(25 days)
No
The document describes a digital X-ray imaging system and its performance characteristics, focusing on hardware components and image quality metrics. There is no mention of AI, ML, or related concepts like deep learning, training sets, or specific algorithms that would indicate the use of AI/ML technology.
No
This device is an X-ray imaging system intended for diagnostic purposes (producing images), not for treating conditions or diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details."
No
The device description explicitly states it is a "digital X-ray imaging system" and mentions hardware components like "detectors" and "CMOS panel," indicating it is a hardware device with integrated software, not a software-only device.
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 about a person's health.
- Device Function: The description clearly states that this device is an X-ray imaging system that produces digital images of the dento-maxillofacial, sinus, and TMJ. It uses X-rays to create images of internal structures.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is purely image acquisition using radiation.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PCH-30CS is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) is an advanced 3-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional) and 3D PHOTO (Optional) imaging capabilities into a single system and acquires 2D diagnostic image data in conventional panoramic and cephalometric modes. The PaX-i Plus / PaX-i Insight dental systems are not intended for CBCT imaging.
Key components of the device:
- PaX-i Plus / PaX-i Insight (Model: PCH-30CS) digital x-ray equipment
- SSXI detector: Xmaru1501CF-PLUS, Xmaru1404CF-PLUS, Xmaru2602CF
- X-ray generator
- PC system
- Imaging software (Image Viewing Program: EasyDent (Cleared under K122155), EzDent-i (K163533))
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillofacial, sinus, TMJ, oral and maxillofacial anatomy
Indicated Patient Age Range
adult and pediatric patients
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 results of all detectors for the Subject device.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note subject device detectors strongly based on predicate detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical performance report, Bench testing, Acceptance test, image evaluation report, Clinical consideration and image quality evaluation report.
Key Results:
- The fundamental technological characteristics of the subject and predicate device are similar.
- The imaging modes are similar; PANO and CEPH (Optional).
- The same x-ray source.
- All viewing software programs have been cleared with previous 510k submissions; EasyDent (K122155).
- The subject device is equipped with new detectors, Xmaru1501CF-PLUS, Xmaru1404CF-PLUS and Xmaru2602CF.
- In addition to modality, the subject device includes imaging modes; 3D PHOTO and Insight PAN(multi layer pano) mode for Panoramic.
- The subject device includes image viewing program; EzDent-i (K163533).
- Electric Power Voltage: Subject device; AC 100-240 V, Predicate device; AC 100-120 V / 200 -240 V.
- Xmaru1404CF-PLUS and Xmaru2602CF have been cleared with previous 510k submissions; on reference device, PHT-35LHS(K162660).
- The additional 3D PHOTO modality is also a function in reference device, PHT-35LHS(K162660).
- Insight PAN modality, only available in EzDent-i (K163533) image viewing program, provides multilayer panorama images with depth information, which a conventional single panorama image could not. Panorama images in Insight PAN mode demonstrate useful diagnostic information of a tooth, from anterior to posterior.
- The CMOS panel of new detectors is exactly same to that of the predicate device.
- The testing image patterns of the subject device show no aliasing phenomenon throughout the same spatial frequency as the predicate device.
- The new detector Xmaru1501CF-PLUS is based on the predicate Xmaru1501CF and bench testing data in the non-clinical consideration shows similar or better performance.
- For the new detector Xmaru1501CF-PLUS and Xmaru2602CF of the Non-Clinical test results demonstrated better performance parameters compared to Xmaru2301CF, respectively, of the predicate device in terms of MTF, DQE and NPS. Furthermore, it results a superior signal-to-noise ratio than the predicate device in all spatial frequencies.
- The new CMOS panel in Xmaru1501CF-PLUS and Xmaru2602CF generates better image quality. All performance parameters for Xmaru2602CF detector have better results than Xmaru1501CF and Xmaru2301CF detector, respectively.
- The CMOS panel of Xmaru1404CF-PLUS is higher performance than that of the predicate device(Xmaru1501CF).
- Pixel resolutions and pixel sizes in 2x2 binning mode for Xmaru1501CF are similar. However, at all spatial frequency(0°5 lp/mm), the Xmaru1404CF-PLUS has much better signal-to-noise ratio performance than the predicative device.
- The Xmaru1404CF-PLUS has higher DQE performance at all spatial frequencies. At low spatial frequency(r0.5 lp/mm), Xmaru1404CF-PLUS has a DQE of 2x2 binning: 57% / 4x4 binning: 56% and that of Xmaru1501CF is 59.7%. This result will be in a superior signal-to-noise ratio than Xmaru1501CF.
