(437 days)
rainbow 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 pediatric 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.
rainbow 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.
The provided text is a 510(k) summary for the "rainbow CT" device. It describes the device, its indications for use, and a comparison to predicate and reference devices. However, this document does not contain the specific details required to answer your request about acceptance criteria and the study proving the device meets them.
The document states:
- "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 device performed similar to those of the predicate device. The pixel resolutions of the subject device in CBCT (2x2 binning) and pano mode are superior to that of the reference device. All test results were satisfactory." (Page 8)
- "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." (Page 8)
- "Clinical Data: Not required for a finding of substantial equivalence." (Page 8)
This means the acceptance criteria and study details (like sample size, number of experts, adjudication methods, ground truth, effect sizes) for clinical performance are not present in this 510(k) summary because clinical data was explicitly stated as "Not required for a finding of substantial equivalence."
The performance testing mentioned (MTF, DQE, pixel resolution) refers to technical imaging performance characteristics of the CT system itself, not clinical diagnostic performance of an AI algorithm on patient images. The acceptance criteria for these technical parameters would likely be engineering specifications, and the "study" would be technical measurements in a lab setting, rather than a clinical trial with human readers and patient data.
Therefore, I cannot populate the table or answer the specific questions about clinical performance, human-in-the-loop studies, or ground truth derivation from the provided text. The document focuses on demonstrating substantial equivalence based on technical characteristics and safety standards, rather than a detailed clinical validation study for an AI component.
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April 16, 2021
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Dentium Co., Ltd (ICT Branch) % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 HOUSTON TX 77054
Re: K200271
Trade/Device Name: rainbow CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: March 10, 2021 Received: March 15, 2021
Dear Mr. 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.
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 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
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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-leam). 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,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200271
Device Name
rainbow CT
Indications for Use (Describe)
rainbow 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
K200271
This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.
| 1. | Date Summary Prepared: | March 10, 2021 |
|---|---|---|
| 2. | Submitter's Identification: | |
| Submitter's Name :Submitter's Address: | Dentium Co., Ltd (ICT Branch)76, Changnyong-daero 256beon-gil, Yeongtong-guSuwon-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) | Dave Kim (davekim@mtech-inc.net) | |
| Address:Telephone: | 7707 Fannin St. Ste 200, Houston, TX 77054+1-713-467-2607 |
3. Device:
| Trade/Proprietary Name: | rainbow CT |
|---|---|
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | 2 |
4. Predicate Device:
| Legally Marketed Predicate Device Information: | |
|---|---|
| 510(k) Number: | K193139 |
| Trade/Proprietary Name: | ProVecta 3D Prime Ceph |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Review Panel: | Radiology |
| Product Code: | OAS |
| Regulation Number: | 892.1750 |
| Device Class: | 2 |
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5. Reference Device:
| 510(k) Number: | K172614 |
|---|---|
| Manufacturer: | Ray Co., Ltd |
| Trade / Proprietary Name: | RCT700 |
| Device: | X-Ray, Tomography, Computed, Dental |
| Regulation Description: | Computed tomography x-ray system. |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | 2 |
6. Device Description:
-
rainbow 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.
