(157 days)
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
GE Healthcare IGS interventional x-ray systems are designed to perform monoplane, biplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration). Additionally, in the OR configuration (with an OR Table), these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.
DiscoveryTM IGS 7 OR, DiscoveryTM IGS 7, InnovaTM IGS 6, InnovaTM IGS 5 are the GE Healthcare IGS interventional X-Ray system product models.
Each product model is designed with a set of components that are combined into different configurations for providing specialized interventional x-ray systems. GE Healthcare IGS interventional x-ray system consists of a C-arm positioner (monoplane or biplane), an x-ray imaging table or the interface to the radiologic table, an x-ray tube assembly (per plane), an x-ray power unit with its exposure control unit (per plane), an x-ray imaging chain (including a digital detector and an image processing unit, per plane).
DiscoveryTM IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 740 configuration with a square 41cm digital detector or in IGS 730 configuration with a square 31cm digital detector. These product configurations are declined in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE OR table
Discovery™ IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed with a square 41cm digital detector or with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Discovery™ IGS 7 OR includes a flat table top configuration for Interventional X-Ray imaging and surgery procedures, an optional universal table top (table top with articulated joints) to enable expansion to surgical procedures requiring advanced patient positioning and with X-Ray imaging capabilities. A set of Magnus OR table accessories is included in the compatible configuration.
Innova™ IGS 6 is a biplane system (a dual C-arm positioner, LC and LP gantry) and is provided with an Omega V table. Innova™ IGS 6 is proposed in IGS 630 configuration with a square 31cm digital detector per plane or in IGS 620 configuration with a square 20.5cm digital detector per plane. These product configurations are available in Standard configuration.
Innova™ IGS 5 is a monoplane system (C-arm positioner with LC gantry) and is proposed with a square digital detector of 41cm or 31cm or 20.5cm. These product configurations are available in Standard configuration with Innova-IQ or Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with GE OR table.
The purpose of this Premarket Notification is for 2 changes:
First, a change of the collision management of Discovery™ IGS 7 OR to enable the use of a Neurosurgical head holder (skull clamp). During trauma neck surgery and stereotactic navigation, a gantry collision with the skull clamp could result in patient harm, delayed or halted surgical procedures. The subject of this submission is to introduce a functionality for adapting the collision avoidance model to the geometrical characteristic of the skull clamp and patient position with a guard volume defined and validated by the operator during the procedure preparation phase. During the procedure, the collision avoidance software will slow down and stop gantry and/or table axis to minimize risk of collision of a motorized moving part with the patient head or the skull clamp. In this configuration, the OR table, the Neurosurgical head holder and its support are from third party Medical device manufacturers. As a consequence, there is no mechanical interfaces between these devices and the Discovery™ 7 OR. Those devices are registered and cleared in the US. The Neurosurgical head holder is from Pro Med Instrument manufacturer (K063494). The OR table is the registered Magnus OR
The second change is for a primary technology change, adding an optional wireless footswitch in the examination room to Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7 and Discovery™ IGS 7 OR. It provides identical functionalities as the wired footswitch for the control of X-ray on and off, and for the control of the table top brake release.
Labelling is updated for the enhanced collision management for the use with Neurosurgical head holder and for the wireless footswitch.
This submission describes modifications to existing GE Healthcare IGS interventional X-ray systems (Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™ IGS 7 OR). The changes are primarily:
- Enhanced collision management for Discovery™ IGS 7 OR: This modification allows the use of a Neurosurgical head holder (skull clamp) by dynamically adapting the collision avoidance model.
- Optional wireless footswitch: This change adds a wireless footswitch with identical functionalities to the existing wired footswitch for controlling X-ray on/off and table-top brake release.
The document states that these modifications did not require clinical studies to support substantial equivalence and that the intended use and indications for use remain unchanged from the predicate devices. Therefore, the information typically requested regarding acceptance criteria, device performance, ground truth, and reader studies is not explicitly provided in the context of a new efficacy study. Instead, the study focuses on proving the safety and effectiveness of the modifications through non-clinical means and demonstrating substantial equivalence to the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no new clinical efficacy study was conducted for these modifications, a table of specific clinical acceptance criteria and device performance metrics (e.g., sensitivity, specificity, accuracy) is not applicable or provided. The "acceptance criteria" here are aligned with safety and effectiveness demonstrated through non-clinical testing and adherence to standards.
| Acceptance Criteria (Implied from the study objectives) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Collision Management: | |
| - Avoidance of collision with skull clamp and patient head | - Collision avoidance software successfully slows down and stops gantry/table axis to minimize risk. |
| - Safety and effectiveness with neurosurgical holder | - Identified hazards mitigated; expansion to X-ray and surgical procedures requiring neurosurgical holder is within current indications. |
| Wireless Footswitch: | |
| - Identical functionality to wired footswitch | - Provides identical functionalities as the wired footswitch. |
| - No impact on X-ray imaging performance | - No impact on X-ray imaging performance. |
| - Electrical and software interface unchanged | - Does not change existing electrical or software interface. |
| - No adverse events due to wireless technology (e.g., EMC, coexistence) | - Meets EMC and coexistence testing requirements per "Radio Frequency Wireless Technology in Medical Devices" Guidance. |
| - Compliance with relevant standards (IEC 60601-2-43, IEC 62304, IEC 62366) | - Conformity to 21CFR 1020.30 and 32, and with voluntary standards IEC 60601-2-43:2010, IEC 62304 (2006) and IEC 62366 (2007). |
| - Design inputs, user requirements, and risk mitigations met | - Design verification and validation testing completed with acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data from patients or images is described in this submission for the modifications. The testing was non-clinical (simulated use, usability validation, product verification, safety testing).
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed in-house by GE Healthcare.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no external ground truth establishment for a clinical test set was performed. Usability validation involved "representatives of actual users, with knowledge of the customer needs and clinical applications," but this does not constitute establishing a ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states that the changes "did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted in the context of diagnostic accuracy. The collision avoidance functionality is integrated into the system, and its "performance" was assessed via risk management, simulated use, and verification testing to ensure it functions as intended to prevent collisions. The wireless footswitch is a control mechanism, not an algorithm for image interpretation.
7. The Type of Ground Truth Used
- For Collision Management: The ground truth for collision avoidance was based on engineering specifications, physical constraints, and risk analysis to ensure the system prevents physical contact with the skull clamp and patient. This was verified through simulated use and product verification testing against defined requirements and hazard mitigations.
- For Wireless Footswitch: The ground truth for the wireless footswitch was its functional equivalence to the wired footswitch. This was verified by ensuring identical functionalities and confirming that it did not introduce new safety or performance issues through safety testing (EMC, coexistence) and product verification.
8. The Sample Size for the Training Set
Not applicable. This submission concerns modifications to existing devices and does not describe the development of a new artificial intelligence algorithm that would require a "training set" in the conventional machine learning sense. The collision avoidance logic is likely based on deterministic geometric models and sensor inputs.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no "training set" described for a new AI algorithm.
§ 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.