Micro C Medical Imaging System, M01

{0}------------------------------------------------ February 4, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. OXOS Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 Re: K212654 Trade/Device Name: Micro C Medical Imaging System, M01 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: January 27, 2022 Received: January 28, 2022 Dear Prithul Bom: 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). 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Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K212654 Device Name Micro C Medical Imaging System, M01 #### Indications for Use (Describe) The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | X Prescription Use (Part 21 CER 801 Subnart D) | | ### 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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K212654 # Section 5 510(k) Summary In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Micro C Medical Imaging System, M01 Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005. | Submitter: | OXOS Medical, Inc<br>1230 Peachtree St NE<br>Suite #300<br>Atlanta, GA 30309<br>Tel: 1-855-SEE-XRAY | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission Contact: | Mo Khosravanipour<br>Director of Program Management<br>OXOS Medical, Inc.<br>Email: Mo@oxos.com<br>Grace Powers, MS, MBA, RAC<br>Founder/Principal Consultant<br>Powers Regulatory Consulting<br>Email: grace@powersregulatory.com | | Submission Date: | July 21, 2021 | | Subject Device: | Trade Name: Micro C Medical Imaging System, M01<br>Common Name: System, X-Ray, Mobile<br>Regulation: 21 CFR § 892.1720<br>Regulatory Classification: 2<br>Product Code: IZL<br>Classification Panel: Radiology | | Predicate Device: | Legally marketed device to which substantial equivalence is claimed:<br>Micro C Medical Imaging System, M01 (K211473) | ### Device Description: The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The {4}------------------------------------------------ Section 5 510(k) Summary Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below. - Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand. - Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module. - Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment. The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet. The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs and transfer radiographs to a PACS server or flash drive. Image /page/4/Figure/8 description: The image shows a white box connected to a handheld device and a square base via cables. Two blue cables connect the box to the handheld device and the square base. Two gray cables also connect the box to the square base. # Figure 5-1: Subject Device - Micro C Medical Imaging System, M01 {5}------------------------------------------------ Image /page/5/Figure/2 description: The image shows a computer setup with a monitor, keyboard, mouse, and a white device. The monitor is connected to the white device, and the keyboard and mouse are also connected to it. The white device has several ports on the back, including a power port, USB ports, and an Ethernet port. There are also two wall outlets visible in the image. ### Intended Use: The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities. #### Indications for Use: The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types. #### Technological Characteristics The Micro C Medical Imaging System, M01 is identical to the predicate device cleared via K211473. The purpose of this submission is to update the software to include AiLARA modes as described below. The table below compares the subject and predicate device. | | Subject Device:<br>Micro C Medical Imaging<br>System, M01 | Predicate Device: Micro<br>C Medical Imaging<br>System, M01 (K211473) | Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | IZL (Mobile X-Ray<br>System) | IZL (Mobile X-Ray<br>System) | Identical | | Regulation | 21 CFR 892.1720 | 21 CFR 892.1720 | Identical | | Classification<br>Name | Mobile X-Ray System | Mobile X-Ray System | Identical | | Classification | Class 2 | Class 2 | Identical | | Indication for<br>Use | The Micro C Medical<br>Imaging System, M01 is a<br>handheld and portable<br>general purpose X-ray<br>system that is indicated<br>for use by | The Micro C Medical<br>Imaging System, M01 is<br>a handheld and<br>portable general<br>purpose X-ray system<br>that is indicated for use | Identical | | Subject Device:<br>Micro C Medical Imaging<br>System, M01 | Predicate Device: Micro<br>C Medical Imaging<br>System, M01 (K211473) | Comparison | | | qualified/trained<br>clinicians on adult and<br>pediatric patients for<br>taking diagnostic static<br>and serial radiographic<br>exposures of extremities.<br>The device is not<br>intended to replace a<br>radiographic system that<br>has both variable tube<br>current and voltages<br>(kVp) in the range that<br>may be required for full<br>optimization of image<br>quality and radiation<br>exposure for different<br>exam types. | by qualified/trained<br>clinicians on adult and<br>pediatric patients for<br>taking diagnostic static<br>and serial radiographic<br>exposures of<br>extremities.