(84 days)
Not Found
No
The document describes a passive RF coil for MRI and does not mention any AI or ML capabilities.
No.
The device is used for obtaining diagnostic images and yields information useful in determining a diagnosis, not for treating a condition.
Yes
The device is described as being "used for obtaining diagnostic images" and the images it produces are stated to "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states that the device is a "multi-element phased array receive-only coil" consisting of physical sections and enclosed in a rigid plastic housing, indicating it is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Champion 5000 Peripheral Vascular Coil is an accessory for an MRI system. Its purpose is to receive radiofrequency signals from the patient's body during an MRI scan to create images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "obtaining diagnostic images of the vasculature and soft tissue anatomy" using an MRI system. This is an in vivo (within the living body) diagnostic process, not in vitro.
Therefore, based on the provided information, the Champion 5000 Peripheral Vascular Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Champion 5000 Peripheral Vascular Coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from the torso to the foot region, in Magnetic Resonance Imaging Systems. The Champion 5000 Peripheral Vascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems America, Inc. The indications for use are the same as for standard MR Imaging.
The Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc.
Anatomic Regions: vasculature and soft tissue anatomy, extending from the torso to the foot region. 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 vield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The Champion 5000 Peripheral Vascular Coil is a multi-element phased array receive-only coil. The coil consists of five sections: a main coil base, three removable top part sections, and a removable foot 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging Systems
Anatomical Site
vasculature and soft tissue anatomy extending from the torso to the foot region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982339, K964531, K000002, K000437
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 2 3 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Champion 5000 Peripheral Vascular Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., |
| 1515 Danner Drive | |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | The Champion 5000 Peripheral Vascular Coil is a |
| multi-element phased array RF coil, used for | |
| obtaining diagnostic images of the vasculature and | |
| soft tissue anatomy extending from the torso to the | |
| foot region, in Magnetic Resonance Imaging | |
| Systems. The Champion 5000 Peripheral Vascular | |
| Coil is designed for use with the Altaire 0.7T MRI | |
| system manufactured by Hitachi Medical Systems | |
| America, Inc. The indications for use are the same | |
| as for standard MR Imaging. | |
| 8. Device Description: | The Champion 5000 Peripheral Vascular Coil is a |
| multi-element phased array receive-only coil. The | |
| coil consists of five sections: a main coil base, three | |
| removable top part sections, and a removable foot | |
| 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. |
1
9. Safety and Effectiveness
| Peripheral Vascular Coil | Comparison to predicate device or other 510(k) cleared products |
|---|---|
| Intended Use: Imaging of the vasculature and soft tissue anatomy extending from the torso to the foot region | -Similar to the Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339) |
| Indications for Use: Identical to routine MRI imaging. | -Similar to the Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339) |
| Coil Enclosure Material: | |
| Flame Retardant Polycarbonate | -Similar to the Profile 7000 Quadrature Volume Neck Coil manufactured by USA Instruments, Inc. (K964531) |
| Flame Retardant Polyurethane | |
| (TD-27702, Polyone U2773 Neutral) | -Similar to the Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K000002). |
| Coil Design: Receive-only phased array coil. | -Similar to the Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K000002). -Similar to the Interventional Body Coil manufactured by USA Instruments, Inc. (K000437) |
| Decoupling: Switching diode decoupling. | -Similar to the Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K000002). -Similar to the Interventional Body Coil manufactured by USA Instruments, Inc. (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 Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339) |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. | -Similar to the Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K000002). -Similar to the Interventional Body Coil manufactured by USA Instruments, Inc. (K000437) |
| Formation of Resonant Loop: | |
| Decoupling isolates the coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping. | -Similar to the Flow 7000 Peripheral Vascular Coil manufactured by USA Instruments, Inc. (K982339) |
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2
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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. . 1515 Danner Drive AURORA OH 44202
Re: K023247
Trade/Device Name: Champion 5000 Perpheral Vascular 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: September 30, 2002
Dear Ms. Schumaker:
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.
3
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,
Henry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known);__Ko2 32 47
Device Name: Champion 5000 Peripheral Vascular Coil
Indications for Use: The Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc.
Anatomic Regions: vasculature and soft tissue anatomy, extending from the torso to the foot region. 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 vield 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)
Eurid A. Shepman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _