(232 days)
bright CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatic patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
bright CT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
Here's an analysis of the acceptance criteria and the study proving the "bright CT" device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the performance characteristics in the way one might typically see for a medical device (e.g., "The MTF for CBCT must be greater than X%"). Instead, the performance claims for the "bright CT" are evaluated against those of a predicate device, the "rainbow CT." The key criteria for substantial equivalence appear to be matching or improving upon the predicate's performance.
| Parameter | Acceptance Criteria (Predicate Device rainbow CT) | Reported Device Performance (bright CT) | Comment |
|---|---|---|---|
| CBCT Image Performance | |||
| MTF@ 1 lp/mm | 53% (C12820DK-40) | 54% (DTX1512), 53% (DTX1524) | Meets/Exceeds: The DTX1512 sensor in bright CT exceeds the predicate, while the DTX1524 matches. The document states "performed similar to or better than." |
| DQE @ 0.5 lp/mm | 85% (C12820DK-40) | 88% (DTX1512), 85% (DTX1524) | Meets/Exceeds: The DTX1512 sensor in bright CT exceeds the predicate, while the DTX1524 matches. The document states "performed similar to or better than." |
| Pixel Resolution | 2 lp/mm – 2x2 binning (C12820DK-40) | 2 lp/mm – 1-4 subsampling | Meets/Exceeds: The "1-4 subsampling" terminology for bright CT is slightly different from "2x2 binning" for the predicate, but the resolution of 2 lp/mm is maintained. The document states "similar or superior." |
| Pixel Size | 240 μm (2x2 binning) (C12820DK-40) | 200 μm (2x2 binning) | Exceeds: Smaller pixel size for bright CT (200 μm) compared to predicate (240 μm) indicates better resolution if other factors are equal. The document states "similar or superior to that of the reference device." |
| FOV | 5x5, 16x10, 16x18 cm | 5x5, 12x9.5, 17.5x9.5, 10x9.5, 5x9.5, 17.5x15 cm | Different: The FOV options are different. This is noted as a difference but deemed not to raise new questions about safety and effectiveness, implying the new FOVs are acceptable for the intended use. |
| Panoramic Image Performance | |||
| MTF@ 1 lp/mm | 53% (DTX1524), 53% (C12820DK-40) | 54% (DTX1512), 53% (DTX1524) | Meets/Exceeds: The DTX1512 sensor in bright CT exceeds the predicate, while the DTX1524 matches. |
| DQE @ 0.5 lp/mm | 85% (DTX1524), 85% (C12820DK-40) | 88% (DTX1512), 85% (DTX1524) | Meets/Exceeds: The DTX1512 sensor in bright CT exceeds the predicate, while the DTX1524 matches. |
| Pixel Resolution | 4 lp/mm | 4 lp/mm – 1x1 | Meets: Matches the predicate. The document states "similar or superior." |
| Pixel Size | 120 μm (C12820DK-40) | 100 μm | Exceeds: Smaller pixel size (100 μm) compared to predicate (120 μm) indicates better resolution if other factors are equal. The document states "similar or superior to that of the reference device." |
| Cephalometric Image Performance | |||
| MTF@ 1 lp/mm | 56% (C10502D-43) | 53% (DTX2906) | Does not meet: The bright CT's DTX2906 sensor has a lower MTF (53%) than the predicate's C10502D-43 (56%). The document broadly states "performed similar to or better than" regarding MTF, DQE, and pixel resolution for the subject device compared to the predicate, but this specific metric appears to be lower. However, the overall conclusion is still substantial equivalence, suggesting this difference was not considered clinically significant. |
| DQE @ 0.5 lp/mm | 60% (C10502D-43) | 80% (DTX2906) | Exceeds: Higher DQE (80%) compared to predicate (60%), indicating better image quality at lower doses. The document states "performed similar to or better than." |
| Pixel Resolution | 4.5 lp/mm | 4.5 lp/mm – 1x1 | Meets: Matches the predicate. The document states "similar or superior." |
| Pixel Size | 100 μm | 100 μm | Meets: Matches the predicate. |
| General Device Characteristics | |||
| Indications for Use | Same as bright CT (K200271) | Same as predicate | Meets: Identical indications for use. |
| Imaging Software | Rainbow 3D ImageViewer | Rainbow 3D ImageViewer | Meets: Identical software. |
| Tube Voltage | 60~100 kV | 60~100kV | Meets: Identical range. |
| Tube Current | 4~12 mA | 4~12 mA | Meets: Identical range. |
| Focal Spot Size | 0.5 mm | 0.5 mm | Meets: Identical. |
| Total Filtration | 2.8 mm Al | 3 mm Al | Different: Slightly higher filtration for bright CT. This is a difference but not identified as a safety or effectiveness concern, likely due to common practices in X-ray systems. |
| Exposure Time | Max. 19 s | Max. 20 s (For Stitching: Max. 40S) | Different: Longer maximum exposure time for bright CT, especially for stitching. This difference is accepted. |
| Software | DICOM 3.0 compatible | DICOM 3.0 Format compatible | Meets: Identical compatibility. |
| Anatomical Sites | Maxillofacial | Maxillofacial | Meets: Identical. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient images or specific clinical cases. The performance evaluation appears to be based on non-clinical data and performance testing directly on the device's physical components and imaging capabilities.
