The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software.

The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest.

When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning.

Device Description

The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths:

AIR Open Head Neck Posterior 9ch
AIR Open Neck Chest Anterior 7ch
AIR Open Head Anterior 16ch .

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MR Overlay for GE Motus, Kizuna, and GEM as well as the associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner)

The 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

The 32Ch AIR Open Coil Suite is intended for use in a manner that is identical to the predicate device described in this submission.

Proposed labeling is documented in the Instructions for Use manual for the 32Ch AIR Open Coil Suite (NC139IFU-en).

AI/ML Overview

The provided text describes the acceptance criteria and study proving a medical device, the 32Ch AIR Open Coil Suite, meets these criteria. However, it focuses primarily on bench testing (performance testing) and briefly mentions clinical performance testing without detailing the specifics typically found in studies designed to prove performance against specific clinical acceptance criteria (like diagnostic efficacy, AI algorithm performance, etc.).

The document outlines a 510(k) submission for an MRI RF Receive-Only Coil, which is an imaging accessory, not an AI-powered diagnostic device. Therefore, the common elements of acceptance criteria and study designs for AI/CADe systems (such as sensitivity, specificity, MRMC studies, expert adjudication, ground truth establishment for a diagnostic output) are not directly applicable or present in this document.

The "study" described herein is a series of engineering and safety tests to demonstrate substantial equivalence to a predicate device, as required for a 510(k) clearance, concerning physical and electrical performance, biocompatibility, and image quality (SNR, uniformity). It does not involve an AI algorithm that produces a diagnostic output, nor does it describe a study like a clinical trial for diagnostic performance.

Given this, I will interpret your request keeping in mind the nature of the device and the provided document. I will focus on the acceptance criteria and performance data that are present, and explicitly state where information relevant to AI/CADe validation is not available or not applicable.

Here's an analysis based on the provided text:

Device Name: 32Ch AIR Open Coil Suite (comprising various 1.5T and 3.0T AIR Open Head Neck Posterior, Neck Chest Anterior, and Head Anterior coils).

Device Type: Magnetic Resonance Imaging (MRI) RF Receive-Only Coils. This is a hardware component for MRI systems, not a software-based AI diagnostic tool.

Purpose of Testing: To demonstrate that the device is safe and effective and performs in a manner that demonstrates substantial equivalence to the predicate device (3.0T GEM RT Open Array, K143389).

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a table outlining various bench tests (non-clinical performance testing). These tests are primarily focused on safety, electrical performance, and physical image quality characteristics of the MRI coils.

Test Performed	Objective(s) of the Test	Pre-defined Pass/Fail Criteria	Reported Device Performance (Results Summary)	Discussions / Conclusions
Biocompatibility Assessment	Assess potential biological risks	Acceptable level of risk	Pass	No identified significant risks.
Electrical Safety (60601-1)	Basic electrical safety/essential performance	Pre-defined performance standards	Pass	Applicable requirements for basic electrical safety and essential performance met.
Electrical Safety (60601-2-33)	Particular electrical requirements; MR equipment	Pre-defined performance standards	Pass	Applicable requirements of the particular standard were met.
Electrical Safety (60601-1-2)	Collateral electrical safety/essential performance	Pre-defined performance standards	Pass	Applicable requirements of the collateral standard were met.
Usability Assessment	Devices meet customer, end user and patient needs	Pre-defined requirements	Pass	The devices met the needs of the customer, end user and patient.
Entrapment, Trapping Zone, Cable Looping (assessment w/ scanner)	Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner	Requirements based on pre-defined requirements in 60601-1 and customer requirements	Pass	Requirements were met.
Surface Temperature	Surface temperatures do not exceed limits	Pre-defined performance standards	Pass	Surface temperatures were within IEC limits.
Unplugged Surface Temperature	Devices remain safe in first fault condition	Acceptable level of risk	Pass	Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner.
Blocking Network Analysis	Ensures devices are designed with adequate active and passive transmit decoupling	Adequate transmit decoupling	Pass	Blocking network demonstrates adequate active and passive transmit decoupling.
Maximum B1 Peak	Demonstrate the devices can withstand the maximum B1 peak without obvious signs of arcing, burning, voltage breakdown	Pre-defined performance standards	Pass	Coils were able to withstand maximum B1 peak without obvious signs of arcing, burning or voltage breakdown.
B1 Field Distortion	Measure amount of distortion produced due to presence of an RF coil in the scanner	Pre-defined performance standards	Pass	B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.
B0 Field Distortion	Measure amount of distortion produced due to presence of an RF coil in the scanner	Pre-defined performance standards	Pass	B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008	Evaluate single-channel non-volume special purpose radiofrequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems	Pre-defined performance standards	Pass	SNR and Image Uniformity are consistent with the requirements for indications for use.

