(86 days)
Xmaru1215CF Master Plus, Xmaru2301 CF
Not Found
No
The summary mentions "computer reconstruction of x-ray image data" and "iterative reconstruction algorithm," which are standard image processing techniques in CT imaging and do not inherently indicate the use of AI/ML. There is no mention of AI, ML, deep learning, or related terms.
No
The device is a diagnostic imaging system, not a therapeutic device. It is used to produce images for diagnosis and treatment planning.
Yes
The "Intended Use / Indications for Use" section states that the device "provides diagnostic details of the anatomic structures" and is intended to "produce panoramic, cephalometric or cross-sectional images of the oral anatomy... for a precise treatment planning". The "Device Description" also mentions that the CMOS CT detector is used to "capture radiographic diagnostic images of oral anatomy". These phrases indicate the device's role in providing information for diagnosis.
No
The device description explicitly states it is a "dental radiographic imaging system" consisting of hardware components like an "x-ray tube, generator and dedicated SSXI detector" and a "CMOS digital X-ray detector." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PHT-30LFO is an imaging system that uses X-rays to create images of the oral anatomy. It does not analyze biological samples.
- Intended Use: The intended use is to produce images for diagnostic details and treatment planning, which is a function of medical imaging devices, not IVDs.
- Device Description: The description details the components and operation of an X-ray imaging system, not an in vitro diagnostic test.
Therefore, the PHT-30LFO falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OAS
Device Description
PHT-30LFO, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-30LFO is a complete dental X-ray system equipped with x-fay tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography.
The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
System's Key Components:
- PHT-30LFO digital x-ray equipment with SSXI detectors (Xmaru1404CF, Xmaru2301CF, . Xmaru2301CF-O, 910SGA, 1210SGA)
- . PC system
- CPU: IntelXeon E5-1607 3GHz, 1600 4C or faster
- RAM: 16GB DDR3-1600 ECC RAM / UDIMM A
- Hard disk drive: 1 TB SATA 1st HDD
- Graphic board: ZOTAC NVIDIA Geforce GTX 780 Ti AMP! D5 3GB
- Imaging software
- EasyDent: 2D viewer and patient management software
- Ez3D Plus: 3D viewer and image analysis software
Mentions image processing
computer reconstruction of x-ray image data
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography x-ray
Anatomical Site
oral anatomy, oral and maxillofacial area, Maxillofacial
Indicated Patient Age Range
adult and pediatric dentistry
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 test and clinical consideration test were conducted for the PHT-30LFO system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE) and Noise to Power Spectrum (NPS).
Based on Non-Clinical Test results of the new detector Xmaru1404CF of the subject device, the measured pixel sizes of the new sensor (Xmaru1404CF) are very similar to that of the predicate device (Xmaru1215CF Master Plus). Therefore, compared to the predicate device, the test patterns of the new sensor images show the test subjects without aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance, given the DQE variation in low frequency ( ~ 0.5 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF and NPS.
For the new detector Xmaru2301CF-O of PHT-30LFO, the Non-Clinical test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device. The change in the data output interface has not caused any changes in the performance or the level of artifacts. All performance parameters for both detectors have shown similar results.
In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
The CBCT image reconstruction for PHT-30LFO applies iterative reconstruction algorithm for the reduction of noise in the CT image capture mode. Iterative reconstruction algorithm reconstructs raw data from the PHT-30LFO dental CBCT system to produce images containing noise levels less than or equal to images produced by standard filtered back projection reconstruction.
In addition to non-clinical tests, clinical images generated from the subject device were compared to a group of images taken from the predicate devices to provide further evidence in addition to the laboratory performance data to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device.
Software verification and validation tests 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.
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.
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.
Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" were performed.
Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were performed.
