DVAS (DVAS-M, DVAS-W)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 8, 2023 GENORAY CO., Ltd % Kaitlynn Min Business Development GENORAY America Inc. 1220 N Simon Circle, Unit B ANAHEIM, CA 92806 Re: K232085 Trade/Device Name: DVAS (DVAS-M, DVAS-W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: June 20, 2023 Received: November 3, 2023 Dear Kaitlynn Min: 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. 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). {1}------------------------------------------------ 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. 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. 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 Diagnostic X-Ray Systems Team 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 {2}------------------------------------------------ # Indications for Use Submission Number (if known) K232085 Device Name DVAS (DVAS-M, DVAS-W) #### Indications for Use (Describe) DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ #### Exhibit 5 K232085 510(k) Summary This 510(k) summary information is prepared in accordance with 21 CFR 807.92 ## 1. Date of Summary Preparation [21 CFR 807.92(a) (1)] : Jun. 20, 2023 # 2. Administrative Information [21 CFR 807.92(a) (1)] | 510(k) Submitter | GENORAY Co.,Ltd | |------------------------|-------------------------------------------------------| | | Address: 512, 560, Dunchon-daero, Jungwon-gu, | | | Seongnam-si, Gyeonggi-Do, Korea | | | Telephone No.: +82-31-5178-5500 | | | Fax: +82-31-5178-5599 | | | Contact Person: Inyoung Kim (iykim@genoray.com) | | Official Correspondent | GENORAY America Inc. | | | Address: 1220N Simon Circle, Anaheim, B, CA 92806 USA | | | Telephone No.: +1-855-436-6729 | | | Fax: +1-714-786-8919 | | | Contact Person: Kaitlynn Min | | | (kaitlynn@genorayamerica.com) | # 3. Device Information [21 CFR 807.92(a) (2)] | Trade / Device Name | DVAS (DVAS-M, DVAS-W) | |---------------------------|-------------------------------| | Common or Usual Name | Dental X-ray system | | Classification Name | Extraoral source X-ray system | | Classification Regulation | 21 CFR 872.1800 | | Class of Device | Class II | | Panel | Radiology | | Product Code | EHD | {4}------------------------------------------------ # 4. Predicate Device Information [21 CFR 807.92(a) (3)] | * Predicate Device | | |---------------------------|-----------------------------------| | Name of Device | RIX 70 DC (K182206) | | Manufacturer | Trident s.r.l., Italy | | Common or Usual Name | Extraoral source X-ray system | | Classification Name | Unit, X-ray, Extraoral with Timer | | Classification Regulation | 21 CFR 872.1800 | | Class of Device | Class II | | Panel | Radiology | | Product Code | EHD | | * Reference Device | | |---------------------------|-----------------------------------| | Name of Device | PORT-X IV (K172810) | | Manufacturer | GENORAY Co., Ltd | | Common or Usual Name | Extraoral source X-ray system | | Classification Name | Unit, X-ray, Extraoral with Timer | | Classification Regulation | 21 CFR 872.1800 | | Class of Device | Class II | | Panel | Radiology | | Product Code | EHD | # 5. Description of the Device [21 CFR 807.92(a) (4)] DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. | No. | Item | Specification | |-----|--------------------------------|-------------------------| | 1 | Pixel Size | ≤ 40 μm | | 2 | Active area size | ≥ 19 mm x 26 mm(Size 0) | | 3 | Resolution | ≥ 10(lm/mm) | | 4 | Digital sensor plate thickness | ≤ 19 μm * 19 μm | | 5 | Interface | USB | {5}------------------------------------------------ DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission. And the minimum integration requirements for intra-oral detectors when used with this device are: ## 6. Indications for use [21 CFR 807.92(a) (5)] DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects. {6}------------------------------------------------ # 7. Substantial equivalence chart [21 CFR 807.92(a) (6)] | | Proposed device | | Predicate device | Reference device | SE Note | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | DVAS-M | DVAS-W | RIX 70 DC | PORT-X IV | | | | Manufacturer | GENORAY Co., Ltd | | Trident s.r.l., Italy | GENORAY Co., Ltd | - | | | 510(k) No. | K232085 | | K182206 | K172810 | - | | | Classification<br>Name | Extraoral source x-ray system | | Extraoral source x-ray system | Extraoral source x-ray system | - | | | Product<br>Code | EHD | | EHD | EHD | - | | | Regulation Number | 872.1800 | | 872.1800 | 872.1800 | - | | | Class | Class II | | Class II | Class II | - | | | Product<br>illustration | Image: DVAS-M and DVAS-W | | Image: RIX 70 DC | Image: PORT-X IV | - | | | Indication | DVAS is an extra-oral source x-ray | | RiX70 DC X-ray Unit is designed for use in | PORT-X IV is a | Same | | | s for use | system to be used by trained dentists<br>and dental technicians as an extra oral x-<br>ray source for producing diagnostic<br>dental radiographic examination and<br>diagnosis of teeth, jaw, and other oral<br>structures using intra oral image<br>receptors. It is intended for both adult<br>and pediatric subjects. | | dental surgery to make endo-oral x-rays for<br>diagnostic purposes. This equipment can be<br>used to produce traditional x-rays developed<br>using chemicals or, alternatively, it can be used<br>with digital x-ray sensors. | | portable X-ray system<br>to be used by trained<br>dentists and dental<br>technicians as a<br>mobile, extraoral x-ray<br>source for producing<br>diagnostic x-ray images<br>using intraoral image<br>receptors. It is intended<br>for both adult and<br>pediatric subjects. | Same | | Patient<br>type | Adult - Child | | Adult - Child | | Adult - Child | Same | | Mechanical | | | | | | | | Mechanical<br>configuration | Floor-mounted<br>type | Wall-mounted<br>type | Floor-mounted<br>type | Wall-mounted<br>type | Mobile type | Same | | Minimum<br>source to<br>skin<br>distance | 200mm | | 200mm | | - | Same | | X-ray<br>field Size<br>(default) | 60mm round | | 60mm round | | 60mm round | Same | {7}------------------------------------------------ {8}------------------------------------------------ | Cycle | | | | | |--------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------| | Target material | Tungsten | Tungsten | Tungsten | Same | | Target angle | 12.5° | 16° | 12.5° | Similar | | Electrical | | | | | | Electrical power voltage | AC 100-240V | AC 100-240V | AC 100-240V | Same | | Focal spot | 0.4mm | 0.4mm | 0.4mm | Same | | Exposure time | 0.05 ~ 1.6s | 0.02~2.0s | 0.05 ~ 1.6s | Similar | | Tube current | 2.0mA fixed | 7mA fixed | 2mA fixed | Similar | | Tube voltage | 70kV fixed | 60, 65, 70kV | 70kV fixed | Similar | | Applied standard | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same | | | IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-65<br>21 CFR 1020.30<br>21 CFR 1020.31 | IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-65<br>21 CFR 1020.30<br>21 CFR 1020.31 | IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-65<br>21 CFR 1020.30<br>21 CFR 1020.31 | | {9}------------------------------------------------ #### 8. Safety, EMC and Performance data comparison to Predicate [21 CFR 807.92(b)] DVAS have been successfully compeleted verification and validation testing per GENORAY quality system as well engineering bench testing in support of successfully completed verification and validation testing per GENORAY quality system and this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3. IEC 60601-1-6. IEC 60601-2-65. IEC 62366. Also. DVAS complies with all applicable 21 CFR performance standards (21 CFR 1020.30, 21 CFR 1020.31) And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed. DVAS can be used not only in adults but also In the pediatric population, and therefore the system has reflected pediatric information in the labeling according to the FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications," dated November 28, 2017" Non-clinical validation testing has been performed to validate that DVAS conform to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. As a results, all test results were satisfactory and the result of bench tests indicates that the new device is as safe and effective as the predicate device. #### 9. Conclusion In reference to the comparison information provided in the substantial equivalence chart, and the most of functions and electronic features are similar with the predicate device. We believe that the DVAS are safe and effective as predicate device, and have no new indication for use. Therefore, DVAS are substantially equivalent to predicate device.