Note: The document also mentions "Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance; Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016." and "No adverse events were reported during clinical performance testing." However, detailed acceptance criteria for clinical performance (e.g., specific image quality metrics, diagnostic accuracy, etc., that would typically be seen for an AI diagnostic device) are not provided in this regulatory summary. The "clinical performance testing" seems to primarily refer to general image observation to ensure functionality, not a rigorous clinical trial for diagnostic performance.

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

Test Set (Clinical Data): The document states "Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance." However, specific sample sizes (number of patients/cases), country of origin, or whether the data was retrospective or prospective are not provided in this summary.
Test Set (Bench Data): For bench testing, the "sample size" is inherently the number of physical coil units tested or the number of experiments performed. This detail is not quantified (e.g., "N=3 coils tested for each parameter").

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable in the context of AI/CADe ground truth: This device is an MRI coil, not a diagnostic AI algorithm that requires expert-established ground truth for diagnostic outputs.
The "clinical performance testing" would likely involve medical professionals (e.g., radiologists) interpreting images for general quality and usability, but the document does not specify the number or qualifications of experts involved in the "clinical data" review. The stated objective for the device is "to produce diagnostic images of the head, neck, and brachial plexus structures. The interpreted by medical professionals or facilitate Radiation Therapy RT planning." This implies human interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of AI/CADe ground truth adjudication: Since this is not an AI diagnostic device, formal adjudication methods for ground truth (like 2+1 or 3+1 consensus) are not described or relevant for the types of tests reported.
For the "clinical performance testing," the method of image assessment (e.g., unanimous agreement on usability/quality by a panel) is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, nor is it applicable: This type of study (comparing human readers with and without AI assistance for diagnostic performance, or comparing different AI algorithms) is specifically for evaluating the effectiveness of AI-powered diagnostic tools or CADe systems. The 32Ch AIR Open Coil Suite is an MRI hardware component.

6. Standalone Performance (Algorithm Only)

Not applicable: This is an MRI coil, a hardware component. There is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its use with an MRI scanner and subsequent human interpretation of the images it helps acquire.

7. Type of Ground Truth Used

Not applicable in the context of AI/CADe diagnostic ground truth.
For the performance testing that was conducted:
- Bench Tests: The "ground truth" for these tests is defined by established engineering and safety standards (e.g., IEC standards, NEMA MS 6-2008). The criteria are objective measurements against these standards (e.g., temperature limits, signal-to-noise ratio, image uniformity).
- Clinical Performance: The "ground truth" for assessing image quality and usability in a clinical context would be the subjective and objective assessment by trained medical professionals (e.g., radiologists) determining if the images are diagnostically acceptable and if the coil is usable. No specific details are provided.

8. Sample Size for the Training Set

Not applicable: This device does not involve a machine learning or AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable: As there is no AI algorithm and no training set, the establishment of ground truth for a training set is irrelevant for this device.

Summary:

The provided document details a regulatory submission (510(k)) that focuses on demonstrating the substantial equivalence of new MRI coils to a previously cleared predicate device. The "acceptance criteria" and "proof" provided are primarily related to general device safety, electrical performance, and basic image quality metrics as measured by engineering tests. While clinical data is mentioned, it appears to be for general observational assessment of usability and image quality rather than for quantifying diagnostic performance outcomes, which would be the case for an AI-powered diagnostic device. Therefore, many of the questions asked, particularly those pertaining to AI/CADe validation (MRMC studies, expert ground truth establishment, training sets), are not applicable to the nature of the device and the testing described in this document.

Summary

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March 11, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

NeoCoil, LLC % Katie Gonzalez Quality Systems and Regulatory Manager N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K213687

Trade/Device Name: 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: February 23, 2022 Received: February 24, 2022

Dear Katie Gonzalez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213687

Device Name

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Oven Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

Indications for Use (Describe)

The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals. for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software.

The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest.

When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The interpreted by medical professionals or facilitate Radiation Therapy RT planning.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. To the left of the company name is a black circular design with a white crescent shape inside. The company name is written in a sans-serif font, with "Neo" in blue and "Coil" in black.

