Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the performance study focuses on a comparative bench test using a specific metric (ΔF average value) rather than evaluating algorithmic performance.

Therapeutic

No
The device is described as an aid in diagnosis and does not administer any treatment or therapy to the patient. Its function is to assist in identifying caries areas.

Diagnostic

Yes

The description explicitly states, "The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions a "main body" and an "LCD screen attached to the main body," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Qraycam PRO is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is "intended to be used as an aid in the diagnosis of dental caries." This is a key characteristic of an IVD, as it is used to provide information for diagnostic purposes.
Device Description: The description further clarifies that it is a "fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations." This reinforces its role in the diagnostic process.
Anatomical Site: While it examines the oral cavity/teeth, the method of examination (fluorescence imaging) and the purpose (aiding in diagnosis) are what classify it as an IVD. IVDs don't necessarily have to analyze bodily fluids or tissues in a lab setting; they can also involve analyzing signals or images from the body to provide diagnostic information.

The fact that it uses fluorescence imaging and provides images to aid in diagnosis aligns with the definition of an IVD. It's providing information in vitro (outside the living body, in the sense of analyzing the fluorescence signal from the teeth) to help make a diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

Product codes (comma separated list FDA assigned to the subject device)

NBL

Device Description

Qraycam PRO is a fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations. The device produces images that can be displayed on an LCD screen attached to the main body or on a computer monitor. It features an integral LED that allows the LED to be changed without detaching the body tube, ease of use with automatic focusing, and images can be captured and saved in electronic charts and insurance claims programs. The device contains its own light source and is used through connection to a desktop PC or laptop in dentistry, illuminating the oral cavity with blue light and a special filter.

Mentions image processing

Images can be captured and saved in electronic charts and insurance claims programs.
Images are obtained by illuminating the oral cavity with the blue light (Wavelength 405nm) and filter. And also, images can be analyzed to quantify the dental caries stages by dedicated software.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluorescence imaging (QLF-D technology)

Anatomical Site

Oral cavity, dental (teeth)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentists and dental specialists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance data:

Electromagnetic compatibility (EMC) Testing: IEC 60601-1-2:2014 compliant.
Electrical Safety Testing: IEC 60601-1:2005+A1:2012 and IEC 80601-2-60:2019 compliant.
Software Verification and Validation: IEC 62304:2015 compliant.
Photobiological Safety Testing: IEC 62471:2006 compliant.
Non-clinical Bench test: Manufacturer conducted a comparative performance evaluation through bench tests to confirm no significant differences in clinical and intended use outcomes between the subject Outral Oral Camera and the predicate Intral Oral Camera under the same conditions and using the same teeth. The ΔF average value, the performance criterion, was found to meet the standard, confirming the clinical performance equivalence of the product.
Biocompatibility Testing: Not conducted, as no part of the device comes into contact with the patient's body directly or indirectly.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bench Test: ΔF average value

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040063

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

September 4, 2024

Aiobio Co., Ltd. % Jeongkeun Kim Regulatory Affairs Consultant KMC,Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea. South

Re: K221275

Trade/Device Name: Qraycam PRO Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NBL Dated: August 6, 2024 Received: August 6, 2024

Dear Jeongkeun 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K221275

Device Name

Qraycam PRO

Indications for Use (Describe)

The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

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.

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."

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K221275 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: Auq 06, 2024

1. Applicant / Submission Sponsor

AIOBIO Co.,Ltd Address: # 306 Sunil Technopia, 555 Dunchon-Daero, Jungwon-Gu Seongnam-Si Gyeonggi, KR 13215 Tel: +82-2-5615101

2. Submission Correspondent

JeongKeun Kim (Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, REPUBLIC OF KOREA Tel: +82-70-8965-5554 Email: jkkim@kmcerti.com

3. Device Identification

Trade/Proprietary Name: Qraycam PRO Common Name: Laser, Fluorescence Caries Detection Classification Regulation: 21CFR 872.17445 Product Code: NBL Device Class: 2

4. Predicate Devices

	Predicate Device #1
Manufacturer	INSPEKTOR DENTAL CARE BV
Device Name	INSPEKTOR™ PRO
510(k) number	K040063

5. Description

Qraycam PRO is a fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations.

The device produces images that can be displayed on an LCD screen attached to the main body or on a computer monitor.

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Image /page/5/Picture/0 description: The image contains the logo for AIOBIO. The letters 'AIO' are in gray, and the letters 'BIO' are in a blue square. The logo is simple and modern.

イ Integral LED that allows the LED to be changed without detaching the body tube
Ease of use with automatic focusing
イ Images can be captured and saved in electronic charts and insurance claims programs

6. Indications for use

The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

7. Substantial Equivalence

Qraycam PRO is substantially equivalent to the predicate devices (InspektorTM Pro, K040063). The following table is presented to demonstrate substantial equivalence.

