(24 days)
No
The summary describes standard image processing and reconstruction techniques for a dental X-ray system and does not mention any AI or ML components.
No.
The device is an imaging system used for diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details of the maxillofacial areas for a dental treatment."
No
The device description explicitly states it is a "digital X-ray imaging system" that incorporates hardware components like an "X-ray generator" and a "dedicated SSXI detector," in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The PHT-35LHS is an X-ray imaging system. It produces images of the oral anatomy and maxillofacial areas by using X-rays and computer reconstruction. It does not analyze biological specimens.
- Intended Use: The intended use is to provide diagnostic details of the oral anatomy for dental treatment and orthodontic treatment by producing images.
- Device Description: The description clearly states it's a digital X-ray imaging system that acquires and processes radiographic images.
Therefore, the PHT-35LHS falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
PHT-35LHS is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is operated and used by physicians, dentists and x-ray technicians.
Product codes
OAS
Device Description
Green Smart (PHT-35LHS) is an advanced 5 in 1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system. Green Smart (PHT-35LHS), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for dentists. Specifically designed for dental radiography, Green Smart (PHT-35LHS) is a complete digital X-ray system equipped with imaging viewers, X-ray generator and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of head, neck, oral surgery, implant and orthodontic treatment. With Auto Pano function, It also reconstructs the 3D CT data and produces 2D panoramic images without an additional X-ray scan. Green Smart (PHT-35LHS) can also acquire 2D diagnostic image data in conventional panoramic and cephalometric imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral anatomy, maxillofacial areas, head, neck
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
physicians, dentists and x-ray technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical performance report using the same test protocol for the subject and 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.
Non-Clinical Test results of Xmaru1404CF-Plus for the subject device showed the CMOS panel is identical to the predicate device (Xmaru1404CF), with no aliasing phenomenon at the same spatial frequency. Performance was similar in DQE, MTF, and NPS.
For the new detector Xmaru2602CF, Non-Clinical test results demonstrated better performance parameters compared to Xmary2301CF of the predicate device in terms of MTF, DQE and NPS, indicating better image quality.
Acceptance test was performed according to 21 CFR Part 1020.33 and IEC 61223-3-5, measuring Contrast, Noise, CNR, and MTF with iterative reconstruction. Results showed the general image quality of the subject device is equivalent or better than the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Green Smart (Model: PHT-35LHS) digital X-ray system is similar to the predicate device in terms of indications for use, materials, safety characteristics, and X-ray source. The fundamental technological characteristics of the proposed and predicate device are similar. All viewing software programs have been cleared with previous 510k submissions; EasyDent (K152106), Ez 3D Plus (K152106), EzDent-i (K161117) and Ez3D-i (K161246). 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 subject device is equipped with new detectors, Xmaru1404CF-Plus and Xmaru2602CF. The subject device includes additional imaging modes; 3D Photo and Model Scan. The subject device includes imaging viewer programs; EzDent-i (K161117) and Ez3D-i (K161246). Based on Non-Clinical Test results of Xmaru1404CF-Plus for the subject device, the CMOS panel of Xmaru1404CF-Plus is exactly same to that of the predicate device (Xmaru1404CF). Therefore, the testing image patterns of the new sensor show no aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new sensor has performed similarly to the predicate device in terms of the DQE, MTF and NPS. All performance parameters for both detectors have shown similar results. For the new detector Xmaru2602CF of the subject device, the Non-Clinical test results demonstrated better performance parameters compared to Xmary2301CF of the predicate device in terms of MTF, DQE and NPS. The new CMOS panel in Xmaru2602CF generates better image quality. All performance parameters for Xmaru2602CF detector have better results than Xmaru2301CF detector. In addition, the acceptance test was performed according to the requirements of 21 CFR Part 1020.33 and IEC 61223-3-5, international performance standard for computed tomography X-ray system. Contrast, Noise, CNR, and MTF, the representative indicators for CT image quality were measured with iterative reconstruction algorithm for the new X-ray equipment. The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device. Software verification and validation activities were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE, MTF, NPS, Contrast, Noise, CNR
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K162660
Trade/Device Name: Green Smart (Model PHT-35LHS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 28, 2016 Received: September 29, 2016
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. 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); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
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
2
Indications for Use
510(k) Number (if known) K162660
Device Name Green Smart (Model: PHT-35LHS)
Indications for Use (Describe)
PHT-35LHS is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is operated and used by physicians, dentists and x-ray technicians.
| 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
1. 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.
