XERO-alpha

{0}------------------------------------------------ November 1, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. DRTECH Corporation % Yeongsuk An Official Correspondent Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29 Dunchon-Daero 541beon-gil Seongnam-si. 13216 SOUTH KOREA Re: K242591 Trade/Device Name: XERO - C Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: August 30, 2024 Received: August 30, 2024 Dear Yeongsuk An: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 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, Lu Jiang Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K242591 Device Name Xero α Indications for Use (Describe) XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter's Information [21 CFR 807.92(a) (1)] - Name of Sponsor: DRTECH Corporation - Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 ● beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, South Korea - Contact Name: Yeongsuk, An - Telephone No.: + 82-31-779-7787 ● - + 82-31-779-7790 . Fax No.: - Email Address : drtechra@drtech.com . - Registration Number: 3005172103 ● - . Name of Manufacturer: Same as Sponsor #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)] - Trade Name: . XERO α - . Common Name: Hand-held intraoral dental x-ray equipment - Classification Name: Extraoral source x-ray system . - . Classification Panel: Radiology - Classification Regulation: 21 CFR 872.1800 . - . Product Code: EHD - Device Class: II ● {5}------------------------------------------------ #### 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] - . 510(k) Number: K200182 - Applicant: Vatech Co., Ltd. - Trade Name: EzRay Air Portable (Model: VEX-P300) ● - Classification Name: Extraoral source x-ray system ● - Classification Panel: Radiology - Classification Regulation: 21 CFR 872.1800 . - . Product Code: EHD - . Device Class: II #### 5. Description of the Device [21 CFR 807.92(a) (4)] XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. But the image detectors (an integral part of a complete dental system) are not part of the device. The operation principle of the device involves emitting x-ray source when a high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit anode to produce X-rays. The device acquires images by emitting X-rays continuously on the human tooth. And the functions of the dental generator XERO a are supported by firmware. This is of basic firmware documentation level, and there is no external data exchange port in the device. Moreover, the XERO a is not wireless. The subject dental system is not a cyber device. #### 6. Indication for Use [21 CFR 807.92(a)(5)] XERO x is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. {6}------------------------------------------------ ### DRTECH #### 7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device [21 CFR 807.92(a)(6), 21 CFR 807.92(b)] The XERO a composed of a x-ray generator, tube, collimator and accessories. This equipment is designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and cavity structures. It is designed to be easily caried from location to location by a single operator. This equipment is used in both professional healthcare facility environment and home healtheare environment. The Proposed device has the same fundamental scientific technologies as the predicate devices. The technological comparison table below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The Technological differences do not affect the intended use of the table 1 below compares the main performance data of the proposed device with the predicate equivalence of the proposed device and predicates. | Parameter | Proposed Device | Predicate Device | Comparison Analysis | | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------| | 510(k) Number | Unknown | K200182 | N/A | | | Model Name | XERO α | EzRay Air Portable<br>(Model: VEX-P300) | N/A | | | Manufacturer | DRTECH Corporation | Vatech Co., Ltd. | N/A | | | Common Name | Hand-held intraoral dental x-<br>ray equipment | Portable X-ray System | Identical | | | Classification Name | Extraoral source x-ray<br>system | Extraoral source x-ray<br>system | Identical | | | Classification Panel | Radiology | Radiology | Identical | | | Classification Regulation | 21 CFR 872.1800 | 21 CFR 872.1800 | Identical | | | Product Code | EHD | EHD | Identical | | | Device Class | Class II | Class II | Identical | | | Intended Use | XERO α is an Hand-held<br>intraoral dental x-ray equipment<br>to produce X-ray images using<br>intraoral image receptors. It is<br>indicated for use by a dentist or a<br>dental technician for both adult<br>and pediatric patients. This<br>equipment is used in the<br>professional healthcare facility<br>environment. | EzRay Air Portable (Model:<br>VEX-P300) is an extraoral<br>diagnostic dental X-ray<br>source to produce X-ray<br>images using intraoral image<br>receptors. It is indicated for<br>use by a dentist or a dental<br>technician for both adult and<br>pediatric patients. | Identical | | | Technological<br>characteristics<br>- Mechanical | Size (L x W<br>x H) | 293 x 155 x 287 mm | 280 x 165 x 296 mm | Identical | | | Source to<br>skin | 200 mm | 200 mm | Identical | 3/7 {7}------------------------------------------------ #### DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea # DRTECH | | distance | | | | |--------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | X-ray field Size | 60 mm round | 60 mm round | Identical | | | User Interface | Jog dial for operating mode selection. Additionally, several user selectable preset times with patient size