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Sample Size for performance tests: Not explicitly stated for each test (e.g., how many measurements for MTF/DQE).
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Data Provenance: The document does not describe the use of patient data for performance evaluation in a testing context. The testing instead involved established international and national standards:
- IEC 60601-1 (Electrical, mechanical, environmental safety)
- IEC 60601-1-3 (Radiation protection)
- IEC 60601-1-6 (Usability)
- IEC 60601-2-63 (Specific requirements for dental x-ray equipment)
- IEC 60601-1-2 (EMC)
- NEMA PS 3.1-3.18 (DICOM)
- FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices"
- IEC 61223-3-4 & IEC 61223-3-5 (Acceptance tests for diagnostic X-ray imaging equipment)
These tests typically involve physical phantoms and measurement equipment, not clinical patient data. Therefore, questions regarding country of origin or retrospective/prospective nature of data are not applicable to the described performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. As noted above, the primary performance evaluation was based on non-clinical, objective measurements of the device's technical specifications against regulatory standards and comparison to a predicate device, not on expert interpretation of clinical images for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device, "bright CT," is a CT X-ray system for acquiring images, not an AI-powered diagnostic aide. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware imaging system. There is no standalone algorithm being evaluated for diagnostic performance.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the technical performance claims (MTF, DQE, pixel resolution, etc.) was established through objective physical measurements using standardized phantoms and measurement techniques as prescribed by the mentioned IEC and NEMA standards. For the safety and efficacy evaluation of the overall device, the ground truth was substantial equivalence to a legally marketed predicate device (rainbow CT), demonstrating that the differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is an imaging acquisition system, not a machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this device.
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December 14, 2023
Dentium Co., Ltd (ICT Branch) % Dave Kim Medical Regulatory Affairs Mtech Group 7505 Fannin St. Suite 610 HOUSTON, TX 77054
Re: K231181
Trade/Device Name: bright CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: April 20, 2023 Received: April 26, 2023
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 (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" (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).
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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 QS 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.
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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231181
Device Name bright CT
Indications for Use (Describe)
bright CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatic patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
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) |
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510(k) Summary K231181
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
| 1.Date Summary Prepared: | November 15, 2023 |
|---|---|
| 2. Submitter's Identification: | |
| Submitter's Name :Submitter's Address: | Dentium Co., Ltd (ICT Branch)76, Changnyong-daero 256beon-gil, Yeongtong-gu,Suwon-si, Gyeonggi-do, 16229Republic of Korea |
| Submitter's Telephone: | ++82-70-7098-6932 |
| Contact person: | Mr. Sang Woo Lee (swlee1@dentium.com) |
| Official Correspondent:(U.S. Designated agent)Address:Telephone:Email: | Dave Kim, MBAMtech Group7505 Fannin St. Ste 610, Houston, TX 77054+1- 713-467-2607davekim@mtechgroupllc.com |
3. Device:
| Trade /Proprietary Name: | bright CT |
|---|---|
| Device Classification Name: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 21 CFR 892.1750 |
| Device Class | 2 |
4. Predicate Device:
| Legally Marketed Predicate Device Information: | |||
|---|---|---|---|
| 510(k) Number: | K200271 | ||
| Trade /Proprietary Name: | rainbow CT | ||
| Device Classification Name: | X-Ray, Tomography, Computed, Dental | ||
| Regulation Description: | Computed tomography x-ray system. | ||
| Review Panel | Radiology | ||
| Product Code | OAS | ||
| Regulation Number | 21 CFR 892.1750 | ||
| Device Class | 2 |
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5. Device Description:
bright CT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.
The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.