2. Date 510K Summary prepared: September 22, 2016
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group
8310 Buffalo Speedway, Houston, TX 77025
Tel: +713-467-2607
Fax: +713-583-8988
Contact person: Mr. Dave Kim (davekim@mtech-inc.net) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
Tel: +82-31-379-9492
Fax: +82-31-379-9400
Contact person: Daniel Kim / Manager (daniel.kim@vatech.co.kr) |
- Device Information
| Type of 510(k) Submission: | Special |
|---|---|
| Trade or Proprietary Name: | Green Smart (Model: PHT-35LHS) |
| Common or Usual Name: | Dental Computed Tomography X-ray System |
| Regulation Classification: | Computed tomography x-ray system (21 CFR 892.1750) |
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
- Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Predicate device: | PaX-i3D Smart (PHT-30LFO) / K152106 |
| Common or Usual Name: | X-Ray, Tomography, Computed, Dental |
| Regulation Classification: | Computed tomography x-ray system (21 CFR 892.1750) |
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
※ This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
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6. Device Description
Green Smart (PHT-35LHS) is an advanced 5 in 1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system.
Green Smart (PHT-35LHS), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for dentists. Specifically designed for dental radiography, Green Smart (PHT-35LHS) is a complete digital X-ray system equipped with imaging viewers, X-ray generator and a dedicated SSXI detector.
The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of head, neck, oral surgery, implant and orthodontic treatment. With Auto Pano function, lt also reconstructs the 3D CT data and produces 2D panoramic images without an additional X-ray scan.
Green Smart (PHT-35LHS) can also acquire 2D diagnostic image data in conventional panoramic and cephalometric imaging.
Key components of the device
-
- Green Smart (Model: PHT-35LHS) digital x-ray equipment
-
- SSXI detector: Xmaru1404CF-Plus, Xmaru2602CF
| Item | Description | |
|---|---|---|
| CBCT/PANO | CEPHALOMETRIC | |
| Model | Xmaru1404CF-Plus | Xmaru2602CF |
| Detector Type | CMOS photodiode array | CMOS photodiode array |
| Pixel Size | 198µm @ 4X4 binning | 200 µm @ 2X2 binning |
| Active Area | CBCT-36.4 x 135.8 mm | |
| PANO-5.9 x 135.8 mm | 15.6 x 36.4 mm | |
| Frame Rate | ~308 fps (4x4 Binning) | ~330 fps (2x2 Binning) |
| Analogue-Digital Conversion | 14 bits | 14 bits |
| Converter | Csl:Ti | Csl:Ti |
| Energy Range | 50 ~ 120 kV | 50 ~ 120 kV |
| Readout Type | Charge amplifier array | Charge amplifier array |
| Video Output | Optic | Optic |
- X-ray generator
| Item | Description | ||
|---|---|---|---|
| High Voltage | |||
| Generator | Model | DG-07E22T2 | |
| Rated output power | 1.6 kW | ||
| Type | Inverter | ||
| Normal/Pulse | kV | 60 ~ 99 kV | |
| mA | 4 ~ 16 mA | ||
| Cooling | Air (Optional fan cooling, ≥ 60 °C) | ||
| Total filtration | Min. 2.5 mm Al | ||
| Added filtration | 1.5 mm Al (Fixed) / PANO and CEPH mode | ||
| 1.5 mm Al (Fixed) + 3.0 mm Al (Automatically added) / CBCT | |||
| mode | |||
| X-ray Tube | Manufacturer | Toshiba | |
| Model | D-052SB (Stationary Anode type) | ||
| Focal spot size | 0.5 x 0.5 mm | ||
| Target Angle | 5 degree | ||
| Inherent Filtration | At least 0.8 mm Al equivalent at 50 kV | ||
| Anode Heat Content | 35 kJ |
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| Item | Description |
|---|---|
| Duty Cycle | 1:60 or more (Exposure time : Interval time) |
4) PC system
| Item | Description |
|---|---|
| Operating System | Windows 8 Professional 64-Bit OS |
| CPU | Intel Xeon E5-1607v3 3.1GHz 1866 4C or faster |
| RAM | 16GB DDR4-2133 Registered RAM |
| HDD | 1TB SATA 1st HDD |
| Graphics board | NVIDIA Geforce GTX970 D5 4GB or greater |
| Ethernet interface | Integrated Intel I218LM PCIeGbE |
| Serial Port (RS232) | HP Serial Port Adapter Kit |
| Power Supply | ≥ 700 Watts (90% Efficiency) |
| Slots | 2 PCI Express Gen3 x16 slot |
| 1 PCI Express Gen3 x8 Slot | |
| 1 PCI Express Gen2 x4 Slot | |
| 1 PCI Express Gen2 x1 Slot | |
| 1 PCI Slot |
5) Imaging software
| Item | Description |
|---|---|
| 2D Image Viewing Program | EasyDent (Cleared under K152106) |
| EzDent-i (K161117) | |
| 3D Image Viewing Program | Ez3D Plus (Cleared under K152106) |
| Ez3D-i (K161246) |
7. Indication for use
Green Smart (Model: PHT-35LHS) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for dental treatments in adult and pediatric dentistry. The system also utilizes for orthodontic treatment. The device is operated and used by physicians, dentists and x-ray technicians.
