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510(k) Data Aggregation
(84 days)
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
The Magnetic Resonance (MR) coil is used with a Philips 1.5T MR scanner. A trained physician interprets the diagnostic images (of the anatomy of interest) produced.
The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
The proposed dS TorsoCardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of torso, cardiac, and neck. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.
The proposed dS MSK S 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of wrist, foot-ankle, and elbow. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.
The proposed dS MSK M 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder, knee, hip, foot, and elbow. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.
The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used with the Philips 1.5T MRI Scanners.
The provided text is a 510(k) summary for Philips Healthcare's MR coils. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and fundamental scientific technology. The document explicitly states that no clinical study was required for this submission.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment concerning clinical data. The document indicates that safety and performance were evaluated through non-clinical testing and compliance with various standards.
Here's a breakdown of what the document does contain regarding performance and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria in the sense of quantitative performance metrics for a clinical study with corresponding reported device performance values. Instead, it describes compliance with recognized standards and similarity to predicate devices as the basis for substantial equivalence.
The "performance" is demonstrated through compliance with the following non-clinical testing standards:
| Standard/Guidance | Purpose (As implied by Title) |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements. For Basic Safety And Essential Performance (IEC 60601-1:2012, MOD) | General requirements for basic safety and essential performance of medical electrical equipment. |
| IEC60601-2-33 Ed. 3.2:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | Specific safety and performance requirements for Magnetic Resonance Equipment. |
| IEC60601-1-2 Ed. 4.0:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | Requirements and tests for electromagnetic disturbances (EMC). |
| ISO 14971 Ed. 2.0:2007 Medical devices – Application of risk management to medical devices. | Application of risk management to medical devices. The document states: "There are no risks identified in risk management documentation that require clinical data for the purpose of clinical evaluation." |
| Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" | Biological evaluation of medical devices. |
| IEC 62366 Edition 1.1: 2014-01 Medical devices Application of usability engineering to medical devices | Application of usability engineering to medical devices. |
| NEMA MS 1-2008(R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging | Standard for determining Signal-to-Noise Ratio in diagnostic MRI. (Implied performance characteristic: SNR performance is comparable to predicate, though no numerical values are given). |
| NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images | Standard for determining Image Uniformity in diagnostic MRI. (Implied performance characteristic: Image uniformity is comparable to predicate, though no numerical values are given). |
| NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images | Standard for characterizing phased array coils for diagnostic MRI. (Implied performance characteristic: Coil characteristics are comparable to predicate, though no numerical values are given). |
| NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems | Standard for characterizing RF coil heating in MRI systems. (Implied performance characteristic: RF heating is within acceptable limits and comparable to predicate, though no numerical values are given). |
| Magnetic Resonance (MR) Receive only Coil Performance ● Criteria for Safety and Performance Based Pathway - issued on December 11, 2020 | This is a specific FDA guidance document likely outlining acceptable performance metrics or methods for demonstrating substantial equivalence for MR receive-only coils. The document states the device complies with this. While specific metrics aren't detailed in this summary, the compliance indicates the device met FDA's expectations for performance for this type of device based on non-clinical data. |
The document confirms: "The results of these tests demonstrate that dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T met the acceptance criteria and are adequate for this intended use."
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not a clinical test set with patient data.
3. 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. As no clinical testing/test set was required, there was no need for expert ground truth establishment in this context. The document mentions "A trained physician interprets the diagnostic images (of the anatomy of interest) produced" as part of the Indications for Use, which is standard for MR devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set data requiring adjudication was generated for this submission.
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 device is an MR coil, which is a hardware component for imaging, not an AI software algorithm. No MRMC study was performed as it's not relevant to this device's function or the nature of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (MR coil), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As there was no clinical study evaluating diagnostic performance, no "ground truth" of this nature was established for the purpose of this submission. Device performance was assessed via compliance with engineering and safety standards.
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. This is not an AI/machine learning device.
In summary: The K212864 submission for Philips Healthcare's dS TorsoCardiac 1.5T, dS MSK S 1.5T, and dS MSK M 1.5T MR coils was cleared based on demonstrating substantial equivalence to legally marketed predicate devices. This equivalence was supported by extensive non-clinical performance testing and compliance with various international and FDA-recognized consensus standards for medical electrical equipment, magnetic resonance equipment, electromagnetic compatibility, risk management, biological evaluation, usability, and specific MRI performance characteristics (SNR, uniformity, coil characterization, RF heating). The FDA letter and the 510(k) summary explicitly state that no clinical study was required to prove safety and effectiveness for these devices.
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