W&H Assistina Twin

{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. December 8, 2017 W & H Dentalwerk Buermoos GmbH Mag. Anja Lindner Manager Regulatory Affairs Ignaz-Glaser-StraBe 53 5111 Buermoos AUSTRIA Re: K171553 Trade/Device Name: W&H Assistina Twin Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: November 7, 2017 Received: November 9, 2017 Dear Mag. Anja Lindner: 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 {1}------------------------------------------------ 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); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K171553 Device Name Assistina Twin MB-302 Indications for Use (Describe) Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. 510(k) Summary ## 510(k) SUMMARY | Submitter | W & H DENTALWERK BÜRMOOS GMBH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Bürmoos<br>Austria<br>Tel.: 0043 -6274 / 6236 -397<br>Fax: 0043 -6274 / 6236 -55 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Registration<br>Number | 9681479 | | Contact<br>Person | Mag. Anja LINDNER | | Date of<br>Submission | 7th of November, 2017 | | Device Name | Assistina TWIN MB-302 | | Classification<br>Name | Dental Handpieces and Accessories | | 510(k) number | K171553 | | Regulation<br>Number | 21 CFR 872.4200 | | Regulatory<br>class | I | | Product Code | EFB | | Predicate<br>Devices | Primary Predicate: "Care3 Plus", NSK.; cleared under K081811<br>Reference Predicate: Assistina 301+, W&H Dentalwerk Bürmoos, cleared<br>under K010127.<br>The predicate has not been subject to a design-related recall. | | Device<br>Description | The W&H Assistina TWIN MB-302 is an electrically and pneumatically<br>driven maintenance device with the following functions:<br>- Rinsing the spray channels with cleaning solution (water basis)<br>and drying with compressed air.<br>- Lubricating the rotational internal gear parts. The oil is spread<br>and a constant lubrication film is set up. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a partial view of a graphic with the words "PEOPLE HAVE PRIORITY" in a green box at the top. Below this, there is a gray graphic element that appears to be part of a larger design, possibly a logo or a visual representation of a concept. The text "IORITY" is visible at the bottom, suggesting that it is part of the word "PRIORITY" from the phrase above. 510(k) Summary | | | <b>Technical data:</b> | | | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------------------|----------|--| | | | <b>Assistina TWIN MB-302</b> | | | | | | | Cycle duration | 10 sec. | | | | | | Air consumption | Approx. 40 NI/min. | | | | | | Operating pressure | 5 – 10 bar (controlled via an integrated, automatic pressure controller) | | | | | | Supply voltage | 100 – 240 VAC | | | | | | Max. power consumption | 18 VA | | | | | | Weight | 3,8 kg | | | | | | Dimensions | 297 x 435 x 190 mm | | | | Indications for Use: | Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers. | | | | | | | Item | New device | Predicate device | Judgment | | | | Name | W&H Assistina TWIN MB-302 | NSK Care3 Plus | --- | | | Technological Characteristics | Photo | Image: W&H Assistina TWIN MB-302 | Image: NSK Care3 Plus | --- | | | | Where used | Dental practice, dental clinic. | Dental practice, dental clinic. | same | | | | Manufacturer | W&H Dentalwerk Bürmoos GmbH<br>www.wh.com | Nakanishi Inc.<br>www.nsk-inc.com | --- | | | | 510(k) | ------ | K081811 | --- | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters "W&H" inside of a white hexagon with rounded corners. The logo is placed on a white background. Above the logo, there is a green bar with the text "PEOPLE HAVE PRIORITY" written in white. 