	Subject Device	Predicate Device
Manufacturer	AIOBIO CO.,LTD	INSPEKTOR DENTAL CARE BV
Device Name	Qraycam PRO	INSPEKTORTM PRO
510(k) number		K040063
Classification
Product
Code /
Regulatory Number	NBL
872.1745	NBL
872.1745
Regulatory Class	Class II	Class II
Indications for Use	The Qraycam Pro is intended to be
used as an aid in the diagnosis of
dental caries.	The InspektorTM Pro is intended to
be used as an aid in the diagnosis
of dental caries.
Prescription or OTC	Prescription use	Prescription use
Operation	The lens and LED lights mounted
on the body tube of the device
can be used with a special filter
to illuminate the oral cavity and
check the state of the patient's
oral health. This caries detection
device contains its own light
source and is used through
connection to a desktop PC or
laptop in dentistry.	The Inspektor Pro intra-oral
camera consists of a control box
that is connected via a liquid light
guide and electrical cable to the
camera handpiece. The control box
contains a 35W arc lamp with a
violet-blue band-pass filter in front
of it. Light passing through the filter
is coupled into a liquid light guide
for delivery to the tooth surfaces,
exposing them to blue light. The
thus obtained fluorescence images
can be visualised on a monitor
real-time, using the miniature CCD
camera inside the handpiece.
Using the Inspektor Pro software
images can easily be captured,
stored and analysed
Technology	QLF-D	QLF-D
Image sensor		- 2.1Megapixel image sensor

CMOS Video image sensor | - 1/4-inch colour CCD sensor |
| Resolution | | - LCD: 3.5inch hdmi monitor
Signal Input Port: hdmi
1920x1080 60p
Physical resolution: 320*480
Adjustable resolution: 320x480 -
1920x1080
Play video: 60Fps high speed
support | Play video: 480p ~ 1080p, 50Fps
speed support |
| LENS | Type | Variable focus Liquid LENS | Single LENS Panasonic video camera |
| | Focus | Trigger AF (50mm ~ 200mm) | N/A |
| | Focal length | 7.5 mm | None |
| | F number | 2.9 | None |
| | Back Focal Length | 4.07 | None |
| Light
Source | White | 4EA White chip LED | None |
| | Blue | 12EA UV chip LED | Short-arc micro-discharge XENON
with blue band pass filter |
| Light wavelength | | 405 nm
(min: 365nm, max: 410nm) | 404 nm |
| Light
Power | White | 3.3W (3.3V, 1000mA) | - |
| | Blue | 1.47W (3.2V-4.2V, 350mA) | 35 W |
| Interface | | PC USB 2.0 | PC USB 2.0 |
| Image analysis | | Qraycam PRO software | INSPEKTOR PRO software |
| Single-use | | Reusable | Reusable |

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Technical Characteristics

Same Points between subject device and predicate device

Item	Description
Product Code	The proposed product code of the subject device is NBL for fluorescence caries
detection aid device function. It is the same product code as the predicate device
in K040063.
Regulatory
number and
classification	The proposed regulatory number of the subject device is 872.1745 and the
classification is Class II. It is same regulatory number and classification as the
predicate device in K040063.
Indications for
Use	The subject device is indicated for use in dental diagnosis procedures for
detecting the dental caries using a fluorescence technology (QLF-D
technologies).
Technology	The same of technology, QLF-D technology to detect caries using a light energy
delivered to the teeth.

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Image /page/7/Picture/0 description: The image shows the logo for AIOBIO. The letters "AIO" are in gray, and the letters "BIO" are in white inside of a blue box. The logo is simple and modern.

Item	Description
	The Quantitative light-induced fluorescence (QLF-D) technology is with QLF-D
the green auto-fluorescence of tooth structures and the red fluorescence of
bacterial metabolites can be assessed.
Light source	The similar method of lighting energy delivered to teeth as UV LED(blue light).
Blue light
wavelength	Images are obtained by illuminating the oral cavity with the blue light
(Wavelength 405nm) and filter. And also, images can be analyzed to quantify the
dental caries stages by dedicated software.
Single Use /
Reusable	The subject device is reusable. It is same with the predicate device.

Different Points between subject device and predicate device

Item	Description
Light source	The subject device has difference Light source about white LED.
White LED is used for the purpose only of illumination and better focusing in the
oral cavity.
And also, we performed photobiological safety of lamps (LED) test complied with
IEC 62471.
Oral camera
type	The subject device is an Outral Oral Camera, whereas the predicate device is an
Intral Oral Camera, presenting some differences. However, both devices share
the same intended use and similar technology, allowing for the identification of
dental caries at an equivalent level within a limited intraoral scope. Additionally,
the manufacturer has specified in the user manual:
"Please do not use the device on teeth where visual identification is difficult due
to malocclusion."
Therefore, it has been confirmed that there is no significant difference in clinical
safety regarding the use and intended purpose of the products.

8. Performance data

The following performance data were provided to support the substantial equivalence determination.

Non-clinical performance data

Non-clinical tests relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

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 disturbances -Requirements and tests

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Image /page/8/Picture/0 description: The image shows the logo for AIOBIO. The letters "AIO" are in gray, and the letters "BIO" are in white on a blue background. The logo is simple and modern.

Electrical Safety Testing
IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 80601-2-60:2019, Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Software Verification and Validation IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
Photobiological Safety Testing IEC 62471:2006, Photobiological safety of lamps and lamp systems
Non-clinical Bench test

The manufacturer conducted a comparative performance evaluation through bench tests to confirm that there are no significant differences in clinical and intended use outcomes between the Outral Oral Camera and the predicate Intral Oral Camera under the same conditions and using the same teeth.

As a result, the ΔF average value, the performance criterion, was found to meet the standard, confirming the clinical performance equivalence of the product.

Biocompatibility Testing
No biocompatibility testing was conducted.
No part of this device comes into contact with the patient's body directly or indirectly.

9. Conclusion

In comparing between the subject device and the predicate device, there are Product code, Regulatory number, Classification, Indications for Use, Technology, Light source, Blue light wavelength, IEC 60601-1, IEC 60601-1-2, IEC 62471 and ISO 14971.

Although the Light source and Oral camera type are difference, these differences do not raise different questions of safety and effectiveness.

Therefore, the subject device is substantially equivalent to the predicate device.