Who is the manufacturer of Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

Noras Mri Products GmbH filed the 510(k) submission for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T (K220144).

What is the FDA product code for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

Breast BI 7 MR Coil Mammavention 3T (K162651); Breast BI 7 MR Coil 1.5T Mammavention (K180123).

Who can help prepare an FDA 510(k) submission like Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K220144 · Noras Mri Products GmbH · MOS · Apr 8, 2022 · Radiology

Device Facts

Record ID	K220144
Device Name	Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
Applicant	Noras Mri Products GmbH
Product Code	MOS · Radiology
Decision Date	Apr 8, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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

Device Story

Specialty MRI coil sets for female breast imaging; used in conjunction with Siemens 0.55T, 1.5T, or 3T MRI scanners. Device consists of rigid coil frame, immobilization system, and biopsy unit. Functions as pure receiving coil; detects high-frequency signals from hydrogen nuclei induced by MRI scanner's transmitter. Signals digitized and processed by MRI system to produce transverse, sagittal, coronal, and oblique images. Used in clinical settings by trained physicians to assist in diagnosis and guide breast biopsies or wire localizations. Benefits include high-resolution imaging and precise MR-guided interventional procedures.

Clinical Evidence

No clinical testing performed. Bench testing included SNR (NEMA MS 1-2008), uniformity (NEMA MS 6-2008), surface coil heating, and usability testing (IEC 62366-1/2, IEC 60601-1-6). Biocompatibility testing per ISO 10993. Sample test images demonstrated good coverage, quality, uniformity, and SNR.

Technological Characteristics

7-channel phased array coil configuration. Materials: fiberglass-reinforced polycarbonate frame, PE breast cushion/headrest, Alexit biocompatible coating. Sensing: pure receiving coil for hydrogen nuclei signals. Connectivity: interfaces with Siemens MRI systems. Standards: IEC 60601-1, IEC 60601-1-2, NEMA MS-1, NEMA MS-6, ISO 10993.

Indications for Use

Indicated for female patients undergoing MR examination of the breast for diagnostic imaging and MR-guided biopsy or localization-wire placement. For use with Siemens 0.55T, 1.5T, and 3T MRI systems.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Breast BI 7 MR Coil Mammavention 3T (K162651)
Breast BI 7 MR Coil 1.5T Mammavention (K180123)

Related Devices

K162651 — Breast BI 7 MR Coil Mammavention 3T · Moras Mri Products GmbH · Jan 18, 2017
K180123 — Breast BI 7 MR Coil 1.5T Mammavention · Noras Mri Products GmbH · Feb 16, 2018
K182958 — 1.5T 16ch Breast Coil · Neocoil, LLC · Nov 16, 2018
K233348 — 16 Breast Coil · Philips Medical System Nederlands B.V. · Oct 24, 2023
K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil · Neocoil, LLC · Oct 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) 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 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ | | K162651: Breast BI 7 MR Coil Mammavention 3T K180123: 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 3T Mammavention 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 ad 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 wire localization of lesions can be performed by a trained physician. The coil system Breast BI 7 MR Coil Mammavention 3T can be used with the following MRI systems: 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra K180123: The intended use of Breast BI 7 MR Coil 1.5T Mammavention 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 wire localization of lesions can be performed by a trained physician. The coil system Breast BI 7 MR Coil Mammavention 1.5T can be used with the following MRI systems: 1.5T: Siemens 1.5T: Avanto fit, Aera, Amira | 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 | Functionally the same. An 0.55 T version has been added. | | | K162651: Breast BI 7 MR Coil Mammavention 3T K180123: 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 Compatible Systems | 1.5 T or 3 T | 0.55 T, 1.5 T, 3 T depending on model chosen. | Wider compatibility | | Standards | IEC 60601-1:2005, IEC 60601-1:2005 /AMD1:2012, Medical Electrical Equipment IEC 60601-1-2:2014/ Electromagnetic disturbances - Requirements and tests NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging ISO 10993-5:2009 Biological evaluation of medical devices Cytotoxicity ISO 10993-10:2009 Biological evaluation of medical devices Irritation and Sensitization 60601-1-6 Edition 3.1 2013-10 Collateral standard: Usability | Current versions used | SAME | | Function | Employs a coil system which serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. | Identical mode of operation | SAME | | Biocompatibility | Patient contact parts tested to ISO 10993 | SAME | SAME | {6}------------------------------------------------ {7}------------------------------------------------ ## 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.