(66 days)
The Spirit 5000 Cardiac Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit 5000 Cardiac Coil is compatible with SENSE technology and designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 0.7T 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 (1) 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 Spirit 5000 Cardiac Coil is a four element receive only phased array coil. The coil is composed of rigid top and bottom pieces. A split top latch releases the coil from either side. 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 have a high impact and tensile strength.
The provided document is a 510(k) premarket notification for the Spirit 5000 Cardiac Coil. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of a novel AI/software medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
Here's why and what information is available:
- Nature of the Device: The Spirit 5000 Cardiac Coil is a hardware component (a receive-only phased array RF coil) for an MRI system, not an AI/software device that generates diagnostic interpretations or measurements.
- 510(k) Process: For devices like this, the primary demonstration of safety and effectiveness is through comparison to legally marketed predicate devices, showing that the new device has "substantially equivalent" technological characteristics and intended use. This typically involves engineering tests, compatibility testing, and performance specifications, but not usually extensive clinical studies with expert-adjudicated ground truth and specific performance metrics like sensitivity/specificity in the context of diagnostic algorithms.
Information that can be extracted or inferred from the document:
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Acceptance Criteria and Reported Device Performance: This information is not provided in the format requested, as the submission focuses on equivalence. The "Safety and Effectiveness" section (page 1, section 9) details product features and compares them to predicate devices, indicating similarity rather than reporting distinct performance metrics against specific acceptance criteria. For example:
- Intended Use: "imaging of the cardiovascular system" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Indications for Use: "Identical to routine MRI imaging" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Coil Enclosure Material: "Flame Retardant Polyurethane, Flame Retardant Polycarbonate" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Coil Design: "Receive-only phased array coil" - "Similar to the Interventional Body Coil (K000437)"
- Prevention of RF Burns: "Does not transmit RF Power, Decoupling isolates the coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing." - "Similar to the Interventional Body Coil (K000437)"
- Radio Frequency Absorption: "Coil is a receive only coil and does not transmit RF power." - "Similar to the Interventional Body Coil (K000437)"
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Sample size for the test set and data provenance: Not applicable/Not provided. The document does not describe a "test set" in the context of evaluating diagnostic performance with patient data or a specific algorithm.
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a requirement for this type of device and submission.
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Adjudication method for the test set: Not applicable/Not provided.
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MRMC comparative effectiveness study: No. This is a hardware component, not an AI system that assists human readers.
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Standalone (algorithm only without human-in-the loop performance) study: No. This is a hardware component.
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Type of ground truth used: Not applicable/Not provided. The "ground truth" for a cardiac coil would relate to its engineering specifications and imaging capabilities (e.g., signal-to-noise ratio, image uniformity), which are part of its technical characteristics, but not "ground truth" for diagnostic accuracy in the way it's used for AI.
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Sample size for the training set: Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document outlines the FDA's decision regarding a traditional medical device hardware component (MRI coil) based on substantial equivalence, and therefore does not contain the detailed performance and study information typically associated with the evaluation of AI/software medical devices.
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SUMMARY OF SAFETY AND EFFECTIVENESS
:
Ko33490
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Spirit 5000 Cardiac 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 beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Spirit 5000 Cardiac Coil is a receive- onlyphased array RF coil, used for obtaining diagnosticimages of the cardiovascular system in MagneticResonance Imaging Systems. The Spirit 5000Cardiac Coil is compatible with SENSE technologyand designed for use with the Altaire 0.7T MRIsystem manufactured by Hitachi Medical Systems,Inc. The indications for use are the same as forstandard MR Imaging. |
| 8. Device Description: | The Spirit 5000 Cardiac Coil is a four elementreceive only phased array coil. The coil iscomposed of rigid top and bottom pieces. A split toplatch releases the coil from either side. The open,patient friendly design minimizes claustrophobiceffects and maximizes patient comfort. The coilelements and accessory electronics are enclosed ina rigid plastic housing, which is fire rated and have ahigh impact and tensile strength. |
Please turn over
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| 9. Safety and Effectiveness | |
|---|---|
| Spirit 5000 Cardiac Coil ProductFeatures | Comparison to predicate or other 510(k)cleared products |
| Intended Use: imaging of thecardiovascular system | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K031172) |
| Indications for Use: Identical toroutine MRI imaging | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K031172)-Similar to the Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
| Coil Enclosure Material:Flame Retardant PolyurethaneFlame Retardant Polycarbonate | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K031172) |
| Coil Design: Receive-only phasedarray coil | -Similar to the Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
| Decoupling: Switching Diodedecoupling | -Similar to the Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
| 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 Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
| Radio Frequency Absorption: Coil isa receive only coil and does nottransmit RF power. | -Similar to the Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
| 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 Interventional Body Coil (K000437)manufactured by USA Instruments, Inc. |
o Safety and Effectiveness
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing the department's focus on people and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2004
Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K033490
Trade/Device Name: Spirit 5000 Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 28, 2003 Received: November 4, 2003
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 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) I ran lotet notification. The FDA finding of substantial equivalence of your device to a legally premainted 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 11 you teen office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Spirit 5000 Cardiac Coil
Indications for Use: The Spirit 5000 Cardiac Coil is designed to provide Magnetic The Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is Roconed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc.
Anatomic Regions: cardiovascular system Hydrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The 0.7T 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 (1) 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.
(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 (Optional Format 1-2-96)
Nancy Brogdon
(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.