To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Device Description

The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only phased array RF coils designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Maqnetic Resonance Imaging (MRI) scanners. The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.

Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy.

The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil 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.

AI/ML Overview

This document describes the marketing approval of NeoCoil's 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil, which are Magnetic Resonance (MR) diagnostic devices. The acceptance criteria and the study proving the device meets these criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611).

The provided document, however, does not contain a specific table of acceptance criteria with reported quantitative performance metrics for the image quality or diagnostic accuracy studies for a novel AI device. Instead, it details the acceptance criteria met for establishing substantial equivalence for an MRI coil. The studies conducted focus on the safety and effectiveness of the coil itself as a medical device component, not on the performance of an AI algorithm interpreting images.

Therefore, I will interpret the request in the context of demonstrating substantial equivalence for an MRI coil, rather than an AI diagnostic device. The "performance" here refers to the physical and electrical performance of the coil that ensures it can produce diagnostic images, rather than algorithmic performance metrics like sensitivity or specificity.

Here's an analysis of the provided information in the requested format, adapted for an MRI coil rather than an AI diagnostic device:

Acceptance Criteria and Study for NeoCoil 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil

The acceptance criteria for these MRI coils are primarily based on demonstrating substantial equivalence to a predicate device (NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611), ensuring the new coils are safe and effective for their intended use. The performance evaluation includes both non-clinical (bench) and clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Objective(s)	Pre-defined Pass/Fail Criteria (General)	Reported Device Performance	Conclusion
Biocompatibility	Assess potential biological risks	Acceptable level of risk	No identified significant risks.	Pass
Electrical Safety	Basic electrical safety/essential performance (IEC 60601-1)	Pre-defined performance standards	Applicable requirements for basic electrical safety and essential performance met.	Pass
Electrical Safety (MR)	Particular electrical requirements; MR equipment (IEC 60601-2-33)	Pre-defined performance standards	Applicable requirements of the particular standard were met.	Pass
Electrical Safety (Collateral)	Collateral electrical safety/essential performance (IEC 60601-1-2)	Pre-defined performance standards	Applicable requirements of the collateral standard were met.	Pass
Usability Assessment	Devices meet customer, end user and patient needs	Pre-defined requirements	The devices met the needs of the customer, end user, and patient.	Pass
Entrapment, Trapping Zone, and Cable Looping	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	Requirements were met.	Pass
Surface Temperature	Surface temperatures do not exceed limits	Pre-defined performance standards (IEC limits)	Surface temperatures were within IEC limits.	Pass
Unplugged Surface Temperature	Devices remain safe in first fault condition (when unplugged in scanner)	Acceptable level of risk (IEC limits)	Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner.	Pass
Blocking Network Analysis	Ensures devices are designed with adequate active and passive transmit decoupling	Adequate transmit decoupling	Blocking network demonstrates adequate active and passive transmit decoupling.	Pass
Maximum B1 Peak	Demonstrate the devices can withstand the maximum B1 peak without obvious signs of arcing, burning, voltage breakdown	Pre-defined performance standards	Coils were able to withstand maximum B1 peak without obvious signs of arcing, burning or voltage breakdown.	Pass
B1 Field Distortion	Measure amount of distortion produced due to presence of an RF coil in the scanner	Pre-defined performance standards	B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.	Pass
B0 Field Distortion	Measure amount of distortion produced due to presence of an RF coil in the scanner	Pre-defined performance standards	B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.	Pass
NEMA MS 6-2008 (SNR & Image Uniformity)	Evaluate single-channel non-volume special purpose radio-frequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems	Pre-defined performance standards	SNR and Image Uniformity are consistent with the requirements for indications for use.	Pass
Clinical Performance (Diagnostic Image Quality)	Produce diagnostic images of the shoulder that can be interpreted by a trained physician	Images suitable for diagnostic interpretation as per clinical assessment/comparison to predicate.	Performed clinical testing to exhibit a mix of technical factors and anatomy; No adverse events were reported. (Implies images were diagnostically acceptable)	Pass (Substantial Equivalence Demonstrated)

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

The document provides limited specific detail on the "sample size" in terms of number of patients or scans for the clinical testing. It states: "Clinical data exhibits a mix of technical factors and anatomy as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016."