Summary of Performance Studies
Non-clinical test and clinical consideration test were conducted for the PHT-30LFO system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE) and Noise to Power Spectrum (NPS). The new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance, given the DQE variation in low frequency ( ~ 0.5 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF and NPS. For the new detector Xmaru2301CF-O of PHT-30LFO, the Non-Clinical test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device. The change in the data output interface has not caused any changes in the performance or the level of artifacts. All performance parameters for both detectors have shown similar results. In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant difference in efficiency and safety. The CBCT image reconstruction for PHT-30LFO applies iterative reconstruction algorithm for the reduction of noise in the CT image capture mode. Iterative reconstruction algorithm reconstructs raw data from the PHT-30LFO dental CBCT system to produce images containing noise levels less than or equal to images produced by standard filtered back projection reconstruction. In addition to non-clinical tests, clinical images generated from the subject device were compared to a group of images taken from the predicate devices to provide further evidence in addition to the laboratory performance data to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device. Software verification and validation tests 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. 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. 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. Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" were performed. Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were performed. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), Noise to Power Spectrum (NPS), Pixel sizes.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines extending above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K152106
Trade/Device Name: PaX-i3D Smart (PHT-30LFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 24, 2015 Received: July 29, 2015
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'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) K152106
Device Name PHT-30LFO PaX-i3D Smart
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510K summary prepared: July 24, 2015
I. SUBMITTER
| Submitter's Name : | Vatech Co., Ltd. |
|---|---|
| Submitter's Address: | 13, Samsung 1-ro 2-gil, Hwaseong-Si, Gyeonggi-Do, 445-170 |
| Republic of Korea | |
| Submitter's Telephone: | +82-31-379-9492 |
| Contact person: | Mr. Daniel.Kim |
| Official Correspondent: | |
| (U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +1- 713-467-2607 |
| Fax: | +1- 713-583-8988 |
II. DEVICE
| Trade/Proprietary Name: | PaX-i3D Smart (PHT-30LFO) |
|---|---|
| Common Name: | Dental Computed Tomography X-ray System |
| Regulation Name: | Computed Tomography X-ray System |
| Classification: | (21CFR 892.1750, Class II) |
| Product Code: | OAS |
4
III. PREDICATE DEVICE
| Primary Manufacturer: | Vatech Co., Ltd |
|---|---|
| Device Name: | PHT-6500 |
| Regulation Name : | Computed Tomography X-ray System |
| Classification No : | 21CFR 892.1750, Class II |
| Product Code: | OAS |
| 510(k) Number: | K122606 |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
PHT-30LFO, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-30LFO is a complete dental X-ray system equipped with x-fay tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography.
The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
System's Kev Components:
- PHT-30LFO digital x-ray equipment with SSXI detectors (Xmaru1404CF, Xmaru2301CF, . Xmaru2301CF-O, 910SGA, 1210SGA)
- . PC system
-
CPU: IntelXeon E5-1607 3GHz, 1600 4C or faster
- RAM: 16GB DDR3-1600 ECC RAM / UDIMM A
-
Hard disk drive: 1 TB SATA 1st HDD
-
Graphic board: ZOTAC NVIDIA Geforce GTX 780 Ti AMP! D5 3GB
-
- Imaging software ●
-
EasyDent: 2D viewer and patient management software
-
Ez3D Plus : 3D viewer and image analysis software
-
5
INDICATIONS FOR USE: v.
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 xray 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Proposed | Predicate | ||
|---|---|---|---|
| Characteristic | Vatech Co., Ltd. | Vatech Co., Ltd. | |
| PHT-30LFO (PaX-i3D Smart) | PHT-6500 (PHT-60CFO) | ||
| 510(k) number | K152106 | K122606 | |
| Indications | |||
| for use | 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. | PHT-6500 (PHT-60CFO) 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. | |||
| Performance Specification | Panoramic, | ||
| cephalometric | |||
| and | |||
| computed tomography | Panoramic, | ||
| cephalometric | |||
| and | |||
| computed tomography | |||
| Input Voltage | AC 100-240 V | AC 100-120/200-240 V | |
| Tube Voltage | 50-99 kV | 50-90 kV | |
| Tube Current | 4 ~16 mA | 4 ~10 mA | |
| Focal Spot Size | 0.5 mm | 0.5 mm | |
| Exposure Time | Max. 18 s | 0.7 - 24 s | |
| Slice Width | 0.1 mm min. | 0.1 mm min. | |
| Total Filtration | 2.8 mmAl | 2.8 mmAl | |
| Chin Rest | Equipped Headrest | Equipped Headrest | |
| 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 | EasyDent | |
| 3D Image Viewing | |||
| Program | Ez3D Plus | Ez3D Plus | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| Computed | |||
| Tomography | Xmaru1404CF | Xmaru0712CF | |
| Xmaru1215CF Plus | |||
| Xmaru1215CF Master Plus | |||
| Image | Panoramic | Xmaru1404CF | Xmaru1501CF |
| Receptor | Cephalometric | Xmaru2301CF | Xmaru2301CF |
| 1210SGA | 1210SGA | ||
| 910SGA | 910SGA | ||
| Xmaru2301CF-O | |||
| Size of Imaging Volume | |||