8. Comparison of Technological characteristics with the predicate device
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Device Name | Green Smart | ||
| (Model: PHT-35LHS) | PaX-i3D Smart | ||
| (Model: PHT-30LFO) | |||
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | |
| 510(k) Number | N/A | K152106 | |
| Device Classification Name | X-Ray, Tomography, Computed, Dental | X-Ray, Tomography, Computed, Dental | |
| Classification Product Code | OAS | OAS | |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Subject Device | Predicate Device | ||
| Indications for Use | PHT-35LHS is a computed tomography | ||
| x-ray system intended to produce | |||
| panoramic, cephalometric or cross- | |||
| sectional images of the oral anatomy | |||
| by computer reconstruction of x-ray | |||
| image data from the same axial plane | |||
| taken at different angles. It provides | |||
| diagnostic details of the maxillofacial | |||
| areas for dental treatments in adult | |||
| and pediatric dentistry. The system | |||
| also utilizes carpal images for | |||
| orthodontic treatment. The device is | |||
| operated and used by physicians, | |||
| dentists and x-ray technicians. | PHT-30LFO is a computed tomography | ||
| x-ray system intended to produce | |||
| panoramic, cephalometric or cross- | |||
| sectional images of the oral anatomy | |||
| on a real time basis by computer | |||
| reconstruction of x-ray image data | |||
| from the same axial plane taken at | |||
| different angles. It provides diagnostic | |||
| details of the anatomic structures by | |||
| acquiring 360° rotational image | |||
| sequences of oral and maxillofacial | |||
| area for a precise treatment planning | |||
| in adult and pediatric dentistry. The | |||
| device is operated and used by | |||
| physicians, dentists, and x-ray | |||
| technicians. | |||
| Panoramic, Cephalometric and computed | Panoramic, Cephalometric and computed | ||
| Performance Specification | tomography | tomography | |
| Input Voltage | AC 100 - 240 V | AC 100 - 240 V | |
| X-Ray source | D-052SB | D-052SB | |
| Tube Voltage | 60 - 99 kV | 60 - 99 kV | |
| Tube Current | 4 - 16 mA | 4 - 16 mA | |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm | |
| Scan Time | Max. 18 s | Max. 18 s | |
| Slice Width | Min. 0.1 mm | Min. 0.1 mm | |
| Total Filtration | Min. 2.5 mm Al | Min. 2.8 mm Al | |
| Mechanical | Compact design | Compact design | |
| Electrical | LDCP logic circuit | LDCP logic circuit | |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| 2D Image Viewing Program | EasyDent (Identical to K152106) | ||
| EzDent-i (K161117) | EasyDent | ||
| 3D Image Viewing Program | Ez3D Plus (Identical to K152106) | ||
| Ez3D-i (K161246) | Ez3D Plus | ||
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| CT&PANO | Xmaru1404CF-Plus | Xmaru1404CF | |
| Xmaru2301CF | |||
| Image | |||
| Receptor | CEPH | 1210SGA | |
| Xmaru2602CF | 910SGA | ||
| Xmaru2301CF-O | |||
| Size of Imaging Volume | Max. 100 x 8.5 mm | Max. 100 x 8.5 mm | |
| CT&PANO | 5 lp/mm -2x2 binning | ||
| Pixel | 2.5 lp/mm -4x4 binning | 2.5 lp/mm -4x4 binning | |
| 5 lp/mm -Xmaru2301CF | |||
| Resolution | CEPH | 2.5 lp/mm -2x2 binning | 3.9 lp/mm -1210SGA |
| 3.9 lp/mm -910SGA | |||
| 5 lp/mm -Xmaru2301CF-O | |||
| 99 µm -2X2 binning | |||
| Pixel Size | CT&PANO | 198 µm @ 4X4 binning | 198 µm -4x4 binning |
| Subject Device | Predicate Device | ||
| CEPH | 200 μm -2X2 binning | 100 μm -Xmaru2301CF | |
| 127 μm -1210SGA | |||
| 127 μm -910SGA | |||
| 100 μm -Xmaru2301CF-O |
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9. Performance Data
Summary of Performance Testing
The Green Smart (Model: PHT-35LHS) digital X-ray 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 proposed device and predicate device:
