(28 days)
The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.
Access Breast Coil 4/SMS is a 4-channel, phased array breast coil optimized for parallel imaging of the chest wall, breast, and axillary tissue. This device is a dual purpose coil, offering both diagnostic imaging and flexibility in interventional access. The coil's open design allows for flexibility in performing interventional procedures with lateral, medial and cranial-caudal access.
The design of the Access Breast Coil 4/SMS focuses on patient ergonomics, allowing for enhanced comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest, armrest and torso pad, help to relieve pressure on the sternum and provide customized patient positioning during the acquisition of diagnostic and interventional breast MR1 studies.
The coil consists of 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 rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength.
The bilateral, open breast coil design offers optimized imaging capabilities and maximum access to aid the physician in localization of lesions during interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Acceptance Criteria and Study for Access Breast Coil 4/SMS
This document describes the acceptance criteria and the study that demonstrates the Access Breast Coil 4/SMS meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Access Breast Coil 4/SMS does not explicitly state quantitative acceptance criteria or a dedicated performance study with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are inferred from the comparison points used to establish substantial equivalence, and the "reported device performance" is a qualitative statement of its comparability.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Intended Use: Produce diagnostic and interventional images of the breast, chest wall, and axillary tissues interpreted by a trained physician. | Meets intended use. "The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) to produce diagnostic and interventional images of the breast, chest wall and axillary tissues that can be interpreted by a trained physician." |
| Regulatory Classification: Class II, Magnetic Resonance Diagnostic Device (Product Code: 90 MOS). | Meets regulatory classification. |
| Technology/Design: | |
| - Function: Receive-only RF coil. | "Both breast coils are designed as receive-only RF coils..." (compared to predicate). |
| - Channels: 4-channel phased array. | "The Access Breast Coil 4/SMS and the predicate device are 4-channel, phased array coils..." |
| - Imaging Capabilities: Supports bilateral and unilateral imaging. | "...that allow bilateral and unilateral imaging of the breast." (compared to predicate). |
| - Compatibility: Designed for use with Siemens 1.5T MRI systems. | "Compatible with Siemens 1.5T MRI systems." and "The Access Breast Coil 4/SMS also is designed for use with the Siemens 1.5T MR scanners." |
| - Open Design: Open coil design to optimize imaging and allow various access. | "Both of these breast coils have an open coil design to optimize imaging of breasts of various sizes." |
| - Interventional Access: Lateral access. | "The Access Breast Coil 4/SMS is designed to allow for lateral, medial and cranial-caudal access to the breast." (Exceeds predicate's lateral-only access). |
| Performance (Qualitative): Provides images comparable to the predicate device. | "The Access Breast Coil 4/SMS provides images comparable to the predicate devices." |
| Safety: Potential hazards studied and controlled (risk analysis, test/design considerations, V&V). | "The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific clinical test set with a particular sample size for demonstrating performance. The submission relies on a comparison to a legally marketed predicate device (MRI Devices Corporation's Model OBC-63 Breast Array Coil, K022488) to establish substantial equivalence.
Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Since no specific clinical test set is described, there is no information provided regarding the number or qualifications of experts used to establish a ground truth.
4. Adjudication Method for the Test Set
As there is no described clinical test set, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Its focus is on demonstrating substantial equivalence of the device's technical specifications and intended use to a predicate device, rather than measuring human reader improvement with or without AI assistance. The device is an RF coil, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the Access Breast Coil 4/SMS is an RF coil, a hardware component for an MRI system, not a standalone algorithm. Its performance is inherent in the image quality it delivers, which is then interpreted by a human physician.
7. Type of Ground Truth Used
Given that the submission relies on substantial equivalence to a predicate device and there is no described clinical performance study, there is no mention of a specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" implicitly assumed is the established performance and safety of the legally marketed predicate device.
8. Sample Size for the Training Set
The provided 510(k) summary does not describe a training set as this is a hardware device (an RF coil) and not a machine learning or AI-driven diagnostic system that requires training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described, this point is not applicable.
§ 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.