(42 days)
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface. (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system.
The Innova IVUS is offered as an option for Innova 2121 IQ, Innova 3131 IQ (cleared under K060259), Innova 4100 (cleared under K033244), Innova 3100 (cleared under K031637), Innova 2100 IQ (cleared under K050489), Innova 4100 IQ and Innova 3100 IQ (cleared under K052412). The Innova Digital Fluoroscopic Imaging Systems are designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane or biplane positioner, a vascular or cardiac table, an X-RAY system and one or two digital detectors. The Innova IVUS option provides enhanced connectivity with third party intravascular ultrasound devices.
The provided text is a 510(k) summary for the GE Healthcare Innova Digital Fluoroscopic Imaging System with the Innova IVUS option. This document primarily describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It does not contain the specific information required to complete the detailed breakdown of acceptance criteria and a study to prove they are met.
Here's why and what's missing:
- Substantial Equivalence: The core of this 510(k) is to demonstrate that the new device (Innova IVUS option) is substantially equivalent to existing marketed devices. This means it doesn't generally require new performance studies against predefined acceptance criteria in the same way a novel device might. Instead, it relies on demonstrating that its technological characteristics, intended use, and safety/effectiveness are comparable to the predicate devices.
- Lack of Performance Data: The document explicitly states: "GE Healthcare considers that Innova IVUS option for Digital Conclusions: Fluoroscopic Imaging Systems... to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova IVUS options are controlled by a risk management plan including: - A hazard identification (Attachment 8) - A risk evaluation (Attachment 8) - Software Development and Validation Process A (Attachment 7)". This suggests that the primary validation strategy focused on risk management and demonstrating equivalence, rather than conducting new performance studies with specific statistical acceptance criteria for imaging performance or diagnostic accuracy.
- Focus on Workflow and Connectivity: The "Innova IVUS option" itself, as described, primarily "simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing patient demographic information... (2) providing a remote access to commonly used IVUS functions... (3) displaying the IVUS Images on the multi-monitor display...". These are functional enhancements, not direct improvements in image quality or diagnostic accuracy of the fluoroscopic system itself. Therefore, the "acceptance criteria" for these features would likely be about proper function and display, not statistical performance metrics against a clinical ground truth.
Therefore, it is not possible to fill out the requested table and answer the questions based on the provided text. The document describes why the device is considered safe and effective (by being substantially equivalent to existing devices) but does not provide details of a study with acceptance criteria and reported performance metrics as if it were a new, de novo device.
§ 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.