PaX-i3D Green Premium (Model: PCT-90LH)

K160882 · VATECH Co., Ltd. · OAS · Oct 28, 2016 · Radiology

Device Facts

• Record ID: K160882
• Device Name: PaX-i3D Green Premium (Model: PCT-90LH)
• Applicant: VATECH Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Oct 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PaX-i3D Green Premium (Model: PCT-90LH) 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 and ENT treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, ENT specialist and x-ray technicians.

Device Story

Digital radiographic imaging system (CBCT) for dental and ENT applications. Inputs: X-ray projections captured via CMOS digital detector (Xmaru3104CF). Operation: X-ray generator produces radiation; detector captures data; system performs computer reconstruction of 3D volumes or 2D panoramic/cephalometric images. Includes iterative reconstruction algorithm to reduce noise. Output: 2D/3D diagnostic images displayed on PC via EzDent-i and Ez3D-i software. Used in dental/ENT clinics by dentists, physicians, and technicians. Clinical utility: Provides anatomical visualization for treatment planning (implants, orthodontics, oral surgery). Benefits: Enhanced diagnostic detail, noise reduction via iterative processing, and multi-modal imaging (PANO, CEPH, CT, 3D photo) in one system.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical testing of the Xmaru3104CF detector (MTF, DQE, NNPS) and CT image quality metrics (Contrast, Noise, CNR, MTF). Results demonstrated performance equivalent or superior to the predicate device. Compliance with IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2, and 21 CFR 1020.30/31/33 confirmed.

Technological Characteristics

Digital CBCT system using CMOS photodiode array detector (Xmaru3104CF) with CsI:Ti scintillator. X-ray generator (1,200W inverter) with 60-120 kV range. Focal spot 0.5 mm. Connectivity: DICOM 3.0 compliant. Software: EzDent-i (2D) and Ez3D-i (3D) viewers. Iterative reconstruction algorithm for noise reduction. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-2, NEMA PS 3.1-3.18.

Indications for Use

Indicated for producing panoramic, cephalometric, or 3D digital X-ray images to provide diagnostic details of dento-maxillofacial, ENT, sinus, and TMJ anatomy in adult and pediatric patients. Includes carpal imaging for orthodontic treatment. Operated by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• PaX-i3D Ortho (TON-95LH) (K132983)

Reference Devices

• PaX-i3D Smart (PHT-30LFO) (K152106)
• EzDent-i (K150747)
• Ez3D-i (K150761)

Submission Summary (Full Text)

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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 graphic of three human profiles facing to the right, resembling a family or group of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2016

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K160882

Trade/Device Name: PaX-i3D Green Premium (Model: PCT-90LH) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 22, 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K160882

Device Name PaX-i3D Green Premium (Model: PCT-90LH)

#### Indications for Use (Describe)

PaX-i3D Green Premium (Model: PCT-90LH) 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 and ENT treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, ENT specialist 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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# Section 7 – 510(k) Summary

## 1. 510(k) Summary

This summary of 510(k) 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: [phone] |
| | Fax: [phone] |
| | Contact person: Mr. Dave Kim ([e-mail]) |
| 510(k) Submitter: | VATECH Co., Ltd. |
| | Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea |
| | Tel: [phone] |
| | Fax: [phone] |
| | Contact person: Daniel Kim / Manager ([e-mail]) |

#### 4. Device Information

| Type of 510(k) Submission: | Traditional |
|----------------------------|----------------------------------------------------|
| Trade or Proprietary Name: | PaX-i3D Green Premium (Model: PCT-90LH) |
| 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 |

#### 5. Predicate Device Information

| Manufacturer: | VATECH Co., Ltd. |
|----------------------------|----------------------------------------------------|
| Predicate device: | PaX-i3D Ortho (TON-95LH) / K132983 |
| 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.

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#### 6. Reference Device Information

| Manufacturer: | VATECH Co., Ltd. |
|----------------------------|----------------------------------------------------|
| Reference 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.

## 7. Device Description

PaX-i3D Green Premium (Model: PCT-90LH), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for a dentist and an ENT specifically designed for dental and ENT radiography, PaX-i3D Green Premium (Model: PCT-90LH) is a complete digital X-ray system equipped with imaging viewers, Xray 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 and craniofacial anatomy for ENT, oral surgery, implant and orthodontic treatment. PaX-i3D Green Premium (Model: PCT-90LH) can also acquire 2D diagnostic image data in panoramic and cephalometric mode.

