UnicLine Mobile

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2015 Heka Dental A/S c/o Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza. Suite 2000 New York, NY 1011 Re: K150490 Trade/Device Name: UnicLine Mobile Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 3, 2015 Received: April 6, 2015 Dear Mr. Yungvirt: 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. {1}------------------------------------------------ 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 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. 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Heka Dental - Unicline Mobile Traditional 510(k) #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expfrabon Date :: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Not Yct Known. K150490 Device Name UnicLine Mobile #### Ind1catlons for Use (Describe) The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals. Type of Use (Select one or both, as applicable) l:8J Prescription Use (Part 21 CFR 801 Subpart D) O 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 STAFFEMAIL 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 OMS number. • {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Heka Dental. The logo is in black and gray, with the word "heka" in black and the word "dental" in gray. Above the logo is some text that reads "+HND 'HQWDO - 8QLF/LQH 0RELOH 7UDGLWLRQDO 510(N)". ## SECTION 5: 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92 ## 510(k) Summary | Date Prepared: | February 12, 2015 | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | HEKA DENTAL A/S<br>Baldershøj 38<br>DK-2635 Ishøj<br>Denmark.<br>Telephone: +45 43 32 09 90<br>Facsimile: +45 43 32 09 80 | | Contact:<br>Trade/Proprietary<br>Name of Device: | Cynthia J. Pillar, RAC<br>Phone: 1 (773) 677-8886 | | | UNICLINE MOBILE | | Common Name<br>of Device: | Dental Operative Unit | | Classification: | Class I per 21 CFR 872.6640, Operative Unit, Dental,<br>Product Code EIA | | Legally Marketed<br>Predicate<br>Device: | Aseptico AMC 20 Mobile Dental System, K101332) Class I<br>per 21 CFR 872.6640, Operative Unit, Dental, Product Code<br>EIA, manufactured by Aseptico, Inc. | | Reference<br>Device: | Planmeca Sovereign Dental Operative Unit, K081699 Class<br>I per 21 CFR 872.6640, Operative Unit, Dental, Product<br>Code EIA, manufactured by Planmeca USA, Inc. | ## Description of New UNICLINE MOBILE Device: The new UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit consisting of a mobile cart, foot control, internal water supply containers, suction, and mobile patient chair. It contains a foot control that allows the dental professional to engage the features using only the foot. Instrument status is viewable in a single place using a multi-display feature. The instrument arms are spring balanced for ease of use and the extra long connection hoses have been designed for use in any position. The new UNICLINE MOBILE is designed to ensure patient comfort and safety in any of {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "hekadental" in a stylized font, with the "heka" part in black and the "dental" part in gray. Above the word, there is some text that appears to be a product code or some other identifier, such as "+HND 'HQWDO - 801 F/L OH ORFI OF". The text is in a smaller font size and is aligned to the right of the word "hekadental". the chair positions. The handles, instrument support, and upholstery are easy to disassemble and clean. The unit uses compressed air and water, and includes a suction element. The cart contains the motors that operate the instrument connections. There are two movable arms that protrude from the top of the cart. One arm contains the optional OEM dental operating lamp that the dentist can position to light the area being worked on. The other arm supports an instrument table. The table contains five spring-loaded smaller arms, an instrument tray, and the instrument display. The new UNICLINE MOBILE spring-loaded arms connect with OEM dental instruments and provide power to them. Once connected, the display indicates whether the air and water spray are on, the time, and the speed of the active motor. The display also includes a timer for use with a light polymerization instrument. The dental professional uses the foot control to operate all functions and instruments of this dental operative unit. The unit was designed for mobility and ease of positioning. The cart is made of fire retardant medium density fiberboard (MDF) coated with paint and its two arms are made of anodized, lacquered aluminum. All selected materials are biocompatible. The chair is made with casted aluminum and imitation leather upholstery. Both the cart and chair contain wheels on one side to allow each piece to be positioned for optimal use of available floor space before connecting via the stabilizing plate. #### Intended