PAX-DUO3D PLUS, PCT-5000

{0}------------------------------------------------ ## Special 510(k) Summary MAY 2 4 2012 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800. Date 4/18/2012 ## Manufacturer Vatech Co., Ltd. 23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic Tel: +82-31-379-9585 Fax: +82-31-379-9638 Contact person: Mr. Sonny Park #### Official Correspondent (U.S. Designated agent) Mtech Group 12946 Kimberley Ln, Houston, TX 77079 Tel: +713-467-2607 Fax: +713-464-8880 Contact person: Mr. Dave Kim (davekim(@mtech-inc.net) #### Trade/Proprietary Name: PaX-Duo3D Plus (PCT-5000) #### Common Name: Computed Tomography X-ray System ### Classification Name: X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2) {1}------------------------------------------------ #### Description: PaX-Duo3D Plus (PCT-5000), a dental radiographic imaging system, consists of dual image acquisition modes; panorama, and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Duo3D Plus (PCT-5000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic dental x-ray system based on CMOS X-ray detector. #### Indication for use: PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dental assistants, x-ray technicians and other professionals who are licensed by the State in which he or she practices to use the device. #### Predicate Device: | Manufacturer | : Vatech Co., Ltd | |---------------|---------------------------------------| | Device | : PaX-Duo3D Plus | | 510(k) Number | : K102102 (Decision Date - 3/11/2011) | #### Substantial Equivalence: PaX-Duo3D Plus (PCT-5000) described in this 510(k) has the similar intended use and technical characteristics as PaX-Duo3D Plus of Vatech Co., Ltd. | Characteristic | Proposed<br>Vatech Co., Ltd.<br>PaX-Duo3D Plus<br>(PCT-5000) | Predicate<br>Vatech Co., Ltd.<br>PaX-Duo3D Plus | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | | K102102 | | Indications<br>for use | PaX-Duo3D Plus is a computed<br>tomography x-ray system intended to<br>take panoramic and cross-sectional<br>images of the oral and craniofacial<br>anatomy to provide diagnostic<br>information for adult and pediatric<br>patients. The device is operated and<br>used by physicians, dentists, dental<br>assistants, x-ray technicians and other<br>professionals who are licensed by the<br>law of the State in which he or she<br>practices to use the device. | PaX-Duo3D Plus is a computed<br>tomography x-ray system intended<br>to take panoramic and cross-<br>sectional images of the oral and<br>craniofacial anatomy to provide<br>diagnostic information for adult<br>and pediatric patients. The device<br>is operated and used by physicians,<br>dentists, dental assistants, x-ray<br>technicians and other professionals<br>who are licensed by the law of the<br>State in which he or she practices<br>to use the device. | | Performance | Panoramic and computed | Panoramic and computed | | Specification | tomography (CBCT) | tomography (CBCT) | | Input Voltage | AC 100-120 / 200-240 V | AC 110 / 230 V ~ | | Tube Voltage | 50-90 kV | 50-90 kV | | Tube Current | 2-10 mA | 2-10 mA | | Focal Spot Size | 0.5 mm | 0.5 mm | | Exposure Time | Max 20.2 s | 6.8 - 24 s | | Total Filtration | 2.8 mmAl | 2.8 mm Al | | Size of Imaging<br>Volume | CT (Xmaru0712CF)<br>: 5 x 5 cm / 8 x 5 cm / 8 x 8 cm<br>CT (Xmaru1215CF Plus)<br>: 5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm / 12 x 8.5 cm<br>CT(Xmaru1215CF<br>Master<br>Plus)<br>: 5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm / 12 x 8.5 cm<br>CT(Xmaru1524CF) :<br>5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm / 12 x 8.5 cm | CT(Xmaru1524CF) :<br>5 x 5 cm / 8 x 5 cm /<br>8.5 x 8.5 cm /12 x 8.5 cm | | | Panoramic<br>(Xmaru1501CF) : 5.0 lp/mm | Panoramic<br>(Xmaru1501CF) : 5.0 lp/mm | | | CT (Xmaru0712CF)<br>: 3.5 lp/mm | | | Pixel Resolution | CT (Xmaru1215CF Plus)<br>: 3.5 lp/mm | | | | CT(Xmaru1215CF Master<br>Plus)<br>: 10.1 lp/mm- full resolution<br>5.0 lp/mm -2x2 binning<br>2.5 lp/mm-4x4 binning | CT (Xmaru1524CF) : 2.5 lp/mm | | | | | | | | | | | | | | | | | | | CT(Xmaru1524CF) : 2.5 lp/mm | | | | Panoramic<br>(Xmaru1501CF): 100 μm | Panoramic<br>(Xmaru1501CF): 100 μm | | | CT (Xmaru0712CF)<br>: 140 μm | | | | CT (Xmaru1215CF Plus)<br>: 140 μm | | | Pixel Size | CT(Xmaru1215CF Master<br>Plus)<br>: 49.5 μm-full resolution<br>99 μm-2x2 binning<br>198 μm-4x4 binning | CT (Xmaru1524CF) : 200 μm | | | | | | | | | | | | | | | CT(Xmaru1524CF): 200 μm | | | | CMOS photodiode array – | | | | panoramic (Xmaru1501CF) &<br>CT(Xmaru0712CF,<br>Xmaru1215CF Plus,<br>Xmaru1215CF Master Plus,<br>Xmaru1524CF) | CT (Xmaru1524CF) with Flat<br>Panel Detector | | Image Receptor | | | | | | | | | | | {2}------------------------------------------------ 510(k) Submission – PaX-Duo3D Plus (PCT-5000) {3}------------------------------------------------ . {4}------------------------------------------------ Indications for use, safety characteristics, and non-clinical performance for panoramic and CBCT sensors of PaX-Duo3D Plus (PCT-5000) and PaX-Duo3D Plus are similar. The primary differences are as follows: PaX-Duo3D Plus (PCT-5000) introduces three new cone beam CT sensors: Xmaru0712CF, Xmaru1215CF Plus. Xmaru1215CF Master Plus. The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the nonclinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Duo3D Plus (PCT-5000) is substantially equivalent, in terms of safety and effectiveness, with PaX-Duo3D Plus, the predicate device. ## 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 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (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. PaX-Duo3D Plus (PCT-5000) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. All test results were satisfactory. #### Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on {5}------------------------------------------------ the information provided in this premarket notification. Vatech Co., Ltd. concludes that PaX-Duo3D Plus (PCT-5000) is safe and effective and substantially equivalent to predicate device as described herein. END {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service . Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTO TX 77079 MAY 2 4 2012 Re: K121236 Trade/Device Name: PaX-Duo3D Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 18, 2012-Received: April 24, 2012 #### 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {7}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health #### Enclosure {8}------------------------------------------------ # Indications for Use 510(K) Number (if known): K12J236 Device Name: PaX-Duo3D Plus Classification: Computed tomography X-ray system #### Indications for Use: PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dentists, dental assistants, x-ray technicians and other professionals who are licensed by the law of the State in which he or she practices to use the device. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF néededi Arul D'A Office of In 510K K121236 Concurrence of CDRH, Office of Device Evaluation(ODE) Page 1 of 1