Traditional 510(k) Summary

Applicant

NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA

Contact

Katie Gonzalez Quality Systems and Regulatory Manager 262-522-6124 (office) 262-347-1251 (fax) Katie.Gonzalez@neocoil.com

Preparation Date

November 18, 2021

Name of Device

. Trade/Proprietary name(s):
32Ch AIR Open Coil Suite

1.5T 32Ch AIR Open Coil Suite

1.5T AIR Open Head Neck Posterior 9ch 1.5T AIR Open Neck Chest Anterior 7ch 1.5T AIR Open Head Anterior 16ch

3.0T 32Ch AIR Open Coil Suite

3.0T AIR Open Head Neck Posterior 9ch 3.0T AIR Open Neck Chest Anterior 7ch 3.0T AIR Open Head Anterior 16ch

Common name: Magnetic Resonance Specialty Coil
. Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS

Predicate Device

3.0T GEM RT Open Array, K143389 cleared on 03/06/2015

Device Description

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Image /page/4/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue and black. The word "Neo" is in blue, while the word "Coil" is in black.

scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths:

AIR Open Head Neck Posterior 9ch
AIR Open Neck Chest Anterior 7ch
AIR Open Head Anterior 16ch .

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are tvpically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MR Overlay for GE Motus, Kizuna, and GEM as well as the associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner)

The 32Ch AIR Open Coil Suite is intended for use in a manner that is identical to the predicate device described in this submission.

Proposed labeling is documented in the Instructions for Use manual for the 32Ch AIR Open Coil Suite (NC139IFU-en).

Intended Use, including indications

The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest.

Technological Characteristics

32Ch AIR Open Coil Suite coils are similar in design, material, chemical composition and energy source to the legally marketed device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015.

At a high level, the 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite included as part of this submission, and the predicate device are based on the following same technological elements:

Prescription use;
Coil designs are receive-only phased array coils; ●
. Decoupling methodology:

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Image /page/5/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol on the left, followed by the word "NeoCoil" in blue and black. The "Neo" part of the word is in blue, while the "Coil" part is in black.

. Patient contacting materials and chemical composition are known materials that have been assessed for compliance with recognized biocompatibility standards;
Energy source for the coils is the MRI scanner; ●
No energy is supplied by the coils; ●
Coils designs are targeted for the head, neck and brachial plexus anatomy; ●
Mechanical designs are contoured for the head, neck and brachial plexus anatomy: ●
Facilitate Radiation Therapy (RT) planning;
Manufactured for use with the same MRI scanner manufacturer.

The following technological differences exist between the subject and predicate device:

Optimized coil dimensions and geometry to support use on state-of-the-art MRI scanners ● and improve usability.
Field strength for the 1.5T 32Ch AIR Open Coil Suite .
. Channel count

The Indications for Use for the 1.5T 32Ch AIR Open Coil Suite and 32Ch AIR Open Coil Suite are similar to the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015.

Clinical and non-clinical testing demonstrates that the safety and/or effectiveness of the 32Ch AIR Open Coil Suites compared to the predicate device is not adversely affected as a result of the differences.

Testing

A combination of clinical and non-clinical performance data is included, referenced, or relied on to demonstrate that the 32Ch AIR Open Coil Suite is safe and effective and performs in a manner that demonstrates substantial equivalence to the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015.

Performance testing - Bench:

A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA quidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016, is outlined below:

