Portable X-ray System

{0}------------------------------------------------ January 17, 2023 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 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. iRay Technology Taicang Ltd. % Wei Pan Registration and Regulatory Affairs Director No.33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA Re: K223010 Trade/Device Name: Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: December 19, 2022 Received: December 19, 2022 Dear Wei Pan: 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 2023.01.17 Lu Jiang 21:51:54 -05'00' Lu Jiang, 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) K223010 Device Name Portable X-ray System #### Indications for Use (Describe) The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☑</span> | |----------------------------------------------|---------------------------------------------------| | 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}------------------------------------------------ iRay Imaging Technology (Haining) Limited # 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS {4}------------------------------------------------ ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (As Required by 21 CFR 807.92) #### 1. Date Prepared [21 CFR 807.92(a)(1)] Sep. 18, 2022 #### 2. Submitter's Information [21 CFR 807.92(a)(1)] | Company Name: | iRay Technology Taicang Ltd. | |------------------|-------------------------------------------------------------------------------| | Company Address: | No.33 Xinggang Rd., Taicang Port Economic &<br>Technological Development Zone | | Contact Person: | Wei Pan | | Phone: | +86 21 50720560 | | Fax: | +86 21 50720561 | | Email: | wei.pan@iraygroup.com | #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name: | Portable X-ray System | |----------------------|-------------------------------| | Common Name: | Extraoral Source X-ray System | | Model Name: | Canis014D07 | | Classification Name: | Extraoral Source X-ray System | | Product Code: | EHD | | Regulation Number: | 21 CFR 872.1800 | | Device Class: | Class II | #### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[ The identification predicates within this submission are as follows: | Manufacturer: | GENORAY Co., Ltd. | |----------------------|-------------------------------| | Trade Name: | PORT-X IV | | Model Name: | PORT-X IV | | Product Code: | EHD | | Classification Name: | Extraoral Source X-ray System | | Regulation Number: | 21 CFR 872.1800 | | Device Class: | Class II | | FDA 510 (k) #: | K172810 | {5}------------------------------------------------ The identification of reference device within this submission are as follows: | Manufacturer: | Aribex, Inc. | |----------------------|-------------------------------| | Trade Name: | NOMAD Pro X-ray system | | Model Name: | NOMAD Pro | | Product Code: | EHD | | Classification Name: | Extraoral Source X-ray System | | Regulation Number: | 21 CFR 872.1800 | | Device Class: | Class II | | FDA 510 (k) #: | K081664 | #### 5. Description of the Device [21 CFR 807.92(a)(4)] The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch. #### 6. Intended Use [21 CFR 807.92(a)(5)] #### 6.1. Indications for use The portable X-Ray system is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician. #### 6.2. Suitable patient The Canis014D07 is intended for adult and pediatric patients. #### 7. Technological Characteristic [21 CFR 807.92(a)(6)] | Item | Predicate Device: | Reference Device: | Proposed Device: | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | PORT-X IV | NOMAD Pro | Canis014D07 | | Model name | PORT-X IV | NOMAD Pro | Canis014D07 | | 510(K) Number | K172810 | K081664 | K223010 | | Classification<br>Name | Extraoral Source X-ray<br>System | Same | Same | | Product Code | EHD | Same | Same | | Item | Predicate Device: | Reference Device: | Proposed Device: | | | PORT-X IV | NOMAD Pro | Canis014D07 | | Regulation Number | 21 CFR 872.1800 | Same | Same | | Panel | Dental | Same | Same | | Classification: | II | Same | Same | | Installation Type: | Portable | handheld | Portable | | Indications for use | PORT-X IV is a<br>portable X-ray system<br>to be used by trained<br>dentists and dental<br>technicians as a mobile,<br>extraoral x-ray source<br>for producing<br>diagnostic x-ray images<br>using intraoral image<br>receptors. It is intended<br>for both adult and<br>pediatric subjects. | The NOMAD Pro X-<br>ray System is intended<br>to be used by trained<br>dentists and dental<br>technicians as an<br>extraoral X-ray source<br>for producing<br>diagnostic X-ray<br>images using intraoral<br>image receptors. Its use<br>is intended for both<br>adult and pediatric<br>subjects | The Portable X-ray<br>System is used as a<br>portable, extra oral x-<br>ray source for<br>producing diagnostic x-<br>ray images using<br>conventional film, PSP<br>(phosphor plates) or<br>digital sensors. It is<br>intended for adult and<br>pediatric patients.