Qraypen

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 18, 2019 AIOBIO Co., Ltd. % Kyoungju Kim Official Correspondent MDLab Room 804, Botanic Park Tower Bldg., 161-17, Magokjungang-ro, Gangseo-gu. Seoul 07788 KOREA Re: K183121 Trade/Device Name: Oraypen Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I Product Code: EIA Dated: April 17, 2019 Received: April 19, 2019 Dear Kyoungju 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. 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 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 Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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) Device Name Qraypen Indications for Use (Describe) Qraypen is to be used as an intraoral video source and is individuals who may benefit from the addition of video images in intraoral dental examinations. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subnart D) | Over - The Counter I Ise (21 CER 801 Subnart 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." Form Approved: OMB No 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below {3}------------------------------------------------ # 510(k) Summary - K183121 AIOBIO Co., Ltd. Qraypen, Dental Intraoral Camera ## 1. Submitter | Submitter: | Hongcheol Yoon<br>Chief Executive Officer<br>AIOBIO Co., Ltd.<br># 306, Sunil Technopia, 555, Dunchon-daero, Jungwon-gu,<br>Seongnam-si, Gyeonggi-do, 13215<br>Republic of Korea<br>Phone: +82-31-698-4991<br>Email: yhc3860@gmail.com | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact Person: | Kyoungju Kim<br>Consultant<br>Room 804, Botanic Park Tower Bldg. Magokjungang-ro,<br>Gangseo-Gu, 07788, Republic of Korea<br>Tel : +82-2-3664-0830<br>Fax : +82-2-3664-0831<br>Email: kj.kim@mdlab.co.kr | | Secondary Contact Person: | Kevin Bang<br>KB Dental Products Inc.<br>177 W. Orangethorpe Ave Placentia CA 92870<br>Phone: +714-591-5851<br>Email: kbdental@att.net | Date prepared: July 15, 2019 ## 2. Device | Device Common/Usual Name: | Dental Intraoral Camera | |---------------------------|-------------------------| | Device Proprietary Name: | Qraypen | | Device Classification: | Class I | | 21 C.F.R. Section | Classification Name | Product Code | |-------------------|---------------------------------------|--------------| | 872.6640 | Dental operative unit and accessories | EIA | ## 3. Substantially Equivalent Device | Device Name | 510(k) Number | |------------------------------------|---------------| | CDR-CAM (SCHICK TECHNOLOGIES, INC) | K963778 | {4}------------------------------------------------ # 510(k) Summary - K183121 AIOBIO Co., Ltd. Oraypen, Dental Intraoral Camera ### 4. Device Description Qraypen, a Dental Intraoral Camera, provides digital color images of intraoral anatomy during oral health examinations by dentists or dental sub-specialists. The output of the images can be shown through a computer monitor. This product is designed only for the use in dentistry and may only be used by trained medical personnel. The Qraypen is not made as a caries detection device. Therefore, Qraypen is not claimed as a caries detection device. - (1) Main components of Oraypen Oraypen is a hand-held device that consists of Oraypen Handpiece, Cradle, Cradle screw, USB 2.0 Cable, Adapter, and User manual. The Qraypen is connected to a compatible Windows PC and power supply by USB 2.0 type cable. - (2) Design features - a) An intraoral camera that is capable of both blue and white LED color imaging - b) Integral LED that allows the color of light to be changed - c) Automatic focusing - d) Compatible with any viewer program that meets the standards of USB video device class (UVC) 1.0 or higher - (3) Three modes are available: - a) White light mode: Qraypen captures images with white LED color light - b) Blue light mode: Oraypen captures images with blue LED color light - c) Orange light mode: Qraypen captures images with white and Blue LED color light in succession #### (4) Technical Specifications The summary of technical specifications was shown in the following table. | | Item | | Detail | |---------------------------|-----------------------|-------|--------------------------------------------------------------------| | Product<br>Specifications | Image sensor | | HD720p C image