(17 days)
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
The USA Instruments 1.5T 12 Channel Torso Coil is a 12- element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. This coil designed for use with the 1.5T Signa Excite MRI scanner, manufactured by General Electric Healthcare. The coil will be available with different connector configurations depending on the configuration of the scanner it will be used with.
The provided text describes a medical device, a Magnetic Resonance Imaging Accessory (1.5T 12 Channel Body Array), and its 510(k) premarket notification. However, the document does not contain detailed information about the specific acceptance criteria or the study that proves the device meets those criteria in the way typically expected for performance claims of AI/ML-based medical devices.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores for specific conditions) | Not explicitly stated. The document only mentions "Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria." These criteria are not detailed. |
| Safety (e.g., no new significant hazards) | "Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards." |
| Substantial Equivalence to Predicate Device | "It is the opinion of USA Instruments that the 1.5T 12 Channel Body Array is substantially equivalent to the GE Healthcare 1.5T 8 Channel Torso Coil (K031209)." |
Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Not specified. The document mentions "Testing was performed," but provides no details about the size or nature of the test set, nor its provenance (country of origin, retrospective/prospective). This device is a hardware component (MRI coil), not an AI/ML algorithm that processes images, so a traditional "test set" with "ground truth" labels for diagnostic performance might not be applicable in the same way. The testing would likely focus on engineering performance, image quality, signal-to-noise ratio, safety, and compatibility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Given that this is a hardware device (MRI coil) and not an AI-based diagnostic tool, traditional "ground truth" and expert consensus for diagnostic accuracy are not the primary focus of the performance evaluation described. The "acceptance criteria" likely relate to physical and electrical performance, image quality metrics, and safety.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As there's no mention of a diagnostic performance study requiring expert review and adjudication for ground truth, this information is not provided.
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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:
- No. This device is an MRI coil, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described. The comparison is between the new 12-channel coil and an existing 8-channel coil.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (MRI coil), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified in a diagnostic sense. For a hardware device like an MRI coil, the "ground truth" for its performance evaluation would typically involve objective measurements of signal-to-noise ratio, uniformity, coverage, artifact levels, safety parameters (e.g., SAR, heating), and image quality assessments against established engineering standards or industry benchmarks. These are not explicitly detailed in the summary.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this hardware device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this hardware device.
Summary of the device's "study" per the provided text:
The "Summary of Studies" section (item 11) states: "Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria." The device is considered "substantially equivalent" to a predicate device (GE Healthcare 1.5T 8 Channel Torso Coil, K031209), primarily due to modifications in the number of elements (12 vs. 8) and coil connector design. The conclusion explicitly states that "Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards." This strongly suggests that the evaluation focused on engineering performance, safety, and compatibility, rather than a diagnostic accuracy study typically associated with AI/ML devices.
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OCT 7 - 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | 1.5T 12 Channel Body Array |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc. (A GE company)1515 Danner Drive,Aurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have been issued underSection 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The USA Instruments 1.5T 12 Channel Body Array is intended tobe used in the abdomen, pelvis and chest regions for 2D and 3DMagnetic Resonance imaging and Parallel body imaging. |
| 8. Device Description: | The USA Instruments 1.5T 12 Channel Torso Coil is a 12-element coil with integrated preamplifiers that providesoptimized geometry for parallel imaging. The coil is designed toprovide imaging of the abdomen, pelvis and chest regions. Thiscoil designed for use with the 1.5T Signa Excite MRI scanner,manufactured by General Electric Healthcare. The coil will beavailable with different connector configurations depending onthe configuration of the scanner it will be used with. |
| 9. Marketed Device: | 1.5T 12 Channel Body Array |
| 10. Comparison with Predicate: | The 1.5T 12 Channel Body Array is a modification of the existingcleared GE Healthcare 1.5T 8 Channel Torso Coil (K031209), withthe main difference being the separation of the 12 individualelements into separate channels and a redesign of the coilconnector to make it compatible with magnetic resonance scannersthat have more then an 8 channel receive chain. |
| 11. Summary of Studies: | Testing was performed to demonstrate that the designmodifications to the 1.5T 12 Channel Body Array meetpredetermined acceptance criteria. |
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Conclusion:
It is the opinion of USA Instruments that the 1.5T 12 Channel Body Array is substantially equivalent to the GE Healthcare 1.5T 8 Channel Torso Coil (K031209). Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards.
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OCT 7 - 2005
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert B. Smith Ouality Assurance/Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K052584 Trade/Device Name: 1.5T 12 Channel Body Array
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 16, 2005 Received: September 20, 2005
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics nedicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you atter Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE
510(k) Number (if known): K052584
Device Name: 1.5T 12 Channel Body Array
Indications for Use:
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801-109) OR
Over-The-Counter Use_
David h. Segrom
510(k) Num
§ 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.