<br>This equipment is<br>available only to<br>trained and qualified<br>dentist or dental<br>technician. | | X-ray Monoblock | Tube Voltage : 70 kV | Tube Voltage : 60 kV<br>fixed | Tube Voltage : 70 kV | | | Tube Current : 2 mA | Tube Current : 2.5 mA | Tube Current : 2 mA | | | Stationary Anode | Stationary Anode | Stationary Anode | | | Focus : 0.4 mm | Focus : 0.4 mm | Focus : 0.4 mm | | | Target Angle : 12.5°<br>Total Filtration : 2.2 | Target Angle : 12.5°<br>Total Filtration :<br>1.5mmAl | Target Angle : 12.5°<br>Total Filtration : 3.1 | | | mmAl | | mmAl | | | (Inherent Filtration : 1.0<br>mmAl; | | (Inherent Filtration : 1.0<br>mmAl; | | | Additional Filtration :<br>1.2 mmAl) | | Additional Filtration :<br>2.1 mmAl) | | Exposure controller | Exposure Time :<br>0.05~1.6 sec. | Exposure Time : 0.02~1<br>sec. | Exposure Time : 0.04~2<br>sec. | | Battery | Rechargeable lithium<br>battery | Same | Same | | Display | LCD panel Dispaly | Same | Same | | Dimensions | (140 × 173 × 254)mm | (280×165×296)mm | (197×139×240) mm | | Weight | 1.6 kg | 2.5kg | 2.2kg | | Item | Predicate Device:<br>PORT-X IV | Reference Device:<br>NOMAD Pro | Proposed Device:<br>Canis014D07 | | Cooling: | Air cooling | Same | Same | | Protection against<br>matter/Water | IPX0 | Same | Same | | Operation: | Temperature: 10 to 35°C | Temperature: -5 to 40°C | Temperature: 10 to 40°C | | | Humidity: 30 to 85%<br>(Non-Condensing) | Humidity: 10 to 80%<br>(Non-Condensing) | Humidity: 10 to 90%<br>(Non-Condensing) | | | Atmospheric pressure:<br>70 to 106 kPa | Atmospheric pressure:<br>70 to 106 kPa | Atmospheric pressure:<br>70 to 106 kPa | | | Altitude: Max. 3000<br>meters | Altitude: Max. 3000<br>meters | Altitude: Max. 3000<br>meters | | | | | | | Humidity: 10 to 90%<br>(Non-Condensing) | Humidity: 95% (Non-<br>Condensing) | Humidity: 5% ~ 95%<br>(Non-Condensing) | | | Atmospheric pressure:<br>50 ~ 106 kPa | Atmospheric pressure: | Atmospheric pressure:<br>70kPa~106kPa | | | Altitude: Max. 3000<br>meters | Altitude: Max. 3000<br>meters | Altitude: Max. 3000<br>meters | | | | | | Software | {6}------------------------------------------------ [510(k)] Application {7}------------------------------------------------ [510(k)] Application #### 8. Safety, EMC and Performance data comparison to Predicate device - 8.1 Safety, EMC and Performance data Canis014D07 complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21CFR 1020.31 to minimize electrical, mechanical and radiation hazards. - Electrical, mechanical, environmental safety and performance testing which are a) mentioned in the standard ANSI ES:60601-1, IEC 60601-1-3 and IEC 60601-2-65 were performed. - EMC testing was conducted in accordance with standard IEC 60601-1-2. b) - Performance testing performed according to FDA 21 CFR 1020.30, 21 CFR c) 1020.31 standards, Software Validation, nonclinical Evaluation. All test # 5 of 7 {8}------------------------------------------------ results were fulfill the requirements. - 8.2 Summary of Performance Testing The performance test for the subject device (Canis014D07) and the predicate device (PORT-X IV, K172810) are identical in the indications for use, patient population, intended operation environment, and electrical safety. They are similar in technical specification. The differences between the proposed device and the predicate device will not raise any new risk to affect safety or effectiveness. #### 9. Nonclinical study - 9.1 Electrical Safety and EMC Summary The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards: - ANSI AAMI ES60601-1:2005 + A1:2012 + A2:2021 a) - b) IEC 60601-1-3:2008 + A1:2013 + A2:2021 - IEC 60601-2-65:2012 + A1:2017 C) - d) IEC 60601-1-2:2014 #### 9.2 Bench Testing Summary The verification test results showed compliance with the above standards. Validation was performed for overall operation by taking and reviewing test images. The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate. - 9.3 Summary of Clinical Tests: The subject of this premarket submission, the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality did not require more clinical studies. #### 10. FDA Guidance Documents Utilized - Format for Traditional and Abbreviated 510(k)s Guidance issued on September 13, a) 2019. - Radio Frequency Wireless Technology in Medical Devices b) - Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards c) # 6 of 7 {9}------------------------------------------------ - Guidance for the Content of Premakret Submissions for Software Contained d) in Medical Devices, issued Nov 28, 2017 - e) Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017 - a) Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014 ### 11. Conclusion [21 CFR 807.92(b)(3)] In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the manufacturer, iRay Imaging Technology (Haining) Limited concludes that Canis014D07 is substantially equivalent to predicate device with regards to safety and effectiveness.