Intraoral Sensor

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June 10, 2020 Dentium Co., Ltd (ICT Branch) % Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 HOUSTON TX 77054 Re: K201247 Trade/Device Name: Intra Oral Sensor (model: IOX 1/ IOX 2) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, MUH Dated: May 4, 2020 Received: May 11, 2020 Dear Dave 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. 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. 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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) 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201247 Device Name Intra Oral Sensor (model: IOX 1 / IOX 2) #### Indications for Use (Describe) Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☐</span> 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}------------------------------------------------ # 510(k) Summary K201247 The summary of 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92. | Date: | 6/8/2020 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | APPLICANT | Dentium Co.,Ltd (ICT Branch) | | ADDRESS | 76, Changnyong-daero 256beon-gil, Yeongtong-gu<br>Suwon-si, Gyeonggi-do, 16229<br>Republic of Korea<br>++82-70-7098-6932 | | Contact Person | Mr. Sang Woo Lee (swlee1@dentium.com) | | Official<br>Correspondent | Dave Kim, MBA<br>Mtech Group<br>7707 Fannin St. Ste 200, Houston, TX 77054<br>TEL : 713-467-2607<br>Email : davekim@mtech-inc.net | # Device Name | Trade Name: | Intra Oral Sensor | |--------------------|-------------------------| | Model Name: | IOX1 / IOX2 | | Regulation Name: | Stationary X-ray System | | Regulatory Number: | 21 CFR 892.1680 | | Regulatory Class: | II | | Product code: | MQB, MUH | | Panel: | Radiology | # Predicate device | Predicate device (K143000) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Trade/Device Name: | RIO Sensor (RIS 500) | | Regulation Number: | 21 CFR 892.1680 | | Regulation Name: | Stationary x-ray system | | Regulatory Class: | II | | Product Code: | MQB | | Reference Device (K090526) | | | ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ | | | Trade/Device Name: | EzSensor | | Regulation Number: | 21 CFR 872.1800 | | Regulation Name: | Extraoral source X-ray system | | Regulatory Class: | II | | Product Code: | MUH | | | | Dentium Co.,Ltd {4}------------------------------------------------ # Descrintion Intraoral Sensor (model: IOX 1 / IOX 2) by Dentium is a medical device that acquires digital images by detecting subject information through X-rays and converting them into electrical image signals to identify teeth and tissues in the mouth. The product consists of the Intraoral Sensor, USB Memory, Sensor Holder, Silicon Cover and Quick Guide. # Indication for use Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists. | Parameter | Proposed Device | Predicated Device | Reference Device | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufac<br>turer | DENTIUM Co., Ltd | RAY Co., Ltd | E-WOO Technology Co., Ltd. | | Device<br>Name | Intra Oral Sensor<br>IOX1 / IOX2 | RIS500 | EzSensor | | 510(K)<br>Number | K201247 | K143000 | K090526 | | Feature | Image: Proposed Device Feature | Image: Predicated Device Feature | Image: Reference Device Feature | | Indications<br>for use | Intra Oral Sensor (model: IOX 1 /<br>IOX 2) is intended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, views and<br>manipulated for diagnostic use by<br>dentists. | This system is intended to collect<br>dental x-ray photons and convert<br>them into electronic impulses that<br>may be stored, views and<br>manipulated for diagnostic use by<br>dentists. | Indicated for 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>dentist. | | Device<br>Description | Intra Oral Sensor (model: IOX 1 /<br>IOX 2) is a medical device that<br>acquires digital images by<br>detecting subject information<br>through X-rays and converting<br>them into electrical image signals<br>to identify teeth and<br>tissues in the mouth. The product<br>consists of the Intraoral Sensor,<br>USB Memory, Sensor Holder,<br>Silicon Cover and Quick Guide | RIOSensor(Model RIS500) is<br>intended to acquire real-time,<br>clinical digital intraoral X-ray<br>images using a solid-state<br>imaging sensor. This system<br>consists of the CMOS sensor and<br>software for image display. This<br>system senses the onset of the X-<br>ray exposure and automatically<br>acquires and save the image data<br>to a PC (software). | The EzSensor is a solid state x-<br>ray imager designed for dental<br>radiographic applications, The<br>EzSensor provides digital image<br>capture for conventional<br>film/screen radiographic dental<br>examinations. The device is used<br>to replace radiographic<br>film/screen system in general<br>dental diagnostic procedures. The<br>captured digital<br>image is transferred to Personal<br>Computer via USB interface port | | Sensor<br>Dimension | IOX 1: 36.7 x 24 mm<br>IOX 2: 42.6 x 29.1 mm | Size 1: 39x25 mm<br>Size 2: 42x30 mm | Size "1.0": 35.7x25.2 mm Size<br>"1.5": 38.7x29.2 mm | | Sensor<br>Thickness | 5.1 mm | 5.6 mm | 4.95mm | | Active<br>Area(m<br>m) | IOX 1: 20 x 30 mm<br>IOX 2: 26 x 36 mm | Size 1: 39x25<br>Size 2: 42x30 | Size "1.0": 20.02x30.03<br>Size "1.5": 24.08x31.85 | | USB<br>Module | Integrated USB 2.0 module | Integrated USB 2.0 module | Integrated USB 2.0 module | | Pixel size | 20x20 μm | 20x20 μm | 35x35 μm | | Pixel Matrix | IOX 1: 1000x1500 pixel IOX 2:<br>1280x1801 pixel | Size 1: 1000x1500 pixel Size 2:<br>1300x1700 pixel | Size "1.0": 572x858 pixel Size<br>"1.5": 686x944 pixel | | Pixel Pitch | 20x20 μm | 20x20 μm | 35x35 μm | | Theoretical<br>Resolution | 25 lp/mm | 25 lp/mm | 14.3 lp/mm | | MTF | More than 30 % at 6 lp/mm | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm | | DQE | More than 40 % at 2.5 lp/mm | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm | ### Statement of Substantial Equivalence {5}------------------------------------------------ The intended use, constructions, construction materials, technical characteristics and safety characteristics between Intra Oral Sensor (model: IOX 1 / IOX 2) and its predicate device are same. The differences include the digital X-ray imager sizes and image viewing software. Performance testing was conducted for the subject device to access whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. All test results were satisfactory. {6}------------------------------------------------ ## Safetv and Effectiveness Information: Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1(2005+ CORR.1(2006)+CORR.2(2007), AMD 1: 2012 was performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2(2014). The software of Intra Oral Sensor (model: IOX 1 / IOX 2) has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document. Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance. Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory. Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". All test results were satisfactory. The tests include the MTF(Modulation Transfer Function) and DOE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 30 % at 6 lp/mm and The DQE of detector shows the resolution more than 40 % at 2.5 lp/mm. Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of Intra Oral Sensor (model: IOX 1 / IOX 2) is substantially equivalent to that of predicate device and there is no significant difference in efficiency and safety. Clinical Data: Not required for a finding of substantial equivalence. ## Conclusions In accordance with the federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Dentium Co., Ltd concludes that the Intra Oral Sensor (model: IOX 1 / IOX 2) present no new risk and perform its intended use substantially equivalent to the predicate device.