(25 days)
The Liberty 5000 Breast Coil with Disposable Biopsy Plates is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 5000 Breast Coil with Disposable Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed for use with the 0.3T Airis MRI scanner manufactured by Hitachi Medical Systems.
The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed for use with the Hitachi Airis II 0.3T scanner.
The indications for use are the same as for standard imaging:
The Airis II 0.3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Liberty 5000 Breast Coil with Disposable Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Liberty 5000 Breast coil with Disposable Biopsy Plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
The provided text describes a 510(k) premarket notification for a medical device, the "Liberty 5000 Breast Coil with Disposable Biopsy Plates." This submission is based on substantial equivalence to a predicate device, rather than a de novo clinical study establishing new safety and effectiveness. Therefore, the information requested about acceptance criteria, detailed study design, and performance metrics in the context of a new efficacy study might not be directly applicable or available in this document.
However, based on the principle of substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The "study" that proves this involves comparing the new device's features, intended use, and technical characteristics to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or image quality scores) for a new clinical study are not provided. Instead, the acceptance criteria are satisfied by demonstrating similarity to the predicate device.
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Breast Imaging for diagnostic purposes, with biopsy access. | Similar to predicate: Intended Use for breast imaging for diagnostic purposes, with a biopsy plate that allows breast access. (K022007) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate: Identical to routine MRI imaging. (K022007) |
| Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate, and Delrin. | Similar to predicate: Uses similar materials. (K022007) |
| Coil Design: Receive-only phased array. | Similar to predicate: Receive-only phased array design. (K022007) |
| Decoupling mechanism: RF Chokes with Switching Diodes. | Similar to predicate: RF Chokes with Switching Diodes. (K022007) |
| Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, non-conductive housing. | Similar to predicate: Does not transmit RF power; decoupling isolates coil elements from RF fields; coil elements and circuitry are enclosed in a non-conductive housing. (K0222007) |
| Radio Frequency Absorption: Receive-only coil, SAR algorithm limits power deposition. | Similar to predicate: Coil is a receive-only coil; power deposition during imaging is limited by SAR algorithm. (K022007) |
| Formation of Resonant Loops: Decoupling isolates coil elements, cable length/stiffness prevents looping. | Similar to predicate: Decoupling isolates coil elements; length of cable and stiffness does not permit looping. (K022007) |
| Compatibility: Designed for use with the 0.3T Airis MRI scanner. | Specified: Designed for use with the 0.3T Airis MRI scanner (Hitachi Medical Systems). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of a new, independent study to establish safety and effectiveness. The comparison is made to a legally marketed predicate device (K022007) by comparing technical and functional characteristics. Therefore, there is no specific sample size or data provenance provided for a test set for a new study. The "data provenance" for the comparison is regulatory documentation of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As explained above, no independent test set with expert-established ground truth was created for this 510(k) submission based on the provided text. The assessment relies on a comparison to the established safety and effectiveness of a predicate device.
4. Adjudication Method for the Test Set
Not applicable. There was no independent test set requiring adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The document relies on substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical MRI coil accessory, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. Its performance is integrated with the MRI scanner and human interpretation.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance of this device is its substantial equivalence to a legally marketed predicate device (Liberty 5000 Breast Coil with Disposable Biopsy Plate, K022007), which has already been determined by the FDA to be safe and effective. This is achieved by demonstrating that the new device has the same intended use, indications for use, technological characteristics, and performance principles as the predicate.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve an AI/algorithm with a training set.
§ 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.