(60 days)
The Flow 7000 Peripheral Vascular Coil is a receive-only quadrature-phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy, extending from the abdomen to the foot region in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Flow 7000 Peripheral Vascular Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.
The Flow 7000 Phased Array Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the abdominal aorta, peripheral vasculature and soft tissue anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.
Anatomic Regions: Abdominal Vasculature, Peripheral Vasculature and soft tissue Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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 Flow 7000 Peripheral Vascular Coil is a 12 element quadrature, phased array, receive-only coil. The coil consists of two sections: an upper and lower section, which are positioned above and below the patient's body (lower torso and legs). The coil sections which contain the coil elements and accessory coil electronics, is enclosed to prevent any exposure to the patient or environment.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Flow 7000 Peripheral Vascular Coil.
Important Note: The provided document is a 510(k) submission for a medical device (an MRI accessory coil). This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical study proving its independent performance against pre-defined acceptance criteria in the way one would for a novel AI algorithm or drug. Therefore, many of the typical acceptance criteria and study elements requested will not be present in this context.
Acceptance Criteria and Device Performance for Flow 7000 Peripheral Vascular Coil (MRI Accessory)
As this is a 510(k) submission for an MRI accessory coil, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, indications for use, safety, and technological characteristics. The "study" proving this involves a direct comparison to these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated through Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | |
| Imaging of vasculature and tissue extending from the torso to the feet. | Meets: Identical Intended Use as the Predicate Device: Peripheral Vascular Coil, Medical Advances Inc. (K964813) - "Imaging of vasculature and tissue extending from the torso to the feet." |
| Indications for Use | |
| Identical to routine MRI imaging (abdominal aorta, peripheral vasculature, soft tissue anatomy), compatible with GE MRI's Signa 1.5T scanner. | Meets: Identical Indications for Use as the Predicate Device: Peripheral Vascular Coil, Medical Advances Inc. (K964813) - "Identical to routine MRI imaging" (specifically for abdominal aorta, peripheral vasculature, and soft tissue anatomy, compatible with GE MR's Signa 1.5T scanner). The fundamental indications for MR imaging are also stated as "distribution of protons exhibiting NMR signal," "depend upon NMR parameters," and "display the soft tissue structure of the head and whole body," yielding diagnostic information when interpreted by a trained physician. |
| Coil Material | |
| Flame Retardant ABS/PVC Plastic alloy, Flame retardant Polyurethane Plastic, Flame retardant Vinyl fabric. | Meets (Similar to existing materials): Compared to: Profile 7000 Volume Neck Coil, USA Instruments (K964531); Leo 7000 Quadrature Knee Coil, USA Instruments (K971246); General Purpose Flex Coil, Picker International (K944469). The materials used are standard for MRI coils and have established safety profiles. |
| Coil Design | |
| Receive-only phased array design. | Meets (Similar to existing designs): Compared to: Insight 7000 Phased Array Torso Coil, USA Instruments (K972340); Phased Array C/T/L Spine Coil, USA Instruments (K980157). The receive-only phased array design is a well-established and safe design for MRI coils. |
| Decoupling | |
| RF Chokes with Switching Diodes. | Meets (Similar to existing methods): Compared to: Insight 7000 Phased Array Torso Coil, USA Instruments (K972340). This is a standard method for decoupling in MRI coils. |
| Prevention of RF Burns | |
| Does not transmit RF Power, Decoupling isolates coil elements from RF fields, Coil elements and circuitry enclosed in non-conductive housing. | Meets (Safety features are standard): Compared to: Insight 7000 Phased Array Torso Coil, USA Instruments (K972340). These are fundamental safety design principles for receive-only MRI coils to prevent RF-induced heating and burns. The device's receive-only nature is a primary safety feature. |
| Radio Frequency Absorption | |
| Coil is a receive-only coil and does not transmit RF power. | Meets (Inherently safe design): Compared to: Insight 7000 Phased Array Torso Coil, USA Instruments (K972340). As a receive-only coil, it does not contribute to SAR (Specific Absorption Rate) heating of the patient. This characteristic is inherently safe regarding RF absorption. |
| Formation of Resonant Loops | |
| Decoupling isolates coil elements from RF fields, length of cable and stiffness does not permit looping. | Meets (Safety features are standard): Compared to: Insight 7000 Phased Array Torso Coil, USA Instruments (K972340). Design considerations (decoupling, cable length/stiffness) are implemented to prevent the formation of resonant loops which could lead to unsafe heating. |
Study Details (Relevant to 510(k) Substantial Equivalence)
Given the nature of a 510(k) for an MRI accessory, a "study" in the traditional sense of a clinical trial with specific endpoints and statistical power calculations is not typically performed or required in the document. Instead, the "study" is a comparison and justification of equivalence to predicate devices based on design and safety characteristics.
Here's how the requested information maps to this type of submission:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable in the provided text. There is no "test set" of patient data or images described for evaluating the coil's performance in a clinical study. The evaluation is based on engineering design, material specifications, and comparison to already approved predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No expert review of a test set is documented. The "ground truth" for a 510(k) submission for a device like this is primarily regulatory acceptance of the safety and performance features as equivalent to existing devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is mentioned.
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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 device is an MRI coil, not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an MRI coil, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k), the "ground truth" for demonstrating safety and effectiveness is the established safety and efficacy profile of the identified predicate devices. The new device's design, materials, and functional principles are compared against these predicates to show that it raises no new questions of safety or effectiveness.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or data-driven model development. Its development is based on engineering principles and existing MRI technology.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of the 510(k) Process for this device:
The "study" for the Flow 7000 Peripheral Vascular Coil is a comparative analysis demonstrating that it is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway that allows new devices to be marketed without requiring entirely new clinical trials if they can be shown to be as safe and effective as existing products.
The key aspects of this demonstration are:
- Identical Intended Use and Indications for Use to the primary predicate (Peripheral Vascular Coil, Medical Advances Inc., K964813).
- Similar (or equivalent safe) Technological Characteristics in terms of coil material, design, decoupling mechanisms, and fundamental safety principles (e.g., receive-only, prevention of RF burns, prevention of resonant loops) as compared to various other predicate MRI coils.
The FDA's letter states: "We have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This confirms that the manufacturer successfully demonstrated equivalence, which is the "acceptance criteria" for a 510(k) submission.
§ 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.