To be used in conjunction with GEHC 1.5T Nagnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy accessories, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

Device Description

The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

AI/ML Overview

The information provided does not describe an AI/ML device but rather a Magnetic Resonance Specialty Coil (NeoCoil 1.5T 16ch Breast Coil). Therefore, most of the requested information (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set) is not applicable or cannot be extracted from the given text.

However, I can provide the acceptance criteria and reported device performance from the "Testing" section for the medical device in question.

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Unplugged Surface Temperature	Acceptable level of risk (not greater than 41°C)	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 (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	Pass: B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008 (SNR and Image Uniformity)	Pre-defined performance standards	Pass: SNR and Image Uniformity are consistent with the requirements for Indications for use.

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

Not applicable/Not provided. The document describes a physical device validation and does not refer to a "test set" in the context of an AI/ML model for data analysis or diagnostic performance. Clinical testing was performed, but specific sample sizes and data provenance details (country of origin, retrospective/prospective) are not mentioned.

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

Not applicable/Not provided. This device is an MRI coil, not an AI/ML diagnostic algorithm that requires expert-established ground truth for its performance evaluation in the described manner.

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

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This is not an AI-assisted device.

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

Not applicable/Not provided. This is a hardware component (MRI coil).

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

Not applicable/Not provided. The performance testing for this device focuses on physical characteristics, safety (temperature, RF fields), and imaging quality (SNR, uniformity) determined by engineering standards and clinical observation, not diagnostic ground truth as defined for AI/ML algorithms. Clinical testing "demonstrated performance adequate to support the Indications for Use," implying that the images produced were suitable for interpretation by a trained physician, which is the "Indication for Use."

8. The sample size for the training set:

Not applicable/Not provided. This is a hardware device, not an AI/ML algorithm.

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

Not applicable/Not provided. This is a hardware device.

Summary

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

November 16, 2018

NeoCoil, LLC Katie Gonzalez Regulatory & Ouality Engineering Manager N27 W23910 A Paul Rd. Pewaukee, Wisconsin 53072

Re: K182958

Trade/Device Name: 1.5T 16ch Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: October 22, 2018 Received: October 24, 2018

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Hole 2. Mild

for Robert A. 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)

K182958

Device Name 1.5T 16ch Breast Coil

Indications for Use (Describe)

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

Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol with an arrow pointing to the right, 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. The logo is simple and modern, and it is likely used to represent a company or product related to coils or other similar technology.

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 (direct) 261-347-1251 (fax) Katie.Gonzalez@neocoil.com
5.3. Preparation Date October 22, 2018
5.4. Name of Device

Proprietary Name: ●
- Common Name:
1.5T 16ch Breast Coil Magnetic Resonance Specialty Coil
Classification:
- 21 CFR 892.1000, Product Code MOS
5.5. Model Numbers

NeoCoil ModelNumber	NeoCoil Model Name
NC091203	Baseplate Assy, Breast Coil, 1.5T
NC091200	Medial Array, Breast Coil, 1.5T
NC091201	Lateral Array, Breast Coil, 1.5T Left
NC091202	Lateral Array, Breast Coil, 1.5T Right
NC091207	Biopsy Array, 1.5T Left
NC091208	Biopsy Array, 1.5T Right

5.6. Device Description

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

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

The NeoCoil 1.5T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

The NeoCoil 1.5T 16ch Breast Coil is intended for use in a manner that is identical to the predicate device described in this submission.

5.7. Predicate Device
- NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017. ●

5.8. Comparison to Predicate

The NeoCoil 1.5T 16ch Breast Coil is similar in physical, performance, design and material characteristics to the legally marketed device, the NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

With the exception of the field strength, the Indications for Use are identical with the predicate device, the NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

Clinical testing demonstrates that the differences in the field strength of 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 coniunction with GEHC 1.5T 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 accessories, 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 1.5T 16ch Breast Coil is safe and effective. The device's 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 meetsperformance 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 swirl inside and an arrow pointing to the right. To the right of the shape is the word "NeoCoil" in a sans-serif font. The "Neo" part of the word is in blue, while 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 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 1.5T 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 1.5T 16ch Breast Coil is equivalent to the predicate, NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

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.