Use/Indications for Use of the New Device: The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals. The indications for use statements of the new UNICLINE MOBILE device and the predicate Aseptico AMC 20 Mobile Dental System device are nearly identical. The new UNICLINE MOBILE indications for use statement includes specific information concerning its use environment, use of instruments, and intended users. This information also applies to the predicate device, but they are not included in the indications for use statement. In addition, the new UNICLINE MOBILE is indicated for general procedures without additionally specifying endodontic procedures, as general procedures encompass general endodontic procedures. These differences are not critical to the intended use of the new UNICLINE MOBILE device, nor do they affect the performance of the device when used as labeled. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with "heka" in black and "dental" in gray. Above the logo, there is some text that appears to be a product code or identifier, reading '+HND 'HQWDO - 8QLF/LQH 0RELOH'. The text is in a smaller font size and is right-aligned relative to the logo. ### Comparison of the Technological Features of the New Device and Predicate Device: We believe that the new UNICLINE MOBILE device has been shown to be substantially equivalent to the predicate Aseptico AMC 20 Mobile Dental System (K101332). The new and predicate devices are very similar in overall design and technology, principles of operation, intended use, materials, construction, and compatibility with OEM instruments. Main differences are as follows: - 1. The new UNICLINE MOBILE cart can be purchased with an optional OEM dental operating lamp and arm that connects to the cart. The predicate AMC 20 Mobile Dental System (K101332) does not offer this optional feature. - 2. The new UNICLINE MOBILE cart contains an instrument arm and is mounted to a mobile patient dental chair designed specifically for the new UNICLINE MOBILE device. The predicate device contains instrument mounts directly on the side of the cart and does not mount to a dental chair. The two devices are similar since both are used with a dental chair and mounted instruments and both must be stable in order for safe and effective use. The differences between the new UNICLINE MOBILE device and the predicate Aseptico AMC 20 Mobile Dental System device do not raise any new questions.. Shown in TABLE 5.1 below are some select properties and characteristics of the new UNICLINE MOBILE and the predicate Aseptico AMC 20 Mobile Dental System device compared side-by-side. | DESCRIPTIVE<br>INFORMATION | NEW UNICLINE<br>MOBILE DENTAL<br>OPERATIVE UNIT | PREDICATE DEVICE:<br>Aseptico AMC 20<br>Mobile Dental<br>System (K101332) | Substantial<br>Equivalence | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The UNICLINE<br>MOBILE is an<br>electrically<br>powered, self-<br>contained mobile<br>dental operative<br>unit intended to<br>supply power to<br>and serve as a<br>base for other<br>dental devices and<br>instruments. The<br>system is indicated | The AMC-20 is a<br>mobile self-contained<br>dental system that is<br>used for endodontic<br>and general dentistry<br>applications. | Similar - No<br>new question<br>of safety and<br>effectiveness | | | for performing<br>general dental<br>procedures. The<br>device is intended<br>for operation and<br>use in a clinical<br>setting by legally<br>qualified<br>professionals. | | | | Product Code | EIA | EIA | Same | | Regulation<br>Number | 872.6640 | 872.6640 | Same | | Regulation<br>Name | Unit, Operative,<br>Dental | Unit, Operative, Dental | Same | | Intended Users | Dentists, Assistants<br>& Hygienists | Dentists, Assistants &<br>Hygienists | Same | | Environment of<br>Use | Clinical Setting | Clinical Setting | Same | | Protection Class | Class 1 equipment | Class I equipment | Same | | Degree of<br>Protection | Type B of applied<br>parts<br>Type BF<br>Equipment | Type B of applied<br>parts<br>Type BF Equipment | Same | | Power Supply | 120V/230V<br>50/60Hz electrical<br>supply | 100V/220V at<br>60Hz/50Hz | Similar - no<br>new question<br>of safety or<br>effectiveness. | | Frequency | Mains Frequency:<br>50/60Hz | Mains Frequency:<br>50/60Hz | Same | | Utility Supply | Compressed Air<br>and Water | Compressed Air and<br>Water | Same | | Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same | | EMC | EN 60601-1-2 | IEC 60601-1-2 | Same | | Display | LED | LED | Same | | Materials | Fire retardant MDF,<br>Aluminum | Stainless Steel,<br>Aluminum, Plastic<br>(Fire Retardant MDF -<br>unknown) | Similar - no<br>new question<br>of safety or<br>effectiveness | | Dimensions<br>(Installed) | Cart: 22.8" W x<br>26.2" L x 34.3" H | Cart: 23.5" W x 30.0"<br>L x 36.5" H | Similar - no<br>new question<br>of safety or<br>effectiveness | | Weight | Cart 90Kg (198 lbs)<br>(Chair 95Kg) | 71.7Kg (158 lbs)<br>(OEM Chair Unknown) | Similar - no<br>new question | | | Total 185Kg) | | of safety or<br>effectiveness | | Features | 2 motors for OEM<br>instruments<br>3-way air/water<br>syringe<br>Self-contained<br>water system<br>Air supply<br>Suction<br>Foot Control<br>Movable arms<br>Dental Operating<br>Lamp | 2 motors for OEM<br>instruments<br>3-way air/water<br>syringe<br>Self-contained water<br>system<br>Air supply<br>Suction<br>Foot Control | Difference -<br>see<br>explanation<br>1. above for<br>lamp & 2.