sensor<br>MOS Video image sensor | | | Output resolution | | MJPG 1280 x 720: 30fps (Default) | | | Image transfer rate | | YUY2 1280 x 720: 9fps | | | LED | WHITE | 7ea White chip LED | | | | | UV | | | Capture System | | Hand-piece button capture | | | Camera Connector | | One touch full-metal connector | | | Interface | | PC USB 2.0 | | | Battery | | AC/DC Adapter: 400mA, 100-240Vac, 50-60Hz<br>Main Unit: 0.5A, 5Vdc | | | Essential Performance | | Auto focus<br>(Image acquisition by taking oral cavity) | | | Dimension | | 27 mm (Ø) x 227 mm (H) | {5}------------------------------------------------ ### AIOBIO Co., Ltd. Oraypen, Dental Intraoral Camera | Weight | 67 g | |--------|------| |--------|------| #### 5. Indications for Use Oraypen is to be used as an intraoral video source and is indicated for individuals who may benefit from the addition of video images in intraoral dental examinations. #### 6. Comparison of Technological Characteristics with the Predicate Device The Qraypen and CDR-CAM, its predicate device, are dental intraoral cameras that employ the same basic scientific technology for the acquisition and the display of video images. Both are operated in the same manner in that lens and LED lights mounted on the head of the camera can be used to illuminate the oral cavity and check the state of the patient's oral health. The Indications for use statement for Qraypen are similar to the predicate device. Both devices are intended for the visualization of oral cavity. They are intended to be used in clinical environments, including hospitals, clinics, and medical office settings, for the examinations of patients. They are also hand-held devices and have compact designed handpieces connected directly to a desktop PC or laptop via a cable. Also, they have focusing functions and capture buttons to assist dentists for taking intraoral images of the patients. | | | Predicate Device | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | AIOBIO Co.,<br>Ltd.<br>Qraypen | SCHICK TECHNOLOGIES, INC. CDR-CAM<br>K963778 | | Indications for<br>Use | Qraypen is to be used as an intraoral video<br>source and is indicated for individuals who<br>may benefit from the addition of video<br>images in intraoral dental examinations. | Schick Technologies Inc., CDR-cam Camera System is intended<br>for use by practitioners in the dental field. The camera system is<br>used to capture, view, and store intra- as well as extra-oral<br>images. The images are used as an aid or adjunct in the diagnosis<br>of anatomy as well as the communication of diagnosis to other<br>dental professionals and / or patients.<br>The camera handpiece is intended to be used with sterile<br>sheaths so as to prevent the spread of infectious disease. | | Target<br>Population | For use in all patients | Identical | | Anatomical sites | Oral cavity | Identical | | Environment of<br>Use | Hospital, clinic, and medical office settings | Identical | | Intended Users | Dentists and sub-specialists | Identical | | Power supply | AC/DC adaptor | Power supplied via USB | | Design | Handheld device | Identical | | Focus range | 5 - 45 mm (0.2 -1.77 in) | 5 - 45 mm (0.2 -1.77 in) | {6}------------------------------------------------ # AIOBIO Co., Ltd. Qraypen, Dental Intraoral Camera | | | Predicate Device | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | AIOBIO Co., Ltd.<br>Qraypen | SCHICK TECHNOLOGIES, INC.<br>CDR-CAM<br>K963778 | | Focus type | Trigger AF (Autofocus) | Fixed | | Imager | CMOS | CCD | | Principle/Method<br>of Operation | The lens and LED lights mounted on the head<br>of the camera can be used to illuminate the<br>oral cavity and to check the state of the<br>patient's oral health. This Dental Intraoral<br>Camera contains its own lighting function<br>and is used in connection to a desktop PC or<br>laptop computer in dentistry. It captures<br>images of oral cavity and the images are<br>shown on the computer monitor. It aids the<br>assessment of oral health and can provide<br>information for patient education. | CDR-CAM supports streaming video and<br>frame<br>capture to<br>help<br>still<br>dental<br>professionals<br>demonstrate<br>the<br>current<br>condition and post-treatment outcomes of<br>their patients' dental health. Video frames<br>can be archived with dental exams as<br>permanent records and retrieved<br>for<br>comparison or subsequent review.