(90 days)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.
This document is a 510(k) Premarket Notification from Portavision Medical LLC for their MobileRay Pulse SE Digital Imaging System, demonstrating its substantial equivalence to a predicate device. The information provided heavily focuses on describing the device, comparing its technical specifications to a predicate, and detailing non-clinical bench testing for safety and effectiveness.
Crucially, the document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification." This means that the device's acceptance criteria and the proof of meeting them are not based on human reader studies, ground truth establishment, or clinical performance metrics discussed in an MRMC or standalone study. Instead, the acceptance criteria are met through demonstrating equivalence in technical specifications and successful completion of robust non-clinical bench testing.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding an AI component, MRMC study, ground truth, and expert adjudication, is not applicable to this specific 510(k) submission. This submission is for a conventional X-ray and fluoroscopy system, not an AI-powered diagnostic device.
However, I can extract information related to the device's performance based on the technical comparison and bench testing described. It's important to frame this within the context of technical equivalence rather than AI-driven performance metrics.
Acceptance Criteria and Device Performance (Based on Technical Equivalence and Bench Testing):
Since no clinical or AI-specific performance study was conducted or presented, the "acceptance criteria" here refer to the demonstration of technical equivalence and adherence to safety and performance standards for an X-ray imaging system. The "reported device performance" is a comparison of its technical specifications and safety/EMC test results against established predicate device characteristics and regulatory standards.
| Acceptance Criterion (Demonstrated by Technical Equivalence / Bench Testing) | Reported Device Performance (MobileRay Pulse SE) |
|---|---|
| Indications for Use Equivalence | Intended for use by qualified/trained medical professionals for radiographic, multi-radiographic, and fluoroscopic imaging during diagnostic, surgery, and interventional procedures in healthcare facilities (skull, spinal column, chest, abdomen, extremities). Applicable to all patients except pediatrics, within device limits, performed sitting, standing, prone, or supine. Not for mammography. هذا يتوافق مع الاستخدامات المماثلة للجهاز السائد. |
| Generator Type Equivalence | High frequency Inverter type (Same as predicate). |
| Radiography KV range Equivalence | 40 – 125 KV (Same as predicate). |
| Radiography mA range Equivalence | 20 – 100 mA (Same as predicate). |
| Radiography mAs range Equivalence | 0.8 – 200 mAs (Same as predicate). |
| Indicator Equivalence | Display on workstation monitor (Same as predicate). |
| Collimator Equivalence | Multi-leaf adjustable motorized (Same as predicate). |
| DICOM Compatibility Equivalence | Yes (Same as predicate). |
| Software Functionality Equivalence | Acquiring image, viewing, changing window/level, inverting, lookup table, zoom, pan, noise reduction, patient information, annotation, image rotation, X-ray generator control, DICOM worklist and Send (All same as predicate). |
| Electrical Safety & EMC Compliance | Compliant with EN 60601-1-2 (2015), EN 301 489-1 V2.2.0 (2017), EN 301 489-17 V3.2.0 (2017), IEC 60601-1: 2005 + Corr.1: 2006 + A1: 2012, EN 60601-1: 2006 + A11: 2011 + A1: 2013 + AC:2014 + A12:2014, UNE-EN 60601-1: 2008 + Corr.: 2010 + A11: 2010 + A11: 2012 + AC:2014 + A12:2015. Confirmed by bench testing. Also, digital panels' EMC and Electrical Safety previously submitted (K161942, K161966). |
| Software Validation Adherence | Validated according to FDA Software Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005." |
| Cybersecurity Adherence | Addressed in accordance with: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014)." |
| X-ray Source & Detector Alignment Safety Compliance | Incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). Includes a radiation inhibit safety circuit to prevent or immediately shut down radiation emission if alignment is lost within predetermined tolerances. |
| Automatic X-ray Beam Limiting Device Compliance | Incorporates an automatic X-ray beam limiting device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). |
| X-ray Generator Thermal Stability (for Fluoroscopy) | Modified the cleared generator (K121410) with cooling fans to allow for repetitive exposures (fluoro/pulsed mode). Internal temperature rise measured during operation found to be acceptable. |
Regarding the specific questions about an AI study (which are NOT applicable to this submission):
- Sample size for the test set and data provenance: No test set of clinical images used for performance evaluation (AI or human reader) was mentioned. The "test set" in this context would be the device itself undergoing bench testing.
- Number of experts used to establish ground truth & qualifications: Not applicable. No clinical ground truth was established for performance evaluation.
- Adjudication method for the test set: Not applicable. No clinical test set to adjudicate.
- MRMC comparative effectiveness study: Not applicable. No MRMC study was done, as this is a traditional imaging device, not an AI-assisted one. The document explicitly states "No clinical data is necessary."
- Standalone performance: Not applicable in the context of AI. The device's "standalone" performance is its technical capability to produce X-ray images, which was assessed through bench testing and comparison to predicate technical specifications.
- Type of ground truth used: Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used for performance evaluation.
- Sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The "study" described in this 510(k) submission is a non-clinical bench testing and technical comparison study.
- Objective: To demonstrate the substantial equivalence of the MobileRay Pulse SE Digital Imaging System to a legally marketed predicate device (EcoTron AnyView 500R Fluoroscopic Mobile X-ray System, K160279) and compliance with relevant safety and performance standards.
- Methodology:
- Technical Comparison: Direct comparison of features, specifications (e.g., KV/mA ranges, generator type, software functions), and indications for use between the proposed device and the predicate.
- Bench Testing: Electrical safety and Electromagnetic Compatibility (EMC) testing according to international standards (e.g., EN 60601-1-2, IEC 60601-1). Thermal stability testing for the X-ray generator to ensure safe operation during fluoroscopy. Validation of software according to FDA guidance. Cybersecurity assessment.
- Data Provenance: The data primarily comes from internal company testing and accredited lab testing for standard compliance. This is "prospective" bench testing data rather than retrospective or prospective clinical data. The country of origin for the data generation would be where the manufacturer and testing labs are located (not specified, but implied to be within typical regulatory testing frameworks).
- Conclusion: The submission concludes that the MobileRay Pulse SE is as safe and effective as the predicate device due to similar indications for use, similar technological characteristics, and successful non-clinical bench testing demonstrating compliance with safety and performance standards. The key difference is the use of digital panels versus an image intensifier, and a unique source-to-image receptor alignment technology, but these are deemed "insignificant technological differences" that do not raise new questions of safety or effectiveness.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.