(56 days)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals.
RCT800 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
The provided text describes the regulatory clearance of a medical device (RCT800), focusing on its substantial equivalence to predicate devices rather than a detailed study proving it meets specific acceptance criteria in the context of AI performance. Therefore, the information needed to fully answer the request, particularly regarding AI performance, ground truth establishment, expert qualifications, and sample sizes for training/test sets in an AI context, is largely absent.
It appears the RCT800 is a dental X-ray system (CBCT, panoramic, cephalometric) and not explicitly an AI-powered diagnostic device from the provided documentation. The "software" mentioned is for image generation, patient data management, and inquiry, with a moderate level of concern, suggesting it functions as control and viewing software rather than an AI-driven interpretation system.
However, I can extract and infer some information based on the request and the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence for an imaging device, the "acceptance criteria" are generally aligned with demonstrating that the new device performs as safely and effectively as legally marketed predicate devices, and meets relevant performance standards.
| Feature/Metric/Test | Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance (RCT800) |
|---|---|---|
| Safety Testing | Conformance to IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63, IEC 60601-1-2 (EMC) | All test results were satisfactory. |
| Imaging Performance Testing | Conformance to IEC 61223-3-4 and IEC 61223-3-5 | All test results were satisfactory. |
| Non-Clinical Performance | Performance (e.g., image quality, dose) similar to predicate devices | Similar to predicate device FXDD-0606CA (for PANO, CBCT, Model Scan) and 1717SCC (for Cephalometric) detectors. |
| Software Validation | Adherence to FDA Guidance for Software Contained in Medical Devices and Cybersecurity Guidance (moderate level of concern) | Validated and documented. Risk analysis indicates no effect on safety/effectiveness. |
| Clinical Operation | System works as intended for dental X-ray. Clinical diagnosis and structures are acceptable in regions of interest. | Observed and verified by two licensed practitioners/clinicians. Clinical images gathered from new detector on random patients. |
| Image Parameters | Matching parameters with predicate devices (see tables) for: Focal size, Field of View (CT), X-ray Voltage/Current, Total Filtration, Detector Pixel size, Magnification, Scan time. | Comparison tables show very close matching or "Same as predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Clinical Images: "random patient age, gender, and size" were used to gather clinical images from the new detector installed with RCT800. The number of patients or images is not specified.
- Non-Clinical Performance: Test results for the new detectors (FXDD-0606CA, 1717SCC) were compared to predicates. This likely involved quantitative testing on phantoms or test objects, not patient data in the same sense as clinical images. The sample size for these non-clinical tests is not specified, but typically involves a defined set of measurements.
- Data Provenance: The new detector was installed at "2 offices where the predicate device is installed." This suggests prospective data collection (images gathered from newly installed RCT800 units in a clinical setting). The country of origin is not explicitly stated for the clinical data, but the manufacturer is in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "two licensed practitioners/clinicians."
- Qualifications of Experts: "licensed practitioners/clinicians." No specific specialization (e.g., radiologist, dentist) or years of experience are provided, but the context of "dental X-ray system" strongly implies dental professionals.
4. Adjudication method for the test set
- The text states: "As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests an assessment of diagnostic acceptability by the two practitioners. An explicit "adjudication method" (like 2+1 or 3+1) is not detailed; it's more of a verification of intended function rather than a formal ground truth consensus process for diagnostic accuracy.
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, an MRMC comparative effectiveness study involving AI assistance was not described. The submission is for an imaging device itself, not an AI-powered diagnostic aid. The device helps acquire images; it does not independently interpret them or assist human readers in interpretation beyond providing the images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not described. This device is an X-ray system; it requires a human operator to acquire images and human practitioners to interpret them. The "software" mentioned supports device operation and image viewing, not autonomous diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical observations, the "clinical diagnosis and structures are acceptable in the region of interests" by "licensed practitioners or clinician diagnoses." This suggests expert diagnostic opinion as the basis for evaluating image acceptability. It does not refer to pathology or outcomes data.
- For non-clinical performance (e.g., image quality, dose), the ground truth would be physical measurements against established standards (IEC norms) or direct comparison to the physical properties/output of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. The RCT800 is an X-ray imaging system, not an AI model requiring a training set in the conventional sense. The software mentioned is for control, patient data management, and image generation, not for learning from a training set to make diagnoses.
9. How the ground truth for the training set was established
- Not applicable. As a non-AI imaging device, there is no "training set" or "ground truth for the training set" in the context of machine learning model development.
