AirRay

{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 20, 2022 POSKOM Co.,Ltd. % Bokyeong Kim Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 SOUTH KOREA Re: K222896 Trade/Device Name: AirRay Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: September 19, 2022 Received: September 23, 2022 Dear Mr. Bokyeong 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 {1}------------------------------------------------ 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 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 (OS) 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, 2022.12.20 12:19:52 -05'00' Lu Jiang 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222896 Device Name AirRay #### Indications for Use (Describe) The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists. Indication: The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts. The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device must be used for stand mounted imaging of the chest. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Contraindication: The use of X-radiation for diagnostic purposes in the following subjects is contraindicated. - Pregnancy, especially first trimester | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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. 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}------------------------------------------------ 5. 510(K) Summary {4}------------------------------------------------ # 510(k) Summary [As Required by 21 CFR 807.92] [510(k) Number: K222896] ## 1. Date Prepared [21 CFR 807.92(a)(a)] September 19, 2022 ## 2. Submitter's Information [21 CFR 807.92(a)(1)] - Name of Manufacturer: POSKOM Co., Ltd. - Address: POSKOM Tower, 227 Sowon-ro, Deogyang-qu, Goyang-si, Gyeonggi-do, 10534, Republic of Korea ● Contact Name: Jong Rae Park / President - Telephone No.: +82−31−906−9007 - Email Address: jerryhana@poskom.com - Registration No.: 892.1720 #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Type Name | AirRay-20H, AirRay-20HL, AirRay-20HW, AirRay-20HLW | |---------------------|----------------------------------------------------| | Product Name | Diagnostic X-ray Unit | | Model Name | AirRay | | Regulation Number | 21CFR892.1720 | | Regulation Name | Mobile X-Ray System | | Regulation Class | II | | Product Code | IZL | | 510(k) Review Panel | Radiology | {5}------------------------------------------------ # 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; ## Predicate Device#1 - 510(k) Number: K182207 - Applicant: MinXray., Inc - Trade/Device Name: TR90BH - Regulation Name: Mobile x-ray system - Regulation Number: 21 CFR 892.1720 - Classification Product IZL Code - Device Class: II - 510(k) Review Panel: Radiology These predicate devices have not been subject to a design-related recall {6}------------------------------------------------ # 5. Description of the Device [21 CFR 807.92(a)(4)] The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission. Image /page/6/Picture/2 description: This image shows a portable X-ray machine. The machine is primarily black and light blue, with a black handle on top. The X-ray emitter is circular and black, with a square opening in the center. The machine appears to be designed for easy transport and use in various locations. #### 5.1 Types of AirRay and differences | Model name | Difference | | | | |--------------|-----------------|------------|------------|-----------------| | | Use environment | Skin guard | Dual Laser | Wireless charge | | AirRay-20H | Human | O | X | X | | AirRay-20HL | Human | O | O | X | | AirRay-20HW | Human | O | X | O | | AirRay-20HLW | Human | O | O | O | #### 5.2 AirRay components | Component | Picture | |---------------------------------|----------------------------------| | 1. Main Body (with skin guard) | Image: Main body with skin guard | | 2. Battery (2EA) | Image: Battery | | 3. Remote Controller (Optional) | Image: Remote controller | {7}------------------------------------------------ | 4. Power cable (1.5m) and Adaptor | Image: Power cable and adaptor | |---------------------------------------------------|--------------------------------| | 5. Hand switch | Image: Hand switch | | 6. Carrying Case (with key and shoulder<br>strap) | Image: Carrying case | | 7. User Manual | Image: User manual | #### 5.3 Device software (firmware) ## 5.3.1 Role of S/W The primary function of the software is the operation of X-ray equipment for image acquisition. The user operates the X-ray Operation Unit to control the X-ray Control Unit. In