(24 days)
The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.
The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123Xe frequency on a 3.0T MRI magnetic field in order to image 129%e nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 1ª3 xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 149Xe in the lungs.
The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
This document describes the XENOVIEW 3.0T Chest Coil (Model 44315-03) and its substantial equivalence to a previously cleared predicate device (Model 44315-01, K212239). The primary difference is the expanded compatibility to include Philips 3T MRI scanners, in addition to the Siemens 3T MRI scanners supported by the predicate.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to conformance with established performance criteria and specific industry standards. The reported "performance" aligns with meeting the requirements of these standards.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Bench Testing | Signal-to-Noise Ratio and Image Uniformity (NEMA MS 6-2008 (R2014)) | Conforms to standard for a flexible, single channel T/R RF coil. |
| Specific Absorption Rate (SAR) (NEMA MS 8-2016) | Conforms to standard for SAR characterization. | |
| RF Coil Heating (NEMA MS 14-2019) | Conforms to standard for RF coil heating characterization. | |
| Electrical Safety | Basic Safety & Essential Performance (IEC 60601-1:2005/(R)2012 and A1:2012) | Conforms to standard. |
| Basic Safety & Essential Performance of MR Equipment (IEC 60601-2-33:2015) | Conforms to standard. | |
| EMC | Electromagnetic Compatibility (IEC 60601-1-2:2020) | Conforms to standard. |
| Biocompatibility | General Biological Evaluation (ISO 10993-1:2018) | Conforms to standard. |
| Cytotoxicity (ISO 10993-5:2009) | Conforms to standard. | |
| Sensitization (ISO 10993-10:2010) | Conforms to standard. | |
| Irritation (ISO 10993-10:2010) | Conforms to standard. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical testing performed on the device itself. Therefore, there is no "test set" in the context of patient data. The testing involves physical devices (XENOVIEW 3.0T Chest Coil) and MRI scanners.
- Sample Size for Test Set: Not applicable as it's not a clinical study involving patient data. The testing was conducted on "the new model of the Chest Coil."
- Data Provenance: Not applicable. The testing was non-clinical (bench testing, electrical safety, EMC, biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a clinical study or a study relying on expert interpretation of diagnostic images. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., NEMA, IEC, ISO) and the physical properties of the device and MRI systems.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication for non-clinical performance and safety testing against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This indicates that no MRMC comparative effectiveness study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a medical accessory (an RF coil for MRI), not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by:
- Established industry standards: NEMA MS, IEC 60601 series, ISO 10993 series. The device's performance against these standards constitutes the "truth" that it is safe and performs as intended.
- Physical and electrical characteristics: The fundamental properties and measurements of the coil (e.g., frequency of operation, SNR, SAR, heating) as measured in a controlled laboratory environment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it.
In summary, the provided document describes the safety and performance verification of an MRI chest coil through non-clinical laboratory testing against established engineering and safety standards, rather than through clinical trials or AI performance evaluations.
§ 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.