(117 days)
Not Found
No
The document describes a passive receiving coil for an MRI system and does not mention any software or processing capabilities that would involve AI or ML.
No.
The device is used for diagnostic imaging and MR-guided biopsy/wire localization, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device" and that the images it provides "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 text, 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 description clearly states that the Breast Bl 7 MR Coil 3T Mammavention is a receiving coil for an MRI system. It receives high-frequency signals from hydrogen nuclei within the breast to create images.
- Intended Use: The intended use is for MR examination of the female breast and MR guided breast biopsy and wire localization. These are imaging and interventional procedures performed directly on the patient, not on samples taken from the patient.
The device is a component of a medical imaging system used for diagnosis, but it does not perform diagnostic tests on in vitro samples.
N/A
Intended Use / Indications for Use
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 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 can be used with the following MRI systems:
- 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra
Product codes
MOS, 90MOS
Device Description
The Breast BI 7 MR Coil 3T 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 -('-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 3T Mammavention which are digitized and further processed in the MRT system
Mentions image processing
Yes
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)
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 3T The power tests which have been done by MRI manufacturer for the whole system can be found in 017 20160728 Prisma Third Party Power Test Breast Bl 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
NORAS MRI products GmbH % Zahed Sedighiani Msc. Medical Engineering Leibnizstr. 4 Hoechberg, Bavaria D-97204 GERMANY
Re: K162651
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 Dated: December 27, 2016 Received: January 5, 2017
Dear Zahed Sedighiani:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162651
Device Name
Breast BI 7 MR Coil Mammavention 3T
Indications for Use (Describe)
The intended use of Breast BI 7 MR Coil 3T 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 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
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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Image /page/4/Picture/1 description: The image contains the logo for NORAS MRI products. The logo is in blue and white. The word "NORAS" is in large, bold letters, and the words "MRI products" are in smaller letters to the right of the word "NORAS".
510(k) SUMMARY
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Image /page/5/Picture/1 description: The image contains the logo for NORAS MRI products. The logo is primarily blue and white. The word "NORAS" is in bold, blue letters, underlined with a blue line. To the right of "NORAS" is a blue line that resembles a heartbeat, and the words "MRI products" are stacked on top of each other in smaller, blue letters.
510(k) Summary
Breast BI 7 MR Coil 3T Mammavention
Date of Summary Preparation: November 03, 2016
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
Zahed Sedighiani MSc. Medical Engineering QA & RA Management NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de
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Image /page/6/Picture/1 description: The image is a logo for NORAS MRI products. The logo features the word "NORAS" in bold, blue letters, underlined with a blue line. To the right of the word "NORAS" is a stylized image of a heartbeat, also in blue. Next to the heartbeat image are the words "MRI products" in smaller, blue letters.
Device Name and Classification 3.
| Trade Name: | Breast BI 7 MR Coil 3T Mammavention |
|---|---|
| Common Name: | Breast BI 7 MR Coil 3T Mammavention |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | 90MOS |
Device Description 4.
The Breast BI 7 MR Coil 3T 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 -('-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 3T Mammavention which are digitized and further processed in the MRT system
5. Intended Use / Indications for Use
The intended use of Breast Bl 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 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 Bl 7 MR Coil Mammavention can be used with the following MRI systems:
- 3T: Siemens 3T: Skyra, Skyra fit, Prisma, Prisma fit, Spectra
7
Image /page/7/Picture/1 description: The image shows the logo for NORAS MRI products. The logo is in blue and white, with the word "NORAS" in large, bold letters. To the right of the word "NORAS" is a line that resembles a heartbeat, and the words "MRI products" are written in smaller letters below the line. The logo is simple and professional, and it effectively communicates the company's focus on MRI products.
6. Substantial Equivalence
NORAS MRI product GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the Breast Bl 7 MR Coil 3T Mammavention is substantially equivalent to the following multipurpose coil:
| Predicate
Device Name
and
Manufacturer | 510(k)
Number | Clearance
Date | Product Code | Comparable
Properties |
|-------------------------------------------------|------------------|-------------------|--------------|--------------------------------------------------------------------|
| Breast Biopsy
4-Ch Coil MR-
BI320-PA 3T | K082373 | Aug 29, 2008 | 90MOS | Proton imaging
High resolution of
breast anatomic
regions |
7. Summary of Technological Characteristics of the Principal Device as Compared with the predicate Device
Summary of technological characteristics of the Breast Bl 7 MR Coil 3T Mammavention are the same as for the predicate device Breast Biopsy 4-Ch Coil MR-BI320-PA 3T
General Safety and Effectiveness Concerns 8.
The Breast BI 7 MR Coil 3T 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 60601-2-33:2002. 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 3T The power tests which have been done by MRI manufacturer for the whole system can be found in 017 20160728 Prisma Third Party Power Test Breast Bl 7.
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 BI 7 MR Coil 3T Mammavention is substantially equivalent to the predicate device listed above.
Zahed Sedighiani QM & RA Manager December 27, 2016