XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

{0}------------------------------------------------ November 16, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Gemss Healthcare Co., Ltd. % Mr. Dave Kim RA Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON TX 77054 Re: K233200 Trade/Device Name: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: September 22, 2023 Received: September 28, 2023 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. 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 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, 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 Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233200 Device Name XPLUS 35 Series (XPLUS 35, XPLUS 35FD) Indications for Use (Describe) XPlus 35 Series (XPLUS 35. XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 16px;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> | |-------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> | #### 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. 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The logo is simple and modern. 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952 South Korea Tel. +82 31-906-9017 Fax. +82 31-906-9019 sales@gemss-healthcare.com # 510(k) Summary K233200 This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: November 15, 2023 ### 1. Applicant / Submitter - GEMSS HEALTHCARE CO., LTD. । - Address: 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952, Republic of Korea । - Tel: +82-31-906-9017 | Fax: +82-31-906-9019 | Email:olivia@gemss.co.kr - - Official Correspondent (U.S): Dave Kim / Mtech Group LLC । 7505 Fannin St. Suite 610, Houston, TX 77054 / Tel) 1-713-467-2607 / davekim@mtechgroupllc.com ### 2. Device Information - Trade/Device Name: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) - - Regulation Number: 21CFR 892.1650 - - Regulation Name: Image-Intensified Fluoroscopic X-ray System - - Device Class: Class II - - । Product Code: OWB - -Subsequence product code: JAA, OXO ### 3. Predicate Device - K Number: K091918 - Manufacturer: GENORAY Co., Ltd. - - Trade Name: ZEN-2090 Pro - - Regulation Number: 21CFR 892.1650 - - Regulation Name: Image-Intensified Fluoroscopic X-ray System - - -Device Class: Class II - Product Code: OWB । - Subsequence product code: JAA, OXO - ### 4. Reference Device - K Number: K222080 - - -Manufacturer: SG HealthCare Co. Ltd. - -Trade Name: Garion - Requlation Number: 21CFR 892.1650 - {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern. - Regulation Name: Image-Intensified Fluoroscopic X-ray System - Device Class: Class II - Product Code: OWB । ## 5. General Description XPLUS 35 Series (XPLUS 35, XPLUS 35FD), C-arm mobile, is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. XPLUS 35 Series (XPLUS 35, XPLUS 35FD) consist of X-ray tube, X-ray generator, C-arm including image receptor, monitor cart, medical monitor and accessories such as foot switch and hand switch. - 1) C-arm - X-ray tube: It converts high voltage currents into an X-ray through a generator. - - -Image receptors: It translates the x-ray, which penetrates the patient's body, into the image signals. - 2) Monitor cart Main C-arm units and monitor cart are connected to each other with a cable. There is a main power cable to supply power to the monitor cart and main unit, which is not a battery type. - Software: The displayed images can be edited and saved, and the images can also be sent to PACS server. Moreover, the patient information and database can be managed through the monitor cart - Medical montor: It displays the images by the monitor through visualizing the image signals. It displays live image on the left, and reference image on the right. - 3) Accessories - Foot switch: It is used for fluoroscopy and can save images. - - Hand switch: It is used in both radiographic and fluoroscopic modes. It controls X-ray generation. ### 6. Indication for use XPlus 35 Series (XPLUS 35, XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for GEMSS Healthcare. The word "GEMSS" is written in orange, and the word "HEALTHCARE" is written in gray below it. The font is sans-serif and the text is left-aligned. Comparison of the subject device to the predicate device. | Descriptive Information | Subject Device | Predicate Device | Reference Device | Note | | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------| | Manufacturer | GEMSS<br>HEALTHCARE CO.,<br>LTD. | GENORAY Co.,<br>Ltd. | SG HealthCare Co.<br>Ltd. | | | | Device Name | XPLUS 35,<br>XPLUS 35 FD | ZEN-2090 Pro | Garion | | | | 510(k) number | K233200 | K091918 | K222080 | - | | | Regulatory Number | 21CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same | | | Product Code | OWB, JAA, OXO | OWB, JAA, OXO | OWB | Same | | | Regulatory Class | 2 | 2 | 2 | Same | | | Indications for Use | XPLUS 35 series<br>(XPLUS 35, XPLUS<br>35FD) are mobile<br>digital C-arms<br>designed to provide<br>fluoroscopic and<br>radiographic images<br>of the patient during<br>diagnostic, surgical<br>and interventional<br>procedures.<br>Examples of clinical<br>application may<br>include orthopedic,<br>neurologic, vascular,<br>cardiac,<br>angiography,<br>endoscopy, urologic,<br>critical care and<br>emergency room<br>procedures. i.e.<br>surgical interventions<br>needing X-ray<br>imaging and/or<br>guidance and<br>interventions inside<br>and outside the<br>operating room. | ZEN-2090 Pro is<br>a mobile digital<br>C-arm designed<br>to provide<br>fluoroscopic and<br>radiographic<br>images of the<br>patient during<br>diagnostic,<br>surgical and<br>interventional<br>procedures.