MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES

K033353 · Usa Instruments, Inc. · MOS · Nov 14, 2003 · Radiology

Device Facts

• Record ID: K033353
• Device Name: MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Liberty 5000 Breast Coil with Disposable Biopsy Plates is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 5000 Breast Coil with Disposable Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed for use with the 0.3T Airis MRI scanner manufactured by Hitachi Medical Systems.

Device Story

Phased array, receive-only MRI coil; consists of supporting base and two insulating chambers for breast imaging. Houses two coil elements per chamber within rigid plastic housing. Used in clinical settings with Hitachi 0.3T MRI scanners. Provides MR images of breast/axillary tissue; includes biopsy plates for procedural access. Decoupled via RF chokes and switching diodes to prevent RF burns and isolate elements during transmission. Does not transmit RF power; SAR limited by scanner algorithm. Physician interprets images to aid diagnosis and biopsy guidance.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only phased array MRI coil. Materials: Polyurethane, ABS, Polycarbonate, Delrin. Decoupling: RF chokes with switching diodes. Non-conductive housing. Designed for 0.3T Hitachi Airis MRI systems. No active RF transmission.

Indications for Use

Indicated for patients requiring MR imaging of breast and axillary tissue and guidance during biopsy procedures. Compatible with Hitachi Airis II 0.3T MRI scanners. For use by trained physicians to visualize soft tissue structure for diagnostic purposes.

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

• Liberty 5000 Breast Coil with Disposable Biopsy Plate (K022007)

Submission Summary (Full Text)

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## NOV 1 4 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Liberty 5000 Breast Coil with Disposable Biopsy<br>Plates |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,<br>Aurora, Ohio 44202, USA<br>Telephone: [phone]; Fax: [phone]. |
| 6. Performance Standard: | No applicable performance standards have been<br>issued under Section 514 of the Food, Drug and<br>Cosmetic Act. |
| 7. Intended Use: | The Liberty 5000 Breast Coil with Disposable Biopsy<br>Plates is a receive-only RF coil, used for obtaining<br>MR images of the breast and axillary tissue. The<br>biopsy plate allows access to the breast anatomy<br>during biopsy procedures. No biopsy needles are<br>included with, or packaged with the Liberty 5000<br>Breast Coil with Disposable Biopsy Plates. The<br>indications for use are the same as for standard MR<br>Imaging. The Liberty 5000 Breast Coil with<br>Disposable Biopsy Plates is designed for use with<br>the 0.3T Airis MRI scanner manufactured by Hitachi<br>Medical Systems. |
| 8. Device Description: | The Liberty 5000 Breast Coil with Disposable Biopsy<br>Plates is a phased array, receive-only MRI coil. The<br>coil consists of three sections: a supporting base<br>and two insulating coil chambers, one for each<br>breast. Each of the hollow coil chambers houses<br>two coil elements that are insulated from the patient<br>by a ridged plastic housing. The coil housing is<br>made of plastic materials, which are fire rated and<br>have high impact and tensile strength. The Liberty<br>5000 Breast coil with Disposable Biopsy Plates is<br>designed to offer optimized imaging capabilities and<br>maximum lateral access to each breast for biopsy<br>procedures. |

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## 9. Safety and Effectiveness

| Liberty 5000 Breast Coil with<br>Disposable<br>Biopsy Plates Product Features | Comparison to predicate device or other<br>510(k) Cleared Products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Breast Imaging for<br>diagnostic purposes. The coil has a<br>biopsy plate that allows access to the<br>breast. | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Indications for Use: Identical to<br>routine MRI imaging | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Coil Enclosure Material:<br>Polyurethane Plastic, ABS Plastic,<br>Polycarbonate, and Delrin. | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Coil Design: Receive-only phased<br>array design | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Decoupling: RF Chokes with<br>Switching Diodes | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Prevention of RF Burns: Does not<br>transmit RF power; decoupling isolates<br>the coil elements from RF fields during<br>RF transmission; coil elements and<br>circuitry are enclosed in a non-<br>conductive housing. | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Radio Frequency Absorption: Coil is<br>a receive only coil and does not<br>transmit RF power; power deposition<br>during imaging is limited by SAR<br>algorithm | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |
| Formation of Resonant Loops:<br>Decoupling isolates coil elements from<br>RF fields during RF transmission:<br>length of cable and stiffness does not<br>permit looping | - Similar to Liberty 5000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K022007) |

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 4 2003

Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K033353

Trade/Device Name: Liberty 5000 Breast Coil with Disposable Biopsy Plates Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: October 15, 2003 Received: October 27, 2003

Dear Ms. Shumaker:

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 reguirements 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 (PMA), 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 (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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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (if known): K033353

Device Name: Liberty 5000 Breast Coil with Disposable Biopsy Plates

Indications for Use: The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Liberty 5000 Breast Coil with Disposable Biopsy Plates is designed for use with the Hitachi Airis II 0.3T scanner.

> Anatomic Regions: Breast Anatomy Hydrogen Nuclei Excited:

The indications for use are the same as for standard imaging:

Prescription Use

(Per 21 CFR 801.109)

The Airis II 0.3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

510/k) Numb