6. Indications for use:
bright CT is a computed tomography x-rav system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
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Summary of the technological characteristics of the device compared to the predicate 7. devices:
| Descriptive Information | bright CTDentium Co., Ltd (ICT Branch) | rainbow CT (K200271)Dentium Co., Ltd (ICT Branch) |
|---|---|---|
| Indications for Use | brightCT is a computedtomography x-ray system intendedto produce 3D, panoramic, andcephalometric diagnostic imagesof the maxillofacial areas fortreatment planning for adult andpediatric patients. The device isoperated and used by physicians,dentists, and x-ray technicians.Rainbow 3D Image Viewersoftware features functions foracquiring, saving, searching,displaying, diagnosing and sendingdigital X-ray image data in dentalpractices and clinics. | rainbow CT is a computedtomography x-ray system intended toproduce 3D, panoramic, andcephalometric diagnostic images ofthe maxillofacial areas for treatmentplanning for adult and pediatricpatients. The device is operated andused by physicians, dentists, and x-ray technicians.Rainbow 3D Image Viewer softwarefeatures functions for acquiring,saving, searching, displaying,diagnosing and sending digital X-rayimage data in dental practices andclinics. |
| Image Acquisition Modes | Panoramic, cephalometric andcomputed tomography | Panoramic, cephalometric andcomputed tomography |
| Imaging Software | Rainbow 3D ImageViewer | Rainbow 3D ImageViewer |
| Input Voltage | AC 100-230V, 50/60 Hz | AC 100-240 V, 50/60 Hz |
| Tube Voltage | 60~100kV | 60~100 kV |
| Tube Current | 4~12 mA | 4~12 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max. 20 sFor Stitching: Max. 40S | Max. 19 s |
| Slice Width | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | 3 mm Al | 2.8 mm Al |
| Chin Rest | Bite block, chin rest and headrest | Bite block, chin rest and headrest |
| Mechanical | Compact design | Compact design |
| Electrical | LDCP logic circuit (Low DarkCurrent Processing) | LDCP logic circuit (Low Dark CurrentProcessing) |
| Software | Rainbow 3D ImageViewer, DICOM3.0 Format compatible | Rainbow 3D ImageViewer, DICOM 3.0Format compatible |
| Anatomical Sites | Maxillofacial | Maxillofacial |
| Image | CBCTDTX1512DTX1524 | C12820DK-40 |
Summary of the Technological Characteristics
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| ReceptorNote: CT andpanoramicimageperformanceis identicalbecause thesensors areidentical. | Panoramic | DTX1512 | DTX1524 | C12820DK-40 |
|---|---|---|---|---|
| MTF@ 1lp/mm | 54% | 53% | 53% | |
| DQE @ 0.5lp/mm | 88% | 85% | 85% | |
| Image Size(cm) | 14.5 x 11 | 14.5 x 22.5 | Max. 10x8.5 | |
| Cephalometric | DTX2906 | C10502D-43 | ||
| MTF@ 1lp/mm | 53% | 56% | ||
| DQE @0.5lp/mm | 80% | 60% | ||
| Image Size(cm) | 26.6 x 29 cm | 22 x 0.6 cm | ||
| Pixel Resolution | CBCT | 2 lp/mm – 1-4subsampling | 2 lp/mm – 1-4subsampling | 2 lp/mm – 2x2 binning |
| Panoramic | 4 lp/mm – 1x1 | 4 lp/mm – 1x1 | 4 lp/mm | |
| Cephalometric | 4.5 lp/mm – 1x1 | 4.5 lp/mm | ||
| Pixel Size | CBCT | 200 μm(2x2 binning) | 200 μm(2x2 binning) | C12820DK-40: 240 μm - um2x2binning |
| Panoramic | 100 μm | 100 μm | C12820DK-40: 120 μm | |
| Cephalometric | 100 μm | 100 μm | ||
| Detector | CBCT | 200 μm(2x2 binning) | 200 μm(2x2 binning) | C12820DK-40 :240 um(2x2 binning) |
| CBCT FOV | 5x5, 12x9.5, 17.5x9.5, 10x9.5,5x9.5, 17.5x15 cm | 5x5, 16x10, 16x18 cm | ||
| Panoramic | 100 μm(2x2 binning) | 100 μm(2x2 binning) | C12820DK-40 :120 μm | |
| Cephalometric | DTX2906 : 100 μm | C10502D-43: 100 μm |
8. Discussion of Similarities and Differences:
bright CT dental computed tomography X-ray system described in this 510(k) is similar to the predicate device in its indications for use, performance, materials, and safety characteristics.
The differences include the digital X-ray imagers with different FOV sizes. 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. The MTF, DQE and pixel resolution of the subject
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device performed similar to or better than those of the predicate device. The pixel resolutions of the subject device in CBCT (2x2 binning) and pano mode are also similar or superior to that of the reference device.
All test results were satisfactory.
9. Non-Clinical Data and Performance Testing
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(2015, A1:2012), IEC 60601-1-3 (2008 + A1: 2013), IEC 60601-1-6 (2010 + A1: 2013), IEC 60601-2-63 (2012, A1:2017)were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
bright CT meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. All test results were satisfactory.
-
- Clinical Data: Not required for a finding of substantial equivalence.
11. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, Dentium Co., Ltd. concludes that the bright CT is substantially equivalent to rainbow CT, the predicate device as described herein.
The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.