(23 days)
The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.
The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
The 3.0T 16 Channel Brain Spine () Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text describes a 510(k) premarket notification for a medical device, specifically a "3.0T 16 Channel Brain-Spine Array Coil". However, it does not explicitly detail the acceptance criteria or a comprehensive study report that proves the device meets specific performance criteria.
The document states: "Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria." but does not provide the criteria themselves or the results of the testing beyond a general statement of "substantial equivalence".
Therefore, I cannot provide the requested information for the following sections based on the input:
- A table of acceptance criteria and the reported device performance: The document mentions "predetermined acceptance criteria" but does not list them or report specific performance metrics against them.
- Sample sized used for the test set and the data provenance: No information is provided about the sample size or data origin for any testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
- 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: This study type is not mentioned or implied.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a hardware device (MRI coil) and not an AI algorithm, this type of study is not applicable and not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
- The sample size for the training set: Not applicable for this type of device and study.
- How the ground truth for the training set was established: Not applicable for this type of device and study.
Key takeaway from the provided text:
The document focuses on substantiating the claim of "substantial equivalence" to a predicate device (USA Instruments 3.0T 8 Channel Neurovascular Array coil, K032618) rather than detailing a specific performance study with explicit acceptance criteria. The modifications primarily involve increasing receive channels and integration for improved workflow and patient coverage, which are likely validated through technical engineering tests for signal quality, safety, and compatibility, rather than clinical efficacy studies with ground truth establishment in the traditional sense of diagnostic algorithms. The FDA review also confirms substantial equivalence, allowing the device to be marketed.
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NOV - 9 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
- Magnetic Resonance Imaging Accessory 1. Device Name: 3.0T 16 Channel Brain-Spine () Array Coil 2. Proprietary Name: Class II 3. Classification: 4. Establishment Registration #: 1529041 USA Instruments, Inc. 5. Manufacture Facility Location: 1515 Danner Drive Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422. No applicable performance standards have been issued under 6. Performance Standard: Section 514 of the Food, Drug and Cosmetic Act. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-7. Intended Use: only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems. The 3.0T 16 Channel Brain Spine () Array Coil is a multi-8. Device Description: element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength. 3.0T Brain / Spine Array 9. Marketed Device: The 3.0T Brain / Spine Array is a modification of the existing 10. Comparison with Predicate: cleared USA Instruments 3.OT 8 Channel Neurovascular Array coil (K032618) with the main difference being the physically integration of the antenna and shape of the Premier III Linear Phased Array CTL Spine Coil with the antenna and shape of the Millennium 9000 Phase Array Neurovascular coil. The integration increases the number of receive channels to 16 to make it compatible with the GE Healthcare Signa Excite 3.0T Magnetic Resonance Scanners. Both coils included spine
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imaging in their indications, but this modification improves user workflow by allowing more comprehensive patient coverage with a single coil.
- Summary of Studies:
Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria.
Conclusion:
It is the opinion of USA Instruments that the 3.07 Brain / Spine Array is substantially equivalent to the USA Instruments 3.0T 8 Channel Neurovascular Array coil (K032618) Usage of the USA Instruments 3.0T Brain / Spine Array does not result in any new potential hazards.
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Public Health Service
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert B. Smith Quality Assurance/ Regulatory Affairs Manager USA Instruments 1515 Danner Drive AURORA OH 44202
K052916 Re.:
Trade/Device Name: 3.0T 16 Channel Brain-Spine (Neurovascular) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 12, 2005 Received: October 17, 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 registrations, 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 advices 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 he Act or any Federal statues 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.
NOV - 9 2005
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to begin manteling of substantial equivalence of your device to a legally premaired noutication: "The PDF maing of sailing or 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 If you desire spective advice for your derroo on 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 Also, please note the regulation entires on your responsibilities under the Act from the 807.97). Tou may obtain other general massage.
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):
3.0 T 16-Channel Brain-Spine (Neurovascular) Array Coil Device Name:
Indications for Use
The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801-109)
OR
Over-The-Counter Use
Nancy C. Horton
§ 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.