- The image quality of Xmaru1404CF-PLUS is higher than Xmaru1501CF at same patient exposure.
- The acceptance test was performed according to the requirements of 21 CFR Part 1020.30. and IEC 61223-3-4, international performance standard for dental x-ray equipment.
- In addition, the dosimetric performance of the subject device and the predicate device was compared in terms of DAP. With the identical FDD(Focal Spot to Detector Distance), DAP measurement in the PANO mode of each device under the similar X-ray exposure conditions (exposure time, tube current) was the similar.
- In CEPH mode, the subject device has two image options, normal and fast, based on the exposure condition (exposure time, tube voltage, tube current) whereas the predicate device has no such option. The direct comparison of the dosimetric performance for each mode available in the subject and predicate device is difficult due to different exposure conditions such as the exposure time. DAP of the fast CEPH mode of the subject device was equivalent to the predicate device.
- The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device.
- Software verification and validation 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.
- A cybersecurity risk analysis was performed on the device software.
- Satisfactory device testing result also indicates that the software part supports proper functioning of the subject device.
- PaX-i Plus / PaX-i Insight (Model: PCH-30CS) conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- MTF (Modulation Transfer Function)
- DQE (Detective Quantum Efficiency)
- NPS (Noise Power Spectrum)
- Signal-to-noise ratio
- DAP (Dose Area Product)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
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
April 4, 2017
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K170731
Trade/Device Name: PaX-i Plus/PaX-i Insight (Model: PCH-30CS) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 8, 2017 Received: March 10, 2017
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) K170731
Device Name PaX-i Plus/PaX-i Insight (Model: PCH-30CS)
Indications for Use (Describe)
PCH-30CS is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
| 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) |
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3
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: March 28, 2017
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: Dongyub Lee / Manager (dongyub.lee@vatech.co.kr) |
4. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | PaX-i Plus/PaX-i Insight (Model: PCH-30CS) |
| Common or Usual Name: | Digital X-ray Imaging System |
| Regulation Classification: | Extraoral Source X-ray System (21 CFR 872.1800) |
| Product Code: | MUH |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Predicate device: | PaX-i (PCH-2500) / K122155 |
| Common or Usual Name: | Digital X-ray Imaging System |
| Regulation Classification: | Extraoral Source X-ray System (21 CFR 872.1800) |
| Product Code: | MUH |
| Class of Device: | Class II |
| Panel: | Radiology |
6. Reference Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Predicate device: | Green Smart (Model: PHT-35LHS) / K162660 |
| Common or Usual Name: | Digital X-ray Imaging System |
4
| Regulation Classification: | X-Ray, Tomography, Computed, Dental (21 CFR 892.1750) |
|---|---|
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
※ This predicate device has not been subjected to a design-related recall.
5
6. Device Description
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) is an advanced 3-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional) and 3D PHOTO (Optional) imaging capabilities into a single system and acquires 2D diagnostic image data in conventional panoramic and cephalometric modes. The PaX-i Plus / PaX-i Insight dental systems are not intended for CBCT imaging
Key components of the device
-
- PaX-i Plus / PaX-i Insight (Model: PCH-30CS) digital x-ray equipment
-
