T1-CS, T1-C

K183475 · Osstem Implant Co., Ltd. · OAS · Aug 30, 2019 · Radiology

Device Facts

• Record ID: K183475
• Device Name: T1-CS, T1-C
• Applicant: Osstem Implant Co., Ltd.
• Product Code: OAS · Radiology
• Decision Date: Aug 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional 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.

Device Story

T1-C/T1-CS is a dental radiographic imaging system for panoramic, cephalometric, and cone beam computed tomography (CBCT). Device uses X-ray tube, generator, and digital solid-state detectors (SSXI) to acquire 360° rotational image sequences of oral/maxillofacial anatomy. System reconstructs 3D images from axial plane data. Operated by physicians, dentists, and X-ray technicians in clinical settings. Output consists of 2D/3D diagnostic images viewed via dedicated software (Xvision, One vision, OneClinic, One 3D) on a PC workstation. Clinicians use these images for precise treatment planning, such as oral surgery or implant placement. Benefits include high-resolution visualization of anatomical structures for improved diagnostic accuracy and surgical planning.

Clinical Evidence

Clinical study conducted to evaluate maxillofacial image quality. Images reviewed by qualified clinicians confirmed acceptable clinical effectiveness for the proposed indications. Results demonstrated that the imaging position, while different from the predicate, yields clinically sufficient image quality.

Technological Characteristics

Dental CBCT system using solid-state X-ray detectors (SSXI models 1515DXT, SEN1, XID-C24DC). Energy source: X-ray generator (60-100 kV, 5-16 mA). Form factor: Floor-mounted system with chin rest/headrest. Connectivity: PC-based workstation (Intel i5, 8GB RAM, Nvidia GTX970). Standards compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 62366.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic, cephalometric, or cross-sectional imaging of the oral and maxillofacial anatomy for dental treatment planning.

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

• PHT-30LFO (Pax-i3D Smart) (K152106)

Submission Summary (Full Text)

{0}------------------------------------------------

August 30, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osstem Implant Co., Ltd. % Peter Lee Official Correspondent Hiossen Inc. 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

# Re: K183475

Trade/Device Name: T1-C. T1-CS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 13, 2018 Received: December 17, 2018

# Dear Peter Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K183475

Device Name T1-C, T1-CS

#### Indications for Use (Describe)

T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional 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.

| <span style="font-family: Arial;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|

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 [e-mail]

"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."

Type of Use (Select one or both, as applicable)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. There is a small orange swirl design to the right of the word "OSSTEM".

# 510(k) Summary

(K183475)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

## 1. Date : 7/31/2019

# 2. Submitter / Correspondent

| Submitter: | OSSTEM IMPLANT Co., Ltd. | | |
|------------|-------------------------------------------------------|--|--|
| | 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, | | |
| | Gyeonggi-do, 15079, Republic of Korea | | |
| | Contact: Jiyoon Ha | | |
| | Tel.: [phone] | | |

| Correspondent's Name: | HIOSSEN Inc. |
|-----------------------|-------------------------------------------------|
| | 85 Ben Fairless Drive, Fairless Hills, PA 19030 |
| | Contact: Peter Lee |
| | Tel.: [phone] |

# 3. Trade/Proprietary Name:

T1-C. T1-CS

## 4. Common Name:

Computed tomography x-rav system

## 5. Classification:

21 CFR 892.1750, Class II Classification Name: Computed tomography X-ray system Product Code, OAS

## 6. Device Description:

"T1-C, T1-CS", 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, "T1-C, T1-CS" are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. 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 X-ray detector. T1-CS provides three modes, Whereas, T1-C provides only panoramic and cone beam computed tomography mode.

## SYSTEM's Key Components:

- · SSXI detectors (1515DXT, SEN1, XID-C24DC)
- · PC system
- CPU: Intel i5-4590 3.0GHz
- RAM: > 8GB
- Hard disk drive: 256GB (SSD recommended)
- Graphic board: Nvidia GeForce GTX970
- Hard disk space: 256GB
- · Imaging Software
- 2D Viewer : Xvision (Model Name : 2D-001), One vision (Model Name : 2D-002)
- 3D Viewer : OneClinic (Model Name : 3D-001), One 3D (Model Name : 3D-002)

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the letters connected in a stylized font. Below "OSSTEM", the word "IMPLANT" is written in gray, in a smaller, sans-serif font. The logo is simple and modern, with a focus on the brand name.

#### 7. Indication for use:

T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional 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.

### 8. Predicate Device:

Manufacturer: Vatech Co., Ltd Device Name: PHT-30LFO (Pax-i3D Smart) Regulation Name: Computed Tomography X-ray System Classification No.: 21CFR 892.1750, Class II Product Code: OAS 510(k) Number: K152106

#### 9. Substantial Equivalence:

"T1-CS, T1-C" described in this 510(k) has the similar intended use and technical characteristics as the PHT-30LFO of Vatech Co., Ltd.