The fundamental technological characteristics of the proposed and predicate device are similar. All viewing software programs have been cleared with previous 510k submissions; EasyDent (K152106), Ez 3D Plus (K152106), EzDent-i (K161117) and Ez3D-i (K161246).
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, Xmaru1404CF-Plus and Xmaru2602CF.
- । The subject device includes additional imaging modes; 3D Photo and Model Scan
- -The subject device includes imaging viewer programs; EzDent-i (K161117) and Ez3D-i (K161246).
Green Smart (Model: PHT-35LHS), a digital radiographic imaging system is equipped with Xmaru1404CF-Plus and Xmaru2602CF. Xmaru1404CF-Plus is a new SSXI detector, which is used to capture an image in panoramic, CBCT and Model Scan. mode Xmaru2602CF, a new scan type detector, obtains a cephalometric image. In addition, the subject device is equipped with 3D photo mode and Model Scan mode. 3D photo mode does not require X-ray exposure. Model scan captures a dental model and reconstructs it in 3D.
Based on Non-Clinical Test results of Xmaru1404CF-Plus for the subject device, the CMOS panel of Xmaru1404CF-Plus is exactly same to that of the predicate device(Xmaru1404CF). Therefore, the testing image patterns of the new sensor show no aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new sensor has performed similarly to the predicate device in terms of the DQE, MTF and NPS. All performance parameters for both detectors have shown similar results.
For the new detector Xmaru2602CF of the subject device, the Non-Clinical test results demonstrated better performance parameters compared to Xmary2301CF of the predicate device in terms of MTF, DQE and NPS. The new CMOS panel in Xmaru2602CF generates better image quality. All performance parameters for Xmaru2602CF detector have better results than Xmaru2301CF detector.
In addition, the acceptance test was performed according to the requirements of 21 CFR Part 1020.33 and IEC 61223-3-5, international performance standard for computed tomography X-ray system. Contrast, Noise, CNR, and MTF, the representative indicators for CT image quality were measured with iterative reconstruction
8
algorithm for the new X-ray equipment. The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device.
Software Verification and Validation Testing
Software verification and validation activities were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." 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.
Green Smart (Model: PHT-35LHS) provides the following imaging viewer programs;
- 2D Image viewing program: EasyDent (K152106), EzDent-i(K161117) -
- -3D Image viewing program: Ez3D Plus (K152106), Ez3D-i(K161246)
Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(Ed. 3, 2005), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-2-63 (Ed. 1, 2012) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.
Green Smart (Model: PHT-35LHS) conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical consideration report according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was provided.
Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed.
All test results were satisfactory.
10. Conclusions
The proposed device and the predicate device have similar indications for use and demonstrated similar technical characteristics. As demonstrated in the performance test, the Xmaru1404CF-Plus and Xmaru2602CF performed similar or better in comparison with the predicate device in various performance parameters such as DQE, MTF and NNPS. In addition, the CT image evaluation of Contrast, Noise, CNR, and MTF further demonstrated the performance equivalency between the subject and predicate device. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the sponsor's opinion that Green Smart (Model: PHT-35LHS) is substantially equivalent to the predicate device as described herein.