(128 days)
The intended use of the SPINE COIL is to enable the MrOpen K101295 systems designed by Paramed to perform MR scan of the human spine either in the conventional recumbent position or with the patient sitting or standing (weight-bearing). The SPINE COIL inherits the same limitations of the Tomograph. The SPINE COIL enables the MRI System to which it is applied to acquire images of the Spine in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The proposed SPINE COIL is a surface coil aimed to the Spine district. It is characterized by the fact of being flexible. This is done to increase patient comfort.
This document is a 510(k) K123708 Summary for a Spine Coil (03-2016) manufactured by Paramed S.r.l. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The document does not describe a study to prove acceptance criteria in the typical sense of a clinical trial or performance study with diagnostic endpoints. Instead, it focuses on demonstrating technological equivalence and performance characteristics through established engineering measures.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly based on demonstrating that the new Spine Coil performs at least as well as, or is technologically equivalent to, the predicate device in terms of relevant physical and performance characteristics for an MRI coil.
| Acceptance Criteria (Implicit) | Reported Device Performance (Spine Coil 03-2016) | Predicate Device Performance (Flexible coil 03-2015) |
|---|---|---|
| Channels | 4 | 1 |
| Minimum SNR (Overall) | 55 | 65 |
| Minimum SNR for each channel | 40 | n.a. (Not Applicable, as it was a single channel) |
| Examined Anatomy | Spine | Spine |
| Outer Surface Material | Ethylene vinyl acetate copolymer foam | Ethylene vinyl acetate copolymer foam |
| Manufacturer (Outer Surface Material) | Leidel & Kracht | Leidel & Kracht |
Note on SNR: The reported "Minimum SNR" of 55 for the new device is lower than the 65 for the predicate. However, the new device has 4 channels compared to the predicate's 1 channel. In multi-channel coils, the overall SNR can be interpreted differently or combined from individual channels. The addition of "Minimum SNR for each channels" with a value of 40 for the new device suggests that individual channel performance is considered, and the multi-channel design likely contributes to overall image quality or specific functionalities not directly comparable by a single overall SNR number from a single-channel coil. The FDA's acceptance of this submission implies that this difference was sufficiently justified for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a clinical "test set" in the context of a diagnostic performance study. The data provided focuses on the engineering specifications and performance characteristics of the coil itself, rather than diagnostic images from a patient population.
Therefore:
- Sample size: Not applicable as no patient data test set is described.
- Data provenance: Not applicable as it's not patient data. The information is derived from engineering specifications and testing of the device hardware.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No ground truth for a diagnostic test set is mentioned. The "ground truth" in this context would be the demonstrated physical and performance characteristics of the MRI coil itself, verified through engineering tests and measurements.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic test set or adjudication process is described.
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. This is not a software or AI device. It is an MRI coil, a hardware accessory.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not a software or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established engineering specifications and performance metrics of the MRI coil (e.g., number of channels, SNR values, material composition). This is established through:
- Internal device testing and quality control processes by the manufacturer.
- Compliance with relevant international standards for MRI equipment.
- Comparison to the documented specifications of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
Summary of the Study (as described in the 510(k))
The "study" described in this 510(k) summary is not a clinical trial but rather a demonstration of technical and functional substantial equivalence of the new "Spine Coil 03-2016" to existing, legally marketed predicate devices (Paramed MrOpen K101295 Flexible COIL 03-2015 and Paramed MrOpen K101295 General Purpose COIL 03-2010).
The primary evidence presented focuses on:
- Intended Use: The intended use of the new device is the same as the predicate devices, enabling MR scans of the human spine in various positions.
- Technological Characteristics: A comparison table highlights similarities and minor differences. While the new coil has more channels (4 vs 1) and a different minimum overall SNR (55 vs 65), it also introduces a per-channel SNR (40) which is relevant for multi-channel coils. The materials in contact with the patient and the manufacturer of those materials are identical to a predicate device.
- Safety: The document states that no new materials are in contact with the patient and that the coil is not intended for invasive use. Cleaning procedures are also consistent with other coils.
The FDA's letter of April 10, 2013, indicates that based on this information, the device was found to be "substantially equivalent" to the predicate devices for its stated indications for use. This means the device met the regulatory acceptance criteria for market authorization based on its engineering specifications and comparison to an established baseline, rather than through a traditional clinical performance study with patient outcome 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.