DEXIS CariVu 3-in-1 by KaVo

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November 23, 2019 Kaltenbach & Voigt GmbH % Frank Ray Regulatory Affairs Manager KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, North Carolina 28273 Re: K182712 Trade/Device Name: DEXIS CariVu 3-in-1 by KaVo Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NTK, NBL Dated: October 18, 2019 Received: October 21, 2019 Dear Frank Ray: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K182712 Device Name DEXIS CariVu 3-in-1 by KaVo Indications for Use (Describe) The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry. Type of Use (Select one or both, as applicable) > 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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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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Kavo Dental Excellence. The logo consists of the word "KAVO" in a bold, sans-serif font, with the letters connected to each other. Below the word "KAVO" is the phrase "Dental Excellence" in a smaller, lighter font. The logo is simple and modern, and the use of the color blue gives it a professional and trustworthy feel. # K182712 – 510(k) Summary for DEXIS CariVu 3-in-1 by KaVo - 1. Submitter Information: Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Germany | Contact Person: | Frank Ray | |-------------------|----------------| | Telephone Number: | (704) 587-7227 | | Fax Number: | (704) 587-7250 | Date Prepared: November 22, 2019 #### 2. Device Name: ● - Proprietary Name: DEXIS CariVu 3-in-1 by KaVo ● - Kaltenbach & Voigt GmbH - Common Name: ● Manufacturer: - Classification Name: ● - Laser fluorescence caries detection device Caries Detector, Laser Light, Transmission - CFR Number: 872.1745 ● - Device Class: II - Product Code: NTK, NBL . #### 3. Primary Predicate Device: O O - DIAGNOcam 2170 (K123402) Proprietary Name: - Kaltenbach & Voigt GmbH Manufacturer: - Common Name: Laser fluorescence caries detection device O - Classification Name: Caries Detector, Laser Light, Transmission O - 872.1745 CFR Number: O - Device Class: II O - NTK Product Code: O Reference Device 1: - Proprietary Name: CamX Triton HD Proxi Head (K172007) O - Manufacturer: Duerr Dental AG O - Common Name: Laser fluorescence caries detection device O - Classification Name: Caries Detector, Laser Light, Transmission O - CFR Number: 872.1745 O - Device Class: O II - Product Code: NTK o {4}------------------------------------------------ Reference Device 2: o O O - Proprietary Name: VistaCam iX "Proof" (K150672) O - Manufacturer: Duerr Dental AG - Common Name: Laser fluorescence caries detection device - Classification Name: Caries Detector, Laser Light, Transmission - CFR Number: 872.1745 o - Device Class: II O - NBL o Product Code: #### 4. Description of Device: The camera enables various applications in health facilities/dental offices, dental clinics, orthodontics and oral and maxillary surgery. Connected to a computer, a monitor and imaging software such as CONEXIO, the DEXIS CariVu 3-in-1 by KaVo can be used to create and save images and videos. The device is used as an intraoral camera to acquire images in the oral cavity of the patient. The camera combines three different known applications from available intraoral cameras in one device. These applications are standard camera functionality, transillumination and fluorescence caries detection. Therefore, the camera uses different light colors for each of the three applications to illuminate the tooth. In combination with an optical system, CMOS sensor, and an internal image processing unit, a digital image of the tooth is generated. The live images are transferred as a standard mjpg video stream via USB interface to a running computer and can interface with a dental imaging software such as for example CONEXIO for basic intraoral camera management functionality. The device may be used as an aid for monitoring caries lesion size and shape by comparing images taken with the Dexis CariVu 3-in-1 by KaVo over time, by using different reference points, such as tooth contour and position the device to optimize capturing tooth features previously recorded in a still or video image. For easy use the camera is equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the imaqe. The autofocus provides the ability to have sharp images from close distances of about 2mm to about 120mm distance. The different operation modes are described as follows: ### 1.) Color mode: For normal color images, a white LED for illumination is used. With this light the camera provides coloured images or videos. