Orthoscan VERSA Mini C-Arm

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January 14, 2025 Ziehm-Orthoscan, Inc. % Kevin Bridgman VP of Regulatory Affairs and Quality Assurance 14555 N. 82nd St. SCOTTSDALE, AZ 85260 Re: K243452 Trade/Device Name: Orthoscan VERSA Mini C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, JAA, MQB Dated: November 21, 2024 Received: November 21, 2024 Dear Kevin Bridgman: 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. 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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/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 Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243452 Device Name Orthoscan VERSA Mini C-Arm #### Indications for Use (Describe) The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgency, traumatology, orthopedic, critical care, or physician office environments. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Wingdings;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Wingdings;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="text-decoration: none;"> <span style="vertical-align: baseline;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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VERSA Mini C-Arm # Submitter: Ziehm-Orthoscan, Inc. 14555 N 82nd St. Scottsdale, AZ 85260 Phone: (480) 503-8010 Fax: (480) 503-8011 Primary Contact: Kevin Bridgman; Kevin.bridgman@ziehm-orthoscan.com Secondary Contact: TuAnh Ngo; tuanh.ngo@ziehm-orthoscan.com Date: October 1, 2024 In accordance with the requirements of 21 CFR §807.92 the following Traditional 510(k) summary of information is provided: | Device Trade Name: | Orthoscan VERSA Mini C-Arm | |-----------------------|-----------------------------------------------------------------| | 510(k) Number: | K243452 | | Common/Usual Names: | Fluoroscopic X-Ray System, Mobile Mini Mobile C-arm, Mini C-arm | | Device Class: | Class II | | Classification(s): | 21CFR 892.1650 | | Classification Names: | Image-intensified fluoroscopic x-ray system | | Product Code: | OXO, JAA, MQB | | Primary Predicate: | Orthoscan TAU Mini C-Arm | |-----------------------|---------------------------------------------| | 510(k) Number: | K213113 | | Classification(s): | 21CFR 892.1650 | | Device Class: | Class II | | Classification Names: | Image-intensified fluoroscopic x-ray system | | Product Codes: | OXO, JAA, MQB | | Secondary Predicate: | Orthoscan Mobile DI Mini C-Arm | |-----------------------|---------------------------------------------| | 510(k) Number: | (K113708) | | Classification(s): | 21CFR 892.1650 | | Device Class: | Class II | | Classification Names: | Image-intensified fluoroscopic x-ray system | | Product Codes: | OXO, JAA, MQB | # General Description: The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan VERSA, for distinction from predicate Orthoscan TAU and Orthoscan Mobile DI) retain identical function as the predicate TAU Mini C-arm (K2131130) and predicate Mobile DI (K113708) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees. The system consists of C-arm support attached to the image workstation. The changes to the Orthoscan VERSA Mini C-arm X-ray system represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-arm (K113708). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04 and related software revisions, modification to the mechanical design to further facilitate desk top use, revisions to {5}------------------------------------------------ generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead and an update to wireless footswitch communication protocol. The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels. For both the predicate and proposed device, the following are unchanged: C-arm support of flat panel detector, generator and x-ray controls, mechanical connections, balancing, locking, rotations, work-station platform, monitor display and main user interface controls, touch screen interface, selectable imaging, Xray technique control, entry of patient information, wired or wireless footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces. #### Indications for Use: The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments. # Indications for Use Comparison: The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series do not change the indications for use. The indications for use are the same as the predicate device TAU (K213113) and Mobile DI (K113708) Mini C-Arms. #### Technology: The changes to the proposed device Orthoscan VERSA Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan Mobile DI (K113708). With the introduction of a Linux based operating system (OS) upgrade from Ubuntu 16.04 to Ubuntu 20.04, an open source highly secure OS, cybersecurity controls are improved, image quality is maintained or improved, and a capability is created for future expansions of the proposed VERSA device. Modification to the predicate Orthoscan Mobile DI model 1000-0005 (K113708) mechanical design further facilitates desk top use by relocating the image processing printed circuit card, power manager circuit card and related hardware and cabling behind the display electronics within the monitor display assembly. Revisions to generator printed circuit board improve power management efficiency and implementation of an alternate generator radiation shielding material reduces environmental impact of lead. Updating the communication protocol of wireless footswitch from fixed pairing method to code-hopping method maintains state of the art wireless communications and perpetuate free operator movement with fewer cables in the way. # Summary of Technological Characteristics: The comparisons of the proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm demonstrate that the scientific and technology characteristics indicate substantial equivalence to the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan Mobile DI Mini C-arm (K113708). # Adverse Effects on Health: The proposed modified Ziehm-Orthoscan, Inc. VERSA Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management and controlled by meeting the applicable CDRH 21CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under Ziehm-Orthoscan, Inc. Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness. {6}------------------------------------------------ # Non-Clinical Testing Summary Verification and Validation, including hazard mitigations and usability testing executed in demonstrated system that met Design Input and user needs. The device was tested by certified test laboratory resulting in device being certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54. Further, the device met all applicable sections of 21 CFR Subchapter J performance standards. The proposed modified Ziehm-Orthoscan, Inc. VERSA Mini C-Arm development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to; - Risk Analysis . - . Required reviews - . Design reviews - Component testing - . Integration testing - . Performance testing - . Safety testing - . Product use and usability testing Performance bench testing included non-clinical testing methods specific to quidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstrating system and imaging performance. Non-clinical image and dose lab testing were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed and images were taken by both the proposed VERSA and the predicate device Orthoscan TAU (K213113). Numerous image comparison sets were taken, and a Radiologist performed an assessment of individual images arranged in groups of image sets. His conclusion was that the image quality at same or similar patient dose rates will result in equivalent or slight improvement in patient care (images) for the proposed modified VERSA device over the predicate device. Therefore, Ziehm-Orthoscan, Inc. believes the VERSA Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Orthoscan TAU (K213113) and Orthoscan Mobile DI (K113708). Usability testing included confirming the usability specifications of the proposed modified Ziehm-Orthoscan, Inc. VERSA Mini C-Arm, as well as the user interface of the device, especially the interfaces that have changed since the predicate devices. Usability testing concluded that there were no previously unknown use errors or hazardous situations and no unacceptable residual risks due to the changes in user interface from the predicate device Orthoscan TAU (K213113) and Orthoscan Mobile DI (K113708). # Summary of Clinical Test Data: Ziehm-Orthoscan, Inc. VERSA mobile fluoroscopic Mini C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the related guidance documents, Premarket Assessment of Pediatric Medical Devices May 24, 2014 and Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Therefore, Ziehm-Orthoscan, Inc. conducted a lab test image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken with Ziehm-Orthoscan, Inc. VERSA Mini C-Arm in comparison to the predicate Orthoscan TAU Mini C-Arm (K213113). # Substantial Equivalence Conclusion: The changes and differences of the proposed Ziehm-Orthoscan, Inc. VERSA Mini C-Arm described do not change the control mechanism, operating principle, energy type, or intended use found on the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan Mobile DI Mini C-arm (K113708). Ziehm-Orthoscan, Inc. considers the proposed modified VERSA Mini C-arm to be as safe, as effective, and performs substantially equivalent to the predicate device Orthoscan TAU Mini C-arm (K213113) and Orthoscan Mobile DI Mini C-arm (K113708) in accordance with its labeling.