7. Indications for use:
rainbow 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 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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8. Summary of the technological characteristics of the device compared to the predicate devices:
| Descriptive Information | Rainbow CTDentium Co., Ltd (ICT Branch) | K193139, ProVecta 3D Prime CephDÜRR DENTAL SE | |
|---|---|---|---|
| Indications for Use | - rainbow CT is a computedtomography x-ray system intendedto produce 3D, panoramic, andcephalometric diagnostic images ofthe 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. | ProVecta 3D Prime Ceph is acomputed tomography x-ray unitintended to generate 3D, panoramicand cephalometric X-ray images indental radiography for adult andpediatric patients. It providesdiagnostic details of the maxillofacialareas for a dental treatment. Thedevice is operated and used byphysicians, dentists, and x-raytechnicians. Not intended formammography use | |
| Image Acquisition Modes | Panoramic, cephalometric andcomputed tomography | Panoramic and computedtomography | |
| Imaging Software | Rainbow 3D ImageViewer | Vision X includes 2D and 3D | |
| Input Voltage | AC 100-240 V, 50/60 Hz | AC 200-240V | |
| Tube Voltage | 60~100 kV | 60-99 KV | |
| Tube Current | 4~12 mA | 4~16mA | |
| Focal Spot Size | 0,5 mm | 0,5 mm | |
| Exposure Time | Max. 19 s | Max. 20 s | |
| Slice Width | 0.1 mm min. | 0.1 mm min. | |
| Total Filtration | 2.8 mm Al | 2.5 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 | VistaSoft, DICOM 3.0 compatible | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| Image | СВСТ | C12820DK-40 | Xmaru1404CE |
| ReceptorNote: CT and | |||
| panoramicimageperformanceis identical | Panoramic | C12820DK-40 | Xmaru1404CF |
| MTF@ 1lp/mm | 53% | 53% | |
| DQE @ 0.5lp/mm | 85% | 64.% | |
| because thesensors areidentical. | Cephalometric | LineScan: C10502D-43 | Xmaru 2602CF |
| Size of Imaging Volume(cm) | C12820DK-40: 5x5, 16x10, 16x18 Xmaru1404CF: Max. 10x8.5 | ||
| CBCT | 2 lp/mm - 2x2 binning | 2.5 lp/mm - 4x4 binning | |
| Pixel Resolution | Panoramic | 4 lp/mm | 2.5 lp/mm - 4x4 binning |
| Cephalometric | LineScan: 4.5 lp/mm | Xmaru2602CF | |
| Pixel Size | CBCT | C12820DK-40: 240 $\mu$ m - $\mu$ m2x2binning | Xmaru1404CF :99 $\mu$ m - 2x2 binning198 $\mu$ m- 4x4 binning |
| Panoramic | C12820DK-40: 120 $\mu$ m | Xmaru1404CF :99 $\mu$ m - 2x2 binning198 $\mu$ m- 4x4 binning | |
| Cephalometric | LineScan: 100 $\mu$ m | Xmaru2602CF: 200x200 $\mu$ m |
Summary of the Technological Characteristics
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| Descriptive Information | Rainbow CT | RCT700 (K182614) | |
|---|---|---|---|
| Dentium Co., Ltd (ICT Branch) | Ray Co., Ltd | ||
| Indications for Use | - rainbow CT is a computedtomography x-ray systemintended to produce 3D,panoramic, and cephalometricdiagnostic images of themaxillofacial areas for treatmentplanning for adult and pediatricpatients. The device is operatedand used by physicians, dentists,and x-ray technicians.Rainbow 3D Image Viewersoftware features functions foracquiring, saving, searching,displaying, diagnosing andsending digital X-ray image datain dental practices and clinics. | CBCT, panoramic x-ray imagingsystem with cephalostat, is an extraoral source x-ray system, which isintended for dental radiographicexamination of the teeth, jaw, andoral structures, specifically forpanoramic examinations andimplantology and for TMJ studiesand cephalometry, and it has thecapability, using the CBVTtechnique, to generate dentalmaxillofacial 3D images. The deviceuses cone shaped x-ray beamprojected on to a flat paneldetector, and the examined volumeimage is reconstructed to beviewed in 3D viewing stations. 2DImage is obtained using thestandard narrow beam technique. | |
| Detector | CBCT | C12820DK-40 :240 μm(2x2 binning) | SiX650HD-E: 150 μm |
| CBCT FOV | 5x5, 16x10, 16x18 cm | 5x5, 10x8, 16x10 cm | |
| Panoramic | C12820DK-40 :120 μm | Six650HD-E: 150 μmC10500D: 100 μm | |
| Cephalometric Scan (model: C10502D-43):100 μm | Scan (model: XID-C24DS): 100 μmOne Shot (model: PaxScan4336Y) : 139μm |
9. Summary of technological characteristics of the device compared with the reference device
10. Discussion of Similarities and Differences:
Rainbow 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 and image viewing software. 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 device performed similar to those of the predicate device. The pixel resolutions of the subject device in CBCT (2x2 binning) and pano mode are superior to that of the reference device.
All test results were satisfactory.
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11. Non-Clinical Data and Performance Testing
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (2001), IEC 60601-1-3 (2008 + A1: 2013), IEC 60601-2-63 (2012 )were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
rainbow 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.
13. 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 rainbow CT is substantially equivalent to ProVecta 3D Prime with VistaSoft, 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.