- SSXI detector: Xmaru1501CF-PLUS, Xmaru1404CF-PLUS, Xmaru2602CF
| Description | ||||
|---|---|---|---|---|
| Item | PANO | CEPH | ||
| PaX-i Plus | PaX-i Insight | PaX-i Plus / PaX-i Insight | ||
| Model | Xmaru1501CF-PLUS | Xmaru1404CF-PLUS | Xmaru2602CF | |
| Detector Type | CMOS photodiode array | CMOS photodiode array | CMOS photodiode array | |
| Pixel Size | $100 \mu m$ | 99 μm -2X2 binning | ||
| (detector spec) | ||||
| 198 μm - 4X4 binning | ||||
| (system spec) | 100 μm- Non binning | |||
| (detector spec) | ||||
| 200 μm -2X2 binning | ||||
| (system spec) | ||||
| Active Area | 151.2 x 6.0 mm | 135.8 x 36.4 mm | 259 x 15.6 mm | |
| Frame Rate | ~287 fps (4x4 Binning) | ~308 fps (4x4 Binning) | ~330 fps (2x2 Binning) | |
| Analogue- | ||||
| Digital | ||||
| Conversion | 14 bits | 14 bits | 14 bits | |
| Converter | CsI:Ti | CsI:Ti | CsI:Ti | |
| Energy Range | 50 ~ 120 kV | 50 ~ 120 kV | 50 ~ 120 kV | |
| Readout Type | Charge amplifier array | Charge amplifier array | Charge amplifier array | |
| Video Output | Optic | Optic | Optic |
3) X-ray generator
| Item | Description | |
|---|---|---|
| High Voltage | ||
| Generator | Model | DG-07D21T2 |
| Rated output power | 1.0 kW | |
| Type | Inverter | |
| Normal/Pulse kV | 60 ~ 99 kV | |
| Normal/Pulse mA | 4 ~ 10 mA | |
| Cooling | Air (Optional fan cooling, ≥ 60 °C) | |
| Total filtration | Min. 2.5 mm Al | |
| Added filtration | 1.5 mm Al (Fixed) | |
| X-ray Tube | Manufacturer | Toshiba |
| X-ray Tube | Model | D-052SB (Stationary Anode type) |
| X-ray Tube | Focal spot size | 0.5 x 0.5 mm |
| X-ray Tube | Target Angle | 5 degree |
| X-ray Tube | Inherent Filtration | At least 0.8 mm Al equivalent at 50 kV |
| X-ray Tube | Anode Heat Content | 35 kJ |
| X-ray Tube | Duty Cycle | 1:60 or more (Exposure time : Interval time) |
- PC system
| Description
| For Start Court of Concessful Concessful |
|---|
| --------------------------------------------------------- |
6
| Item | Description | |
|---|---|---|
| PaX-i Plus | Operating System | Window 10 Home 64-bit OS |
| CPU | Intel Core i3-6100 3.7G 3M 2133 2C CPU | |
| RAM | 4GB DDR4-2133 DIMM(1x4GB) RAM | |
| HDD | 500GB 7200 RPM SATA 6G 3.5 HDD | |
| Graphics board | Integrated Graphic Card | |
| Ethernet interface | Intel Ethernet I210-T1 PCIe x1 Gb NIC | |
| Serial Port (RS232) | Integrated Motherboard | |
| Power Supply | ≥ 280 Watts (90% efficient) | |
| Slots | 1 full-height PCIe x16 (x4) | |
| 1 full-height PCIe x16 | ||
| 2 full-height PCIe x1 | ||
| 1 PCI (optional) | ||
| PaX-i Insight | Operating System | Windows 10 Professional 64-Bit OS |
| CPU | Intel Xeon E5-1607v3 3.1GHz 1866 4C | |
| RAM | 16GB DDR4-2133 Registered RAM | |
| HDD | 1TB SATA 1st HDD | |
| Graphics board | NVIDIA Geforce GTX970 D5 4GB | |
| Ethernet interface | Integrated Intel I218LM PCIeGbE | |
| Serial Port (RS232) | HP Serial Port Adapter kit | |
| Power Supply | ≥ 700 Watts (90% efficient) | |
| 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 |
|---|---|
| Image Viewing Program | EasyDent (Cleared under K122155) |
| EzDent-i (K163533) |
7. Indication for use
PCH-30CS is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
7
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| PaX-i Plus / PaX-i Insight | PaX-i | Green Smart | |
| Device Name | (Model: PCH-30CS) | (Model: PCH-2500) | (Model: PHT-35LHS) |
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | VATECH Co., Ltd. |
| 510(k) Number | N/A | K122155 | K162660 |
| Device Classification Name | System, X-Ray, Extra oral Source, Digital | System, X-Ray, Extra oral Source, Digital | X-Ray, Tomography, Computed, Dental |
| Classification Product Code | MUH | MUH | OAS |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 | 21 CFR 892.1750 |
| Indications for Use | PCH-30CS is intended to produce | ||
| panoramic or cephalometric digital x- | |||
| ray images. It provides diagnostic | |||
| details of the dento-maxillofacial, | |||
| sinus and TMJ for adult and pediatric | |||