#### Key components of the device

- 1) PaX-i3D Green Premium (Model: PCT-90LH) digital x-ray equipment
- 2) SSXI detector: Xmaru3104CF

| Item | Description |
|-----------------------------|---------------------------------------------------|
| Model | Xmaru3104CF |
| Detector Type | CMOS photodiode array |
| Pixel Size | 99 µm @ 2X2 binning : PANO |
| | 198 µm @ 4X4 binning : Dental CT, ENT CT, i-CEPH |
| Active Area | 310.4 x 36.4 mm |
| Frame Rate | 107 fps (2x2 Binning) : PANO |
| | 308 fps (4x4 Binning) : Dental CT, ENT CT, i-CEPH |
| Analogue-Digital Conversion | 14 bits |
| Converter | Csl:Ti |
| Energy Range | 60 ~ 120 kV |
| Readout Type | Charge amplifier array |
| Video Output | Optic |

#### 3) X-ray generator

#### - Option 1

| Item | | Description |
|---------------------------|--------------------|-------------|
| High Voltage<br>Generator | Model | DG-08C22S1 |
| | Rated output power | 1,200 W |
| | Type | Inverter |
| | Normal/Pulse kV | 60 ~ 120 kV |

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| Item | | Description |
|------------|---------------------|----------------------------------------------|
| | mA | 4 ~ 10 mA |
| | Cooling | Air (Optional fan cooling, ≥ 60 ℃ ) |
| | Total filtration | Min. 2.5 mm Al |
| | Added filtration | 2.0 mm Al |
| X-ray Tube | Manufacturer | Superior |
| | Model | SXR-130-15-0.5 (Stationary Anode type) |
| | Focal spot size | 0.5 mm |
| | Target Angle | 15 degree |
| | Inherent Filtration | At least 1.1 mm Al equivalent at 80 kV |
| | Anode Heat Content | 21 kJ |
| | Duty Cycle | 1:20 or more (Exposure time : Interval time) |

### - Option 2

| Item | Description | |
|---------------------------|--------------------------|----------------------------------------------|
| High Voltage<br>Generator | Model | DG-08C22S2 |
| | Rated output power | 1,200 W |
| | Type | Inverter |
| | Normal/Pulse<br>kV<br>mA | 60 ~ 120 kV<br>4 ~ 10 mA |
| | Cooling | Air (Optional fan cooling, ≥ 60 °C) |
| | Total filtration | Min. 2.5 mm Al |
| | Added filtration | 2.0 mm Al |
| X-ray Tube | Manufacturer | C.E.I |
| | Model | OX/115-05 (Stationary Anode type) |
| | Focal spot size | 0.5 mm |
| | Target Angle | 15 degree |
| | Inherent Filtration | 0.5mm Al |
| | Anode Heat Content | 30 kJ |
| | Duty Cycle | 1:60 or more (Exposure time : Interval time) |

## 4) PC system

| Item | Description |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|
| Operating System | Windows 8.1 Professional 64-Bit OS |
| CPU | Intel Xeon E5-1620v3 3.5GHz 2133 10MB cache CPU |
| RAM | 32GB DDR4-2133 ECC RAM |
| HDD | 1TB SATA 1st HDD |
| Graphics board | NVIDIA GEFORCE GTX980 Ti OC D5 6GB or greater |
| Ethernet interface | Broadcom 5761 Gigabit PCIe NIC |
| Serial Port (RS232) | HP Serial Port Adapter Kit |
| Power Supply | ≥ 700 Watts (90% Efficiency) |
| Slots | 1 PCI Express Gen3 x 8 Slot<br>2 PCI Express Gen3 x 16 slot<br>1 PCI Express Gen2 x 8 Slot<br>1 PCI Express Gen2 x 4 Slot |

# 5) Imaging software

- ① EzDent-i: 2D viewer and patient management software
|

- ・ Manufacturer: EWOO SOFT Co., Ltd.

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- · 510(k) Number: K150747
- · Classification Number: 21CFR892.2050
- Product code: LLZ
- ② Ez3D-i: 3D image viewer
- Manufacturer: EWOO SOFT Co., Ltd.
- · 510(k) Number: K150761
- · Classification Number: 21CFR892.2050
- · Product code: LLZ

#### 8. Indication for use

PaX-i3D Green Premium (Model: PCT-90LH) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