Although the detector sizes of our device and the predicate device are different, this difference does not affect the substantially equivalent performance of our device to the predicate, and it does not affect the scope of intended use compared to the predicate device.

| Characteristic | Subject Device<br>OSSTEM IMPLANT Co., Ltd.<br>T1-CS, T1-C | Predicate Device<br>Vatech Co., Ltd.<br>PHT-30LFO (PaX-i3D Smart) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K183475 | K152106 |
| Indications for Use | T1-C, T1-CS are a computed<br>tomography x-ray system intended<br>to produce panoramic,<br>cephalometric or crosssectional<br>images of the oral anatomy on a<br>real time basis by computer<br>reconstruction of X-ray image data<br>from the same axial plane taken at<br>different angles. It provides<br>diagnostic details of the anatomic<br>structures by acquiring 360°<br>rotational image sequences of oral<br>and maxillofacial area for a precise<br>treatment planning in adult and<br>pediatric dentistry. The device is<br>operated and used by physicians,<br>dentists, and X-ray technicians.<br>T1-CS provides three modes,<br>whereas, T1-C provides only<br>panoramic and cone beam<br>computed tomography mode. | PHT-30LFO is a computed<br>tomography x-ray system intended<br>to produce panoramic,<br>cephalometric or crosssectional<br>images of the oral anatomy on a<br>real time basis by computer<br>reconstruction of X-ray image data<br>from the same axial plane taken at<br>different angles. It provides<br>diagnostic details of the anatomic<br>structures by acquiring 360°<br>rotational image sequences of oral<br>and maxillofacial area for a precise<br>treatment planning in adult and<br>pediatric dentistry. The device is<br>operated and used by physicians,<br>dentists, and X-ray technicians. |
| Performance Specification | Panoramic, cephalometric<br>and | Panoramic,<br>cephalometric<br>and |
| | computed tomography | computed tomography |
| Input Voltage | AC 100-240 V | AC 100-240 V |
| Tube Voltage | 60-100 kV | 50-99 kV |
| Tube Current | 5~16 mA | 4~16 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max. 22 s | Max. 18 s |
| Slice Width | 0.2-1.0mm | 0.1 mm min |

{5}------------------------------------------------

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea

Image /page/5/Picture/2 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern, and it is likely used to promote the company's dental implant products.

| | Chin Rest | Equipped Headrest | Equipped Headrest |
|--------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mechanical | Compact design | Compact design |
| | 2D Image Viewing Program | Model Name: 2D01, 2D02 | EasyDent |
| | 3D Image Viewing Program | Model Name: 3D01, 3D02 | Ez3D Plus |
| | Anatomical Sites | Maxillofacial | Maxillofacial |
| Image<br>Receptor | Computed<br>Tomography | 1515DXT<br>SEN1 | Xmaru1404CF |
| | Panoramic | 1515DXT<br>SEN1 | Xmaru1404CF |
| | Cephalometric | XID-C24DC | Xmaru2301CF<br>1210SGA<br>910SGA<br>Xmaru2301CF-O |
| Size of Imaging Volume<br>(cm) | | 1515DXT : Max. 15x9<br>SEN1 : Max 15x10 | Xmaru1404CF : Max. 10x8.5 |
| Pixel<br>Resolution | Computed<br>Tomography | 1515DXT :<br>- 3.94 lp/mm -1x1 binning<br>- 1.97 lp/mm - 2x2 binning<br>SEN1 :<br>- 4.0 lp/mm - 1x1 binning<br>- 2.0 lp/mm - 2x2 binning | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning |
| | Panoramic | 1515DXT : 3.94 lp/mm<br>SEN1 : 4.0 lp/mm | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning |
| | Cephalometric | XID-C24DC : 5 lp/mm | 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 | 1515DXT :<br>- 127 $μm$ - 1x1 binning<br>- 254 $μm$ - 2x2 binning<br>SEN1 :<br>- 125 $μm$ - 1x1 binning<br>- 250 $μm$ - 2x2 binning | Xmaru1404CF :<br>- 99 $μm$ - 2x2 binning<br>- 198 $μm$ - 4x4 binning |
| | Panoramic | 1515DXT: 127 $μm$<br>SEN1: 125 $μm$ | Xmaru1404CF :<br>- 99 $μm$ - 2x2 binning<br>- 198 $μm$ - 4x4 binning |
| | Cephalometric | XID-C24DC: 100 $μm$ | Xmaru2301CF : 100 x 100 $μm$<br>1210SGA : 127 x 127 $μm$<br>910SGA : 127 x 127 $μm$<br>Xmaru2301CF-O : 100 x 100 |
| Active Area | | [CT]<br>· 1515DXT : 146 x 146 mm<br>· SEN1 : 160 x 128 mm<br>[Pano]<br>· 1515DXT : 146 x 8.13 mm<br>· SEN1 : 160 x 8 mm<br>[Ceph] | [CT]<br>· Xmaru1404CF : 135.8 x 36.4 mm<br>[Pano]<br>· Xmaru1404CF : 135.8 x 5.94 mm<br>[Ceph]<br>· Xmaru2301CF : 5.9 x 230.4 mm<br>· 1210SGA : 260.1 x 325.1 mm |

# 10. Performance Data:

Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

## Non-Clinical Performance Data

We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors.

### Clinical Performance Data

A clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area. The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The images acquired using T1-C. T1-CS were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.

#### Software Verification and Validation Testing

Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005. The software for this device contains "Moderate" level of concern software.

#### Safety, EMC and Performance Data

T1-C, T1-CS complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.

- A IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 Medical electrical equipment - General requirements for basic safety and essential performance
- > IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability
- > IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X ray equipment
- > IEC 60601-2-63:2012 (First Edition) Medical electrical equipment - Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
- > IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- > IEC62366:2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices
- A Non-Clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Device"
- > Testing to confirm compliance with Acceptance Tests

#### 11. Conclusion:

The indication for use and the technical characteristics of the is substantially equivalent to the predicate device. It is substantially equivalent to predicate device in output characteristics and operation mode (CT, Cephalo, Panorama). The major difference is active area size, however, the nonclinical and clinical study results show that the subject device is substantially equivalent to the predicate device. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and Based on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.