To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

Device Description

The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.

AI/ML Overview

The provided text describes the NeoCoil 3.0T 16ch Breast Coil and its performance testing to support its substantial equivalence to a predicate device. However, it does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/algorithm-driven diagnostic device. The device in question is a magnetic resonance imaging (MRI) coil, which is a hardware component, not an AI or software device.

Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable to the information provided for this hardware device.

Here's an attempt to extract the relevant information and indicate where the requested details are not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Unplugged Surface Temperature	Acceptable level of risk (not greater than 41°C when unplugged in MRI scanner)	Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
Surface Temperature	Pre-defined performance standards (RF and Eddy current heating not greater than 41°C)	Pass: RF and Eddy current heating is not greater than 41°C.
Blocking Network Analysis	Adequate transmit decoupling	Pass: Blocking network demonstrates adequate active and passive transmit decoupling.
B1 Field Distortion	Pre-defined performance standards (meet Toshiba performance requirements, adequate decoupling)	Pass: B1 field inhomogeneity meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008 (SNR and Image Uniformity)	Pre-defined performance standards (consistent with requirements for indications for use)	Pass: SNR and Image Uniformity are consistent with the requirements for indications for use.
Clinical Performance Testing	Performance adequate to support Indications for Use	Pass: No adverse events were reported. The 3.0T 16ch Breast Coil demonstrated performance adequate to support the Indications for Use. (Ability to produce diagnostic and interventional planning images of the breast, axilla, and chest wall.)

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not explicitly stated for specific tests. The document mentions "clinical performance testing" but does not quantify the number of patients or images.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only mentions "clinical data in this section exhibits a mix of technical factors and anatomy".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a hardware device (MRI coil) and its performance is evaluated based on physical measurements (temperature, RF properties) and image quality metrics (SNR, uniformity) rather than specific diagnostic outcomes requiring expert consensus on a test set of cases. The "Indications for Use" mention interpretation by a "trained physician," but this is for general clinical use, not for establishing ground truth in a performance study of the coil itself.

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

Not Applicable. See point 3.

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:

No. This is not an AI device.

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

Not Applicable. This is not an AI device.

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

Not Applicable in the context of diagnostic accuracy for a specific disease. The "ground truth" for this device's performance involves objective physical measurements and adherence to engineering and imaging standards (e.g., temperature limits, signal-to-noise ratios, image uniformity as per NEMA MS 6-2008).

8. The sample size for the training set:

Not Applicable. This is not an AI device that requires a training set.

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

Not Applicable. This is not an AI device.

Summary

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November 28, 2017

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are both in color and are placed side-by-side.

NeoCoil, LLC % Mr. Michael Leigh Director, Regulatory Affair N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K173377

Trade/Device Name: 3.0T 16ch Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 26, 2017 Received: October 31, 2017

Dear Mr. Leigh:

We have reviewed vour 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. 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); 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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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173377

Device Name 3.0T 16Ch Breast Coil

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Image /page/3/Picture/2 description: The image shows 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 circular shape is the word "NeoCoil" in blue and black font. The "Neo" part of the word is in blue, and the "Coil" part is in black.

5. Traditional 510(k) Summary

5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
5.2. Contact Michael Leigh Director, Regulatory 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com
5.3. Preparation Date October 23, 2017
5.4. Name of Device
- Proprietary Name: 3.0T 16ch Breast Coil ●
- . Common Name:
  - Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS
- Classification: .
5.5. Model Numbers

NeoCoil ModelNumber	NeoCoil Model Name
NC088203	Baseplate Assy, Breast Coil, 3.0T
NC088200	Medial Array, Breast Coil, 3.0T
NC088201	Lateral Array, Breast Coil, 3.0T Left
NC088202	Lateral Array, Breast Coil, 3.0T Right
NC088207	Biopsy Array, 3.0T Left
NC088208	Biopsy Array, 3.0T Right

5.6. Device Description

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

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 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. The word "Neo" is in blue, and the word "Coil" is in black.

The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.

The NeoCoil 3.0T 16ch Breast Coil are intended for use in a manner that is similar to the predicate device described in this submission.

5.7. Predicate Device
- 3.0T HD Breast Array, K052585, as cleared on 10/04/2005. ●

5.8. Comparison to Predicate

The NeoCoil 3.0T 16ch Breast Coil is similar in physical, performance, design and material characteristics to the legally marketed device, the 3.0T HD Breast Array, K052585, as cleared on 10/04/2005.

The Indications for Use are consistent with the capabilities of the predicate device, the USA Instruments 3.0T HD Breast Array, K052585 as cleared on 10/04/2005, and marketed by GEHC as the 8 Ch Breast Coil.

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

5.9. Indications for Use
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

5.10. Intended Use

Intended use is identical to that of routine imaging; specifically to produce diagnostic and interventional planning images of the breasts. axilla and chest wall. Use of the device in conjunction with an MRI scanner is unchanged.

5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil 3.0T 16ch Breast Coil is safe and effective. The devices' performance meets the requirements of pre-defined acceptance criteria and intended uses.

Test	Pass/Fail Criteria	Result
Unplugged SurfaceTemperature	Acceptable level of risk	Pass: Surface temperature is not greater than41°C when the coil is left unplugged in the MRIscanner.
Surface Temperature	Pre-definedperformance standards	Pass: RF and Eddy current heating is notgreater than 41°C.
Blocking NetworkAnalysis	Adequate transmitdecoupling	Pass: Blocking network demonstratesadequate active and passive transmitdecoupling.
B1 Field Distortion	Pre-definedperformance standards	Pass: B1 field inhomogeneity meets Toshibaperformance requirements and demonstratesadequate active and passive transmitdecoupling.

Performance testing - Bench:

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Image /page/5/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 lettering. The "Neo" part of the word is in blue, and the "Coil" part is in black.

Test	Pass/Fail Criteria	Result
NEMA MS 6-2008	Pre-definedperformance standards	Pass: SNR and Image Uniformity areconsistent with the requirements for indicationsfor use.

Published Standards testing:

Standard	Purpose
IEC 60601-1	Electromechanical safety
IEC 60601-1-2	ESD
IEC 60601-1-6	Usability
IEC 60601-2-33	Electromechanical safety
ISO 10993-1	Biocompatibility
NEMA MS-6	SNR and Image Uniformity

Performance testing - Clinical:

The clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes 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; the 3.0T 16ch Breast Coil demonstrated performance adequate to support the Indications for Use.

5.12. Conclusion

This submission demonstrates that the Indications for Use are in line with the predicate device to produce diagnostic images of the breasts, axilla and chest wall and are as safe and effective as the predicate device. As such, the 3.0T 16ch Breast Coil is equivalent to the predicate, USA Instruments 3.0T HD Breast Array, K052585 as cleared on 10/04/2005, and marketed by GEHC as the 8 Ch Breast Coil.

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.