<br>CDR-CAM provides slim, smooth contours<br>and a small head profile for comfortable use<br>and operation. Taking images with the CDR-<br>CAM integrated capture button makes video<br>frame capture a simple one-pushbutton step.<br>Bright, built-in LEDs supply<br>superior<br>illumination and advanced optics provide<br>excellent depth of field for optimal<br>performance. | | Image Display | Desktop PC and laptop | PC workstation | | Light source | Multiple LED | Identical | | Camera<br>Connection to<br>Display | Wired (USB) | Identical | | Software | Qraypen software | CDR DICOM software | | System<br>Components | Handheld device with USB cable and<br>software | Identical | | Disinfection | Disposable, single use plastic sleeve.<br>The handpiece and cradle also be disinfected<br>with 70% isopropyl alcohol solution. | Disposable, single use plastic sleeve.<br>The handpiece and cradle also be disinfected<br>with Cavi-Wipes (Metrex Research, Kerr) | | Portable | Yes | Yes | | Standard met | IEC 60601-1. IEC60601-1-2. IEC 80601-2-<br>60, IEC 62471 | C22.2<br>No.601.1-M90,<br>EC<br>CAN/CSA<br>93/42/EEC, IEC 60601-1, IEC60601-1-2,<br>UL60601-1 | | Thermal safety | When in use, the LEDs of the Oraypen may<br>generate surface temperature up to 133°F<br>(56℃). To avoid the potential risk of burn,<br>do not use the Qraypen continuously<br>(Operating cycle: 50 s activation (on) time/1<br>min deactivation (off) time). As an<br>additional safety measure, the Qraypen is<br>equipped with a sleep mode feature. This<br>feature turns off the LEDs in the Qraypen<br>automatically after 2 minutes of continuous<br>use. The LEDs can be turned back on by<br>simply pressing any buttons on the<br>handpiece. | When in use, the LEDs in the CDR-CAM<br>may generate surface temperatures in excess<br>of 106°F (41°C). To avoid the potential risk<br>of burn, do not use the CDR-CAM in a<br>single hand-held position for a prolonged<br>period. As an additional safety measure, the<br>CDR-CAM is equipped with an Auto-Off<br>feature. This feature turns off the camera<br>automatically after 5 minutes of continuous<br>use. The camera can be turned back on by<br>simply pressing the ON/OFF button on the<br>handpiece. | {7}------------------------------------------------ ### AIOBIO Co., Ltd. Oraypen, Dental Intraoral Camera #### 7. Summary of Non-Clinical Performance Testing The following performance data were provided to support the substantial equivalence determination. #### Non-Clinical Testing Non-clinical tests relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards: #### י Electromagnetic Compatibility (EMC) Testing IEC 60601-1-2:2014, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests #### Electrical Safety Testing . IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 80601-2-60:2012, Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment #### . Software Verification and Validation Software documentation for moderate level of concern was provided per the FDA Guidance for Software Contained in Medical Devices #### Photobiological Safety Testing . IEC 62471:2006, Photobiological safety of lamps and lamp systems #### . Cleaning and Disinfection Validation Cleaning and disinfection validation were conducted per the FDA Guidance Document for Reprocessing of Medical Devices. #### Biocompatibility Testing . No biocompatibility testing was conducted. - No part of this device comes into contact with the patient's body directly or indirectly. - A Disposable sleeve covers the camera and provides a sanitary shield for the patient. #### Bench Testing . {8}------------------------------------------------ ## AIOBIO Co., Ltd. Qraypen, Dental Intraoral Camera Bench testing was conducted to demonstrate appropriate output with an FDA cleared barrier sleeve over the device. #### Animal Study . No animal studies were conducted. ### 8. Conclusion In accordance with the above data and based on the information provided in this premarket notification AIOBIO Co., Ltd. concludes that the Qraypen is substantially equivalent to CDR-CAM of SCHICK TECHNOLOGIES, INC. in terms of design, performance, technological characteristics, and indications for use as described herein. ### END