Halifax Imaging Kit

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October 31, 2018 Halifax Biomedical, Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114 Re: K182880 Trade/Device Name: Halifax Imaging Kit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: October 11, 2018 Received: October 15, 2018 Dear Daniel Kamm: 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. 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Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182880 Device Name Halifax Imaging Kit Indications for Use (Describe) This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography. | 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. 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The logo includes a square with arrows pointing inward and the company name in two lines, with "Halifax" in a larger, orange font and "Biomedical Inc." in a smaller, blue font. 11493 Route 19, Mabou Nova Scotia, Canada, BOE 1X0 Phone +1 902 945 2762 Fax +1 902 945 2324 Chad Munro, CEO, President Date Prepared: October 30, 2018 # 1. Identification of the Device: Proprietary-Trade Name: Halifax Imaging Kit Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System 2. Equivalent legally marketed device: Halifax SR Suite 1.0, K121345 Regulation Number: 892.1680 Regulation Name: Stationary x-ray system. Regulatory Class: II Product Codes: KPR, MQB, LLZ Common/Usual Name: Stationary X-Ray System ## 3. Contact: Daniel Kamm, P.E., Tel 239-234-1735, Email fda.help.now@gmail.com - 4. Indications for Use: This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography. - 5. Description of the Device: The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability. The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM). {4}------------------------------------------------ The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits: a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345. b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components: •GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus). · EMD Technologies Epsilon Series generator. (Or generators already on site) Image /page/4/Picture/5 description: The image shows a diagram of a setup with two cameras positioned at an angle of 30 degrees relative to a central point. The cameras are mounted above a black platform, and the distance from the cameras to the platform is labeled as 150 cm. The cameras are pointed downwards, and their fields of view converge on the platform, which has two objects with red lines and crosshairs on them. - 6. Safety and Effectiveness, comparison to predicate device. The results of bench and standards testing indicates that the new device is as safe and effective as the predicate device. Risk analysis has been performed. - 7. Substantial Equivalence Chart, Halifax Imaging Kit {5}------------------------------------------------ | Characteristic | Halifax SR Suite 1.0 K121345 | Halifax Imaging Kit Option<br>*Utilizes existing radiography system<br>OR new components. | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | This is a stationary digital x-ray system for<br>general radiography and RSA (Roentgen<br>Stereophotogrammetric Analysis<br>procedures.) Not for mammography. | This is a stationary digital x-ray system for<br>general radiography and RSA (Roentgen<br>Stereophotogrammetric Analysis<br>procedures.) Not for mammography. | | Generator | Sedecal SHF635RF (Two used) | • Sedecal SHF515C or<br>• Sedecal SHF635RF<br>• Or equivalent Sedecal Generator<br>• EMD Epsilon Generator<br>(Two generators used) | | Maximum output | 64 kW (Two used) | 45-80 kW depending on model selected<br>(Two used) or units already in place. | | Stand | Sedecal and Acceleray | Utilizes existing radiography system OR<br>SYFM Stand | | Image Acquisition | Digital, dual panels. | Digital, dual panels. | | Digital Panel Size | 17 x 17 | 17 x 17 or 14 x 17 or 16 x 16 (Flashpad) | | Digital Panel<br>Supplier | Canon CXDI-50RF (Two used, cleared in<br>K092429) | Two of any of the following (all previously<br>cleared):<br>• Agfa DX-D30C or<br>• Canon CXDI-501G or<br>• Canon CXDI-70C or<br>• Canon CXDI-701C or<br>• GE Flashpad (WDR1 Kit)<br>• Any imaging panel with 510(k) clearance<br>which meets Halifax validation criteria. | | Digital Resolution | Pixel size 160 × 160 µm<br>Image matrix size 2208 × 2688 pixels<br>Number of pixels Approx. 5.9 million pixels | Agfa DX-D30C 139 µm 7.9 million pixels<br>Canon CXDI-501G 125 µm 9.5 million pixels<br>Canon CXDI-70C 125 um 9.5 million pixels<br>Canon CXDI-701C 125 µm 9.5 million pixels<br>200 µm , 4.1 million pixels<br>GE Flashpad | | Software | The SR Suite employs the software cleared<br>in K042383, the RSA-CMS. The software<br>was designed specifically to perform<br>Roentgen Stereophotogrammetric Analysis. | Unchanged | | Acquisition<br>Software | SR Suite 1.0 employs the acquisition<br>software cleared in K092429 for the digital<br>panel. | Unchanged | | Collimator | Ralco R225 | Ralco R225 Unchanged | | Safety | UL listings and EMC Tested. | UL listed and EMC tested power supply<br>used in the Imaging Kit | Reference to Digital Panel Clearances: - Agfa DX-D30C K141602 - Canon CXDI-501G K111682) {6}------------------------------------------------ - Canon CXDI-70C K102012 - Canon CXDI-701C K131106 - GE Flashpad (WDR1 Kit) K102116 ## 8. Summary of Bench Testing and development activities conducted: The following Risk Management and Risk Analysis documents were created: Risk Management Plan - Halifax Imaging Kit Risk Management Plan - Imaging Kit Control Module Risk Analysis - Imaging Kit Control Module Risk Analysis - Halifax Imaging Kit - L-Arm Support Fault-Tree Analysis - Imaging Kit Control Module Design Verification Testing of the Universal Synchronization Switch was performed in order to verify (a) Proper Board level functionality, firmware and (b) Proper Enclosure internal wiring assemblies and connections. Finite element analysis was performed on the support structures followed by design verification reviews. Verification and Validation reports were executed for the new Imaging Kit, Control Module, and Universal Synchronization Switch. Labeling: Installation and User Manuals were developed for the modified portions of the system, and the original labeling was updated according to the FDA Guidance on Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. The following reports were prepared documenting bench testing activities: Design Verification Test, Universal Synchronization Switch Imaging Kit Control Module Verification Report Imaging Kit Control Module Validation Test Report In addition a Requirements Traceability analysis was performed for the Imaging Kit Control Module. The power supply chosen for the Imaging Kit Control Module is UL listed and EMC compliant for medical applications per IEC Standards: IEC 60601-1 and IEC 60601-1-2. Every installation undergoes a precision validation test prior to turn over to the customer. "The precision of a Radiostereometric Analysis (RSA) System is affected by the components of the RSA System set-up as well as by the features of the individual joint and implant under examination. To validate a new Halifax Imaging Kit at "[Hospital]" in [City] ([Room details]), [State/Province], [Country], a phantom study was undertaken using a small carbon fibre box. Phantom studies, commonly used for RSA validation [1-12], are a technique used to calculate in vitro precision and accuracy of an RSA System." - 9. Summary of Clinical Testing: Clinical testing was not required to establish equivalence because all of the new digital receptor panels already have their own 510(k) clearances. - 10. Conclusion: After analyzing bench testing, standards testing data, and risk analysis it is the conclusion of Halifax Biomedical that the Halifax Imaging Kit Option is as safe and effective as the predicate device, has no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.