The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems

Device Description

These three models are known as specialty MRI coils for use in generating MRI images of the female breast. MRI procedures that include the evaluated device are conducted for clinical purposes at the discretion of the ordering physician. The Breast BI Coil Sets described in this document has been designed, depending upon model type, for use with an MRI system with field strength of 0.55T 1.5T or 3.0T. The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen-('H)-nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRI device. The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system. The Breast BI Coil Sets consist of a rigid Coil Frame with Immobilization, Biopsy and Breast Coil System. Imaging is performed with a 7-Channel "phased array" Coil developed and manufactured by the NORAS company. The coils are mounted in the rigid Coil Frame. Interconnection is handled by the software of the MRI. The Breast BI Coil Set 0.55T is an innovative concept designed to offer flexible use to meet the needs of the procedure to be performed in your clinic. It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths. The rigid Coil Frame forms a high resolution, 7-channel "phased array" configuration. The Coil Frame is made of fiberglass-reinforced polycarbonate. The surface has been finished with Alexit biocompatible coating. The breast cushion and the headrest are made of PE

AI/ML Overview

The provided text describes a 510(k) premarket notification for a new set of breast MRI coils. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials typical for novel high-risk devices. Therefore, the information provided focuses on engineering and performance testing, largely comparing the new device to existing cleared devices.

As such, the document does not detail a study that proves the device meets specific performance-based acceptance criteria in a clinical setting related to diagnostic accuracy or AI performance. Instead, it focuses on demonstrating that the new coils are functionally equivalent and equally safe compared to predicate devices through engineering and performance testing.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for medical image analysis, expert ground truth establishment, MRMC studies, or AI performance are not applicable or not provided in this document because the device itself is an MRI coil, not an AI diagnostic algorithm or a device requiring a clinical efficacy study beyond demonstrating image quality and safety.

However, I can extract the information relevant to the performance and safety testing that was conducted according to the document.

Acceptance Criteria and Device Performance (Based on Engineering and Safety Testing):

The acceptance criteria for this device are not defined in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) as it is an imaging coil, not a diagnostic algorithm. Instead, the performance is assessed based on engineering standards for image quality and safety.

Acceptance Criteria Category	Reported Device Performance (Summary)
Safety Testing	Devices subjected to IEC60601-1 Safety Testing and IEC60601-1-2 ESD Testing. Patient contact materials subjected to ISO 10993 tests for Cytotoxicity, Irritation, and Sensitization. (Successful)
Image Quality (SNR)	Testing performed in accordance with NEMA MS 1-2008 (R2014, R2020) for Signal-to-Noise Ratio (SNR). (Assured good S/N performance)
Image Quality (Uniformity)	Uniformity testing performed in accordance with NEMA MS 6-2008. (Successfully performed)
Heating	Surface coil heating testing. (Successfully performed)
Usability	Usability testing performed in accordance with IEC 62366-1.2015, IEC/TR 62366-2:2016, and IEC 60601-1-6:2016. (Successfully performed)
Clinical Image (New Model)	Clinical sample test images obtained for the new 0.55T model exhibited: good coverage, quality, uniformity, and SNR. (Qualitative assessment to demonstrate functional equivalence for the new field strength option.)

Since the device is an MRI coil and not an AI-powered diagnostic tool, the following sections are largely not applicable or the information is not provided in this type of submission.

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 for typical clinical diagnostic test set for AI. The "clinical sample test images" mentioned were likely acquired for qualitative assessment of functional performance (image quality) of the coil itself rather than a diagnostic study with a human-in-the-loop or standalone AI. The sample size for this qualitative assessment is not specified, nor is the provenance of the patients from whom the images were acquired.
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. Ground truth in the context of diagnostic accuracy via expert consensus is not described as the focus is on the performance of the coil itself in generating images, not on interpreting those images for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. Similarly, no adjudication method is described as the document does not detail a diagnostic performance study.
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 Done. This is an MRI coil, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Done. This is an MRI coil, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided. For the image quality assessment, the "ground truth" is adherence to engineering specifications for SNR, uniformity, etc., and qualitative assessment of images ("good coverage, quality, uniformity and SNR") by experienced personnel.
The sample size for the training set:
- Not Applicable / Not Provided. This document is for an MRI coil, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not Applicable / Not Provided. As above, this document is for an MRI coil, not an AI model.

In summary, the provided document is a 510(k) submission for a medical device (MRI coils), not an AI algorithm or a device requiring a clinical study for diagnostic efficacy. The acceptance criteria and "study" are therefore focused on demonstrating the device's conformance to established engineering standards for safety and image quality, and proving its substantial equivalence to previously cleared predicate devices.

Summary

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April 8, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized image of an eagle. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.

NORAS MRI Products GmbH % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct NAPLES FL 34114

Re: K220144

Trade/Device Name: Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: February 17, 2022 Received: February 18, 2022

Dear Daniel Kamm:

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 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 (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)

K220144

Device Name

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

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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510(k) Summary K220144

Image /page/3/Picture/1 description: The image is a logo for NORAS MRI products. The logo is in blue and white, with the word "NORAS" in large, bold letters. Underneath the word "NORAS" is a horizontal line that extends to the right and forms a heartbeat-like line. To the right of the heartbeat line are the words "MRI products" in smaller letters.

NORAS MRI Products GmbH Leibnizstrasse 4 Hoechberg Germany 97204 Telephone: +49 931/2 99 27-0 Telefax: +49 931/2 99 27-20 E-Mail: mri@noras.de www.noras.de Date Prepared: April 8, 2022

A) SUBMITTED BY: NORAS MRI Products GmbH, Inc
B) CONTACT: Manuel Noras, Chief Executive Officer
C) Device Identification

Trade/Device Names: Breast Bl Coil Set 0.55T; Breast Bl 7 MR Coil Set 1.5T; Breast Bl 7 MR Coil Set 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: ll Product Code: MOS

D) Predicate Device:	K162651
Manufacturer:	NORAS MRI Products GmbH
Trade/Device Name:	Breast BI 7 MR Coil Mammavention 3T
Regulation Number:	21 CFR 892.1000
Regulation Name:	Magnetic resonance diagnostic device
Regulatory Class:	II
Product Code:	MOS

Additional Predicate Device: K180123 Manufacturer: NORAS MRI Products GmbH Trade/Device Name: Breast Bl 7 MR Coil 1.5T Mammavention Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: ll Product Code: MOS

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D) DEVICE DESCRIPTION: These three models are known as specialty MRI coils for use in generating MRI images of the female breast. MRI procedures that include the evaluated device are conducted for clinical purposes at the discretion of the ordering physician.

The Breast BI Coil Sets described in this document has been designed, depending upon model type, for use with an MRI system with field strength of 0.55T 1.5T or 3.0T.

The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen-('H)-nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRI device.

The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system.

The Breast BI Coil Sets consist of a rigid Coil Frame with Immobilization, Biopsy and Breast Coil System. Imaging is performed with a 7-Channel "phased array" Coil developed and manufactured by the NORAS company. The coils are mounted in the rigid Coil Frame. Interconnection is handled by the software of the MRI.

The Breast BI Coil Set 0.55T is an innovative concept designed to offer flexible use to meet the needs of the procedure to be performed in your clinic. It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths. The rigid Coil Frame forms a high resolution, 7-channel "phased array" configuration.

The Coil Frame is made of fiberglass-reinforced polycarbonate. The surface has been finished with Alexit biocompatible coating. The breast cushion and the headrest are made of PE

E) INDICATIONS FOR USE The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems.

F) SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION: Except for the new MR field strength of 0.55 T the devices are functionally identical. All models conform to NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002. All device testing have been completed successfully. The indications for use statements are functionally identical. Please refer to the detailed comparison table presented below. The added models do not raise any new questions about safety or effectiveness.

