(78 days)
The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck in Magnetic Resonance Imaging Systems. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.
The 1.5T MRI 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 Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a multi-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, a sliding head section, and a removable chin coil section. The open, patient friendly design minimizes claustrophobic effects 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 document is a 510(k) summary for the Excalibur 9000 TotalSENSE™ Quad Array Head Coil, an accessory for Magnetic Resonance Imaging systems. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or not provided in this type of regulatory submission.
However, I can extract the information that is present and explain why other sections are not covered.
Acceptance Criteria and Device Performance (Not Applicable as Defined for AI/Software)
| Acceptance Criteria (Expected for AI/Software) | Reported Device Performance (Provided for MRI Coil) |
|---|---|
| Not explicit as this is not an AI/software device. | Intended Use: Imaging of the brain, upper cervical spine, and soft tissues and vasculature of the head and neck. Reported Performance: "Similar to the Millennium 9000 Phased Array Neurovascular Coil manufactured by USA Instruments, Inc. (K001870)" and "Similar to the Profile 7000 Quadrature Volume Neck Coil manufactured by USA Instruments. Inc. (K964531)" regarding material, design, decoupling, prevention of RF burns, radio frequency absorption, and prevention of resonant loop formation. The device is confirmed to produce images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, T1, T2) and (3) display the soft tissue structure of the head and whole body. |
| Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not defined here as it is a hardware accessory. | Overall Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This implies it meets the same safety and effectiveness standards as those established for the predicates, primarily through demonstration of equivalent technical characteristics. |
Study Details (Not Applicable/Not Provided for this Type of Device Submission)
- Sample sizes used for the test set and the data provenance: Not applicable/Not provided. This is a hardware accessory, not a software algorithm that would typically use a test set of data. The submission relies on technical comparisons to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for an AI/software algorithm is not relevant for an MRI coil accessory.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not 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: Not applicable. This device is an MRI coil, not an AI-powered diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the context of an imaging modality like MRI relates to the physical and chemical properties it measures. The images produced by the coil are interpreted by trained physicians for diagnosis, as per standard MRI practices.
- The sample size for the training set: Not applicable/Not provided. This is a hardware accessory, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable/Not provided.
Explanation for Missing Information:
This document is a 510(k) summary for a hardware medical device (an MRI coil). The primary mechanism for clearance for such devices is demonstrating substantial equivalence to a predicate device already on the market. This often involves:
- Showing the new device has the same intended use and indications for use as a predicate.
- Comparing technological characteristics (materials, design, safety features, performance specifications like signal-to-noise ratio, etc.) to the predicate.
- Demonstrating that any differences in technological characteristics do not raise new questions of safety or effectiveness.
The types of studies (e.g., AI performance metrics, sample sizes for training/test sets, ground truth establishment, MRMC studies) you've asked about are characteristic of submissions for software as a medical device (SaMD) or AI-powered medical devices. These require different types of evidence and evaluation processes than simple hardware accessories.
In this case, the "study" that proves the device meets acceptance criteria is the comparison to predicate devices as detailed in the "Safety and Effectiveness" section. The "acceptance criteria" are implicitly met by demonstrating that the new coil performs comparably to or within the established safety and effectiveness parameters of the already cleared predicate devices, in line with general MRI system performance standards.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Excalibur 9000 TotalSENSE™ Quad Array HeadCoil |
| 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 beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Excalibur 9000 TotalSENSE™ Quad ArrayHead Coil is a receive-only phased array RF coil,used for obtaining diagnostic images of the brain,upper cervical spine, and the soft tissues andvasculature of the head and neck in MagneticResonance Imaging Systems. The Excalibur 9000TotalSENSE™ Quad Array Head Coil is designed foruse with the ExcelArt 1.5T MRI systemmanufactured by Toshiba Medical Systems, Inc. Theindications for use are the same as for standard MRImaging. |
| 8. Device Description: | The Excalibur 9000 TotalSENSE™ Quad ArrayHead Coil is a multi-element quadrature phasedarray, receive-only coil. The coil consists of threesections: a main coil base, a sliding head section,and a removable chin coil section. The open, patientfriendly design minimizes claustrophobic effects andmaximizes patient comfort. The coil elements andaccessory electronics are enclosed in a rigid plastichousing, which is fire rated and has a high impactand tensile strength. |
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9. Safety and Effectiveness
| Excalibur 9000 TotalSENSE™ QuadArray Head Coil | Comparison to predicate device or other 510(k)cleared products | ||
|---|---|---|---|
| Intended Use: Imaging of the brain,upper cervical spine and the softtissues and vasculature of the head andneck. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Indications for Use: Identical to routineMRI imaging. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Coil Enclosure Material:AcetalPolycarbonatePolyurethane | - Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870)-Similar to the Profile 7000 Quadrature VolumeNeck Coil manufactured by USA Instruments. Inc.(K964531) | ||
| Coil Design: Receive-only quadraturephased array coil. | - Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Decoupling: Switching diodedecoupling. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Prevention of RF Burns: Does nottransmit RF power; decoupling isolatesthe coil elements from RF fields duringRF transmission; coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) | ||
| Formation of Resonant Loop:Decoupling isolates the coil elementsfrom RF fields during RF transmission;length of cable and stiffness does notpermit looping. | -Similar to the Millennium 9000 Phased ArrayNeurovascular Coil manufactured by USAInstruments, Inc. (K001870) |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the edge. In the center of the logo is a stylized image of a person with their arms outstretched. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2002
Ms. Christie Shumaker Manager OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K022582
Trade/Device Name: Excalibur 9000 TotalSENSE Quad Head Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Shumaker:
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 (PMA), it may be subject to 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
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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510(k) Number (if known): K024582
Device Name: Excalibur 9000 TotalSENSE™ Quad Array Head Coil
Indications for Use: The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Nancy Chrogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022582
§ 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.