BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC

K052987 · Noras Rontgen-Und Medizintechnik GmbH · LNH · Nov 8, 2005 · Radiology

Device Facts

• Record ID: K052987
• Device Name: BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
• Applicant: Noras Rontgen-Und Medizintechnik GmbH
• Product Code: LNH · Radiology
• Decision Date: Nov 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.

Device Story

Breast immobilization and biopsy accessory; compatible with breast array coils. Shapes breast tissue into 'brick' form via mild compression; enables efficient slice utilization during MR imaging. Includes needle positioning components for aiming at lesions identified on MR scans. Compatible with MR-safe biopsy or wire localization needles. Used in clinical settings by trained physicians. Device does not control life-sustaining functions; does not alter MR coil performance. Clinician performs scan with needle in situ to verify lesion targeting; accounts for potential needle deflection or slice warp. Benefits include improved imaging efficiency and precise lesion localization for biopsy.

Clinical Evidence

No clinical data. Bench testing only. Device performance is verified by the clinician performing a scan with the needle in the breast to ensure accurate placement into the lesion.

Technological Characteristics

Breast immobilization and biopsy accessory; compatible with MR breast array coils. Mechanical compression mechanism for tissue shaping. MR-compatible materials. No electronic components or software. Standalone accessory.

Indications for Use

Indicated for use with Magnetic Resonance Scanners to perform MR-guided breast biopsy and wire localization of lesions in patients requiring such procedures, to be performed and interpreted by a trained physician.

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 IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY MR BI 160 (K010570)

Submission Summary (Full Text)

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NOV - 8 2005

**510(k) Summary of Safety & Effectiveness**

(as required by 21 CFR 807.92c)

Date Prepared:

October 11, 2005

#### Submitter's Information:

NORAS RONTGEN-UND MEDIZINTECHNIK GMBH Leibnizstrasse 4 97204 Hochberg Germany Phone: [phone]

# Trade Name, Common Name, Classification:

| Trade name: | Breast Immobilization and Biopsy Device BI 160-O, BI<br>160-PA, and BI 160-CC |
|----------------------|-------------------------------------------------------------------------------|
| Common name: | Breast Immobilization and Biopsy Device |
| Classification name: | Magnetic resonance diagnostic device |
| Product Code: | 90 LNH |

#### Predicate Device:

| DEVICE CLASSIFICATION<br>NAME | system, nuclear magnetic resonance<br>imaging |
|-------------------------------|------------------------------------------------------------------|
| REGULATION NUMBER | 892.1000 |
| 510(K) NUMBER | K010570 |
| DEVICE NAME | BREAST IMMOBIIZATION AND<br>BIOPSY DEVICE MR-BIOPSY MR<br>BI 160 |
| APPLICANT | MRI Devices Corporation |
| PRODUCT CODE | LNH |
| DECISION DATE | 04/09/2001 |

#### Device Description:

The BI 160-O, BI 160-PA, and Bl 160-CC device is a breast immobilization and biopsy accessory compatible with breast array coils and has the benefit of shaping the breast tissue into a "brick" shape, through mild compression. This allows for more efficient slice utilization. (i.e., fewer slices are needed to image the same amount of tissue).

The needle positioning devices allow the needle to be aimed at the lesion identified on the MR scan. Either MR compatible biopsy needles or MR compatible wire localization needles may be used.

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(as required by 21 CFR 807.92c)

# Indications for Use:

The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.

# Performance Data:

The BI 160-O. BI 160-PA, and BI 160-CC does not alter the performance of the coil in which it is placed.

No accuracy claims are made for the device. Slice warp in the MR image, needle deflection, and other factors will affect the accuracy of placing the needle into the breast lesion of interest. It is imperative that the clinician perform a scan with the needle in the breast to ensure that the needle has indeed entered the lesion of interest.

### Conclusion:

The Breast Immobilization and Biopsy Device BI 160-O, BI 160-PA, and BI 160-CC is a modification of the MR BI 160 K010570.

Similar to the predicate device, the BI 160-O, BI 160-PA, and BI 160-CC does not control any life sustaining functions or services. The unmodified and modified device does not alter the performance of the MR coil in which it is placed.

Any differences between the predicate and subject devices will not affect safety or efficacy.

Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing left. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and "INSTITUTE OF HEALTH."

#### Public Health Service

# NOV - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Noras Rontgen-Und Medizintechnik GMBH Re.: % Carl Alletto 1600 Manchester Way CORINTH TX 76210

K052987 Trade/Device Name: Breast Immobilization and Biopsy Device. Models BI 160-O, BI 160-PA and BI 160-CC Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Regulation Number: 21 CFR 892.1000 Regulatory Class: II Product Code: MOS Dated: October 10, 2005 Received: October 24, 2005

Dear Mr. Alletto:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Name.
Breast Immobilization and Biopsy Device Models BI 160-O, BI 160-PA, and BI 160-CC

Indications for Use:

The Breast Immobilization and Biopsy Device Models BI 160-O, Bl 160-PA, The Breast In mobilization and Gritic Resonance Scanner and DF 100 OO are acca in sonjary and wire localization of lesions that can be to pormed and interpreted by a trained physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C)

(Please do not write below This Line-continue on another Page OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE.)

Nancy C. Broadon

lon of Reproductive, Abdominal, and Radiological De 510(k) Number

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