X-ray Operation Unit, user can use Power On / Off, X-ray setting, irradiation, and options of X-ray Control Unit. The X-ray control unit carries out the X-ray setting and irradiation with the information transmitted from the X-ray operation #### 5.3.2 Revision Level History #### MCU Firmware | Version | Description of changes | Date | |---------|----------------------------------------------------------|------------| | U1.00 | First Release | 2022.06.14 | | U1.01 | Add function of Password ON/OFF and Changed Passwor<br>d | 2022.10.20 | #### Charger Firmware | Version | Description of changes | Date | |---------|------------------------|------------| | C1.00 | First Release | 2022.06.14 | #### 5.3.3 Operational Environment MCU firmware - -Version: U1.00 - -Control of parameters to be used for acquiring the images - -Controlling Generator {8}------------------------------------------------ ## MCU Board Micom - Vender: ST - Model: STM32F103VCT6 # Flash Memory - Vender: ST - Model: SST25VF020B ## Charger firmware - Version: C1.00 - - Charging voltage control - Charger Interface Board Micom - Vender: ST - Model: STM32F103RCT6 {9}------------------------------------------------ ## 6. Indications for use [21 CFR 807.92(a)(5)] The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists. #### Indication: The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts. The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device must be used for stand mounted imaging of the chest. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. #### Contraindication: The use of X-radiation for diagnostic purposes in the following subjects is contraindicated. - -Pregnancy, especially first trimester {10}------------------------------------------------ # 7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6)] Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)] There are no significant differences in the technological characteristics of these devices compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the AirRay and the predicate device: | | Proposed Device | Predicate Device | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | K Number | - | K182207 | | | Manufacturer | POSKOM Co., Ltd. | MinXray., Inc. | | | Trade Name | AirRay | TR90BH | | | Device<br>Classification<br>Name | Mobile x-ray system | Mobile x-ray system | Same | | Product Code | IZL | IZL | Same | | Regulation<br>Number | 21CFR892.1720 | 21CFR892.1720 | Same | | 510(k) Review<br>Panel | Radiology | Radiology | Same | | Intended Use | The POSKOM Portable X-ray<br>unit is a device that can<br>conveniently generate X-rays<br>for diagnosis when the patient<br>condition is difficult to move.<br>Mainly used by trained<br>specialists, doctors or<br>radiologists.<br>Indication:<br>The POSKOM Battery Type<br>Portable X-ray Unit is intended<br>for use by a qualified/trained<br>doctor or technician on both<br>adult and pediatric subjects for<br>taking diagnostic radiographic<br>exposures of the body parts.<br>The device must be used for<br>stand mounted diagnostic<br>imaging of head, abdomen, or<br>extremities.<br>The device must be used for<br>stand mounted imaging of the<br>chest. | The TR90BH is a portable X-<br>ray system with following<br>limitations of use:<br>The device may be used for<br>handheld diagnostic imaging of<br>body extremities. The device<br>may be used for stand<br>mounted diagnostic imaging of<br>head, abdomen, or<br>extremities. The device may<br>be used for stand mounted<br>imaging of the chest when<br>used without a grid. - Not to<br>be used on bariatric patients,<br>unless imaging body<br>extremities - Not for<br>mammography use - The<br>TR90BH is not intended to<br>replace a stationary<br>radiographic system, which<br>may be required for full<br>optimization of image quality<br>and radiation exposure for<br>different exam types. | Similar | | | Proposed Device | Predicate Device | | | | Applications can be performed<br>with the patient sitting,<br>standing, or lying in the prone<br>or supine position.