TON-95LH, PAX-I3D ORTHO

K132983 · VATECH Co., Ltd. · OAS · Aug 7, 2014 · Radiology

Device Facts

• Record ID: K132983
• Device Name: TON-95LH, PAX-I3D ORTHO
• Applicant: VATECH Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

PaX-i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images 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 acquires carpal images for orthodontic treatment. The device is operated and used by physicians, dentists, and x-ray technicians.

Device Story

Dental CBCT system; captures radiographic data of oral/maxillofacial anatomy using X-ray tube, generator, and CMOS digital detector. Transforms X-ray projections into 3D cross-sectional images and reconstructs 2D panoramic/cephalometric images. Operated by physicians, dentists, and X-ray technicians in clinical settings. Healthcare providers use viewing software (EzDent-i, Ez3D-i Ortho) to visualize anatomy; supports clinical decisions for oral surgery, implants, and orthodontics. Benefits include high-definition diagnostic imaging for treatment planning.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical tests including Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), and Noise to Power Spectrum (NPS) to compare the new SSXI detector against the predicate. Compliance with IEC 60601 series (safety/EMC) and IEC 61223 series (CT image evaluation) confirmed. All test results were satisfactory.

Technological Characteristics

Dental CBCT system; CMOS digital X-ray detector (CT-Xmaru2430CF Master Plus); 50-120 kV tube voltage; 4-10 mA tube current; 0.5 mm focal spot; 2.8 mmAl filtration. Connectivity via DICOM 3.0. Software includes EzDent-i (2D) and Ez3D-i Ortho (3D) viewing programs. Universal power input (100-240V).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic imaging of the maxillofacial area for dental treatment planning and carpal imaging for orthodontic treatment.

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-Zenith3D (K102196)

Submission Summary (Full Text)

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

August 7, 2014

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

Re: K132983

Trade/Device Name: TON-95LH and PaX-i3D Ortho Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 7, 2014 Received: July 9, 2014

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.


for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K132983

#### Device Name PaX-i3D Ortho (TON-95LH)

Indications for Use (Describe)

PaX i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images 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 acquires 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.p)

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# 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 7th, 2014

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | Vatech Co., Ltd. |
|----------------------------------------------------|------------------------------------------------------------------------------|
| Submitter's Address: | 23-4, Seogu-Dong, Hwaseong-Si,<br>Gyeonggi-Do, 445-170,<br>Republic of Korea |
| Submitter's Telephone: | [phone] |
| Contact person: | Mr. Daniel Kim |
| Official Correspondent:<br>(U.S. Designated agent) | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/Proprietary Name: | PaX-i3D Ortho (TON-95LH) |
|-------------------------|--------------------------------------------------------------------------|
| Common Name: | Dental Computed Tomography X-ray System |
| Classification Name: | System, X-ray, Tomography, Computed, Dental(21CFR 892.1750,<br>Class II) |
| Product Code: | OAS |

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### Predicate Device:

| Manufacturer: | Vatech Co., Ltd |
|----------------|-----------------|
| Device Name: | PaX-Zenith3D |
| 510(k) Number: | K102196 |

### Device Description:

PaX-i3D Ortho (TON-95LH) is a dental radiographic imaging system with cone beam computed tomography (CBCT) to offer high definition digital diagnostic images in multi FOV for dental practitioners. Specifically designed for dental radiography of the teeth or jaws, TON-95LH is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental CBCT radiography.

The PaX-i3D Ortho (TON-95LH) dental CBCT system is equipped with a CMOS digital Xray detector which is used to capture radiographic diagnostic image data of oral and maxillofacial anatomy and reconstruct a three dimensional (3D) image for dental treatments such as oral surgery, implant and orthodontic. The PaX-i3D Ortho (TON-95LH) dental CBCT system also can reconstruct 2D panoramic and cephalometric images from the same diagnostic image data which the system originally obtained.

#### Indication for use:

PaX-i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images 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 acquires carpal images for orthodontic treatment. The device is operated and used by physicians, dentists, and x-ray technicians.