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. ### 2. Fluorescence mode: For the fluorescence mode the blue LED illumination is used. The blue light excites bacterial porphorines as an aid to detect caries. To enhance the image quality and to minimize external light influence on the fluorescence effect the accessories Fluorescence Cover Vision Full HD can be used optionally with the camera. The Fluorescence Cover Vision Full HD is a rubber cap which can be slipped on the front camera head and prevent or minimize external light on the images surface of the tooth. After each usaqe the Fluorescence Cover Vision Full HD will be reprocessed separately. {5}------------------------------------------------ The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. This mode is used to record images and videos to aid in the diagnosis of caries (mainly in the occlusal area) and plaque by means of fluorescent effect. ### 3. Transillumination mode (by the use of near infrared light): The transillumination mode provides images to aid in the detection of caries. For this mode near infrared light will be used. The near infrared light penetrates the side of the tooth near gingiva and illuminates the enamel of the tooth to produce gray scale images whereby intact enamel appears bright, and defects such as caries or cracks result in diffusion of light path and create an area of dark appearance. To use this mode, the Tip Vision Full HD must be attached to the device as the LEDs for the illumination are located inside the Tip Vision Full HD. The Tip Vision Full HD touches the side of the tooth and gingiva and illuminates it from two sides whereas the image is taken from the top. The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to store the device on a dental unit with a cable length of 1.55 meters (model 1.013.1700). All critical components within the DEXIS CariVu 3in-1 by KaVo are common. A disposable sheath is used with the device to mitigate the potential for cross contamination. #### 5. Indications for Use: The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry. #### 6. Comparison to Predicate Device: The proposed device (DEXIS CariVu 3-in-1 by KaVo) from Kaltenbach & Voigt GmbH function in a manner similar to and are intended for the same indications for use as the primary predicate device DIAGNOcam 2170 (K123402) marketed by Kaltenbach & Voigt GmbH. There are numerous identical design and technological characteristics such as Transillumination, CMOS sensor high performance, Power Source (USB - 5V), orientation of light source transillumination mode, and Optical System. Also, both the proposed device and the predicate device have an identical Principles of Operation (Transillumination) as they use the tooth structure which has ability of light transmission. If the light transmission is interrupted due to caries lesions a dark shadow appears. Furthermore, the proposed device has an identical Principle of Operation (Fluorescence Mode) as the Reference Device #1 CamX Triton HD Proxi Head (K172007) and Reference Device #2 VistaCam iX "Proof". The Technical Specifications Optical Radiation I/O Mode, Orientation of Light Source I/O Mode, and the Optical Radiation Fluorescence Mode are identical. However, there are different technological characteristics such as the proposed device has a Resolution of 1920 x 1080px where the Primary Predicate device has 640 x 480px and the image size (9,2mm working distance) is 27 x 14 mm for the proposed device and is 20 x 13 mm for the Primary Predicate device. The proposed device is 253mm long compared to the primary predicate device being 245mm long. {6}------------------------------------------------ These different technological characteristics do not raise new concerns of substantial equivalence. The device comparison table below for the DEXIS CariVu 3-in-1 by KaVo (proposed device) and the DIAGNOcam 2170 (primary predicate device) are substantially equivalent in terms of indication for use, technology and performance specifications as the few differences between the proposed device and the predicate device do not impact substantial equivalence. The performance testing results provided in this submission supports that the proposed device performs as well as the primary predicate and reference device for its intended use. #### Reference Device Reference Device #2 Primary Predicate #1 Proposed Device Device VistaCam iX "Proof" Descriptive CamX Triton HD (K150672) Information DEXIS CariVu 3-in-1 DIAGNOcam 2170 Proxi Head by KaVo (K123402) (K172007) Indications for Use DIAGNOcam The 2170 is a diagnostic aid for the detection of open or incipient The DEXIS CariVu 3caries lesions above in-1 by KaVo acquires the gingiva and for patient images as a monitoring the The CamX Triton HD diagnostic aid for progress of such Proxi Head is a detection of smooth lesions. diagnostic aid for the The surface caries, Indications: VistaCam iX detection of *Detection of smooth "Proof" is intended to occlusal caries. interproximal caries proximal caries, initial be used as an aid in the surface caries lesions above the Indications for Use caries, secondary *Detection of occlusal detection and gingiva and for caries, and tooth carries diagnosis of dental monitorina the