(14 days)
The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T 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 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI systems manufactured by GE Medical Systems.
The 1.5T Brain / Spine Array Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine in GE 1.5T MR Imaging systems.
The open design of the 1.5T Brain / Spine Array Coil reduces claustrophobic effects and allows for increased patient comfort. The coil elements are enclosed in a rigid plastic housing. The housing is designed to conform to the patient anatomy. The design of the coil allows for easy positioning of the patient and provides patient comfort.
The mechanical housing of 1.5T Brain / Spine Array Coil consists of four main parts: (1) a main head coil base, (2) a split-top head coil housing (3) a chest coil housing and (4) a T-L Spine housing. The chest coil housing is free floating and it rests on the patient's chest.
The 1.5T Brain / Spine Array Coil has an array of 21 coil elements in the Brain Unit and 8 coil elements in the Spine Unit; The 21 coil elements in the brain unit are Loop elements. Twelve loop coils (L1 to L12) cover the head region. Another four loop coils (L13 to L16) cover the Lower neck and torso regions. Five Loop coils (L17 to L21) cover the upper neck and the chest region. The Spine Unit has an array of four loop coils and four saddle coils which cover the thoracic and lumbar spine regions.
For operation, the 1.5T Brain / Spine Array Coil does not require any change to the software used on the GE Medical Systems Inc. 1.5T MRI system.
The provided text describes a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the 1.5T 16 Channel Brain-Spine Array Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for an AI/ML device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and AI-specific study details (MRMC, standalone performance) cannot be extracted from this document, as it pertains to the approval of an MRI coil, not an AI/ML diagnostic algorithm.
The document indicates that "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria." However, it does not specify these criteria or the results of the testing.
No information regarding acceptance criteria or a study with performance metrics for an AI/ML device is available in the provided text.
Here's a breakdown of why the requested information is absent or not applicable:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Testing was performed to demonstrate that the design modifications... meet predetermined acceptance criteria," but does not list these criteria or the test results.
- 2. Sample size used for the test set and the data provenance: Not provided. This information is relevant for AI/ML device studies, not for the approval of an MRI coil based on substantial equivalence.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for image interpretation is not part of an MRI coil's 510(k) submission based on substantial equivalence.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is for AI-assisted diagnostic devices, not MRI hardware.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. This is for AI/ML device development.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
The submission focuses on the substantial equivalence of the "1.5T 16 Channel Brain-Spine Array Coil" to a legally marketed predicate device (Millennium 9000 Phased Array Neurovascular coil K001870). The changes primarily involve physical integration of components and an increased number of receive channels (to 16) to be compatible with GE Healthcare Signa Excite 1.5T MRI Scanners. The comparison emphasizes improved user workflow and more comprehensive patient coverage. The "Summary of Studies" section vaguely mentions "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria," but no details on these criteria or the study results are provided.
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KD52621
OCT 7 - 2005
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | 1.5T 16 Channel Brain-Spine () Array Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.1515 Danner DriveAurora, 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 1.5T Brain / Spine Array Coil is designed for use with the1.5T MRI system manufactured by GE Healthcare. The coil is forimaging of the brain, cervical spine, soft tissues and vasculatureof the head, neck, upper chest, thoracic and lumbar spine. Thenucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil isdesigned for use with the 1.5T MRI systems manufactured by GEMedical Systems. |
| 8. Device Description: | The 1.5T Brain / Spine Array Coil is a receive-only RF coil, usedfor obtaining diagnostic images of the brain, cervical spine, softtissues and vasculature of the head, neck, upper chest, thoracicand lumbar spine in GE 1.5T MR Imaging systems.The open design of the 1.5T Brain / Spine Array Coil reducesclaustrophobic effects and allows for increased patient comfort.The coil elements are enclosed in a rigid plastic housing. Thehousing is designed to conform to the patient anatomy. Thedesign of the coil allows for easy positioning of the patient andprovides patient comfort.The mechanical housing of 1.5T Brain / Spine Array Coil consistsof four main parts: (1) a main head coil base, (2) a split-top headcoil housing (3) a chest coil housing and (4) a T-L Spine housing.The chest coil housing is free floating and it rests on the patient'schest.The 1.5T Brain / Spine Array Coil has an array of 21 coil elementsin the Brain Unit and 8 coil elements in the Spine Unit; The 21 coilelements in the brain unit are Loop elements. Twelve loop coils(L1 to L12) cover the head region. Another four loop coils (L13 to |
| L16) cover the Lower neck and torso regions. Five Loop coils(L17 to L21) cover the upper neck and the chest region. TheSpine Unit has an array of four loop coils and four saddle coilswhich cover the thoracic and lumbar spine regions. | |
| For operation, the 1.5T Brain / Spine Array Coil does not requireany change to the software used on the GE Medical Systems Inc.1.5T MRI system. | |
| 9. Marketed Device: | 1.5T Brain / Spine Array |
| 10. Comparison with Predicate: | The 1.5T Brain / Spine Array is a modification of the existingcleared USA Instruments Millennium 9000 Phased ArrayNeurovascular coil (K001870) with the main difference being thephysically integration of the antenna and shape of the PremierCTL coil with the antenna and shape of the Millennium 9000Phase Array Neurovascular coil. The integration increases thenumber of receive channels to 16 to make it compatible with theGE Healthcare Signa Excite 1.5T Magnetic ResonanceScanners. Both coils included spine imaging in their indications,but this modification improves user workflow by allowing morecomprehensive patient coverage with a single coil. |
| 11. Summary of Studies: | Testing was performed to demonstrate that the designmodifications to the 1.5T Brain / Spine Array meet predeterminedacceptance criteria. |
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Conclusion:
It is the opinion of USA Instruments that the 1.5T Brain / Spine Array is substantially equivalent to the USA Instruments Millennium 9000 Phase Array Neurovascular coil (K001870) Usage of the USA Instruments 1.5T Brain / Spine Array does not result in any new potential hazards.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert B. Smith Quality Assurance/Regulatory Affairs Manager USA Instruments, Inc. 1515 Danner Road AURORA OH 44202
Re: K052621
Trade/Device Name: 1.5T Brain/Spine Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 19, 2005 Received: September 23, 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) This letter will and w yourse of substantial equivalence of your device to a legally premaired predication: "The PDF missification 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 If you desire specific at nee 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 Also, process note the regulation emation on your responsibilities under the Act from the 807.77). I od may obtain sturers, 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): _K052621
1.5T Brain / Spine Array Coil Device Name:
Indications For Use
The 1.5T Brain / Spine Array Coil is designed for use with the Excite 1.5T incl system The 1.51 Brail / Spine Array Ool is Goligi is for imaging of the brain, cervical spine, soft manufactured by GE Healthoale. The soll is for maging these on himbar spine. The nucleus excited is hydrogen.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ × (Per 21 CFR 801-109) OR
Over-The-Counter Use_
Daniel A. Swanson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.