(139 days)
HeartNavigator is a tool to assist the user with the treatment of structural heart diseases using minimal invasive interventional techniques. In addition to the conventional live fluoroscopy it provides the user with tools to plan and guide the procedure using 3D image data.
The HeartNavigator software tool is intended to be used in combination with the primary predicate device Allura X-ray system (K130638) to assist cardiac surgeons and interventional radiologists with the planning and treatment of structural heart diseases using minimal invasive interventional techniques. In addition to conventional live fluoroscopy HeartNavigator provides the user with tools to plan and guide the procedure using 3D image data; by enabling the use of previously acquired DICOM cardiac CT data of the patient in conjunction with the X-ray image data from the Allura X-ray system. While HeartNavigator Release 1.0 (K111245) and Release 2.0 share the same technological characteristics, HeartNavigator Release 2.0 offers enhancements to existing functions, i.e., (1) automatic anatomical distance measurements, and (2) tracking movements of the table and L-arm of the connected Allura X-ray system during live guidance. The modifications represented by HeartNavigator Release 2.0 do not affect the safety and effectiveness of the device.
Here's a summary of the acceptance criteria and the study details for the HeartNavigator Release 2.0 based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list specific quantitative "acceptance criteria" in a table format with corresponding "reported device performance" metrics related to the device's diagnostic or clinical accuracy. Instead, it states that "The test results demonstrate that HeartNavigator Release 2.0 meets the acceptance criteria, and is adequate for its intended use."
The performance data mentioned is more about adherence to international standards and internal verification/validation processes.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| General Performance | "Meets the acceptance criteria, and is adequate for its intended use." |
| Regulatory Standards | Conforms to: |
- IEC 62366 (Usability Engineering)
- IEC 62304 (Medical Device Software Life Cycle)
- ISO 14971 (Risk Management)
- NEMA PS 3.1-3.2 (DICOM Set) |
| Equivalence to Predicate | "Performs as well or better than the secondary predicate device HeartNavigator Release 1.0 (K111245)." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" and its sample size for evaluating the device's clinical performance. The performance data section refers to "Non-clinical verification and validation tests" which were likely internal engineering and software tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a clinical study involving human experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on substantial equivalence based on non-clinical performance and internal verification/validation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The document describes HeartNavigator as a "tool to assist the user" and "intended to be used in combination with the primary predicate device Allura X-ray system." This indicates it's an assistive device meant for human-in-the-loop use. There is no information provided about standalone algorithm performance without human interaction.
7. Type of Ground Truth Used:
For the "non-clinical verification and validation tests," the ground truth would have been established by the requirement specifications themselves (e.g., software functions performing as designed, calculations being accurate). There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used for the performance evaluation described.
8. Sample Size for the Training Set:
Not applicable. The description of HeartNavigator Release 2.0 does not suggest it is a machine learning or AI-based device that would require a "training set" in the context of typical AI device development. The enhancements are described as "automatic anatomical distance measurements, and (2) tracking movements of the table and L-arm," which can be rule-based or algorithmic without extensive machine learning training data.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set is indicated.
§ 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.