(20 days)
The 1.5T Pelvic Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the 1.5T Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.
The MEDRAD 1.5T Pelvic Imaging System Interface Device maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. The device is a receive-only surface coil that interfaces with 1.5T GE Signa EXCITE scanners and MEDRAD 1.5T Endorectal Coils and GE 8- or 12-channel Body Array. It utilizes active and passive decoupling and performs RF signal pre-amplification for the Endorectal Coil.
This document provides a 510(k) summary for the MEDRAD 1.5T Pelvic Imaging System Interface Device, which is a medical device accessory used in Magnetic Resonance Imaging (MRI). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics that would be typical for an AI/ML or diagnostic image analysis device.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from the provided text, as this is a submission for a hardware interface device, not a diagnostic algorithm.
Here's an analysis of the provided information based on your request, highlighting what can and cannot be extracted:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission is for a hardware interface device (an accessory for MRI coils), not a diagnostic algorithm with measurable performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" for such a device are typically related to safety, interoperability, and functional equivalence to a predicate device. The document states that the device "maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no "test set" in the context of diagnostic image data for this hardware device. The comparison is feature-based against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this hardware interface device.
4. Adjudication Method for the Test Set
Not applicable. No test set or expert adjudication is described for this hardware device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for diagnostic performance is irrelevant for this hardware device. The "ground truth" for this submission is effectively the functional specification and performance of the predicate device, against which the new device is compared for equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a hardware device, not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Equivalence (from the document):
The submission demonstrates substantial equivalence by comparing the MEDRAD 1.5T Pelvic Imaging System Interface Device to its predicate, the MEDRAD, INC. 1.5T ATD-T Interface Device (K974438). The comparison table highlights the following:
| Feature | (Predicate) MEDRAD 1.5T ATD-T | (Proposed) MEDRAD Pelvic Imaging System Interface Device |
|---|---|---|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Scanner Interface | 1.5T GE Signa scanners | 1.5T GE Signa EXCITE scanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils, GE 4-channel Torso Array | MEDRAD 1.5T Endorectal Coils, GE 8- or 12-channel Body Array |
| Decoupling | Active and passive | Active and passive |
| RF Signal Pre-Amplification | Performed by the scanner for both the Endorectal Coil and the Torso Array. | Performed by the interface device for the Endorectal Coil (RF output from Body Array is already preamplified). |
| Tuning | Requires tuning to be set in production since ATD-T uses system preamplifier for signal amplification. | Does not require tuning to be set in production since interface device has a preamplifier. |
Conclusion from FDA:
The FDA determined that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to be marketed. This determination is based on the comparison of intended use, operational parameters, labeling, and how the device is used, as outlined in the submission. The key changes, such as the specific GE scanner model (EXCITE) and the pre-amplification location, were deemed not to raise new questions of safety or effectiveness.
§ 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.