and tooth selection icons on a display module. | Jog dial for operating mode selection. Additionally, several user-selectable preset times with patient size and tooth selection icons on a display module. | Identical | | | Backscatter radiation protection | Back Scattering shield | 165 mm dia., Pb-filled acrylic plastic, Back Scattering shield | Identical | | | Exposure Switch | Exposure button on the handset | Exposure button on the handset | Identical | | | Tube head mounting | Handheld | Handheld | Identical | | Technological characteristics - Electrical | Energy source | Rechargeable 22.2 V DC Li-ion polymer battery pack (Nominal Capacity: 900 mAh) | Rechargeable 21.6 V DC Li-ion polymer battery pack (Nominal Capacity: 2,500 mAh) | Identical, Justification for Identical : Although there is a difference in battery capacity compared to the predicate device, Rechargeable 22.2 V DC Li-ion polymer battery pack has been tested and is in conformity with the standard IEC 62133(Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications). | | | Exposure time | 0.05~1.0sec (in 0.01 second increments) | 0.05 - 1.0 seconds in 0.01 increments | Identical | | | mA | 3 mA | 2.5 mA fixed | Identical, Justification for Identical : The Performance Bench Testing demonstrated that these | {8}------------------------------------------------ #### DRTECH Corporation Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea ### DRTECH | | | | differences do not raise<br>new questions of safety<br>and effectiveness in<br>comparison with the<br>predicate device. | |---------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | kVp | 70 kV XERO α | 60 or 65 kVp fixed | Identical | | Waveform | Constant Potential (DC) | Constant Potential (DC) | Identical | | Applied<br>Standard | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-3,<br>IEC 60601-2-65 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-3,<br>IEC 60601-2-65 | Identical | There are no significant differences between the XERO a and the predicate device that would have a negative impact on the product's use. Therefore, the subject device is considered substantially equivalent to the predicate device. {9}------------------------------------------------ ### DRTECH #### 9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)] The XERO a comply with the following international and FDA-recognized consensus standards list in Table 2. | Table 2. International and FDA-recognized consensus standards | | |----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Standards development<br>organization, reference<br>number, and date | Standard name | | ISO 14971: Third Edition<br>2019-12 | Medical devices - Application of risk management to medical devices | | IEC 60601-1 Edition 3.2<br>2020-08<br>CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 1: General requirements for basic<br>safety and essential performance | | IEC 60601-1-2 Edition 4.1<br>2020-09<br>CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests | | 60601-1-6 Edition 3.2<br>2020-07<br>CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 1-6: General requirements for basic<br>safety and essential performance - Collateral standard: Usability | | IEC 62366-1 Edition 1.1<br>2020-06<br>CONSOLIDATED<br>VERSION | Medical devices - Part 1: Application of usability engineering to<br>medical devices | | IEC 60601-2-65 Edition<br>1.2 2021-05<br>CONSOLIDATED<br>VERSION | Medical electrical equipment - Part 2-65: Particular requirements for the<br>basic safety and essential performance of dental intra-oral X-ray<br>equipment | | IEC 62304 Edition 1.1<br>2015-06<br>CONSOLIDATED<br>VERSION | Medical device software - Software life cycle processes | Table 2. International and FDA-recognized consensus standards {10}------------------------------------------------ ### ORTECH And XERO a comply with the FDA guidance documents listed in Table 3. #### Table 3. FDA Guidance Documents | Title of Guidance Document | Issue Date | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Guidance for Industry and Food and Drug Administration Staff: The 510(k)<br>Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | July 28, 2014 | | Content of Premarket Submissions for Device Software Functions, Guidance for<br>Industry and Food and Drug Administration Staff | June 14, 2023 | | Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray<br>Imaging Devices Conformance with IEC Standards | May 8, 2019 | | Pediatric Information for X-ray Imaging Device Premarket Notifications,<br>Guidance for Industry and Food and Drug Administration Staff | November 28, 2017 | The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the specifications have met the acceptance criteria. Verification testing were found acceptable to support the claim of substantial equivalence. #### 10. Summary of Clinical Data [21 CFR 807.92(b)(2)] #### Not Applicable Clinical studies are unnecessary to validate the safety and effectiveness of the Stationary x-ray system, XERO a, the subject of this 510(k) notification. #### 11. Conclusion [21 CFR 807.92(b)(3)] The XERO a is substantially equivalent to the currently marketed predicate device (K200182) in terms of technical characteristics, general function, application and indications for use, safety, and effectiveness. Substantial equivalence for Hand-held intraoral dental x-ray equipment(XERO d) was demonstrated through the nonclinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-2-65 and IEC 62304. The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the XERO a is substantially equivalent to the predicate devices.