<br>above for the<br>movable<br>instrument<br>arm | | Dental Chair | Cart mounts to<br>Heka Dental chair | Cart does not mount to<br>chair | Difference -<br>see<br>explanation<br>2. above | | Air Pressure | 65 - 88psi — default<br>setting<br>110 psi - max | 110psi | Same | | Water Supply -<br>Flow Rate | 0.15 liter/min | 5.07 fl. oz./min (0.15<br>liter/min) | Same | | Suction<br>Connection -<br>Flow Rate | 67.0 - 80.0<br>Liters/Min | 42.3 – 189.7 liters/min | Similar - no<br>new question<br>of safety or<br>effectiveness | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Heka Dental. The word "heka" is in black font, while "dental" is in gray. To the right of the logo is some text that appears to be a product code or some other identifier, which reads "+HND 'HQWDO - 8QLF/LQH ORELOH 7UDGLWLRQDO 510(N)". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with the "heka" portion in black and the "dental" portion in gray. Above the logo, there is some text that appears to be technical or product-related information, including '+HND 'HQWDO - 8QLF/LQH 0RELOH 7UDGEWLRODO 5100'. The text is smaller and less prominent than the logo. ## TABLE 5.1 ## Testing: ## Non-Clinical Performance Data Testing: Performance bench testing was conducted to verify that the new UNICLINE MOBILE device meets all design specifications and demonstrates substantial equivalence to its predicate Aseptico AMC 20 Mobile Dental System (K101332). The results of testing demonstrate that the new UNICLINE MOBILE device complies with the following standards: - IEC 60601-1 Medical electrical equipment part 1, General o requirements for safety - IEC 60601-1-2 Medical electrical equipment part 1-2, General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility, Requirements and tests {8}------------------------------------------------ - . IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General Requirements for basic safety and essential performance - Collateral standard: Usability - IEC 62366 - Medical devices - Application of usability engineering to medical devices - IEC 80601-2-60 - Medical electrical equipment - Part 2: Particular requirements for basic safety and essential performance of dental equipment - ISO 7494-2 Dentistry Dental Units Part 2: Water and air supply ● - ISO 7494-1 Dentistry Dental Units Part 1: General requirements and o test methods - . ISO 21530 - Dentistry - Materials used for dental equipment surfaces -Determination of resistance to chemical disinfectants - ISO 6875 Dentistry Patient Chair ● Biocompatibility: The new UNICLINE MOBILE direct and indirect patient contacting materials are biocompatible. The direct patient contacting upholstery is the same material and color as used in reference device, the Planmeca Sovereign Dental Operative Unit, K081699. The indirect patient contacting materials comply with 21 CFR 177.2600. # Software: In addition, the software has been validated and complies with the FDA Guidance for the content of Premarket Submission for Software Contained in Medical Devices as well as IEC 62304: 2006. Medical device software -Software life cycle processes. # Risk Analysis: Risk management activities were performed throughout development of the new UNICLINE MOBILE unit. Potential individual risks were identified, evaluated, and mitigated to the extent possible. Remaining overall residual risk was assessed and determined that any remaining risk is as low as possible and is outweighed by the benefits of the new UNICLINE MOBILE. # Clinical Performance Testing: No clinical testing has been performed in support of this UNICLINE MOBILE 510(k) submission. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with the "heka" portion in bold black and the "dental" portion in a lighter gray. Above the logo, there is some text that appears to be a product code or identifier, reading "+HND 'HQWDO - 8QLF/LQH 0RELOH". The text is in a smaller font size compared to the logo. ## Conclusion: The conclusions drawn from the specifications and performance testing of the new UNICLINE MOBILE device demonstrate that the new UNICLINE MOBILE device is at least as safe and as effective and performs as well as the predicate Aseptico AMC 20 Mobile Dental System (K101332). For these reasons, we believe the new UNICLINE MOBILE device is substantially equivalent to the predicate device.