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July 27, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ray Co., Ltd. % Changhwan Lee RA Manager 332-7, Samsung 1-ro Hwaseong-si, Gyeonggi-do 18380 REPUBLIC OF KOREA
Re: K181452
Trade/Device Name: RCT800 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 27, 2017 Received: June 6, 2018
Dear Changhwan Lee:
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. 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 807); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
for
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
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Indications for Use
510(k) Number (if known)
Device Name
RCT800
Indications for Use (Describe)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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510(k) Summary
1. 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
| 2. Date: | May 27, 2018 |
|---|---|
| 3. 510(k) Number | K181452 |
| 4. Administrative Information | |
| APPLICANT | RAY Co.,Ltd |
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea |
| Manufacturer | RAY Co.,Ltd |
| 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 18380, Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | e-mail : ch0406.lee@raymedical.co.kr |
5. Device Information
Device Name
Trade/Proprietary Name: RCT800 Common Name: Dental panoramic/tomography and cephalometric x-ray system
Classification
Classification Name: Computed tomography x-ray system Regulation Number : 21 CFR 892.1750 Class : II Product code : OAS Panel : Radiology
6. Predicate device
| Parameter | Predicate Device-1 | Predicate Device-2 |
|---|---|---|
| Device Name | RCT700 | Green Smart(Model: PHT-65LHS) |
| Manufacturer | RAY Co., Ltd | Vatech Co., Ltd. |
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| 510(K) Number | K160525Traditional 510k | K170066Traditional 510k |
|---|---|---|
| Classification name | Computed tomography x-raysystem | Computed tomography x-raysystem |
| Regulation number | 892.1750 | 892.1750 |
| Primary product code | OAS | OAS |
7. Device Description
System purpose RCT800 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle.
Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
8. Indication for use
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals.
9. Patient population
The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure.
There is no restriction for ethnic group, Gender, weight, health, or condition.
We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.
10. Operating principle
The purpose of this unit is diagnose clinical structures of a tooth and head areas mainly by using the characteristics of permeability from X-ray. The principle of functioning are as following. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also, an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable depending on height of a patient and PC system to reconstruct an image.
The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-Ray Co.,Ltd Page 2
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ray generator to get the image of interests. The purpose of this mechanism is to provide the images in 2D or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, or Panorama only system depending on the needs. To provide the features as mentioned above, digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct method depending on the interior structure materials.
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11. Comparison with predicate device
The product is principally just the same as in the previous 510(k) #K160525.
The indications for use are expanded to include the model scan. But, the operating principle of the model scan is thought to be similar to previous 510(k) #K170066.
The expanded intended use of the RCT800 and the predicate device #K160525 and #K170066 is identical.
The compared technical features for imaging parameters, resolution, and other basic characteristics are matching very closely, and the differences are so small that they do not have any effect on performance in practice. Both devices conformance standards.
| Parameter | Proposed Device | Predicate Device | Predicated Device | |
|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | Vatech Co., Ltd. | |
| Device name | RCT800 | RCT700 | Green16/Green18 | |
| 510(K) Number | K181452(Traditional 510K) | K160525(Traditional 510K) | K170066(Traditional 510K) | |
| CommonName | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | Dental Computed Tomography X-raySystem | |