<br>The device is not<br>intended to replace a<br>radiographic system<br>that has both variable<br>tube current and<br>voltages (kVp) in the<br>range that may be<br>required for full<br>optimization of image<br>quality and radiation<br>exposure for different<br>exam types. | | | | Contraindications | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Identical | | Age of Device Use | Adults and Pediatric | Adults and Pediatric | Identical | | Principle of Operation | General purpose diagnostic X-ray | General purpose diagnostic X-ray | Identical | | Image type produced | Static, serial radiographic<br>and photographic images<br>for convenience. | Static, serial<br>radiographic and<br>photographic images for<br>convenience. | Identical | | Detector | 6 x 6" digital detector | 6 x 6" digital detector | Identical | | Collimator | The removable fixed<br>collimators (referred to<br>as pucks) | The removable fixed<br>collimators (referred to<br>as pucks) | Identical | | Weight | Emitter: 2.86kg (6.3lbs) | Emitter: 2.86kg (6.3lbs) | Identical | | | Subject Device:<br>Micro C Medical Imaging<br>System, M01 | Predicate Device: Micro<br>C Medical Imaging<br>System, M01 (K211473) | Comparison | | Dimension/<br>Size | Cassette: 6.5kg (14.3lbs)<br>Control Unit: 8.6kg<br>(19.0lbs)<br>Emitter: 9.3"H x 3.5"W x<br>8.3"L (excluding SSD<br>Cone)<br>Cassette: 15.5"H x<br>15.5"W x 2.8"L<br>Control Unit: 16.4"H x<br>12.9"W x 5.5"L | Cassette: 6.5kg (14.3lbs)<br>Control Unit: 8.6kg<br>(19.0lbs)<br>Emitter: 9.3"H x 3.5"W x<br>8.3"L (excluding SSD<br>Cone)<br>Cassette: 15.5"H x<br>15.5"W x 2.8"L<br>Control Unit: 16.4"H x<br>12.9"W x 5.5"L | Identical | | Triggering<br>Mechanism | Two stage triggering | Two stage triggering | Identical | | Minimum<br>Source to<br>skin distance<br>(SSD) | 20 cm SSD Cone ensures<br>minimum SSD of 20 cm | 20 cm SSD Cone ensures<br>minimum SSD of 20 cm | Identical | | Source to<br>Detector<br>distance | 20 - 45 cm | 20 - 45 cm | Identical | | Light Field | Virtual light field on<br>Monitor UI. No projected<br>light field. | Virtual light field on<br>Monitor UI. No<br>projected light field. | Identical | | Energy<br>Source | 120 VAC / 60 Hz (no<br>rechargeable battery) | 120 VAC / 60 Hz (no<br>rechargeable battery) | Identical | | Exposure<br>Time | 33 ms - 99 ms | 33 ms, 66 ms, 99 ms | Similar- The overall range is<br>identical. Single AiLARA<br>mode allows for ms values<br>throughout the range. Serial<br>AiLARA mode has a fixed<br>output of 33 ms. | | mA | 1.0 mA fixed | 1.0 mA fixed | Identical | | kVp | 40kVp-60kVp | 40kVp, 50kVp, and<br>60kVp | Similar- The overall range is<br>identical. AiLARA allows for<br>kVp values throughout the<br>range. | | Scintillator<br>Resolution/<br>Pixel size | Cesium lodide (CsI)<br>99 μm | Cesium Iodide (Csl)<br>99 μm | Identical | | DQE @<br>0Lp/mm<br>MTF @ 1<br>Lp/mm,<br>RQA5 | 70%<br>60% | 70%<br>60% | Identical | | | Subject Device:<br>Micro C Medical Imaging<br>System, M01 | Predicate Device: Micro<br>C Medical Imaging<br>System, M01 (K211473) | Comparison | | Ingress<br>Protection<br>Rating | IPOO | IPOO | Identical | | Image<br>Processing | User Interface can be<br>used to drag, zoom,<br>rotate and also adjust<br>brightness, contrast, and<br>sharpness. | User Interface can be<br>used to drag, zoom,<br>rotate and also adjust<br>brightness, contrast,<br>and sharpness. | Identical | | Connectivity<br>Options | WiFi, Ethernet, Four USB<br>2.0 ports | WiFi, Ethernet, Four<br>USB 2.0 ports | Identical | | DICOM | Yes- DICOM 3.0<br>Compliant | Yes- DICOM 3.0<br>Compliant | Identical | | Device<br>Package<br>Contents | • Cassette<br>• Control Unit<br>• Emitter<br>• Collimation Pucks<br>• SSD Cone<br>• Cassette Power<br>Cable<br>• Cassette Data Cable<br>• Control Unit Power<br>Cable<br>• Connector Covers<br>• Instructions for Use<br>• Case | • Cassette<br>• Control Unit<br>• Emitter<br>• Collimation Pucks<br>• SSD Cone<br>• Cassette Power<br>Cable<br>• Cassette Data Cable<br>• Control Unit Power<br>Cable<br>• Connector Covers<br>• Instructions for Use<br>• Case | Identical | ### Table 5-2: Device Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### AiLARA Software The purpose of this Traditional 510(k) is to update the Micro C Medical Imaging System, M01 software to include two additional modes of use referred to as AiLARA is a static artificial intelligence (AI) based algorithm in the updated software. AiLARA adds two additional modes for the M01 device: Single AiLARA and Serial AiLARA. In these modes, the device determines and recommends a power setting and an exposure time for the X-ray without user input. This mode may help ensure that a clinically relevant image is taken and reduce overexposures and retaking of images. The Micro C software, including the new AiLARA algorithm, has a Moderate level of concern per with Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005); software developmentation was provided in accordance with the guidance. There was no change to the Micro C software level of concern with the addition of the AiLARA algorithm. The software development lifecycle followed IEC 62304:2015, Medical device software – Software life cycle processes. Risk analysis to address the new algorithm was performed in accordance with ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices. {9}------------------------------------------------ ### Section 5 510(k) Summary ### Non-Clinical Performance Data Testing specific to the Micro C software with AiLARA modes was performed and included with the 510(k) submission: | Performance Test | Description | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AiLARA Algorithm<br>Verification | AiLARA's full development dataset was split into a training set (80% of<br>the data) and a testing set for algorithm verification (20% of the data)<br>per Good Machine Learning Practices as outlined in