The 3.0T 8 Channel Neurovascular (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest in Magnetic Resonance Imaging Systems. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 3.0T 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.

Device Description

The 3.0T 8 Channel Neurovascular (NV) Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3.0T 8 Channel Neurovascular (NV) Array Coil:

Summary of Device Performance Study

The provided document (K032618) is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials as would be required for a New Drug Application (NDA) or a Premarket Approval (PMA) application. Therefore, the "study" described herein is a comparison to predicate devices and relies on established performance characteristics, rather than a clinical trial with specific endpoints and patient outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implied by comparison to the predicate devices. The device is deemed acceptable if its features, intended use, and indications for use are similar to legally marketed predicate devices, and if it addresses safety concerns (like RF burns and resonant loops) in a similar manner.

Acceptance Criterion (Implied by Predicate Comparison)	Reported Device Performance and Compliance
Intended Use: Imaging of the brain, cervical spine, soft tissues, and vasculature of the head, neck, and upper chest.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA instruments, Inc. (K001807)."
Indications for Use: Identical to routine MRI imaging (as defined for the 3.0T MRI system by GE Medical Systems).	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)." The specific indications for the 3.0T MRI system (proton distribution, NMR parameters, soft tissue structure for diagnosis by trained physician) are explicitly adopted.
Coil Enclosure Material: Flame Retardant Polyurethane, Flame Retardant Polycarbonate, Delrin Acetal.	Meets: "Similar to the Champion 5000 Peripheral Vascular coil manufactured by USA Instruments, Inc. (K023247)."
Coil Design: Receive-only phased array coil.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)."
Decoupling Method: Switching diode decoupling.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)."
Prevention of RF Burns: Does not transmit RF power; decoupling isolates coil elements from RF fields; elements/circuitry in non-conductive housing.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)." The device is a receive-only coil.
Radio Frequency Absorption: Coil is receive-only, does not transmit RF power.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)."
Prevention of Resonant Loop Formation: Decoupling isolates coil elements; cable length and stiffness prevent looping.	Meets: "Similar to the Millennium 9000 Phased Array Neurovascular coil manufactured by USA Instruments, Inc. (K001807)."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not describe a "test set" in the traditional sense of a clinical study involving patients or a defined set of images for evaluation. The safety and effectiveness are established through comparison to predicate devices (Millennium 9000 Phased Array Neurovascular coil and Champion 5000 Peripheral Vascular coil, both manufactured by USA Instruments, Inc.).
Data Provenance: This is not a study involving patient data. The "data" here refers to the design specifications, technical characteristics, and regulatory history of the predicate devices, which are presumed to be established as safe and effective. The manufacturer is USA Instruments, Inc., located in Aurora, Ohio, USA. The nature of the comparison is retrospective, as it relies on previously cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As this is a 510(k) submission based on substantial equivalence to predicate devices, there was no independent "test set" requiring ground truth established by experts in the context of clinical image interpretation or diagnosis of pathology. The FDA's review process itself involves expertise to determine substantial equivalence based on engineering, regulatory, and clinical considerations.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication in the context of image interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted to evaluate the diagnostic performance of a new imaging modality or AI algorithm, often comparing it against established methods or human readers. The 510(k) process for this device focused on validating its technical specifications and equivalency to existing, cleared coils, not on a new diagnostic algorithm or comparative diagnostic effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is an MRI accessory (a receive-only coil), not an algorithm or AI software. It does not perform any diagnostic interpretation independently; rather, it facilitates the acquisition of MRI images which are then interpreted by human clinicians.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's features and performance are compared against these predicates to demonstrate that it raises no new questions of safety or effectiveness. This is implicit regulatory ground truth rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (an MRI coil), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this hardware device.

Summary

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Ko32618

SEP 1 2 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device Name:	Magnetic Resonance Imaging Accessory
2. Proprietary Name:	3.0T 8 Channel Neurovascular (NV) 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 beenissued under Section 514 of the Food, Drug andCosmetic Act.
7. Intended Use:	The 3.0T 8 Channel Neurovascular (NV) Array Coilis a receive-only phased array RF coil, used forobtaining diagnostic images of the brain, cervicalspine, soft tissues and vasculature of the head, neckand upper chest in Magnetic Resonance ImagingSystems. The 3.0T 8 Channel Neurovascular (NV)Array Coil is designed for use with the 3.0T MRIsystems manufactured by GE Medical Systems.
8. Device Description:	The 3.0T 8 Channel Neurovascular (NV) Array Coilis a multi-element phased array receive only coil.The coil has a rigid enclosure. The open, patientfriendly design eases patient handling andpositioning and maximizes patient comfort. The coilelements and accessory electronics are enclosed ina rigid plastic housing, which is fire rated and has ahigh impact and tensile strength.

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9. Safety and Effectiveness

3.0T 8 Channel Neurovascular (NV) ArrayCoil product features	Comparison to predicate device or other 510(k)cleared products
Intended Use: Imaging of the brain, cervicalspine, soft tissues and vasculature of thehead, neck, and upper chest	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA instruments,Inc. (K001807)
Indications for Use: Identical to routineMRI imaging	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)
Coil Enclosure Material:Flame Retardant PolyurethaneFlame Retardant PolycarbonateDelrin Acetal	-Similar to the Champion 5000 Peripheral Vascular coilmanufactured by USA Instruments, Inc. (K023247)
Coil Design: Receive-only phased arraycoil	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)
Decoupling: Switching diode decoupling	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)
Prevention of RF Burns: Does not transmitRF power; decoupling isolates the coilelements from RF fields during RFtransmission; coil elements and circuitry areenclosed in a non-conductive housing.	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)
Radio Frequency Absorption: Coil is areceive only coil and does not transmit RFpower	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)
Formation of Resonant Loop: Decouplingisolates the coil elements from RF fieldsduring RF transmission; length of cable andstiffness does not permit looping	-Similar to the Millennium 9000 Phased ArrayNeurovascular coil manufactured by USA Instruments,Inc. (K001807)

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, composed of three parallel, curved lines that suggest movement and wings. Encircling the bird is text arranged in a circular pattern, likely the name of an organization or institution. The text is oriented to follow the curve of the circle, with the top portion of the text appearing larger and more prominent.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K032618

Trade/Device Name: 3.0T 8-Channel Neurovascular (NV) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 21, 2003 Received: August 26, 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 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) 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 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 vours.

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

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510(k) Number (if known):__ Ko 3 乙んし

Device Name: 3.0T 8 Channel Neurovascular (NV) Array Coil

Indications for Use: The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest 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)
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Prescription Use(Per 21 CFR 801.109)	✓
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Over-The-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K032618

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.