpm) (standard mode) | 1,000 - 40,000 rpm | 1,000 - 40,000 rpm | | Range of rotation speed (rpm) (endo mode) | 100 – 5,000 rpm | 100 - 5,000 rpm | | Rotating direction | Forward and Reverse | Forward and Reverse | | Torque<br>- Standard Mode Maximum Torque (Stall Torque) | 4.00 Ncm (Measured value) | 4.10 Ncm (Measured value) | | - Endo Mode Torque Range | 0.30 - 3.00 Ncm | 0.30 - 3.00 Ncm | | Coolant mechanism | Coolant air | Coolant air | | Sterilization | Sterilized by user<br>(steam sterilization) | Sterilized by user<br>(steam sterilization) | | Available Handpiece type | E-type (ISO3964) | E-type (ISO3964) | | Usage environment | Temperature : 0 - 40°C<br>Humidity : 30 - 75% RH | Temperature : 10 - 33 ℃ | In the comparison table, there are some differences in characteristics between the A-dec NLZ electric motor system and the predicate. We considered that the differences did not affect the identical principles of operation between the A-dec NLZ electric motor system and the predicate. Performance testing including biocompatibility testing, Electric safety and EMC testing, bench testing was performed in order to demonstrate substantial equivalence to the predicate. Also, sterilization and software validation were performed in accordance with FDA guidance. The A-dec NLZ electric motor system met all requirements of the standards. Therefore, the A-dec NLZ electric motor system demonstrated substantial equivalence to the predicate. #### j. Biocompatibility Following biocompatibility test was performed: - . Cytotoxicity (ISO 10993-5:2009) - Sensitization (ISO 10993-10: 2010) Image /page/6/Picture/8 description: The image shows a hand holding a blue object that resembles a pen or stylus. The hand is white and appears to be wearing a glove. The blue object has a sharp, angular design. Below the hand, the words "Powerful Partners" are written in a small, light-colored font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the logo for NSK, a company specializing in motion and control technologies. The logo is displayed in white against a blue background. The letters "NSK" are prominently featured, with a stylized line above the letters, adding a dynamic element to the design. Irritation (ISO 10993-10: 2010) . In the biocompatibility testing reports, no biocompatibility concern was raised. #### k. Bench Testing The bench tests were performed in order to verify conformity to ISO 14457. All A-dec NLZ electric motor system samples were compliant with ISO 14457. Also, electromagnetic compatibility testing in accordance with IEC 60601-1-2 and electrical safety testing in accordance with IEC 60601-1 were performed. Those test results indicate that the A-dec NLZ electric motor system does not raise concern. Software validation was conducted in accordance with FDA guidance entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005" and sterilization of the Motor was conducted in accordance with FDA guidance entitled "Reprocessing Medical Devices in Health Care Settings: Validation Method and Labeling Guidance for Industry and Food and Drug Administration Staff". In addition, infection/cross-contamination risk analysis of the Motor tubing in accordance with ISO14971 was conducted. Based on the risk analysis, verification testing was performed in order to evaluate the possible introduction of biological materials (e.g. blood, bone, saliva) into the Motor tubing due to backflow. No backflow into the Motor and Motor tubing was detected in the verification testing. In order to evaluate extractables of the water circuit of the subject device, the elution testing was performed. The extractables/leachables were not detected. No animal or clinical testing was performed. #### l. Conclusion The indications for use of the A-dec NLZ electric motor system is similar to the predicate. Although there are some differences in characteristics between the A-dec NLZ electric motor system and the predicate, a number of performance testing indicated that the A-dec NLZ electric motor system met the requirement of the standards. Based on above results, we conclude the A-dec NLZ electric motor system is substantially equivalent to the predicate. Image /page/7/Picture/12 description: The image shows a hand holding a blue pen with the letters "GS" on it. The hand is wearing a white glove. The text "Powerful Partners" is at the bottom of the image.