| Indicationsfor use | RCT800 is CBCT and panoramic x-rayimaging system with cephalometric.Which is intended to radiographicexamination of the dento-maxillofacial,sinus, TMJ, Airway for diagnosticsupport for adult and pediatric patients.And a model scan is included as anoption.Cephalometric image is also includeswrist to obtain carpus images for growthand maturity assessment for orthodontictreatment.The device is to be operated and usedby dentists or other legally qualifiedheath care professionals. | RCT700, panoramic x-ray imagingsystem with cephalostat, is an extraoralsource x-ray system, which is intendedfor dental radiographic examination ofthe teeth, jaw, and oral structures,specifically for panoramic examinationsand implantology and for TMJ studiesand cephalometry, and it has thecapability, using the CBVT technique, togenerate dento-maxillo-facial 3Dimages. The device uses cone shapedx-ray beam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique. | PHT-65LHS is intended to producepanoramic, cephalometric or 3D digitalx-ray images. It provides diagnosticdetails of the dento-maxillofacial, ENT,sinus and TMJ for adult and pediatricpatients. The system also utilizes carpalimages for orthodontic treatment. Thedevice is to be operated by healthcareprofessionals. | |
| Mode ofOperation | Same as predicate device #1 | Continuous operation withintermittent, stated permissibleloading | Continuous operation withintermittent, stated permissibleloading | |
| 3D technology | Same as predicate device #1 | CBCT Cone beamComputed Tomography | CBCT Cone beamComputed Tomography | |
| PerformanceSpecification | 1) CBCT Computed tomography- Patient- Dental Model Scan(Optional)2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- One shot type | |
| FunctionalOption | Same as predicate device #1 | BaseCT+PANOOption(CEPH)CT + PANO + SCAN CEPHCT + PANO + One shot(One shot,Standard Type)CT + PANO + One shot(One shot,Large Type). | BaseCT+PANOOption(CEPH)CT + PANO + CEPH | |
| DetectorType | CT | FXDD-0606CA | SIX 650HD-E | Xmaru1314CF |
| SIX 650HD-E | Xmaru1515CF | |||
| PANO | FXDD-0606CA | C10500D | Xmaru1314CF | |
| SIX 650HD-E | Xmaru1515CF | |||
| XID-C15DP | ||||
| Ceph (Scan) | Same as predicate device #1 | XID-C24DC | ||
| Ceph (One shot) | 1717SCC | PaxScan 4336X | ||
| Same as predicate device #1 | PaxScan 2530C | Xmaru2602CF | ||
| Exposure switchType | Same as predicate device #1 | "Deadman" Button type | "Deadman" Button type | |
| MainComponents | Same as predicate device #1 | Ceph Apparatus | Ceph Apparatus | |
| Same as predicate device #1 | Vertical Carriage | Vertical Carriage | ||
| Same as predicate device #1 | Rotator | Rotator | ||
| Same as predicate device #1 | X-RAY Generator | X-RAY Generator | ||
| Same as predicate device #1 | X-ray tube | X-ray tube | ||
| Same as predicate device #1 | High Frequency Generator | High Frequency Generator | ||
| Same as predicate device #1 | Column | Column | ||
| Same as predicate device #1 | Touch monitor (panel) | Touch monitor (panel) | ||
| Detector- CTFXDD-0606CA- PANOFXDD-0606CA- CephXID-C24DC(Scan)1717SCC(One shot, Large Size)PaxScan 2530C(One shot, StandardSize) | Detector- CTSIX 650HD-E- PANOC10500DSIX 650HD-EXID-C15DP | Detector- CTXmaru1314CFXmaru1515CF- PANOXmaru1314CFXmaru1515CF- CephXmaru2602CF | ||
| Same as predicate device #1 | Chinrest | Chinrest | ||
| Same as predicate device #1 | Head rest | Head rest | ||
| Same as predicate device #1 | Automatic Collimator | Unknown | ||
| Same as predicate device #1 | Exposure switch | Exposure switch | ||
| Same as predicate device #1 | Emergency stop switch | Emergency stop switch | ||
| Same as predicate device #1 | Console PC set | Console PC set | ||
| AutomaticCollimator | Same as predicate device #1 | CT examsPanoramic examsCephalometric exams | Unknown | |
| Display Type | Same as predicate device #1 | TFT LCD type(Normally black)*1280x800 pixel | Unknown | |
| Class | Same as predicate device #1 | Class I with type B applied partsaccording to IEC 60601-1 | Class I with type B applied partsaccording to IEC 60601-1 | |
| Focal size | Patient 0.5Model scan 0.04 (Optional) | 0.5 | 0.5 | |
| Field ofView(CT) | Same as predicate device #1 | Max.160x100 mm | Max. 180x100mm | |
| X-ray Voltage(Patient) | Same as predicate device #1 | 60~90kVp | 60~99kVp | |
| X-ray Current(Patient) | Same as predicate device #1 | 4~17mA | 4~16mA | |
| X-ray Voltage(Model Scan, Optional) | 50~80kVp | 60~99kVp | ||
| X-ray Current(Model Scan, Optional) | 0.4~0.7mA | 4~16mA | ||
| Total Filtration | Min. 2.8 mm Al equivalent | Min. 2.75 mm Al equivalent | Min. 2.5 mm Al equivalent | |
| DetectorPixel size | CT | FXDD-0606CA: 119μm | SiX 650HD-E: 150μm | Xmaru1314CF: 99μm - 2x2 binning(detector Spec)198μm – 4x4 binning(System Spec) |
| Xmaru1515CF: 99μm - 2x2 binning(detector Spec)198μm – 4x4 binning(System Spec) | ||||
| PANO | FXDD-0606CA: 119μm | C10500D: 100μm | Xmaru1314CF: 99μm - 2x2 binning(detector Spec)198μm – 4x4 binning(System Spec) | |
| SIX 650HD-E: 150μm | Xmaru1515CF: 99μm – 2x2 binning(detector Spec)198μm - 4x4 binning(System Spec) | |||
| XID-C15DP: 100μm | ||||
| Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 100μm | ||
| 1717SCC: 127μm | PaxScan 4336X: 139μm | |||
| Ceph(One shot) | Same as predicate device #1 | PaxScan 2530C: 139μm | Xmaru2602CF: 100μm - Non binning(Detector Spec)200μm - 2x2 binning(System Spec) | |
