(31 days)
Not Found
No
The document describes a passive receiving coil for an MRI system and mentions standard signal processing within the MRI system, but there is no mention of AI or ML being used for image interpretation, analysis, or any other function.
No
The device is described as a "diagnostic imaging device" used to produce images for diagnosis, and it also permits MR-guided breast biopsy and wire localization, which are diagnostic/interventional procedures, not therapeutic.
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. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis."
No
The device description explicitly states it is a "coil system" and a "receiving coil" for MR signals, indicating it is a hardware component.
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.
- Device Function: The Breast BI 7 MR Coil 1.5T Mammavention is a medical device used in conjunction with an MRI scanner to produce images of the female breast. It receives high-frequency signals from hydrogen nuclei within the body.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts with the body directly to generate images.
- Imaging Modality: The input imaging modality is Magnetic Resonance, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
The device is a diagnostic imaging device used to aid in diagnosis based on the interpretation of images by a trained physician. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 1.5T Mammavention can be used with the following MRI systems:
1.5T: Siemens 1.5T: Avanto fit, Aera, Amira
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Breast BI 7 MR Coil 1.5T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system 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. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 1.5T Mammavention which are digitized and further processed in the MRT system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Breast BI 7 MR Coil 1.5T Mammavention is conform with the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2011. All device testing have been completed successfully before device clearance. This assures that the performance of this device can be considered safe and effective when used with the currently available Siemens MAGNETOM 1.5T The power tests which have been done by MRI manufacturer for the whole system can be found in 076 Third Party Power Test Breast Bl 7 MR Coil 1.5T.pdf.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 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.
February 16, 2018
Noras MRI products GmbH Jens Heidenmann Official Correspondent Leibnizstrasse 4 Hoechberg, 97204 De
Re: K180123
Trade/Device Name: Breast BI 7 MR Coil 1.5T Mammavention Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: December 28, 2017 Received: January 16, 2018
Dear Jens Heidenmann:
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. 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);
1
Page 2 - Jens Heidenmann
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 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 A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K 180123
Device Name
Breast BI 7 MR Coil Mammavention 1.5T (PN:118879)
Indications for Use (Describe)
The intended use of Breast BI 7 MR Coil 1.5T Mammavention 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 physican, 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 chan 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
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
Image /page/3/Picture/1 description: The image shows the logo for NORAS MRI products. The word "NORAS" is in large, bold, blue letters. To the right of the word "NORAS" is a blue line that resembles a heartbeat, and the words "MRI products" are to the right of the line.
510(k) SUMMARY
4
Image /page/4/Picture/1 description: The image shows the logo for NORAS MRI products. The word "NORAS" is in large, bold, blue letters. To the right of the word "NORAS" is a blue line that resembles a heartbeat. To the right of the heartbeat line are the words "MRI products" in smaller, blue letters. The logo is set against a white background with a blue shape on the left side.
510(k) Summary
Breast BI 7 MR Coil 1.5T Mammavention
Date of Summary Preparation: 2018 - 02 - 14
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
1. General Information
Importer/Distributor Name and Address NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
Manufacturing Site Name and Address NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
2. Contact Person
Jens Heidenmann QA & RA Management NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 jens.heidenmann@noras.de
5
Image /page/5/Picture/1 description: The image shows the logo for NORAS MRI products. The logo is in blue and white, and it features the word "NORAS" in large, bold letters. To the right of the word "NORAS" is a line that resembles a heart rate monitor. To the right of the line is the text "MRI products" in smaller letters.
3. Device Name and Classification
| Trade Name: | Breast BI 7 MR Coil 1.5T Mammavention (PN:118879) |
|---|---|
| Common Name: | Breast BI 7 MR Coil 1.5T Mammavention |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | 90MOS |
| Submission Number: | K180123 |
4. Device Description
The Breast BI 7 MR Coil 1.5T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system 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. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 1.5T Mammavention which are digitized and further processed in the MRT system
5. Intended Use / Indications for Use
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 1.5T Mammavention can be used with the following MRI systems:
1.5T: Siemens 1.5T:
Avanto fit, Aera, Amira
6
Image /page/6/Picture/1 description: The image shows the logo for NORAS MRI products. The logo is in blue and white. The word "NORAS" is in large, bold letters. To the right of the word "NORAS" is a line that resembles a heartbeat, and the words "MRI products" are below the line. The logo is simple and professional.
Substantial Equivalence 6.
NORAS MRI product GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the Breast BI 7 MR Coil 1.5T Mammavention is substantially equivalent to the following multipurpose coil:
| Predicate
Device Name
and
Manufacturer | 510(k)
Number | Clearance
Date | Product Code | Comparable
Properties |
|-------------------------------------------------|------------------|--------------------|--------------|--------------------------------------------------------------------|
| Breast BI 7 MR
Coil 3T
Mammavention | K162651 | January 18
2017 | 90MOS | Proton imaging
High resolution of
breast anatomic
regions |
Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device
Summary of technological characteristics of the Breast Bl 7 MR Coil 1.5T Mammavention are the same as for the predicate device Breast BI 7 MR Coil 3T Mammavention
General Safety and Effectiveness Concerns 8.
The Breast BI 7 MR Coil 1.5T Mammavention is conform with the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2011. All device testing have been completed successfully before device clearance. This assures that the performance of this device can be considered safe and effective when used with the currently available Siemens MAGNETOM 1.5T The power tests which have been done by MRI manufacturer for the whole system can be found in 076 Third Party Power Test Breast Bl 7 MR Coil 1.5T.pdf.
9. Conclusion as to Substantial Equivalence
NORAS MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the Breast Bl 7 MR Coil 1.5T Mammavention is substantially equivalent to the predicate device listed above.
Jens Kude
Jens Heidenmann QM & RA Manager
February 14. 2018