| (cm) | Xmaru1404CF : Max. 10x8.5 | Xmaru0712CF : Max. 8x8 | |
| Xmaru1215CF Plus : Max. | |||
| 12x9 | |||
| Xmaru1215CF Master Plus : | |||
| Max. 12x9 | |||
| Computed | |||
| Tomography | Xmaru1404CF : |
- 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning | Xmaru0712CF : 3.5 lp/mm |
| | | | Xmaru1215CF Plus : 3.5 lp/mm |
| Pixel
Resolution | | | Xmaru1215CF Master Plus : - 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning |
| | Panoramic | Xmaru1404CF : - 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning | Xmaru1501CF :
5 lp/mm |
| | | | |
| | Cephalometric | Xmaru2301CF : 5 lp/mm | Xmaru2301CF : 5 lp/mm |
| | | 1210SGA : 3.9 lp/mm | 1210SGA : 3.9 lp/mm |
| | | 910SGA : 3.9 lp/mm | 910SGA : 3.9 lp/mm |
| | | Xmaru2301CF-O : 5 lp/mm | |
| Pixel Size | Computed
Tomography | Xmaru1404CF : - 99 $\mu$ m- 2x2 binning
- 198 $\mu$ m- 4x4 binning | Xmaru0712CF : 140 × 140 $\mu$ m
Xmaru1215CF Plus : 140 × 140
$\mu$ m
Xmaru1215CF Master Plus : - 99 $\mu$ m- 2x2 binning
- 198 $\mu$ m- 4x4 binning |
| | Panoramic | Xmaru1404CF : - 99 $\mu$ m- 2x2 binning
- 198 $\mu$ m- 4x4 binning | Xmaru1501CF:
100 × 100 $\mu$ m |
| | Cephalometric | Xmaru2301CF : 100 × 100 $\mu$ m | Xmaru2301CF : 100 × 100 $\mu$ m |
| | | 1210SGA : 127 × 127 $\mu$ m | 1210SGA : 127 × 127 $\mu$ m |
| 910SGA : 127 × 127 $\mu$ m | | 910SGA : 127 × 127 $\mu$ m | |
| Xmaru2301CF-O : 100 × 100 $\mu$ m | | | |
The PHT-30LFO dental CBCT system described in this 510(k) has the similar intended use and technical characteristics as the PHT-6500 of Vatech Co.,Ltd.
6
510(k) Submission – PHT-30LFO
7
VII. PERFORMANCE DATA
Summary of Performance Testing:
The PHT-30LFO dental CBCT system described in this 510(k) is similar to the predicate device in its indications for use, materials, safety characteristics, X-ray source.
Moreover, the following information further substantial equivalence between two devices:
The fundamental technological characteristics of the subject and predicate device are similar.
Laboratory and clinical performance testing using the same test protocols as used for the cleared detectors was evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.
For both devices, the differences are as follows.
8
510(k) Submission – PHT-30LFO
-
- Change to Free Input Voltage: For the predicate device, changing the input voltage from 110V to 230V would require A separate tools and electrical work whereas the new device is equipped with a new power board which is capable of handling the input power between 100 V and 240 V without a separate tool or electrical modification.
-
- The CBCT reconstruction algorithm for the subject device is different from the predicate device.
Non-clinical test and clinical consideration test were conducted for the PHT-30LFO system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE) and Noise to Power Spectrum (NPS).
Based on Non-Clinical Test results of the new detector Xmaru1404CF of the subject device, the measured pixel sizes of the new sensor (Xmaru1404CF) are very similar to that of the predicate device (Xmaru1215CF Master Plus). Therefore, compared to the predicate device, the test patterns of the new sensor images show the test subjects without aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance, given the DQE variation in low frequency ( ~ 0.5 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF and NPS.
For the new detector Xmaru2301CF-O of PHT-30LFO, the Non-Clinical test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device. The change in the data output interface has not caused any changes in the performance or the level of artifacts. All performance parameters for both detectors have shown similar results.
In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
The CBCT image reconstruction for PHT-30LFO applies iterative reconstruction algorithm for the reduction of noise in the CT image capture mode. Iterative reconstruction algorithm reconstructs raw data from the PHT-30LFO dental CBCT system to produce images containing noise levels less than or equal to images produced by standard filtered back projection reconstruction.
In addition to non-clinical tests, clinical images generated from the subject device were compared to
9
a group of images taken from the predicate devices to provide further evidence in addition to the laboratory performance data to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device.
Software Verification and Validation Testing
Software verification and validation tests 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.
The predicate device and the proposed device utilize the identical image viewing software.
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.
PHT-30LFO 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.
Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" were performed.
Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were performed.
All test results were satisfactory.
10
VIII. CONCLUSIONS
The proposed device and the predicate device have the same indications for use and demonstrate the similar technical characteristics. As demonstrated in the non-clinical considerations, the new detectors performed similar or better than the predicate device in various performance parameters such as DQE, MTF and NPS. The risks of different voltage requirement of the new device is evaluated and mitigated in electrical safety test. The functionality and safety of the new iterative reconstruction algorithm for the CT capture mode were assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Vatech Co., Ltd. concludes that PHT-30LFO is safe and effective and substantially equivalent to the predicate device as described herein.
END