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| | Subject Device | Predicate Device | Reference Device | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PaX-i3D Green Premium<br>(Model: PCT-90LH) | PaX-i3D Ortho (TON-95LH) | PaX-i3D Smart (PHT-30LFO) | |
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | VATECH Co., Ltd. | |
| 510(k) Number | N/A | K132983 | K152106 | |
| Device Classification Name | X-Ray, Tomography, Computed,<br>Dental | X-Ray, Tomography, Computed,<br>Dental | X-Ray, Tomography, Computed,<br>Dental | |
| Classification Product Code | OAS | OAS | OAS | |
| Regulation Number | 21 CFR 892.1750 | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Indications for Use | PaX-i3D Green Premium (Model: PCT-<br>90LH) is intended to produce<br>panoramic, cephalometric or 3D<br>digital x-ray images.<br>It provides diagnostic details of the<br>dento-maxillofacial, ENT, sinus and<br>TMJ for adult and pediatric patients.<br>The system also utilizes carpal images<br>for orthodontic treatment. The device<br>is to be operated by healthcare<br>professionals. | PaX-i3D Ortho (TON-95LH) is a<br>computed tomography x-ray system<br>intended to produce cross-sectional<br>images of the oral anatomy by<br>reconstructing a three dimensional<br>radiographic images from the same<br>axial plane taken at different angles.<br>It provides diagnostic details of the<br>maxillofacial areas for a dental<br>treatment in adult and pediatric<br>dentistry. The system also acquires<br>carpal images for orthodontic<br>treatment. The device is operated<br>and used by physicians, dentists,<br>and x-ray technicians. | PHT-30LFO is a computed tomography<br>x-ray system intended to produce<br>panoramic, cephalometric or cross-<br>sectional images of the oral<br>anatomy on a real time basis by<br>computer reconstruction of x-ray<br>image data from the same axial<br>plane taken at different angles. It<br>provides diagnostic details of the<br>anatomic structures by acquiring<br>360° rotational image sequences of<br>oral and maxillofacial area for a<br>precise treatment planning in adult<br>and pediatric dentistry. The device is<br>operated and used by physicians,<br>dentists, and x-ray technicians. | |
| Performance Specification | Panoramic, Cephalometric and<br>computed tomography | Computed tomography | Panoramic, cephalometric and<br>computed tomography | |
| Input Voltage | AC 100 - 240 V | AC 100 - 240 V | AC 100 - 240 V | |
| X-Ray source | (Option 1) SXR-130-15-0.5<br>(Option 2) OX/115-05 | SXR-130-15-0.5 | D-052SB | |
| Tube Voltage | 60 - 120 kV | 50 - 120 kV | 50 - 99 kV | |
| Tube Current | 4 - 10 mA | 4 - 10 mA | 4 - 16 mA | |
| Focal Spot Size | 0.5 mm | | 0.5 mm | |
| Exposure Time | Max. 18 s | | Max. 18 s | |
| Slice Width | Min. 0.1 mm | Min. 0.1 mm | Min. 0.1 mm | |
| Total Filtration | (Option 1) Min. 2.5 mm Al | Min. 2.8 mm Al | 2.8 mm Al | |
| | | (Option 2) 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 |
| | 2D Image Viewing Program | EzDent-i | EzDent-i | EasyDent |
| 3D Image Viewing Program | | Ez3D-i | Ez3D-i Ortho | Ez3D Plus |
| Anatomical Sites | | Maxillofacial | Maxillofacial | Maxillofacial |
| Image<br>Receptor | Computed<br>Tomography | | Xmaru2430CF Master Plus | Xmaru1404CF |
| | Panoramic | Xmaru3104CF | Reconstructed from 3D image data | |
| | Cephalometric | | Reconstructed from 3D image data | Xmaru2301CF<br>1210SGA<br>910SGA<br>Xmaru2301CF-O |
| Size of Imaging Volume | | Max. 210 x 190 mm | Max. 240 x 210 mm | Xmaru1404CF: Max. 10 x 8.5 mm |
| Pixel<br>Resolution | Computed<br>Tomography | 2.5 lp/mm -4x4 binning | 5 lp/mm -2x2 binning<br>2.5 lp/mm -4x4 binning | Xmaru1404CF:<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning |
| | Panoramic | 5 lp/mm -2x2 binning | N/A | Xmaru1404CF:<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning |
| | Cephalometric | 2.5 lp/mm -4x4 binning | N/A | Xmaru2301CF: 5 lp/mm<br>1210SGA: 3.9 lp/mm<br>910SGA: 3.9 lp/mm<br>Xmaru2301CF-O: 5 lp/mm |
| | | | | |
| Pixel Size | Computed<br>Tomography | 198 $\mu$ m -4x4 binning | 99 $\mu$ m-2x2 binning<br>198 $\mu$ m-4x4 binning | Xmaru1404CF:<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning |
| | Panoramic | 99 $\mu$ m -2X2 binning | N/A | Xmaru1404CF:<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning |
| | Cephalometric | 198 $\mu$ m -4x4 binning | N/A | Xmaru2301CF: 100 x 100 $\mu$ m<br>1210SGA: 127 x 127 $\mu$ m<br>910SGA: 127 x 127 $\mu$ m<br>Xmaru2301CF-O: 100 x 100 $\mu$ m |

# 9. Comparison of Technological characteristics with the predicate device

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## VATECH Co., Ltd. Premarket Notification 510(k)

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## 10. Performance Data

## Summary of Performance Testing

The PaX-i3D Green Premium (Model: PCT-90LH) digital X-ray system described in this 510(k) is similar to the predicate device, PaX-i3D Ortho (TON-95LH) in terms of indications for use, materials, safety characteristics, and X-ray source.

Furthermore, the following information further substantial equivalence between the subject device and predicate device:

The fundamental technological characteristics of the subject and predicate device are similar.

The sponsor tested the subject device in a laboratory and provided a non-clinical performance report. The same test protocol was used to test the predicated device for the purpose of comparing the performance between the predicate device. 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 Xmaru3104CF, a SSXI detector, which is used to capture PANO, i-। CEPH, CT (Dental / ENT) images.
- । The subject device utilizes iterative reconstruction algorithm, a CBCT imaging processing algorithm.
- -In addition to th…