cracks. The DEXIS *Detection of caries. progress of such Cari Vu 3-in-1 by proximal caries lesions. KaVo is designed for *Detection of initial use by a trained caries See Note* above professional in the *Detection of field of dentistry. secondary caries *Detection of cracks The device is intended for use in a dentist's office or dental clinic. Device Design Design Handheld device Handheld device Handheld device Handheld device Color Color Operational Modes Fluorescence Transillumination Fluorescence Fluorescence Transillumination Transillumination Computer based Computer based Computer based Computer based software which software which software which software which enables Installation enables the user to enables the user to enables the user to the user to update the update the software update the software update the software software Dimension 253mm 245 mm 200mm 190mm (Handpiece length) USB - 5V USB - 5V USB - 5V ### Device Comparison Table: USB - 5V Power Source {7}------------------------------------------------ | Compatibility | USB 2 or USB 3<br>connection | USB 2 or USB 3<br>connection | USB 2 or USB 3<br>connection | USB 2 or USB 3<br>connection | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Autoclavable | Yes<br>(Tip and fluorescence<br>cover of the product) | Yes<br>(Tip of the product) | Yes<br>(Distance spacer<br>(fluorescence cover)<br>of the product) | Yes<br>(Distance spacer<br>(fluorescence cover) of<br>the product) | | LED's/Wavelength | Color:<br>2x white<br>Fluorescence:<br>2 x UV (405nm)<br>Transillumination:<br>2x nIR (850nm) | Transillumination:<br>2x laser diode(780nm) | Color:<br>2x white<br>Fluorescence:<br>2 x UV (405nm)<br>Transillumination:<br>2x nIR (850nm) | Color:<br>2x white<br>Fluorescence:<br>4 x UV (405nm)<br>Transillumination:<br>2x nIR (850nm) | | Device adaptation when<br>operation mode is<br>changed | None, all components<br>are integrated in the<br>device | N/A | Change of heads<br>required | Change of heads<br>required | | Optical System | Multiple lens system<br>with protective glass | Multiple lens system<br>with protective glass | Multiple lens system<br>with protective glass | Multiple lens system<br>with protective glass | | Sensor | CMOS<br>high performance | CMOS<br>high performance | CMOS<br>high performance | CCD<br>Color Interline Transfer | | Resolution | 1920 x 1080px | 640 x 480px | 1280 x 1024px | 704 x 576 px | | Image size<br>(9,2mm working<br>distance) | 27 x 14 mm | 20 x 13 mm | 13 x 8 mm | | | Autofocus | Autofocus using liquid<br>lens technology | Fix focus for a single<br>working distance | Autofocus using<br>liquid lens technology | Fix focus for a single<br>working distance | | Software | Computer based<br>Software to<br>Show/display pictures<br>Show live stream<br>Save pictures<br>Steering of camera<br>functions | Computer based<br>Software to<br>Show/display<br>pictures<br>Show live stream<br>Save pictures<br>Steering of camera<br>functions | Computer based<br>Software to<br>Show/display<br>pictures<br>Show live stream<br>Save pictures<br>Steering of camera<br>functions | Computer based<br>Software to<br>Show/display pictures<br>Show live stream<br>Save pictures<br>Steering of camera<br>functions | ### Non-Clinical Test Data: Performance bench testing for the Dexis CariVu 3-in-1 by Kavo was performed according to international standards for Laser fluorescence caries detection devices. Also, testing for the Dexis CariVu 3-in-1 by Kavo was conducted to standards IEC 60601-1-2 Forth Edition (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance), ANSI AAMI ES60601-1 and IEC 60601-1:2005 (Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance), CAN/CSA-C22.2 No. 60601-1 (Medical Electrical Equipment - Part 1: General Reg. for Basic Safety & Essential Performance), IEC 62304: 2006 Edition 1.1 (Medical device software - Software life cycle processes),ISO 17665-1 First edition (Sterilization of health care products - Moist heat), AAMI / ANSI ST79 2017 (Comprehensive guide to steam sterility assurance in health care facilities), ISO 10993-1 Fourth Edition (Biological evaluation of medical devices), and ISO 7405 Second edition (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry). {8}------------------------------------------------ Moreover, ISO 14971 2007 and 2012 (Medical devices - Application of risk management to medical devices), Guidance for Industry and FDA Staff 2014-10-02 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Guidance for Industry and FDA Staff 2017-06-09 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling was performed. Clinical Performance Data: Clinical testing was not conducted on this product. #### Conclusion as to Substantial Equivalence: Based upon a comparison of indications for use and technological characteristics, together with results from non-clinical performance testing, we believe that DEXIS CariVu 3-in-1 by KaVo is substantially equivalent to the predicate devices.