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	K162651: Breast BI 7 MR Coil Mammavention 3TK180123: Breast BI 7 MR Coil 1.5T Mammavention	Breast BI Coil Set 0.55T;Breast BI 7 MR Coil Set 1.5T;Breast BI 7 MR Coil Set 3T	Comparison
Indication for Use	K162651: The intended use of Breast BI 7 MR Coil 3TMammavention is, in conjunction with a MagneticResonance Scanner, the MR examination of the femalebreast. It is indicated for use as a diagnostic imaging deviceto produce transverse, sagittal, coronal ad oblique imagesof the internal structures of the female breast. Wheninterpreted by a trained physician, these images provideinformation that can be useful in determining diagnosis.The included Breast Biopsy Unit permits MR guided breastbiopsy and wire localization of lesions can be performed bya trained physician. The coil system Breast BI 7 MR CoilMammavention 3T can be used with the following MRIsystems: 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prismafit, SpectraK180123: The intended use of Breast BI 7 MR Coil 1.5TMammavention is, in conjunction with a MagneticResonance Scanner, the MR examination of the femalebreast. It is indicated for use as a diagnostic imaging deviceto produce transverse, sagittal, coronal and oblique imagesof the internal structures of the female breast. Wheninterpreted by a trained physician, these images provideinformation that can be useful in determining diagnosis.The included Breast Biopsy Unit permits MRguided breast biopsy and wire localization of lesions canbe performed by a trained physician.The coil system Breast BI 7 MR Coil Mammavention 1.5Tcan be used with the following MRI systems: 1.5T: Siemens1.5T: Avanto fit, Aera, Amira	The intended use of the Breast Coil is, in conjunctionwith a Magnetic Resonance Scanner, the MRexamination of the female breast. It is indicated foruse as a diagnostic imaging device to producetransverse, sagittal, coronal and oblique images of theinternal structures of the female breast. Wheninterpreted by a trained physician, these imagesprovide information that can be useful in determiningdiagnosis. The included Breast Biopsy Unit permitsMR guided breast biopsy and placement oflocalization-wire by a trained physician. For use withSiemens 0.55T, 1.5T, and 3T systems	Functionally thesame. An 0.55 Tversion has beenadded.
	K162651: Breast BI 7 MR Coil Mammavention 3TK180123: Breast BI 7 MR Coil 1.5T Mammavention	Breast BI Coil Set 0.55T;Breast BI 7 MR Coil Set 1.5T;Breast BI 7 MR Coil Set 3T	Comparison
Appearance	Image: Breast BI 7 MR Coil Mammavention 3T and Breast BI 7 MR Coil 1.5T Mammavention	Image: Breast BI Coil Set 0.55T, Breast BI 7 MR Coil Set 1.5T, and Breast BI 7 MR Coil Set 3T	SIMILAR
MR CompatibleSystems	1.5 T or 3 T	0.55 T, 1.5 T, 3 T depending on model chosen.	Widercompatibility
Standards	IEC 60601-1:2005, IEC 60601-1:2005 /AMD1:2012, MedicalElectrical EquipmentIEC 60601-1-2:2014/ Electromagnetic disturbances -Requirements and testsNEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio(SNR) in Diagnostic Magnetic Resonance ImagingISO 10993-5:2009 Biological evaluation of medical devicesCytotoxicityISO 10993-10:2009 Biological evaluation of medical devicesIrritation and Sensitization60601-1-6 Edition 3.1 2013-10 Collateral standard: Usability	Current versions used	SAME
Function	Employs a coil system which serves solely as a receiving coilfor the reception of high frequency signals from thehydrogen -(1-H) nuclei. The hydrogen nuclei are inducedinto precession by the transmitting coil of the MRT device.	Identical mode of operation	SAME
Biocompatibility	Patient contact parts tested toISO 10993	SAME	SAME

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G) SUMMARY OF PERFORMANCE TESTING.

Patient contact materials were subjected to ISO 10993 tests for: Cytoxicity, Irritation, and sensitization. The devices were subjected to IEC60601-1 Safety Testing and IEC60601-1-2 ESD Testing.

Testing was performed to in accordance with NEMA MS 1-2008 (R2014, R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Resonance Imaging in order to assure good S/N performance. Additionally, uniformity (NEMA MS 6-2008) and surface coil heating testing was successfully performed.

Usability testing was performed in accordance with: IEC 62366-1.2015 Medical Devices - Part 1: Application of Usability Engineering To Medical Devices IEC/TR 62366-2:2016 Medical Devices - Part 2: Guidance On The Application Of Usability Engineering To Medical Devices, and IEC 60601-1-6:2016 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability

Clinical sample test images were obtained for the new model listed above. The images exhibited good coverage, quality, uniformity and SNR.

H) CLINICAL TESTING: Not required.

I) CONCLUSION:

In all material aspects, the new models of breast MR coils performed equivalently to the predicate device, had similar construction methods, and have not raised any new issues of safety or effectiveness. They have an indications for use statement that is virtually identical to the predicate, thus rendering the new models of MRI coils substantially equivalent to the predicate.

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.