Rodo Smilekey

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Rodo Medical, Inc. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteen Street NW Washington, District of Columbia 20004 May 23, 2018 Re: K180609 Trade/Device Name: Rodo Smilekey Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 8, 2018 Received: March 8, 2018 Dear Randy Prebula: 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 {1}------------------------------------------------ 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 (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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K180609 Device Name Rodo Smilekey Indications for Use (Describe) The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating. 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. 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}------------------------------------------------ # 510(k) SUMMARY Rodo Medical, Inc.'s Rodo Smilekey (K180609) #### Submitter | Company: | Rodo Medical, Inc. | |-----------------|------------------------------------------------------------| | Address: | 6399 San Ignacio Avenue<br>Suite 100<br>San Jose, CA 95119 | | Phone: | 408-245-7636 | | Facsimile: | 408-338-6940 | | Contact Person: | Michael Parsons | | Date Prepared: | May 10, 2018 | ## Subject Device | Name of Device: | Rodo Smilekey | |----------------------|------------------------------------| | Classification Name: | Endosseous Dental Implant Abutment | | Regulation: | 21 C.F.R. § 872.3630 | | Regulatory Class: | Class II | | Product Code: | NHA | ## Predicate Device | Company: | Rodo Medical, Inc. | |----------------|----------------------| | Device Name: | Rodo Abutment System | | 510(k) Number: | K160786 | | Regulation: | 21 C.F.R. § 872.3630 | | Product Codes: | NHA | ## Device Description The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed. {4}------------------------------------------------ ## Intended Use / Indications for Use The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating. #### Performance Data The following bench testing was conducted to demonstrate the performance of the Smilekey: - Electrical safety testing according to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, ● C1:2009/(R)2012 And A2:2010/(R)2012 - . EMC testing according to AAMI/ANSI/IEC 60601-1-2:2014 - Biocompatibility evaluation of the patient contacting materials . - Identical Handle material to predicate Smileloc Activator (K160786) O - FDA guidance document titled, "Use of International Standard ISO 10993-1, O 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued on June 16, 2016 - o Cytotoxicity testing of the tip housing material according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - . Cleaning and disinfection testing with simulated challenge soiling and organism - FDA guidance document titled, "Reprocessing Medical Devices in Health Care O Settings: Validation Methods and Labeling", issued on May 2, 2011 - AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for O reprocessing in health care facilities: A quide for medical device manufacturers - Software verification and validation testing . - FDA quidance document titled, "Content of Premarket Submission for Software O Contained in Medical Devices", issued on May 11, 2005 - Battery testing according to IEC 62133:2012 . - Usability testing according to IEC 60601-1-6 Edition 3.1 2013 - . Thermal safety testing to evaluate the temperature rise on implant, abutment and restoration during the unlocking procedure using the Smilekey induction activator, to ensure that temperatures do not exceed established safety limits. - ASTM F2182-11 testing guidelines were used which included gel media and O simulated use conditions. - The thermal safety limits were equivalent to the predicate Smileloc Activator O (K160786). - The results demonstrated that the temperatures were within safe limits. O ## Substantial Equivalence The proposed Rodo Smilekey and the predicate Smileloc Activator (part of the Rodo Abutment System K160786) have a similar intended use and similar indications of removing the Smileloc Sleeve from the Rodo Abutment. Both devices are intended to activate the Smileloc Sleeve to release a compatible prosthesis with the Rodo Abutment. Although the subject device uses induction heating instead of resistance heating, this difference in technological characteristics does not raise different questions of safety or effectiveness. Both devices deliver energy to increase the temperature of the Smileloc Sleeve. The induction energy is within safe levels for {5}------------------------------------------------ the oral application. In addition, the performance of the Rodo Abutment System and the thermal safety was verified and validated using the same scientific methodology as the predicate device. In addition, bench testing of the subject device has demonstrated substantial equivalent performance to the predicate device. # Conclusions The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). Similar to the predicate Smileloc Activator, the Smilekey uses heat to activate and to remove the Smileloc Sleeve. Although the Smilekey has a different heating method when compared to the Smileloc Activator, this difference in technological characteristics does not raise different questions of safety or effectiveness. Performance bench testing of the Smilekey demonstrated equivalent performance as the predicate device. Thus, the Smilekey can be found substantially equivalent to the predicate device. | | Subject Device<br>Rodo Smilekey | Predicate Device<br>Smileloc Activator of Rodo<br>Abutment System (K160786) | Comparison | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Rodo Smilekey is intended to<br>be used with the Rodo Abutment<br>System for removing prostheses<br>compatible with Smileloc Sleeve<br>by using induction heating. | Rodo Abutment System is<br>intended to be used in<br>conjunction with compatible<br>implant systems in the maxillary<br>or mandibular arch to provide<br>support for crowns, bridges or<br>overdentures. | The Indications for Use of<br>the subject device is derived<br>from the labeling of the<br>Smileloc Activator<br>component of the<br>overarching Rodo Abutment<br>System. | | Heating Method | Induction heating | Resistance heating | Difference in heating<br>method does not raise<br>different questions of safety<br>or effectiveness | | Type of battery<br>charge | Lithium Ion | Lithium Ion | Same | | Is battery<br>rechargeable? | Yes | No | Battery rechargeability does<br>not raise additional<br>questions of safety or<br>effectiveness | | Time needed for<br>tip on crown to<br>activate | 5 seconds for acrylic restorations,<br>9 seconds for non-acrylic<br>restorations (e.g., lithium<br>disilicate, zirconia) | 15 seconds | Difference in activation time<br>does not raise different<br>questions of safety or<br>effectiveness. Maximum<br>implant and abutment<br>temperatures reached<br>during activation remain<br>below safety limits. | | Maximum<br>implant/abutment<br>temperature<br>reached during<br>activation | Maximum implant and abutment<br>temperatures during activation<br>remain below safety limits<br>established by AAMI/ANSI<br>ES60601-1:2005/® 2012 and<br>A1:2012, c1:2009/® 2012 and<br>a2:2010/® 2012 and Eriksson, AR<br>et al. | Maximum implant and abutment<br>temperatures during activation<br>remain below safety limits<br>established by AAMI/ANSI<br>ES60601-1:2005/® 2012 and<br>A1:2012, c1:2009/® 2012 and<br>a2:2010/® 2012 and Eriksson, AR<br>et al. | Same | # Table 1: Comparison of Subject and Predicate Devices {6}------------------------------------------------ | | Subject Device<br>Rodo Smilekey | Predicate Device<br>Smileloc Activator of Rodo<br>Abutment System (K160786) | Comparison | |-------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------|------------| | Type of<br>indicators to<br>inform the end<br>user | LED | LED | Same | | Regulation of<br>energy delivery | Internal timer | Internal timer | Same | | Type of barrier<br>employed for<br>infection control<br>of device | FDA-cleared dental barrier sleeve | FDA-cleared dental barrier sleeve | Same |