| patients. The system also utilizes | |||
| carpal images for orthodontic | |||
| treatment. The device is to be | |||
| operated by physicians, dentists, and | |||
| x-ray technicians. | PCH-2500 is a digital extra oral source | ||
| x-ray system intended to take | |||
| panoramic and cephalometric images | |||
| of the oral and maxillofacial anatomy | |||
| to provide diagnostic information for | |||
| adult and pediatric patients. The | |||
| device should be operated and used | |||
| by dentists, x-ray technicians and | |||
| other professionals licensed by the | |||
| law of the state in which the device is | |||
| used. | 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. | |||
| Performance Specification | Panoramic, Cephalometric | Panoramic, Cephalometric | Panoramic, Cephalometric and computed |
| tomography | |||
| Input Voltage | AC 100 - 240 V | AC 100 - 120 / 200-240 V | AC 100 - 240 V |
| X-Ray source | D-052SB | D-052SB | D-052SB |
| Tube Voltage | 60 - 99 kv | 60 - 90 kv | 60 - 99 kV |
| Tube Current | 4 - 10 mA | 4 - 10 mA | 4 - 16 mA |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm | 0.5 x 0.5 mm |
| Scan Time | Max. 21 s | Max. 20.2 s | Max. 18 s |
| Slice Width | Min. 0.1 mm | Min. 0.1 mm | Min. 0.1 mm |
| Total Filtration | Min. 2.5 mm Al | 2.8 mm Al | Min. 2.5 mm Al |
| Mechanical | Compact design | Compact design | Compact design |
| Electrical | LDCP logic circuit | LDCP logic circuit | LDCP logic circuit |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Image Viewing Program | EasyDent (Cleared under K122155) | EasyDent (Cleared under K122155) | EasyDent (Cleared under K162660) |
8. Comparison of Technological characteristics with the predicate device
8
| Subject Device | Predicate Device | Reference Device | |||
|---|---|---|---|---|---|
| EzDent-i (K163533) | EzDent-i (K161117) | ||||
| Ez3D Plus (Cleared under K162660) | |||||
| Ez3D-i (K161246) | |||||
| Anatomical Sites | Maxillofacial | Maxillofacial | Maxillofacial | ||
| Image | |||||
| Receptor | PANO | Xmaru1501CF-PLUS | Xmaru1501CF | (PANO/CBCT) Xmaru1404CF-PLUS | |
| Xmaru1404CF-PLUS | |||||
| CEPH | Xmaru2602CF | Xmaru2301CF | Xmaru2602CF | ||
| Pixel | |||||
| Resolution | PANO | Xmaru1501CF- | |||
| PLUS | 5 lp/mm | 5 lp/mm | |||
| Xmaru1404CF- | |||||
| PLUS | 5 lp/mm -2x2 binning | ||||
| (detector spec) | |||||
| 2.5 lp/mm -4x4 binning | |||||
| (system spec) | 5 lp/mm -2x2 binning (detector spec) | ||||
| 2.5 lp/mm -4x4 binning (system spec) | |||||
| CEPH | 5 lp/mm-Non binning (detector spec) | ||||
| 2.5 lp/mm -2x2 binning (system spec) | 5 lp/mm | 5 lp/mm-Non binning (detector spec) | |||
| 2.5 lp/mm -2x2 binning (system spec) | |||||
| Pixel Size | PANO | Xmaru1501CF- | |||
| PLUS | 100 μm | 100 μm | 99 µm -2X2 binning (detector spec) | ||
| 198 µm - 4X4 binning (system spec) | |||||
| Xmaru1404CF- | |||||
| PLUS | 99 µm -2X2 binning | ||||
| (detector spec) | |||||
| 198 μm - 4X4 binning | |||||
| (system spec) | |||||
| CEPH | 100 um- Non binning (detector spec) | ||||
| 200 um -2X2 binning (system spec) | 100 μm | 100 um- Non binning (detector spec) | |||
| 200 um -2X2 binning (system spec) |
※ The PaX-i Plus / PaX-i Insight dental systems are not intended for CBCT imaging.
9
9. Performance Data
Summary of Performance Testing
The PaX-i Plus/PaX-i Insight(Model: PCH-30CS) digital X-ray system described in this 510(k) is similar to the predicate device and reference 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:
- a. The fundamental technological characteristics of the subject and predicate device are similar.
- b. The imaging modes are similar; PANO and CEPH (Optional).
- c. The same x-ray source
- d. All viewing software programs have been cleared with previous 510k submissions; EasyDent (K122155)
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 between the subject device and the predicate device:
- a. The subject device is equipped with new detectors, Xmaru1501CF-PLUS, Xmaru1404CF-PLUS and Xmaru2602CF.
