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.

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.

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.

AI/ML Overview

This document is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Champion 5000 Peripheral Vascular Coil. It is a premarket notification for a Class II device.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic algorithm. This document is for a physical medical device (an MRI coil), and its "acceptance criteria" are related to its safety, intended use, and substantial equivalence to previously cleared predicate devices, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm.

Therefore, many of the requested elements for describing a study and acceptance criteria related to algorithmic performance cannot be extracted from this document.

However, I can extract information related to the device's characteristics and its comparison to predicate devices, which serve as the basis for its substantial equivalence and "acceptance" by the FDA.

Here's the breakdown of what can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an MRI coil and not a diagnostic algorithm, the "acceptance criteria" are framed as comparisons to predicate devices to establish substantial equivalence. Performance is described in terms of functional similarities and safety features.

Acceptance Criteria (based on predicate device comparison)	Reported Device Performance (Champion 5000 Peripheral Vascular Coil)
Intended Use: Imaging of the vasculature and soft tissue anatomy extending from the torso to the foot region.	Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000's intended use is the same: imaging of vasculature and soft tissue anatomy from torso to foot region.
Indications for Use: Identical to routine MRI imaging.	Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000's indications for use are the same as for standard MR Imaging.
Coil Enclosure Material: Flame Retardant Polycarbonate / Flame Retardant Polyurethane.	Similar to Profile 7000 Quadrature Volume Neck Coil (K964531), Magna 5000 Phased Array CTL Spine Coil (K000002). Uses Flame Retardant Polycarbonate and Flame Retardant Polyurethane (TD-27702, Polyone U2773 Neutral).
Coil Design: Receive-only phased array coil.	Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). The Champion 5000 is a multi-element phased array receive-only coil.
Decoupling: Switching diode decoupling.	Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). Uses switching diode decoupling.
Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements; enclosed in non-conductive housing.	Similar to Flow 7000 Peripheral Vascular Coil (K982339). The Champion 5000 does not transmit RF power, uses decoupling, and elements/circuitry are in a non-conductive housing.
Radio Frequency Absorption: Receive-only, does not transmit RF power.	Similar to Magna 5000 Phased Array CTL Spine Coil (K000002), Interventional Body Coil (K000437). The coil is receive-only and does not transmit RF power.
Formation of Resonant Loop: Decoupling isolates elements; cable length/stiffness prevents looping.	Similar to Flow 7000 Peripheral Vascular Coil (K982339). Decoupling isolates elements, and cable properties prevent looping.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes an MRI coil, not a diagnostic algorithm that would typically use a "test set" of data in the sense of patient images for performance evaluation. The "testing" referred to is likely engineering validation and verification of the physical device's characteristics against its design specifications and safety requirements, often in a laboratory or simulated environment, rather than a clinical dataset for performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. See point 2. Ground truth in this context would relate to the physical properties and safety of the coil, not diagnostic interpretations from images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

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 device is an MRI coil, not an AI algorithm. Therefore, no MRMC study or AI-assisted improvement metrics would be relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is an MRI coil, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable / Inferred as engineering specifications and regulatory standards. For an MRI coil, the "ground truth" for its safety and effectiveness would be established through engineering tests verifying its physical, electrical, and RF safety properties, as well as its ability to produce images (signal-to-noise ratio, uniformity, etc.) that are comparable to predicate devices. This is based on objective measurements and established standards for MRI hardware, rather than medical ground truths like pathology.

8. The sample size for the training set

Not Applicable. This device is an MRI coil, not an AI algorithm that would have a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K823247

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 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 Champion 5000 Peripheral Vascular Coil is amulti-element phased array RF coil, used forobtaining diagnostic images of the vasculature andsoft tissue anatomy extending from the torso to thefoot region, in Magnetic Resonance ImagingSystems. The Champion 5000 Peripheral VascularCoil is designed for use with the Altaire 0.7T MRIsystem manufactured by Hitachi Medical SystemsAmerica, Inc. The indications for use are the sameas for standard MR Imaging.
8. Device Description:	The Champion 5000 Peripheral Vascular Coil is amulti-element phased array receive-only coil. Thecoil consists of five sections: a main coil base, threeremovable top part sections, and a removable footsection. The open, patient friendly design minimizesclaustrophobic effects and maximizes patientcomfort. The coil elements and accessoryelectronics are enclosed in a rigid plastic housing,which is fire rated and has a high impact and tensilestrength.

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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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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.

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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,

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

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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:

(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)

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 _

Regulation Number and Section

§ 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.