Test Set Sample Size: Not explicitly quantified in terms of number of subjects/scans. The "clinical" section lists examples of sequences tested (e.g., Oblique Axial PD, Oblique Coronal T1). This suggests a limited number of test cases sufficient to demonstrate clinical image interpretability.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective or specifically conducted for regulatory submission, given the explicit mention of "Clinical performance testing" and comparison to FDA guidance.

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

This information is not explicitly provided in the document. For an MRI coil, the "ground truth" for diagnostic image quality would typically be judged by trained physicians (e.g., radiologists) interpreting the images. The document states the coils are "to produce diagnostic images of the shoulder that can be interpreted by a trained physician," implying such interpretation was part of the clinical assessment. However, the exact number and qualifications of these interpreting physicians are not detailed.

4. Adjudication Method for the Test Set

Not specified. For an MRI coil that is part of the image acquisition chain, the assessment is more about whether the images produced are diagnostically acceptable and substantially equivalent to images from the predicate device, rather than classifying presence/absence of a condition which would typically require an adjudication process.

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

No evidence of a formal MRMC study as would be conducted for an AI diagnostic algorithm. The evaluation is focused on the coil's ability to produce diagnostically interpretable images comparable to the predicate. The statement "Clinical testing demonstrates that the differences in the compatible scanners of the devices do not affect the safety and/or the effectiveness of the device when used as labeled" and "Clinical and non-clinical testing demonstrates that the safety and effectiveness of the 1.5T 16ch Shoulder Coil compared to the predicate device is not adversely affected as a result of the differences" suggests a comparative assessment, but not an MRMC study measuring human reader performance with/without AI assistance.

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

Not applicable. This submission is for an MRI coil, which is a physical device component, not an AI algorithm. Its "standalone performance" refers to its physical and electrical characteristics (bench testing) and its ability to produce images, not to interpret them.

7. The Type of Ground Truth Used

For the non-clinical (bench) testing:
- Engineering/Physics Measurements: Quantitative measurements (e.g., surface temperature, B1/B0 field distortion, SNR, image uniformity based on NEMA MS 6-2008).
- Compliance with Standards: Verification against recognized safety and performance standards (e.g., IEC 60601 series).
For the clinical testing:
- Clinical Interpretability: The "ground truth" implies that the images produced by the new coils were subjectively assessed as being of sufficient diagnostic quality to be interpreted by a trained physician, in comparison to images from the predicate device. The absence of adverse events further supported the safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is for an MRI coil, not an AI algorithm that requires a training set.

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

Not applicable. This is for an MRI coil, not an AI algorithm.

Summary

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June 2, 2020

Image /page/0/Picture/1 description: The image shows 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 % Ms. Katie Gonzalez Regulatory & Quality Engineering Manager N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K201101

Trade/Device Name: 1.5T 16ch Shoulder Coil. 3.0T 16ch Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: April 22, 2020 Received: April 24, 2020

Dear Ms. 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/cfpmp/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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)

K201101

Device Name 1.5T 16ch Shoulder Coil

Indications for Use (Describe)

To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

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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Indications for Use

510(k) Number (if known)

Device Name 3.0T 16ch Shoulder Coil

Indications for Use (Describe)

To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/4/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with a white crescent moon shape inside, and a black arrow pointing to the right. To the right of the logo is the word "NeoCoil" in blue and black lettering.

K201101

5. Traditional 510(k) Summary

5.1. Applicant
NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
5.2. Contact
Katie Gonzalez Regulatory & Quality Engineering Manager 262-522-6124 (office) 262-347-1251 (fax) Katie.Gonzalez@neocoil.com
5.3. Preparation Date
April 22, 2020
5.4. Name of Device
- Trade/Proprietary name(s): 1.5T 16ch Shoulder Coil . 3.0T 16ch Shoulder Coil . Common name: Magnetic Resonance Specialty Coil . Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS

5.5. Predicate Device

NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.

5.6. Device Description

The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are intended for use in a manner that is identical to the predicate device described in this submission.

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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 with an arrow on the left side, 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.

Proposed labeling is documented in the Instructions for Use manuals for the 1.5T 16ch Shoulder Coil (NC143IFUF-EN) and 3.0T 16ch Shoulder Coil (NC143IFU-EN).

5.7. Intended Use
The intended use for the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil are identical to that of the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.

The intended use is:

ldentical to that of routine imaging; specifically to produce diagnostic images of the shoulder.

Use of the device in conjunction with an MRI scanner is unchanged.

5.8. Indications for Use

1.5T 16ch Shoulder Coil:

To be used in coniunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

3.0T 16ch Shoulder Coil:

To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

5.9. Technological Characteristics

Both the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil are similar in design, material, chemical composition and energy source to the legally marketed device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.

At a high level, the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil 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; ●
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 imaging the shoulder anatomy; .
Mechanical designs are contoured for the shoulder anatomy: ●
Manufactured for use with the same MRI scanner manufacturer.

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

The exterior of the predicate device is a flexible foam whereas the 1.5T 16ch ● Shoulder Coil and 3.0T 16ch Shoulder Coil exterior is comprised of a rigid posterior array and a flexible anterior array;
Predicate device incorporates 8 channels whereas the1.5T 16ch Shoulder Coil and . the 3.0T 16ch Shoulder Coil incorporate 16 channels;

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Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with a white crescent shape inside, and a black arrow pointing to the right. To the right of the circular shape is the word "NeoCoil" in blue and black letters. The "Neo" part of the word is in blue, and the "Coil" part is in black.

. Different system cable connectors for the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil compared to the predicate to interface with the newer MRI scanners.
. Field strength for the 1.5T 16ch Shoulder Coil

The Indications for Use for the 1.5T 16ch Shoulder Coil is similar to the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007 differing in compatible scanner(s) and field strength.

With the exception of compatible scanner(s), the Indications for Use for the 3.0T 16ch Shoulder Coil are identical to the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.

Clinical testing demonstrates that the differences in the compatible scanners of the devices do not affect the safety and/or the effectiveness of the device when used as labeled.

Clinical and non-clinical testing demonstrates that the safety and effectiveness of the 1.5T 16ch Shoulder Coil compared to the predicate device is not adversely affected as a result of the differences.

5.10. Testing
A combination of clinical and non-clinical performance data is included, referenced or relied on to demonstrate that the 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are safe and effective and perform in a manner that demonstrates substantial equivalence to the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/207.

Performance testing - Bench:

A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA guidance 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	Discussions /Conclusions
NEMA MS 6-2008	Evaluate single-channel non-volumespecial purpose radio-frequency (RF) coilsfor use with magneticresonance (MR)imaging (MRI)systems	MRI scannertest	Pre-definedperformancestandards	Pass	SNR and ImageUniformity areconsistent with therequirements forindications for use.

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Image /page/7/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. The word "Neo" is in a lighter shade of blue than the word "Coil".

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Image /page/8/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular design 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.

Performance testing - Clinical:

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

No adverse events were reported during clinical performance testing.

1.5T 16ch Shoulder Coil	3.0T 16ch Shoulder Coil
Oblique Axial PD	Oblique Axial PD
Oblique Coronal T1 (no fat sat)	Oblique Coronal T1 (no fat sat)
Oblique Sagittal T2 (no fat sat)	Oblique Coronal T2 (fat sat)

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Image /page/9/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like shape with an arrow at the end, followed by the word "NeoCoil" in blue. The coil shape is on the left side of the logo, and the word "NeoCoil" is on the right side.

Image /page/9/Picture/2 description: This image shows two MRI scans of a shoulder, comparing the results from a 1.5T 16ch Shoulder Coil and a 3.0T 16ch Shoulder Coil. The scan on the left, labeled "Oblique Sagittal T2 (fat sat)," was taken using the 1.5T coil, while the scan on the right, labeled "Oblique Sagittal T2 (no fat sat)," was taken using the 3.0T coil. The image shows the difference in image quality and fat saturation between the two coils.

5.11. Conclusion

This submission demonstrates by means of nonclinical and clinical testing that the 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are safe and effective and perform as well as or better than the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007 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.