EzRay Air 2 Wall (Model: VEX-S350W)

{0}------------------------------------------------ October 26, 2022 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin Street, Suite 610 HOUSTON TX 77054 Re: K223058 Trade/Device Name: EzRay Air 2 Wall (Model: VEX-S350W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: September 22, 2022 Received: September 30, 2022 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. 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223058 Device Name EzRay Air 2 Wall (Model: VEX-S350W) #### Indications for Use (Describe) The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over The Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Special 510(k) Summary This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### 2. Date 510K Summary prepared: October 20, 2022 #### 3. Administrative Information | Official Correspondent: | Dave Kim / Mtech Group | |-------------------------|--------------------------------------------------------------| | | Address: 7505 Fannin Street, Suite 610, | | | Houston, TX 77025 | | | Tel: +713-467-2607 | | | 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: Daniel Kim / Manager (daniel.kim@vatech.com) | 4. Device Information | Type of 510(k) Submission: | Special | |----------------------------|-------------------------------------------------| | Trade or Proprietary Name: | EzRay Air 2 Wall (Model: VEX-S350W) | | Common or Usual Name: | Dental X-ray system | | Regulation Classification: | Extraoral source X-ray system (21 CFR 872.1800) | | Product Code: | EHD | | Class of Device: | Class II | | Panel: | Radiology | ### 5. Predicate Device Information | Manufacturer: | VATECH Co., Ltd. | |----------------------------|-------------------------------------------------| | Predicate device: | EzRay Air Wall (Model: VEX-S300W) / K163705 | | Common or Usual Name: | Dental X-ray system | | Regulation Classification: | Extraoral source X-ray system (21 CFR 872.1800) | | Product Code: | EHD | | Class of Device: | Class II | | Panel: | Radiology | {4}------------------------------------------------ #### 6. Device Description The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray system intended for intra-oral imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. The X-ray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The functions of the VEX-S350W intra-oral system are supported by software (firmware). The software is based on the predicate device and is of Moderate level of concern. The system can be used with an imaging system. #### 7. Indication for use The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors. {5}------------------------------------------------ | 8. Substantial Equivalence Chart | | Subject Device | Predicate Device | |----------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | | EzRay Air 2 Wall (Model: VEX-S350W) | EzRay Air Wall (Model: VEX-S300W) | | Applicant Name | | VATECH Co., Ltd. | VATECH Co., Ltd. | | | 510(k) Number | N/A | K163705 | | Device Classification Name | | Extraoral source x-ray system | Extraoral source x-ray system | | Classification Product Code | | EHD | EHD | | Regulation Number | | 21 CFR 872.1800 | 21 CFR 872.1800 | | Indications for Use | | The EzRay Air 2 Wall (Model: VEX-<br>S350W) is a dental X-ray system<br>intended for use by a trained and<br>qualified dentist or dental technician<br>for both adult and pediatric subjects<br>for producing diagnostic dental<br>radiographs for the treatment of<br>diseases of the teeth, jaw, and other<br>oral structures using intra-oral image<br>receptors. | The EzRay Air W (Model: VEX-S300W)<br>is an intra-oral dental X-ray system<br>(extra-oral X-ray source system)<br>intended for use by a trained and<br>qualified dentist or dental technician<br>for both adult and pediatric subjects<br>for producing diagnostic dental<br>radiographs for treatment of diseases<br>of the teeth, jaw, and other oral<br>structures using intra-oral image<br>receptors. | | | Minimum Source to<br>skin distance | 200 mm | 200 mm | | Mec<br>hani<br>cal | X-ray field Size<br>(default) | 60 mm round | 60 mm round | | | Focal spot | 0.4 mm | 0.4 mm | | | Minimum half-<br>value layer | 1.5 mm Al | 1.5 mm Al | | | Electric Power<br>Voltage | AC 100-240 V | AC 100-240 V | | | Rated Current | 10 A (at AC 250 V) | 10 A (at AC 250 V) | | Elect<br>rical | Exposure time | 0.05 - 2.0 seconds in 0.01<br>increments | 0.05 - 0.5 seconds in 0.01<br>increments | | | Tube current | 5.0 mA fixed | 2.5 or 3.0 mA fixed | | | Tube voltage | 65 / 70 kVp fixed | 65 kVp fixed | | | Operation mode | Manual Mode | Manual Mode, Auto Mode | | | Applied Standard | IEC 60601-1,<br>IEC 60601-1-3,<br>IEC 60601-2-65,<br>IEC 60601-1-2, | IEC 60601-1,<br>IEC 60601-1-3,<br>IEC 60601-2-65,<br>IEC 60601-1-2, | | | | 21 CFR 1020.30, 1020.31 | 21 CFR 1020.30, 1020.31 | # 8. Substantial Equivalence Chart {6}------------------------------------------------ #### 9. Performance Data #### - Summary of Performance Testing The performance test for the subject device, EzRay Air 2 Wall (Model: VEX-S350W) and the predicate device, VEX-S300W (K163705) confirmed that the focal spot to skin distance for both devices was longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex. < kVp +10 %). Both devices demonstrated similar performance outcomes in terms of HVL (half-value layer) and limitation of the x-ray field test which rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. #### - Safety, EMC and Performance Data The subject device complies with the safety and performance standards listed in the chart above, 'Substantial Equivalence Chart'. Electrical, mechanical, environmental safety, and performance testing according to standard IEC 60601-1(Ed. 3.1, 2012), IEC 60601-1-3 (Ed. 2.1, 2013), IEC 60601-2-65 (Ed. 1.1, 2017) were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Test reports were provided to demonstrate conformance. All test results complied with the requirements. #### 10. The differences between the subject device and the predicate device The EzRay Air 2 Wall (Model: VEX-S350W) described in this special 510(k) is similar to the predicate device in its indications for use, design, technology, functions, and principle of operation. The differences between the subject device and the predicate device are as follows: The predicate device (EzRay Air Wall (Model: VEX-S300W) - K163705) is optimized for a digital sensor as an imaging receptor but EzRay Air 2 Wall (Model: VEX-S350W) can be used with a digital sensor or a phosphor plate as an imaging receptor according to the user's preference. For the user of a phosphor plate, EzRay Air 2 Wall (Model: VEX-S350W) provides increased tube voltage, tube current, and irradiation time compared to the predicate device. The tube voltage can be selected as either 65/70 kVp and the tube current is fixed at 5.0 mA The irradiation time has been increased up to 2.0 sec. Based on the increased irradiation conditions, electrical safety and EMC test have been conducted. The performance of the EzRay Air 2 Wall (Model: VEX-S350W) was tested through Accuracy of loading factors, HVL, limitation of the x-ray field, reproducibility of Air KERMA, and Linearity of AIR KERMA. All test results are in compliance with Federal Standard (21CFR 1020.30 and 31) requirements. A digital sensor and phosphor plate were used to verify the image performance for each image receptor. The image performance was evaluated with low contrast and line pair according to the IEC standard through performance bench testing. The Performance Bench Testing demonstrated that these differences do not raise new questions of safety and effectiveness in comparison with the predicate device. {7}------------------------------------------------ ### 11. Conclusions The subject device and the predicate device have similar indications for use and demonstrated similar design, technology, functions, and principle of operation. As demonstrated in the performance bench testing, X-ray safety and performance and Image evaluation of the new and predicate devices were tested in accordance with Federal Standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-2-65, and 61223-3-4. Both the subject and predicate devices met the essential performance parameters including accuracy of loading factors, Reproducibility of Air KERMA, Focal Spot to Skin Distance, and Low Contrast & Line Pair performance requirements. 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 EzRay Air 2 Wall (Model: VEX-S350W) is substantially equivalent to the predicate device as described herein.