<br>Examples of<br>clinical<br>application may<br>include<br>cholangiography,<br>endoscopy,<br>orthopedic,<br>neurologic, stone<br>location, critical<br>care and<br>emergency room<br>procedures<br>i.e. surgical<br>interventions<br>needing X-ray<br>imaging and/or<br>guidance and<br>interventions<br>inside and<br>outside the<br>operating room. | The Garion is<br>intended to be<br>used and<br>operated by:<br>adequately<br>trained, qualified<br>and authorized<br>health care<br>professionals who<br>have full<br>understanding of<br>the safety<br>information and<br>emergency<br>procedures as well<br>as the capabilities<br>and functions of<br>the device. The<br>device is used for<br>radiological<br>guidance and<br>visualization<br>during diagnostic,<br>interventional and<br>surgical<br>procedures on all<br>patients, except<br>neonates (birth to<br>one month),<br>within the limits of<br>the device. The<br>device is to be<br>used in healthcare<br>facilities both<br>inside and outside<br>the operating<br>room, sterile as<br>well as non-sterile<br>environment in a<br>variety of<br>procedures. | Similar | | | Radiogra | kV range | 40 to 110 kV | 40 to 110 kV | 40 to 125 kV | Same | | phic | mA Range | 30 to 45 mA | 20 mA | 0.3~ 32 mA | Similar | | Mode | mAs Range | 1.0 to 200 mAs | 0.4 to 100 mAs | 0.2 ~ 100 mAs | Similar | | Fluorosco<br>pic Mode | kV range | 40 to 110 kV | 40 to 110 kV | 40 to 110 kV | Same | | | mA range | 0.2 to 8 mA<br>10 mA (Boost Mode) | 0.2 to 6 mA<br>10 mA (Boost<br>mode) | 0.3 ~ 6.3 mA | Similar | | | Pulse<br>Fluoro | Yes | Yes | Yes | Same | | C-arm | Range of<br>C-arm Rail<br>Rotation | I.I Type: 135 ° (90<br>° / 45 °)<br>FPD Type: 165°<br>(120° / 45°) | 120 °<br>(90 ° / 30 °) | 150 ° | Similar | | | Range of<br>the<br>Horizontal<br>C-arm<br>Movement | 200 mm | 200 mm | 200 mm | Same | | | Range of<br>the Vertical<br>C-arm<br>Movement | 500 mm | 400 mm | 400 mm | Similar | | | Range of<br>Swing-arm<br>Movement | + 12.5 ° | + 12.5 ° | + 15 o | Same | | | Range of<br>Stay-arm<br>Rotation | 225 ° | 180 ° | 180 ° | Similar | | Image<br>Receptor | Image<br>Intensifier | E5830SD-P4A<br>(Manufactured by<br>TOSHIBA)<br>9″ / 6″ / 4.5″ | E5830SD-P4A<br>(Manufactured<br>by TOSHIBA)<br>9″ / 6″ / 4.5″ | - | Same | | | Flat Panel<br>Detector | Mercu 0909F<br>(Manufactured by<br>IRay) 9″ | | Mercu 0909F<br>(Manufactured by<br>IRay) 9″ | | | | Pixel Pitch | 205µm | N/A | 205um | Same | | | DQE @ 0<br>lp/mm | 77% at 0lp/mm | 65% at 0lp/mm | 77% at 0lp/mm | Same | | | MTF @<br>1lp/mm | 61% | N/A | 61% | Same | | | Frame<br>rates (fps<br>values) | N/A for I.I.<br>Up to 60fps for FPD | N/A | Up to 60fps | Same | | Collimators | | Iris and Leaf | Iris and Leaf | Motor<br>control/rotation | Same | | Laser Guide | | Yes | Yes | Yes | Same | | | Model | DF-151SBR<br>(Manufactured by<br>Canon) | DF-151SBR<br>(Manufactured<br>by Canon) | Rotating Anode<br>(200kHU) | Same | | X-ray<br>Tube | Anode<br>Type | Stationary Anode | Stationary Anode | Rotating anode | Same | | Focal size | | 0.5/1.5 mm | 0.5/1.5 mm | 0.3/0.6 mm | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for GEMSS Healthcare. The logo consists of the word "GEMSS" in orange, with the word "Healthcare" in gray underneath. The font is sans-serif and the letters are bold. 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952 South Korea {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern. XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is substantially equivalent to the predicate device ZEN-2090 Pro (K091918) and Garion (K222080) These devices are very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, different X-ray generators, the appearance, and the user interfaces are different. The Xray generator capacity of the subject device has higher maximum power output compared with the predicate devices. The subject device utilized both solid state X-ray imager (FPD) and image intensifier which are the same as the predicate devices. All detectors used for the subject devices have been already cleared by FDA and do not raise new concerns for safety and effectiveness. However, these small and minor differences do not raise any new questions of safety and effectiveness. #### 8. Safety, EMC and Performance data comparison to Predicate - IEC60601-1 (ed3.1, 2012), Medical electrical equipment Part 1: General requirements for basic safety and essential performance (Recognition No: 19-4) - -IEC60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests (Recognition No: 19-8) - IEC60601-1-3 (ed 2.1, 2013), Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition No: 12-269) - -IEC60601-2-28 (ed 3, 2017) Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Recognition No: 12-309) - IEC60601-2-43 (ed 2.2, 2019) Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Recognition No: 12-329) In addition, the device complies with the FDA Radiation Safety Performance Standard Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32); Small Entity Compliance Guide. In addition, labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff. Labeling also includes reference to the Image Gently website (http://www.imagegently.org/). Also we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for GEMSS Healthcare. The logo consists of the word "GEMSS" in orange, with the word "HEALTHCARE" in gray underneath. The font is sans-serif and the letters are bold. Software verification testing of the functional requirements as well as performance and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices" to ensure substantial equivalence. Results demonstrated that all executed verification tests were passed. Non-clinical validation testing has been performed to validate that XPLUS 35 Series (XPLUS 35, XPLUS 35FD) conforms 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 and clinical evaluation indicates that the new device is as safe and effective as the predicate device. ### 9. Conclusion In reference to the comparison provided in substantial equivalence chart, and the most of functions and electronic features are similar with predicate device. We believe that the XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is safe and effective as predicate device, and has no new indication for use. Therefore, XPLUS 35 Series (XPLUS 35FD) is substantially equivalent to predicate device.