← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K180123

# Breast BI 7 MR Coil 1.5T Mammavention (K180123)

_Noras Mri Products GmbH · MOS · Feb 16, 2018 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K180123

## Device Facts

- **Applicant:** Noras Mri Products GmbH
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Feb 16, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended 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.

## Device Story

Device is a dedicated breast receive-only MRI coil system; used with Siemens 1.5T MRI scanners (Avanto fit, Aera, Amira). Coil detects high-frequency signals from hydrogen nuclei induced by the MRI scanner's transmitter; signals are digitized and processed by the host MRI system to generate diagnostic images. Includes a Breast Biopsy Unit for MR-guided biopsy and wire localization. Operated by trained physicians in clinical imaging environments. Output consists of high-resolution anatomical images of breast structures; assists physicians in lesion diagnosis and interventional guidance. Benefits include improved visualization of internal breast structures for diagnostic and biopsy procedures.

## Clinical Evidence

Bench testing only. Device performance and safety parameters verified against FDA-recognized NEMA standards and IEC 60601-2-33:2011. Power tests conducted for the integrated system.

## Technological Characteristics

Receive-only RF coil for 1.5T MRI; compatible with Siemens Avanto fit, Aera, and Amira systems. Complies with IEC 60601-2-33:2011. No internal software algorithms; functions as a passive signal receiver for the host MRI system.

## Regulatory 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 3T Mammavention ([K162651](/device/K162651.md))

## Submission Summary (Full Text)

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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);

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## 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

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## 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)

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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

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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

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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

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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<br>Device Name<br>and<br>Manufacturer | 510(k)<br>Number | Clearance<br>Date  | Product Code | Comparable<br>Properties                                           |
|-------------------------------------------------|------------------|--------------------|--------------|--------------------------------------------------------------------|
| Breast BI 7 MR<br>Coil 3T<br>Mammavention       | K162651          | January 18<br>2017 | 90MOS        | Proton imaging<br>High resolution of<br>breast anatomic<br>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

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K180123](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K180123)

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