FDA's Proposed<br>Regulatory Framework for Modifications to Artificial<br>intelligence/Machine Learning (AI/ML) Based Software as a Medical<br>Device (SaMD)(2019). AiLARA's model was trained, and at the end of<br>every epoch, the full testing set was sent into the model and was<br>predicted to show the model's performance on unseen data. The model<br>was able to learn the trend of the training dataset (truth). The mean<br>squared error of the training and verification testing datasets were<br>plotted, and the trend lines showed that the model had learned the<br>general trend present in the data. Both training and testing Mean<br>Squared Error and Mean Absolute Error showed that additional training<br>(epochs) would have no added benefit. | | Software Verification | Software verification was performed to ensure the updated Micro C<br>software met system-level software requirements. Software outputs<br>met the expected result in all cases, with no anomalies found. | | Image Quality Validation<br>Study | An image quality study validation dataset was collected after the<br>AiLARA algorithm was frozen, finalized, and transferred to the Micro C<br>device. This validation set was completely independent of the algorithm<br>training and verification testing set. The emitter can move freely in<br>space (not attached to the detector), therefore the validation images<br>were collected with independent inputs that the algorithm had not<br>seen previously. The independent inputs were achieved by taking<br>images of phantoms at different emitter orientations and angles<br>(geometries). The validation dataset included images taken from ankle,<br>elbow, hand, foot, knee, toe, and wrist phantoms; each phantom was<br>captured at multiple distinct SIDs that spanned the full device SID range<br>of 20 cm to 45 cm. Additionally, each phantom view/SID combination<br>was captured at multiple orientations. Once the validation images were<br>collected, the images were reviewed and rated by board certified<br>radiologists and an orthopedic surgeon. All images were determined to<br>be diagnostically and clinically relevant. | | Radiation Dose Testing | AiLARA technique and dose evaluation testing was performed to<br>evaluate AiLARA mode's radiation outputs as compared to diagnostic<br>reference levels from literature, to ensure an acceptable amount of<br>radiation was delivered. Additionally, AiLARA's dose outputs from the<br>auto-selected techniques were compared to the predicate device's<br>manual mode dose outputs that result from the techniques<br>recommended in the Instructions for Use. Results showed that all<br>AiLARA dose values were below the established Diagnostic Reference | | Radiation Dose Testing on<br>Small/Pediatric Anatomies | Levels (DRLs) and there was no statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses.<br>Testing was conducted to evaluate AiLARA's radiation outputs for small size extremity anatomies (representing low thicknesses seen for small patients, especially pediatrics) as compared to diagnostic reference levels from literature to ensure an acceptable amount of radiation was delivered. This study also included recording dose outputs at different Source to Image Distance (SID) and emitter orientation configurations to ensure doses are consistently acceptable at various emitter orientations and small anatomy thicknesses. Results showed that all AiLARA dose values were below the established Diagnostic Reference Levels (DRLs) for small size anatomies, and doses were similar among captures for each orientation within the same target thickness and SID category. | | Usability Evaluation | A usability evaluation was performed for the addition of the AiLARA modes for single radiography and serial radiography (DDR) imaging to ensure the Micro C Medical Imaging System, M01 has acceptable use-related risks and effectiveness during use. The study included 15 participants who were licensed to perform x-ray procedures and had previous experience operating x-ray devices. All the identified critical use tasks were completed with a passing result by 100% of participants. The usability evaluation was performed in accordance with IEC 62366-1:2020, Medical devices - Part 1: Application of usability engineering to medical devices and Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (2016) | #### Table 5-3: Non-Clinical Performance Data {10}------------------------------------------------ In addition, the following specific FDA guidance documents were utilized in the device development to ensure the safety of this device for both the operators and patients: - Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards (2019) ● - Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (2016) - Radiation Safety Considerations for X-ray Equipment Designed for Hand-held Use (2008) - Pediatric Information for X-ray Imaging Device Premarket Notifications (2017) # Clinical Performance Data Non-clinical data generated using imaging phantoms representative of the intended patient populations was sufficient to support the updates to the Micro C device software; no clinical studies were performed. The determination of substantial equivalence is not based on an assessment of clinical performance data. # Conclusion The Micro C Medical Imaging System, M01 is identical in physical design to the legally marketed predicate device. The updated software is acceptable as demonstrated by the performance data and does not raise different questions of safety and effectiveness.