Qraypen 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.

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

AI/ML Overview

The provided text is a 510(k) summary for the AIOBIO Co., Ltd. Qraypen, a Dental Intraoral Camera. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or the study design for proving these criteria.

Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance (1), sample size and data provenance (2), number and qualifications of experts for ground truth (3), adjudication method (4), multi-reader multi-case study details (5), standalone performance (6), type of ground truth used (7), training set sample size (8), or how the training set ground truth was established (9).

The document primarily discusses:

Device Description: What the Qraypen is, its components, design features, and technical specifications (blue and white LED imaging, automatic focusing, compatibility with UVC viewers).
Indications for Use: Used as an intraoral video source for dental examinations.
Comparison to Predicate Device (CDR-CAM): Highlights similarities in indications for use, target population, anatomical sites, environment of use, intended users, design, focus range, light source, camera connection, system components, portability, and standards met. It also notes differences like power supply, focus type, imager type, principle/method of operation, software, and disinfection methods.
Summary of Non-Clinical Performance Testing: Lists compliance with various standards for Electromagnetic Compatibility (EMC), Electrical Safety, Software Verification and Validation, Photobiological Safety, and Cleaning and Disinfection Validation. It also mentions bench testing for barrier sleeves but without specific performance metrics.
Biocompatibility Testing: Stated that no biocompatibility testing was conducted because the device does not directly or indirectly contact the patient's body, as a disposable sleeve covers the camera.

The document does not provide any quantitative performance data such as sensitivity, specificity, accuracy, or any metrics that would constitute "acceptance criteria" and "reported device performance." It also doesn't detail any clinical studies, reader studies, or how ground truth was established for performance evaluation with respect to diagnostic accuracy or other performance parameters.

Summary

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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.

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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

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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)

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510(k) Summary - K183121 AIOBIO Co., Ltd. Qraypen, Dental Intraoral Camera

1. Submitter

Submitter:	Hongcheol YoonChief Executive OfficerAIOBIO Co., Ltd.# 306, Sunil Technopia, 555, Dunchon-daero, Jungwon-gu,Seongnam-si, Gyeonggi-do, 13215Republic of KoreaPhone: +82-31-698-4991Email: yhc3860@gmail.com
Primary Contact Person:	Kyoungju KimConsultantRoom 804, Botanic Park Tower Bldg. Magokjungang-ro,Gangseo-Gu, 07788, Republic of KoreaTel : +82-2-3664-0830Fax : +82-2-3664-0831Email: kj.kim@mdlab.co.kr
Secondary Contact Person:	Kevin BangKB Dental Products Inc.177 W. Orangethorpe Ave Placentia CA 92870Phone: +714-591-5851Email: 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

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510(k) Summary - K183121 AIOBIO Co., Ltd. Oraypen, Dental Intraoral Camera

4. Device Description

(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
ProductSpecifications	Image sensor		HD720p C image sensorMOS 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, 50-60HzMain Unit: 0.5A, 5Vdc
	Essential Performance		Auto focus(Image acquisition by taking oral cavity)
	Dimension		27 mm (Ø) x 227 mm (H)

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AIOBIO Co., Ltd. Oraypen, Dental Intraoral Camera

Weight	67 g
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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.,Ltd.Qraypen	SCHICK TECHNOLOGIES, INC. CDR-CAMK963778
Indications forUse	Qraypen is to be used as an intraoral videosource and is indicated for individuals whomay benefit from the addition of videoimages in intraoral dental examinations.	Schick Technologies Inc., CDR-cam Camera System is intendedfor use by practitioners in the dental field. The camera system isused to capture, view, and store intra- as well as extra-oralimages. The images are used as an aid or adjunct in the diagnosisof anatomy as well as the communication of diagnosis to otherdental professionals and / or patients.The camera handpiece is intended to be used with sterilesheaths so as to prevent the spread of infectious disease.
TargetPopulation	For use in all patients	Identical
Anatomical sites	Oral cavity	Identical
Environment ofUse	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)

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AIOBIO Co., Ltd. Qraypen, Dental Intraoral Camera

		Predicate Device
Characteristic	AIOBIO Co., Ltd.Qraypen	SCHICK TECHNOLOGIES, INC.CDR-CAMK963778
Focus type	Trigger AF (Autofocus)	Fixed
Imager	CMOS	CCD
Principle/Methodof Operation	The lens and LED lights mounted on the headof the camera can be used to illuminate theoral cavity and to check the state of thepatient's oral health. This Dental IntraoralCamera contains its own lighting functionand is used in connection to a desktop PC orlaptop computer in dentistry. It capturesimages of oral cavity and the images areshown on the computer monitor. It aids theassessment of oral health and can provideinformation for patient education.	CDR-CAM supports streaming video andframecapture tohelpstilldentalprofessionalsdemonstratethecurrentcondition and post-treatment outcomes oftheir patients' dental health. Video framescan be archived with dental exams aspermanent records and retrievedforcomparison or subsequent review.CDR-CAM provides slim, smooth contoursand a small head profile for comfortable useand operation. Taking images with the CDR-CAM integrated capture button makes videoframe capture a simple one-pushbutton step.Bright, built-in LEDs supplysuperiorillumination and advanced optics provideexcellent depth of field for optimalperformance.
Image Display	Desktop PC and laptop	PC workstation
Light source	Multiple LED	Identical
CameraConnection toDisplay	Wired (USB)	Identical
Software	Qraypen software	CDR DICOM software
SystemComponents	Handheld device with USB cable andsoftware	Identical
Disinfection	Disposable, single use plastic sleeve.The handpiece and cradle also be disinfectedwith 70% isopropyl alcohol solution.	Disposable, single use plastic sleeve.The handpiece and cradle also be disinfectedwith Cavi-Wipes (Metrex Research, Kerr)
Portable	Yes	Yes
Standard met	IEC 60601-1. IEC60601-1-2. IEC 80601-2-60, IEC 62471	C22.2No.601.1-M90,ECCAN/CSA93/42/EEC, IEC 60601-1, IEC60601-1-2,UL60601-1
Thermal safety	When in use, the LEDs of the Oraypen maygenerate surface temperature up to 133°F(56℃). To avoid the potential risk of burn,do not use the Qraypen continuously(Operating cycle: 50 s activation (on) time/1min deactivation (off) time). As anadditional safety measure, the Qraypen isequipped with a sleep mode feature. Thisfeature turns off the LEDs in the Qraypenautomatically after 2 minutes of continuoususe. The LEDs can be turned back on bysimply pressing any buttons on thehandpiece.	When in use, the LEDs in the CDR-CAMmay generate surface temperatures in excessof 106°F (41°C). To avoid the potential riskof burn, do not use the CDR-CAM in asingle hand-held position for a prolongedperiod. As an additional safety measure, theCDR-CAM is equipped with an Auto-Offfeature. This feature turns off the cameraautomatically after 5 minutes of continuoususe. The camera can be turned back on bysimply pressing the ON/OFF button on thehandpiece.

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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 .

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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

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.