(79 days)
Not Found
No
The device description focuses on the hardware components of the MRI coil and its function in receiving signals. There is no mention of AI or ML in the intended use, device description, or performance studies. The "further processed in the MRI system" likely refers to standard image reconstruction algorithms, not AI/ML.
No.
The device is described as a diagnostic imaging device used to produce images and facilitate biopsy, which are diagnostic procedures, not therapeutic ones.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "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." It also adds that these images, when interpreted by a trained physician, "provide information that can be useful in determining diagnosis."
No
The device description explicitly details physical components like a rigid Coil Frame, Breast Coil System, and materials like fiberglass-reinforced polycarbonate and PE, indicating it is a hardware device. While it interacts with MRI system software, the core device itself is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an MRI coil used in conjunction with an MRI scanner. Its function is to receive signals from the body during an MRI scan to produce images of the breast. It also facilitates MR-guided biopsy and localization-wire placement.
- No Sample Analysis: The device does not analyze samples taken from the body. It is an external component used during an imaging procedure.
- Imaging Modality: The input imaging modality is Magnetic Resonance, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
Therefore, while the device is a medical device used for diagnostic purposes, it falls under the category of medical imaging equipment rather than an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
MOS
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
Mentions image processing
The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner (MRI)
Anatomical Site
female breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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.