510(k) Summary | Indication for<br>Use | Unit for cleaning the spray channels<br>and lubricating the moving parts of<br>dental and surgical handpieces,<br>turbines, air motors and air- driven<br>scalers. | Care3 Plus is intended for<br>internal cleaning e.g. purging<br>of old lubricant, for the<br>maintenance of rotating<br>dental and surgical<br>instruments. | Similar | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Scope of<br>submission | - Assistina TWIN MB-302<br>device<br>- Adapter HPI<br>- Air supply hose<br>- TWIN Care Set (including<br>- lubricant, detergent and<br>HEPA filter)<br>- Power supply unit | - Care3 unit<br>- AC power cord<br>- Maintenance oil<br>- Oil supply funnel<br>- with filter<br>- Mist filter set<br>- Air tube<br>- Oil absorber sheet<br>- O- ring set<br>- Test bur<br>- Magnet | Similar | | Dimensions | 297 x 435 x 190mm (WxDxH) | 280 x 275 x 360mm<br>(WxDxH) | Similar | #### Technical Da | Technical Data: | | | | |----------------------|--------------------------------------------------------------------------------------------------------|--------------------------------|----------| | Item | New device<br>MB-302 | Predicate device<br>Care3 Plus | Judgment | | Power<br>supply | 100 – 240 V AC ± 10% | 120 – 230 V AC ± 10% | Similar | | Power<br>consumption | 18 VA | 19.5 VA | Similar | | Air pressure | 5 – 10 bar | 3.5 – 6 bar | Similar* | | Cleaning | Clean the process chambers with a dry cloth and wipe- disinfect the exterior and the process chambers. | <i>Not known</i> | Similar | ## Process liquids: | | Lubricant | W&H Service Oil F1 MD-<br>302 (cartridge containing<br>200ml lubricant)* | NSK maintenance oil<br>(1 liter bottle) | Similar | |--|-----------|--------------------------------------------------------------------------|-----------------------------------------|---------| | | Detergent | W&H Activefluid MC-302<br>(cartridge containing 200ml<br>detergent)** | not applicable | --- | {6}------------------------------------------------ ## 510(k) Summary | | 301+ only without alcohol and is therefore no dangerous good any more. | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The technical principle is the same as within the predicate device.<br>The main technological characteristics are the same or, at least, quite<br>similar to those of the comparable product.<br>The intended use is identical to the predicate device | | Comparison of<br>the device to<br>the predicate<br>device | The target field of application, the intended use, performance parameter<br>and material are the same or, at least, quite similar to those of the<br>predicate device.<br>The only differences are some technological features: different modes,<br>different number of buttons, different number of chambers.<br>The predicate device has no cleaning function. However, these<br>differences do not have any negative effect on the safety and/or<br>effectiveness of the subject device.<br>The new device is substantially equivalent to the predicate device. | | Performance<br>Testing | Electrical Safety Tests according to IEC 61010-1, Safety requirements for<br>electrical equipment for measurement, control and laboratory use – Part<br>1: General requirements for safety | | | Electromagnetic Compatibility Test according to IEC 61326-1: Electrical<br>equipment for measurement, control and laboratory use, EMC<br>requirements – Part 1: General requirements for safety | | | Software validation according to IEC 62304:2006: Medical device<br>software - Part 1: Guidance on the application of ISO 14972 to medical<br>device software | | | Biological Assessment and Cytotoxicity Testing of the liquids according<br>to EN ISO 10993 was performed. The evaluation meets the<br>requirements. | | | Risk Analysis according to ISO 14971. | | | Testing of cleaning performance according to ISO 15883.<br>Validation of wipe disinfection according to the IFU. | | | Different Bench Tests like Lifetime tests - Activation of start button,<br>moving/removing of sliding door, Lifecycle test according to internal<br>requirements. The results demonstrate substantial equivalence in this<br>regards. | | | Clinical<br>Testing | | Conclusion | W&H considers the Assistina Twin MB-302 to be substantially equivalent<br>to the predicate device listed above. This conclusion is based on the<br>similarities in intended use, principles of operation, functional design, and | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the text "W&H" inside a rounded hexagon shape. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo and banner are set against a light gray background. 510(k) Summary establishment medical use. Differences between the devices shown in the side-by-side comparison table above are minor and do not have any negative effect on equivalence.