(856 days)
The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.
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.
The provided text describes the Qraycam PRO device and its FDA 510(k) clearance. The information regarding acceptance criteria and the study proving it is extracted primarily from the "8. Performance data" section.
Acceptance Criteria and Device Performance:
The document mentions one specific performance criterion that was evaluated: the ΔF average value. This value is a measure of the fluorescence change, which is central to QLF-D (Quantitative Light-induced Fluorescence - Digital) technology used for caries detection.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| ΔF average value | Met the standard | Confirmed clinical performance equivalence. |
Study Details:
The study referenced is a non-clinical bench test that evaluated the comparative performance between the Qraycam PRO (subject device) and the predicate device (Inspektor™ PRO).
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "using the same teeth" for comparison, implying a set of teeth, but the specific number is not provided.
- Data provenance: The data is from a non-clinical bench test. The country of origin is not specified but is presumably where AIOBIO Co., Ltd. (South Korea) conducted its internal testing. The study is retrospective in the sense that it compares a new device against an established predicate device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study is a non-clinical bench test assessing a technical performance parameter (ΔF average value), not a clinical trial with human expert-based ground truth.
4. Adjudication method for the test set:
This information is not provided. As it was a non-clinical bench test focused on a technical parameter, an adjudication method in the context of expert review would not be applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study described is a non-clinical bench test comparing the subject device's performance to a predicate device based on a technical parameter (ΔF average value). There is no mention of human readers or AI assistance in the context of this performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device (Qraycam PRO) is described as an "aid in the diagnosis," indicating it is an assistive tool for dentists. The performance evaluation focuses on the device's ability to measure the ΔF average value, confirming its capability to function as intended. While the device itself processes images and utilizes QLF-D technology, the document does not distinguish between a standalone algorithm-only performance and its use as an aid. The "Qraycam PRO software" is mentioned for image analysis, implying an algorithmic component, but its standalone performance in isolation from clinical interpretation is not separately reported.
7. The type of ground truth used:
The ground truth for the non-clinical bench test appears to be based on the established standard for the ΔF average value, which is a quantitative measure derived from QLF-D technology. The document states that "the ΔF average value, the performance criterion, was found to meet the standard." This suggests a quantitative, objective measure rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
The document does not provide information about a training set. The descriptions relate to a performance evaluation of the final device, not the development or training of an AI model within it.
9. How the ground truth for the training set was established:
Since no training set information is provided, how its ground truth was established is not applicable based on the given text.
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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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows 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.
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 | ||
| ClassificationProductCode /Regulatory Number | NBL872.1745 | NBL872.1745 | |
| Regulatory Class | Class II | Class II | |
| Indications for Use | The Qraycam Pro is intended to beused as an aid in the diagnosis ofdental caries. | The InspektorTM Pro is intended tobe used as an aid in the diagnosisof dental caries. | |
| Prescription or OTC | Prescription use | Prescription use | |
| Operation | The lens and LED lights mountedon the body tube of the devicecan be used with a special filterto illuminate the oral cavity andcheck the state of the patient'soral health. This caries detectiondevice contains its own lightsource and is used throughconnection to a desktop PC orlaptop in dentistry. | The Inspektor Pro intra-oralcamera consists of a control boxthat is connected via a liquid lightguide and electrical cable to thecamera handpiece. The control boxcontains a 35W arc lamp with aviolet-blue band-pass filter in frontof it. Light passing through the filteris coupled into a liquid light guidefor delivery to the tooth surfaces,exposing them to blue light. Thethus obtained fluorescence imagescan be visualised on a monitorreal-time, using the miniature CCDcamera inside the handpiece.Using the Inspektor Pro softwareimages 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 monitorSignal Input Port: hdmi1920x1080 60pPhysical resolution: 320*480Adjustable resolution: 320x480 -1920x1080Play video: 60Fps high speedsupport | Play video: 480p ~ 1080p, 50Fpsspeed 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 | |
| LightSource | White | 4EA White chip LED | None |
| Blue | 12EA UV chip LED | Short-arc micro-discharge XENONwith blue band pass filter | |
| Light wavelength | 405 nm(min: 365nm, max: 410nm) | 404 nm | |
| LightPower | 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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Image /page/6/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.
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 cariesdetection aid device function. It is the same product code as the predicate devicein K040063. |
| Regulatorynumber andclassification | The proposed regulatory number of the subject device is 872.1745 and theclassification is Class II. It is same regulatory number and classification as thepredicate device in K040063. |
| Indications forUse | The subject device is indicated for use in dental diagnosis procedures fordetecting the dental caries using a fluorescence technology (QLF-Dtechnologies). |
| Technology | The same of technology, QLF-D technology to detect caries using a light energydelivered 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-Dthe green auto-fluorescence of tooth structures and the red fluorescence ofbacterial metabolites can be assessed. | |
| Light source | The similar method of lighting energy delivered to teeth as UV LED(blue light). |
| Blue lightwavelength | Images are obtained by illuminating the oral cavity with the blue light(Wavelength 405nm) and filter. And also, images can be analyzed to quantify thedental 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 theoral cavity.And also, we performed photobiological safety of lamps (LED) test complied withIEC 62471. |
| Oral cameratype | The subject device is an Outral Oral Camera, whereas the predicate device is anIntral Oral Camera, presenting some differences. However, both devices sharethe same intended use and similar technology, allowing for the identification ofdental 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 dueto malocclusion."Therefore, it has been confirmed that there is no significant difference in clinicalsafety 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.
§ 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.