TestPerformed	Objective(s) of theTest	Test MethodDescription	Pre-definedpass/failcriteria	ResultsSummary	Discussions /Conclusions
BiocompatibilityAssessment	Assess potentialbiological risks	Evaluation ofdata; historicaluse, biologictesting, wherewarranted	Acceptablelevel of risk	Pass	No identified significantrisks.
ElectricalSafety	Basic electricalsafety/essentialperformance, 60601-1	Test Lab	Pre-definedperformancestandards	Pass	Applicablerequirements for basicelectrical safety andessential performancemet.
ElectricalSafety	Particular electricalrequirements; MRequipment, 60601-2-33	Test Lab	Pre-definedperformancestandards	Pass	Applicablerequirements of theparticular standardwere met.
TestPerformed	Objective(s) of theTest	Test MethodDescription	Pre-definedpass/failcriteria	ResultsSummary	Discussions /Conclusions
ElectricalSafety	Collateral electricalsafety/essentialperformance, 60601-1-2	Test Lab /Bench Testing	Pre-definedperformancestandards	Pass	Applicablerequirements of thecollateral standard weremet.
UsabilityAssessment	Devices meetcustomer, end userand patient needs	Actual,simulated orretrospectiveevaluation ofthe deviceand/or data	Pre-definedrequirements	Pass	The devices met theneeds of the customer,end user and patient.
Entrapment,Trapping Zoneand CableLooping(assessment w/scanner)	Assess the device forpinch points,entrapment, cablelooping - interfacingwith MRI scanner	Evaluation ofcoil-to-scannerentrapment,trapping andcable loopingnot covered bytest labassessments.	Requirementsbased on pre-definedrequirementsin 60601-1and customerrequirements	Pass	Requirements weremet.
SurfaceTemperature	Surface temperaturesdo not exceed limits	MRI scannertest	Pre-definedperformancestandards	Pass	Surface temperatureswere within IEC limits.
UnpluggedSurfaceTemperature	Devices remain safe infirst fault condition	MRI scannertest	Acceptablelevel of risk	Pass	Surface temperatureswere within IEC limitswhen the coil is leftunplugged in the MRIscanner.
BlockingNetworkAnalysis	Ensures devices aredesigned withadequate active andpassive transmitdecoupling	Theoreticalcalculations	Adequatetransmitdecoupling	Pass	Blocking networkdemonstrates adequateactive and passivetransmit decoupling.
Maximum B1Peak	Demonstrate thedevices can withstandthe maximum B1 peakwithout obvious signsof arcing, burning,voltage breakdown	MRI scannertest and visualinspection	Pre-definedperformancestandards	Pass	Coils were able towithstand maximum B1peak without obvioussigns of arcing, burningor voltage breakdown.
B1 FieldDistortion	Measure amount ofdistortion produceddue to presence of anRF coil in the scanner	MRI scannertest	Pre-definedperformancestandards	Pass	B1 field inhomogeneitymeets performancerequirements anddemonstrates adequateactive and passivetransmit decoupling.
B0 FiledDistortion	Measure amount ofdistortion produceddue to presence of anRF coil in the scanner	MRI scannertest	Pre-definedperformancestandards	Pass	B0 field inhomogeneitymeets performancerequirements anddemonstrates adequateactive and passivetransmit decoupling.
TestPerformed	Objective(s) of theTest	Test MethodDescription	Pre-definedpass/failcriteria	ResultsSummary	DiscussionsConclusions
NEMA MS 6-2008	Evaluate single-channel non-volumespecial purposeradiofrequency (RF)coils for use withmagnetic resonance(MR) imaging (MRI)systems	MRI scannertest	Pre-definedperformancestandards	Pass	SNR and ImageUniformity areconsistent with therequirements forindications for use.

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 Fax: (262) 347-1251

Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape on the left and the word "NeoCoil" in blue on the right. The circular shape appears to be a stylized representation of a coil or spiral.

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Image /page/7/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The wordmark is in a sans-serif font and is slightly larger than the circular shape.

Performance testing - Clinical:

Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance; Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016.

No adverse events were reported during clinical performance testing.

Image /page/7/Picture/6 description: The image shows a comparison of MRI scans taken with 1.5T and 3.0T 32Ch AIR Open Coil Suites. The top row displays coronal T2-weighted images without fat saturation, while the bottom row shows sagittal T2-weighted images, also without fat saturation. The left column shows images from the 1.5T suite, and the right column shows images from the 3.0T suite, allowing for a direct visual comparison of image quality and detail between the two different MRI systems.

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Image /page/8/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol on the left and the word "NeoCoil" in blue on the right. The coil symbol has an arrow pointing to the right, suggesting movement or flow.

Image /page/8/Figure/2 description: The image shows a comparison of MRI scans taken with 1.5T and 3.0T 32Ch AIR Open Coil Suites. The top row displays axial T2-weighted images of the brain without fat saturation, while the bottom row shows axial T2-weighted images of the neck without fat saturation. The left column shows images taken with the 1.5T coil, and the right column shows images taken with the 3.0T coil. The images show the differences in image quality and resolution between the two coil suites.

Conclusion

This submission demonstrates by means of nonclinical and clinical testing that the 32Ch AIR Coil Suite are safe and effective and perform as well as or better than the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015 for the indications claimed.

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.