- b. In addition to modality, the subject device includes imaging modes; 3D PHOTO and Insight PAN(multi layer pano) mode for Panoramic
- c. The subject device includes image viewing program; EzDent-i (K163533)
- d. Electric Power Voltage
- Subject device; AC 100-240 V
- Predicate device; AC 100-120 V / 200 -240 V
Xmaru1404CF-PLUS and Xmaru2602CF have been cleared with previous 510k submissions; on reference device, PHT-35LHS(K162660).
The additional 3D PHOTO modality is also a function in reference device, PHT-35LHS(K162660). In addition, Insight PAN modality, only available in EzDent-i (K163533) image viewing program, provides multilayer panorama images with depth information, which a conventional single panorama image could not. Panorama images in Insight PAN mode demonstrate useful diagnostic information of a tooth, from anterior to posterior.
Based on Non-Clinical Test results of all detectors for the Subject device, the CMOS panel of new detectors is exactly same to that of the predicate device. Therefore, the testing image patterns of the subject device show no aliasing phenomenon throughout the same spatial frequency as the predicate device.
The new detector Xmaru1501CF-PLUS is based on the predicate Xmaru1501CF and bench testing data in the non-clinical consideration shows similar or better performance.
For the new detector Xmaru1501CF-PLUS and Xmaru2602CF of the Non-Clinical test results demonstrated better performance parameters compared to Xmaru2301CF, respectively, of the predicate device in terms of MTF, DQE and NPS. Furthermore, it results a superior signal-to-noise ratio than the predicate device in all spatial frequencies. The new CMOS panel in Xmaru1501CF-PLUS and Xmaru2602CF
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generates better image quality. All performance parameters for Xmaru2602CF detector have better results than Xmaru1501CF and Xmaru2301CF detector, respectively.
Based on Non-Clinical Test results of Xmaru1404CF-PLUS for the subject device, the CMOS panel of Xmaru1404CF-PLUS is higher performance than that of the predicate device(Xmaru1501CF). Pixel resolutions and pixel sizes in 2x2 binning mode for Xmaru1501CF are similar. However, at all spatial frequency(0°5 lp/mm), the Xmaru1404CF-PLUS has much better signal-to-noise ratio performance than the predicative device.
The Xmaru1404CF-PLUS has higher DQE performance at all spatial frequencies. At low spatial frequency(r0.5 lp/mm), Xmaru1404CF-PLUS has a DQE of 2x2 binning: 57% / 4x4 binning: 56% and that of Xmaru1501CF is 59.7%. This result will be in a superior signal-to-noise ratio than Xmaru1501CF. Therefore, the image quality of Xmaru1404CF-PLUS is higher than Xmaru1501CF at same patient exposure.
The acceptance test was performed according to the requirements of 21 CFR Part 1020.30. and IEC 61223-3-4, international performance standard for dental x-ray equipment.
In addition, the dosimetric performance of the subject device and the predicate device was compared in terms of DAP. With the identical FDD(Focal Spot to Detector Distance), DAP measurement in the PANO mode of each device under the similar X-ray exposure conditions (exposure time, tube current) was the similar. In CEPH mode, the subject device has two image options, normal and fast, based on the exposure condition (exposure time, tube voltage, tube current) whereas the predicate device has no such option. The direct comparison of the dosimetric performance for each mode available in the subject and predicate device is difficult due to different exposure conditions such as the exposure time. DAP of the fast CEPH mode of the subject device was equivalent to the predicate device. Any user adjustment of the exposure setting in normal and fast mode of the subject device should consider the patient exposure level to be as low as possible.
Moreover, PANO / CEPH images from the subject and predicate devices are evaluated in the Clinical consideration and image quality evaluation report. The results demonstrated that the general image quality of the subject device is equivalent or better than the predicate device.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note subject device detectors strongly based on predicate detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
Software Verification and Validation Testing
Software verification and validation 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. A cybersecurity risk analysis was performed on the device software.
Satisfactory device testing result also indicates that the software part supports proper functioning of the subject device.
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) provides the following image viewing programs;
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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 the records are available for review.
PaX-i Plus / PaX-i Insight (Model: PCH-30CS) 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.
Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" were performed.
Acceptance test and image evaluation report according to IEC 61223-3-4 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 Xmaru1501CF-PLUS and Xmaru2602CF performed similar or better in comparison with the predicate device in various performance parameters such as DQE, MTF and NNPS. 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, VATECH Co., Ltd. concludes that PaX-i Insight (Model: PCH-30CS) is substantially equivalent to the predicate device as described herein.