#### Summary of the technological characteristics of the device compared to the predicate device:

The PaX-i3D Ortho (TON-95LH) dental CBCT system described in this 510(k) has the similar intended use and technical characteristics as PaX-Zenith3D of Vatech Co.,Ltd.

| Characteristic | Proposed<br>Vatech Co., Ltd.<br>PaX-i3D Ortho (TON-95LH) | Predicate<br>Vatech Co., Ltd.<br>PaX-Zenith3D |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K132983 | K102196 |
| Indications<br>for use | PaX-i3D Ortho (TON-95LH)<br>is a computed tomography x-ray<br>system intended to produce cross-<br>sectional images of the oral<br>anatomy by reconstructing a three<br>dimensional radiographic images<br>from the same axial plane taken at<br>different angles. It provides<br>diagnostic details of the<br>maxillofacial areas for a dental<br>treatment planning in adult and<br>pediatric dentistry. The system also<br>utilizes carpal images for<br>orthodontic treatment. The device<br>is operated and used by physicians,<br>dentists, and x-ray technicians. | PaX-Zenith3D is a computed<br>tomography x-ray system<br>intended to take panoramic,<br>cross-sectional images of the<br>oral and craniofacial anatomy<br>and provide diagnostic<br>information for children and<br>adults clinical care in dentistry.<br>The device is operated and used<br>by x-ray technicians and dentists<br>including oral surgeons. |
| Performance<br>Specification | computed tomography | Panoramic and computed<br>tomography |
| Input Voltage | AC 100-240 V | 110V/230 V~ |
| Tube Voltage | 50-120 kV | 50-120 kV |
| Tube Current | 4 ~10 mA | 4 ~10 mA |
| Exposure Time | Max. 24 s | 9.7s-24 s |
| X-ray Source | SXR-130-15-0.5 | SXR-130-15-0.5 |
| X-ray Generator | DG-08B11S1 | EXG8 |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Slice Width | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Chin Rest | Equipped Headrest | Equipped Headrest |
| Performance<br>Specification | Computed tomography | Computed tomography |
| 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<br>Program | EzDent-i | EasyDent |
| | | |
| 3D Image Viewing<br>Program | Ez3D-i Ortho | Ez3D Plus |
| Anatomical Sites | Maxillofacial | Maxillofacial |
| Image Receptor<br>(CMOS photodiode<br>array) | CT- Xmaru2430CF Master Plus | CT- Xmaru2430CF |
| | | Panoramic- Xmaru1501CF |
| Size of Active<br>Imaging Area | CT- 289.4 x 230.8 mm | CT- 288 x 238.4 mm |
| | - | Panoramic- 150.4 x 6 mm |
| Pixel Resolution | CT- 5 lp/mm -2x2 binning<br>2.5 lp/mm -4x4 binning | CT- 2.5 lp/mm |
| | - | Panoramic- 5 lp/mm |
| Pixel Size | CT- 99 μm-2x2 binning<br>198 μm-4x4 binning | CT- 200 μm |
| | - | Panoramic- 100 μm |

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# 510(k) Submission – PaX-i3D Ortho (TON-95LH)

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510(k) Submission - Pax-i3D Ortho (TON-95LH)

## Summary of Performance Testing:

The PaX-i3D Ortho (TON-95LH) 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 substantiates the substantial equivalence between two devices:

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

Laboratory and clinical performance testing using the same test protocols as used for the cleared detectors was evaluated by qualified individuals employed by the

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### 510(k) Submission - PaX-i3D Ortho (TON-95LH)

sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

For both devices, the differences are as follows.

A new SSXI detector, Xmaru2430CF Master Plus for PaX-i3D Ortho (TON-95LH) has different active areas compared with PaX-Zenith3D (K102196), the predicate device.

Change to Free Input Voltage: For the predicate device, changing the input voltage from 110V to 230V would require separate tools and electrical works 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.

Non-clinical test and clinical consideration test were conducted for the PaX-i3D Ortho (TON-95LH) 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 the Non-Clinical Test results, even though the new SSXI detector differs in term of the pixel size and active area, 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.

## Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (Ed. 2, 2000), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (Ed. 2, 1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) 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.

PaX-i3D Ortho (TON-95LH) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

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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.

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.

## Conclusion:

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-i3D Ortho (TON-95LH) is safe and effective and substantially equivalent to the predicate device as described herein.

END