(101 days)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems with bFFE-XD, IRIS Zoom, MEGA, SENC, and SyntAc software features are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) MR systems. The systems and aforementioned software features of the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018) and the legally marketed reference devices Ingenia Elition S and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S and Ingenia Ambition X (K180479, 08/03/2018). This submission includes the software modifications below for the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, there are no hardware changes: 1. bFFE-XD 2. IRIS Zoom 3. MEGA 4. SENC (Spiral Cardiac) 5. SyntAc (MDME)* * This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems. The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems submission also includes minor changes to the existing software features listed below since the clearance of the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018): 1. VAPOR 2. sLASER 3. Spiral Brain 4. 3D Non-selective 5. Diffusion XD TSE 6. 2KDTI 7. Advanced diffusion gradient control 8. K-t SENSE 9. Cardiac ZOOM 10. Retrospective EPI 11. mFFE Echo Summation* 12. Contrast Card* 13. Autostart* * This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems. The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. MRE (K140666) 5. mDIXON XD (K143128) 6. O-MAR K143253 7. MultiBand SENSE (K143606) 8. 3D APT (K172920) 9. Ingenia Coils, see Appendix 011
This Philips K183063 510(k) premarket notification describes new software features for their Ingenia MR Systems (Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition models). The submission states that no clinical study was required to demonstrate substantial equivalence to the legally marketed predicate device (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079)). Therefore, the acceptance criteria and study details you requested for an AI/CAD-like device are not directly applicable in this context.
This submission focuses on non-clinical performance data (verification and validation tests) to prove that the proposed new software features of the MR systems meet acceptance criteria and are adequate for clinical use, and are substantially equivalent to the predicate device.
Here's a breakdown of the information provided within the context of a general medical device submission (even though it's not specifically an AI/CAD study):
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/CAD performance study, there's no table presenting sensitivity, specificity, or similar metrics. Instead, the "acceptance criteria" are compliance with established international and FDA-recognized consensus standards, and the "performance" is the device's adherence to these standards and its functional capabilities.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with International and FDA-recognized Consensus Standards (e.g., IEC, NEMA, ISO) | The proposed Ingenia MR Systems comply with: |
| • IEC60601-1 Edition 3 | |
| • IEC60601-1-2 Edition 4 | |
| • IEC60601-1-6 Edition 3 | |
| • IEC62366-1 Edition 1 | |
| • IEC60601-1-8 Edition 2 | |
| • IEC60601-2-33 Edition 3 | |
| • IEC 62304 Edition 1 | |
| • NEMA MS-1 2008 | |
| • NEMA MS-4 2010 | |
| • NEMA MS-8 2008 | |
| • NEMA PS 3.1-PS 3.20 | |
| • ISO 14971 Edition 2 | |
| Compliance with Device-Specific Guidance Documents | Complies with "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (Nov 18, 2016 – document 340) |
| Compliance with Software Guidance Documents | Complies with "Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005 – document 337) |
| Adequacy for Intended Use | Non-clinical verification and validation tests demonstrate that the proposed systems meet acceptance criteria and are adequate for their intended use. |
| Safety and Effectiveness Substantial Equivalence to Predicate Device | Demonstrated through non-clinical performance (verification and validation) tests, showing no different questions of safety and effectiveness compared to the predicate. |
Regarding AI/CAD-specific questions:
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI/CAD study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established for an AI/CAD test set.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was conducted or required.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is describing new software features for an MR system, not a standalone algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/CAD study. Ground truth in this submission refers to the established standards and specifications verified through non-clinical testing.
- 8. The sample size for the training set: Not applicable. There is no mention of an AI model being trained with a dataset.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the Document:
The document states: "The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
The device's performance is demonstrated through compliance with a comprehensive list of international and FDA-recognized consensus standards (e.g., IEC, NEMA, ISO standards for medical electrical equipment, quality management systems, and specifically MR devices) and relevant FDA guidance documents. Non-clinical verification and validation tests were performed to confirm that the new software features function as intended, meet their specifications, and manage risks appropriately, thus demonstrating safety and effectiveness without requiring clinical data.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.