Breast BI 7 MR Coil Mammavention 3T

K162651 · Moras Mri Products GmbH · MOS · Jan 18, 2017 · Radiology

Device Facts

• Record ID: K162651
• Device Name: Breast BI 7 MR Coil Mammavention 3T
• Applicant: Moras Mri Products GmbH
• Product Code: MOS · Radiology
• Decision Date: Jan 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended 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

Device Story

Breast BI 7 MR Coil 3T Mammavention is a specialized receiving coil for Siemens 3T MRI systems; designed for female breast imaging and MR-guided biopsy. Device functions as a receiver for high-frequency signals from hydrogen nuclei induced by the MRI scanner's transmitter. Induced potential differences are digitized and processed by the host MRI system to generate transverse, sagittal, coronal, and oblique images. Used in clinical settings by trained physicians to visualize internal breast structures, aid in diagnosis, and perform interventional procedures like wire localization. Benefits include high-resolution anatomical imaging for diagnostic and interventional guidance.

Clinical Evidence

Bench testing only. Device performance and safety parameters were verified against FDA-recognized NEMA standards and IEC 60601-2-33:2002. Power testing was conducted for the integrated system with Siemens MAGNETOM 3T scanners.

Technological Characteristics

Receiving coil for 3T MRI systems; compatible with Siemens Skyra, Skyra fit, Prisma, Prisma fit, and Spectra. Sensing principle: induction of potential differences from hydrogen nuclei precession. Conforms to IEC 60601-2-33:2002 and NEMA standards for MRI safety and performance. Includes integrated Breast Biopsy Unit.

Indications for Use

Indicated for diagnostic MR imaging of the female breast and MR-guided breast biopsy/wire localization of lesions. For use by trained physicians.

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 Biopsy 4-Ch Coil MR-BI320-PA 3T (K082373)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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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

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### 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)

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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 [e-mail]

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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

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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<br>Device Name<br>and<br>Manufacturer | 510(k)<br>Number | Clearance<br>Date | Product Code | Comparable<br>Properties |
|-------------------------------------------------|------------------|-------------------|--------------|--------------------------------------------------------------------|
| Breast Biopsy<br>4-Ch Coil MR-<br>BI320-PA 3T | K082373 | Aug 29, 2008 | 90MOS | Proton imaging<br>High resolution of<br>breast anatomic<br>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