| Magnification | CT | FXDD-0606CA: 1.44(Patient)1.91(Model Scan) | SiX 650HD-E: 1.39 | Unknown |
| PANO | FXDD-0606CA: 1.3 | C10500D: 1.31 | Unknown | |
| SiX 650HD-E: 1.31 | Unknown | |||
| XID-C15DP: 1.31 | Unknown | |||
| Ceph (Scan) | Same as predicate device #1 | XID-C24DC: 1.11 | Unknown | |
| Ceph(One shot) | Same as predicate device #1 | PaxScan 4336X: 1.13 | Unknown | |
| Same as predicate device #1 | PaxScan 2530C: 1.12 | Unknown | ||
| Scan time | CT : below 14sec(Patient)CT : below 180sec(Model Scan) | CT : below 14sec(Patient) | CT : 14sec | |
| Same as predicate device #1 | Pano : below 14sec | Pano : 14sec | ||
| Ceph[Scan type] : below 19sec | Ceph[Scan type] : below 18sec | Ceph[Scan type] : below 18sec | ||
| Same as predicate device #1 | Ceph[One shot type]:below 2sec | Ceph[One shot type, α-Multi3D]:0.3sec~3.0sec | ||
| Format compatible | Same as predicate device #1 | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| Image Viewing Software | Same as predicate device #1 | RayScan(Cleared under K160535) | Ezdent-i(K161117) | |
| Image acquisition | Same as predicate device #1 | Giga-Ethernet Network | Giga-Ethernet Network | |
| Total Height | Same as predicate device #1 | Max 2,296mm | Max 2,304mm | |
| Weight | 1) Computed Tomography(CT) +Panoramic(PANO)=189kg(416.6lb) ±10% | 1) Computed Tomography(CT) +Panoramic(PANO)=150kg(331lb) ±10% | 1) Computed Tomography(CT) +Panoramic(PANO)=187kg(412.3lb) ±10% | |
| 2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)= 219kg (482.8lb) ± 10% | 2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)= 166kg (366lb) ± 10% | 2) Computed Tomography(CT) +Panoramic(PANO) + Ceph212kg (467.4lb) ± 10% | ||
| 3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 217kg (478.4lb) ± 10% | 3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 166kg (366lb) ± 10% | |||
| 4) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Large size)212kg (467.3lb) ± 10% | 4) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Large size)166kg (366lb) ± 10% | |||
| Type ofinstallation | Same as predicate device #1 | Wall or floor mount | Wall or floor mount | |
| Patient position | Same as predicate device #1 | Standing / Wheelchair | Standing / Wheelchair | |
| ApplicableStandards | Same as predicate device #2 | IEC 60601-1IEC 60601-1-3IEC 60601-2-28IEC 60601-2-63IEC 60601-1-2 | IEC 60601-1IEC 60601-1-3IEC 60601-2-63IEC 60601-1-2 |
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12. Safety and Effectiveness Information
RCT800 system described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source.
The following information further substantial equivalence between the subject device and predicate device.
The fundamental technological characteristics of the subject and predicate device are similar.
The imaging modes are similar; PANO, CEPH (Optional), CBCT, Model Scan All viewing software programs have been cleared with previous 510k submissions; RAYSCAN(K160525).
The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences are as follows.
- The subject device is equipped with new detectors, FXDD-0606CA, 1717SCC. And new High Voltage Generator, X-ray Tube for Model Scan.
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1: 2005/AMD1:2012(3.1 Edition), IEC 60601-1-3: 2008/AMD1:2013(Second Edition), IEC 60601-1-6:2010(Third Edition) and IEC 60601-2-63: 2012(first Edition) were performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2014(Edition 4.0).
The software of RCT800 saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT800 equipment and various sensors for diagnosis. And that has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence. The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator. As a result, we identified the level of concern associated with new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"
Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
All test results were satisfactory.
Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
RCT800 is equipped with FXDD-0606CA. FXDD-0606CA is a new SSXI detector, which is used to capture an image in panoramic, CBCT and Model Scan mode.
Based on Non-Clinical Test results of FXDD-0606CA for the subject device, is similar to that of the SiX 650HD-E for the Predicate device. And equipped with 1717SCC is a new SSXI detector, which is used to capture an image in Cephalometric. Based on Non-Clinical Test results of 1717SCC for the subject device, is similar to that of the PaxScan 4336X for the Predicate device.
All test results were satisfactory.
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Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RCT800.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT800 on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
12. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., Ltd. concludes that the newly RCT800 is safe and effective and substantially equivalent to predicate device as described herein.
§ 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.