<br>Contraindication: | | | | | The use of X-radiation for<br>diagnostic purposes in the<br>following subjects is<br>contraindicated. | | | | | Pregnancy, especially<br>-<br>first trimester | | | | Principle of<br>Operation | General Purpose Diagnostic X<br>ray | General Purpose Diagnostic X<br>ray | Same | | Size | 325 X 268 X 250 mm | 219 x 442 x 190 mm | Similar | | Weight | 5.0kg | 7.5kg | Similar | | Energy source | Lithium Polymer Battery 3.7V<br>5000mAh | Lithium-ion Rechargeable<br>Battery (57.6DC), 300<br>exposures per charge. | Similar | | Exposure times | 0.02 sec - 2 sec | 0.01 sec - 1.0 sec : 0.01 sec<br>Step High Power Mode | Similar | | | | 0.01 sec - 0.3 sec : 0.01 sec<br>Step | | | | 20mA (50 ~ 80kV / 0.4 ~<br>3.2mAs) | 20 mA @ 40 kVDC - 60 KVDC<br>(2 kVP steps) | Similar | | | 10mA (50 ~ 70kV / 3.6 ~<br>20mAs) | 15 mA @ 62 kVDC - 80 kVDC<br>(2 kVP steps) | | | Tube current<br>[mA] | 10mA (71 ~ 80kV / 3.6 ~<br>16mAs) | 10 mA @ 82 kVDC – 90 kVDC<br>(2 kVP steps) | | | | 15mA (81 ~ 90kV / 0.4 ~<br>3.2mAs) | High Power Mode | | | | 8mA (81 ~ 90kV / 3.6 ~<br>16mAs) | 15 mA @ 82 kVDC - 90 kVDC<br>(2 kVP steps) | | | | | Comment: 90 kVP maximum<br>instead of 120 kVP maximum. | | | Tube Voltage<br>Range [kVp] | 50 - 90kVp | 40 - 90kVp | Similar | | Memory settings | 10 Memories | 10 memories | Same | | HF Generator | High frequency | High frequency | Same | | Output power<br>[kW] | 1.6kW | 1.35 kW | Similar | | X-ray Tube | OX/70-1.0 (C.E.I.) | D-0814 | Different | | Collimator | Double slit type and manually<br>operation with LED Light<br>indicator | Mikasa BLD34L | Different | | Performance<br>standard | IEC 60601-1-3:2008<br>+AMD:2013 | IEC 60601-1-3:2008<br>IEC 60601-2-28:2010 | Similar | | | Proposed Device | Predicate Device | | | | IEC 60601-2-28:2017<br>IEC 60601-2-54:2009<br>+AMD2:2018 | IEC 60601-2-54:2009 | | | Electrical safety | IEC 60601-1:2005<br>+AMD1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-3:2008<br>+AMD:2013<br>IEC 60601-1-6:2010<br>+AMD1:2013<br>IEC 62304: 2006<br>IEC 62366:2007 +AMD1:2014 | IEC 60601-1:2012<br>IEC 60601-1-2:2007<br>IEC 60601-1-6:2010<br>IEC 62304:2006<br>IEC 62366:2007 | Similar | # [Table 1. Comparison of Proposed Device to Predicate Devices] {11}------------------------------------------------ {12}------------------------------------------------ The table also provides rationale for a little difference in support of substantial equivalence to the predicate devices. #### Justification to Support Substantial Equivalence AirRay is hardly different from the TR90BH except for Collimator and X-ray Tube. But the above differences are inherent characteristics of device. The most important tube current and tube voltage range are similar to predicate device. And Size, Weight, Energy source, Exposure times, Performance standard, Electrical safety are also similar to predicate devices, but they are not items that significantly affect performance, and their intended use is equivalent. The proposed device, AirRay has been tested about electrical safety, EMC and software has been validated. #### 8. Non-Clinical Test summary The AirRay complies with voluntary standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination: #### 1) Electrical Safety, Electromagnetic Compatibility and Performance: The AirRay complies with the electrical safety and electromagnetic compatibility requirements established by the standards. - IEC 60601-1:2005/AM1:2012 Medical electrical equipment - Part 1: General requirement for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment - Part1-2: General requirements Section1.2 Collateral standard: Electromagnetic compatibility - IEC 60601-1-3:2008 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-Ray equipment {13}------------------------------------------------ - . IEC 60601-2-54:2009/AM2:2018 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-Ray equipment for radiography and radioscopy #### 2) Software Validation The AirRay contain MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: - "The content of premarket submissions for software contained in medical devices, on May 11, 2005" - IEC 62304:2006 (First Edition) Medical device software: Software life-cycle processes Rechargeable Li-ion polymer battery pack has been tested and is in conformity with the standard IEC 62133. And we performed the battery performance test about battery charging time. discharge time and usage count, Battery rated load, overcurrent protection and recovery. Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients: "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use" The device also conforms to the following: 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products 21 CFR 1020.30: Diagnostic x-ray system and their major components 21 CFR 1020.31: Radiographic Equipment {14}------------------------------------------------ # 9. Conclusion [21 CFR 807.92(b)(3)] The AirRay has similar intended use and technical characteristics to the predicate device. Based on this information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness.