Digital Dental Intra Oral Sensor, EzSensor Smart

{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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Ravence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025 Re: K150797 Trade/Device Name: Digital Dental Intra Oral Sensor, EzSensor Smart: IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 24, 2015 Received: April 29, 2015 Dear Mr. Kim: 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 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. {1}------------------------------------------------ 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" (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 yours, Robert A Ochs Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150797 #### Device Name EzSensor Smart Digital Dental Intra Oral Sensor IOS-U15VF, IOS-U1 OVF, IOS-U1 OI, IOS-U15VB, IOS-U10VB, IOS-U10VB, IOS-U151B, IOS-U1 OIB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U1 ODF #### Indications for Use (Describe) Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists. 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 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}------------------------------------------------ # 1. 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date 510K summary prepared: March 25, 2015 Submitter's Name, address, telephone number, a contact person: | Submitter's Name : | Rayence Co., Ltd. | |-------------------------|---------------------------------------------------------| | Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea | | Submitter's Telephone: | +82-31-8015-6459 | | Contact person: | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | (U.S. Designated agent) | | | Address: | 8310 Buffalo Speedway, Houston, TX 77025 | | Telephone: | +713-467-2607 | | Fax: | +713-583-8988 | Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: | Trade/proprietary name: | IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, | | | |-------------------------|--------------------------------------------------------|--|--| | | IOS-U10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, | | | | | HDI-U15DF, HDI-U10DF | | | | Common Name: | EzSensor Smart, Digital Dental Intra Oral Sensor | | | | Regulatoin number: | 21 CFR 872.1800 | | | | Classification Name : | Extraoral source X-ray system | | | | Product Code: | MUH | | | ### Predicate Device : | Manufacturer | : Rayence Co., Ltd. | | | |-----------------------|---------------------|--|--| | Device | : EzSensor | | | | 510(k) Number | : K090526 | | | | The Regulation Number | :21 CFR 872.1800 | | | | | 1 | | | {4}------------------------------------------------ Classification Name : Extraorla Source X-rav System Primary Product Code : MUH # 2. Device Description Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy. - · Excellent image quality based on advanced CMOS technology - · A more comfortable sensor ergonomic shape for the human oral structure - · Lower dose exposure (Compared to film sensor) - Enhanced durability - Easy-to-use USB interface ## 3. Indication for use Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists. ## 4. Summary of Design Control Risk management The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted. # 5. Summarv of the technological characteristics of the device compared to the predicate device Digital Dental Intra Oral Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, EzSensor of Rayence Co., Ltd. {5}------------------------------------------------ - 5.1 Feature Image /page/5/Figure/2 description: The image shows two diagrams of a device labeled as 'Proposed: IOS-U15VF AND 11MODELS' and 'Predicate: EzSensor'. Both diagrams depict a device with three main components labeled A, B, and C. Component A is identified as a USB Connector, component B is an Interface Board, and component C is a Sensor Head. Mechanical design change point | | Proposed | Predicate | |---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | A | 1) Ensure robustness by using the stainless steel material to the<br>inside of the frame.<br><br>2) Soft silicone material surrounds the USB Connector to<br>reduce the protected from a potential external impact when it<br>is positioned behind the PC. | No stainless steel frame<br>No silicon material<br>protecting USB connector | | B | 1) Easy-to-use USB Interface with the interface board already<br>integrated with the A. | The interface board requires<br>a separate USB cable to<br>connect to PC | | C | 1) structure is similar<br>2) Improved waterproofing structure<br>(prevents moisture permeation of external environment). | - | {6}------------------------------------------------ 510(k) Submission - IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF The potential risks of IOS-U15VF AND 11 MODELS such as electroic shock, device failure, misdiagnosis, tissue damage, serious leakage current, etc... were analyzed by conducting complete verification for IEC/EN 60601-1 and drop & vibration test. (Completed the risk analysis for A,C above). While applying the stainless steel material to the inside of the frame, soft silicon material surrounds the exterior of the USB connector to reduce the protected from a potential external impact. Additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits. | Characteristic | Proposed<br>Rayence Co., Ltd.<br>IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF,<br>IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB,<br>HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF | Predicate<br>Rayence Co., Ltd.<br><i>EzSensor</i> | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Image: Proposed Rayence Co., Ltd. | Image: Predicate Rayence Co., Ltd. EzSensor | | 510(k) number | - | K090526 | | Indications<br>for use | Intra-Oral Sensor is intended to<br>collect dental x-ray photons and<br>convert them into electronic impulses<br>that may be stored, viewed and<br>manipulated for diagnostic use by<br>dentists. | EzSensor, an Intra-oral Imaging<br>System, is intended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, viewed, and<br>manipulated for diagnostic use by<br>dentists. | | Sensor<br>Dimension(mm) | Size 1.0: 37.6 x 25.4<br>Size 1.5: 39.5 x 29.2 | Size 1.0: 35.7 x 25.2<br>Size 1.5: 38.7 x 29.2 | | Sensor<br>Thickness(mm) | 4.8 | 4.9 | | Active Pixel<br>Area(mm) | Size 1.0: 1352 x 2028 pixels<br>(20.00 x 30.01 mm)<br>676 x1014 pixels<br>@Binning Mode<br>Size 1.5: 1620 x 2230 pixels<br>(23.98 x 33.00 mm)<br>810 x 1115 pixels<br>@Binning Mode | Size 1.0: 20.02 x 30.03<br>Size 1.5: 24.08 x 31.85 | ### 5. 2 Characteristic {7}------------------------------------------------ 510(k) Submission – IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF | USB Module | Integrated USB 2.0 module | | Integrated USB 2.0 module | |----------------------------------|-------------------------------------------------------------------|-------|---------------------------| | Pixel Pitch( $\mu$ m) | Full Resolution | 14.8 | 35 | | | Binning mode | 29.6 | | | DQE(6 lp/mm) | Full Resolution | 0.38 | 0.123 | | | Binning mode | 0.34 | | | MTF(6 lp/mm) | Full Resolution | 0.642 | 0.382 | | | Binning mode | 0.630 | | | Typical dose<br>range( $\mu$ Gy) | Incisor & Canine : 300 ~ 500 $\mu$ Gy / Molar: 400 ~ 600 $\mu$ Gy | | | | Viewer Software | Easydent<br>Dental Imaging Viewer<br>EzDent i (K131594) | | Easydent | ### 5. 3 Viewer Software | Characteristic | Proposed<br>Rayence Co., Ltd.<br>IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF,<br>IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB,<br>HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF | Predicate<br>Rayence Co., Ltd.<br><i>EzSensor</i> | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Viewer Software | Easydent (Same viewer software used<br>for EzSensor Soft, K143753)<br>Dental Imaging Viewer<br>EzDent i (K131594) | Easydent | With the identical hardware configuration, the subject device has different model names distinguished by the sensor size and type of image viewing software utilized. The software functions include the patient information management, image capture, and an image viewer. Easydent/Dental Imaging Viewer and EzDent i image viewing software have the same functionality and performance. The main difference is the design of the user interface (UI) and new consulting simulation tool for EzDent i. EzDent i requires a license registration for a fee whereas Easydent/ Dental Imaging Viewer is provided free of charge. | Viewer Software | 510(k) Number | Manufacturer | Comment | |-----------------------|---------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------| | Easydent | Same viewer<br>software used<br>for EzSensor<br>Soft, K143753 | Rayence Co., Ltd. | Easydent and Dental Imaging<br>Viewer is same Software. Difference<br>is that CI is displayed on the UI for<br>marketing purposes. | | Dental Imaging Viewer | - | Rayence Co., Ltd. | - | | EzDent i | K131594 | EWOO SOFT | - | {8}------------------------------------------------ | | Easydent | EzDent i | |--------------------------------|----------------------------------------------------------|---------------------------------------------------------------------| | | Dental Imaging Viewer | | | Function | Patient<br>View<br>Acquisition<br>Consultation<br>Report | Patient<br>View<br>Acquisition<br>Consultation<br>Report<br>License | | The initial<br>screen shot | Image: Easydent initial screen shot | Image: EzDent i initial screen shot | | Image<br>Acquisition<br>screen | Image: Easydent acquisition screen | Image: EzDent i acquisition screen | ## 1) Difference for Easydent/Dental Imaging Viewer and EzDent i {9}------------------------------------------------ - 2) Features added to EzDent i ## 2.2.1. Acquisition CONSULT Tab Acquisition CONSULT Tab is a consulting tool and provides a video simulation of the treatment process with the acquired images in sequence. Image /page/9/Picture/4 description: The image shows a screenshot of a dental imaging software interface. On the left, there is a search panel with options like 'Favorites' and categories such as 'Bridge' and 'Crown'. The central part of the screen displays a dental X-ray image, while the right side features a diagram of a tooth and a video player with thumbnails labeled 'CONSULT CONTENTS THUMBNAIL'. ### 2.2.2. License EzDent i requires a fee based license registration whereas EasyDent is provided free of charge. # 6. Summary of Performance Testing The IOS-U15VF AND 11MODELS are the modification of EZSensor. FDA cleared predicate device under the document number K090526 and the performance of both subject and predicate devices are substantially equivalent in terms of safety and effectiveness. The intended use, application and detector type for both IOS-U15VF AND 11MODELS and the predicate device are identical. Both IOS-U15VF AND 11MODELS and EzSensor use the same amorphous silicon alley and materials for fluorescent as the sensing means. The performance test results indicate that the IOS-U15VF AND 11MODELS detector performed consistently better than EzSensor,the predicated device, in terms of image quality. No additional safety risk is identified in the bench test: Non-clinical report. With a smaller measured pixel size of IOS-U15VF AND 11MODELS, both in full resolution and in 2x2 binning mode, DQE, MTF, and linear response to X-ray exposure test demonstrated that IOS-U15VF AND 11MODELS has consistently performed better than EzSensor, the predicate sensor. Especially, the response of IOS-U15VF AND 11MODELS as a function of X-ray exposure is very linear and has better linearity, close to 1, than EzSensor in the same dynamic range. {10}------------------------------------------------ 510(k) Submission - IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF Total 30 sets of radiographic image samples were reviewed by a licensed dentist. Based on the reviewer's conclusion, IOS-U15VF AND 11MODELS (Binning Mode and Full Resolution Mode) produce images which are superior EzSensor in terms of diagnostic quality in most cases. There is negligible difference between Binning Mode and Full Resolution Mode. All images from both devices present no significant difficulty in evaluating a range of anatomic structures necessary to provide a correct diagnosis while minimizing radiation exposure to patients. These images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the subject devices operate as indicated. Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. # 7. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Rayence Co., Ltd. concludes that IOS-U15VF AND 11MODELS is safe and effective and substantially equivalent to predicate device as described herein.