LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE

K041695 · Usa Instruments, Inc. · LNH · Jul 23, 2004 · Radiology

Device Facts

• Record ID: K041695
• Device Name: LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
• Applicant: Usa Instruments, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the Excite 1.5T system, manufactured by General Electric Healthcare.

Device Story

Phased array, receive-only MRI coil; designed for breast and axillary imaging. Features main supporting base, sternum bridge, and two lateral wings creating two breast-receiving segments; each segment houses four coil elements. Includes disposable biopsy plate for procedural access. Used in clinical MRI suites; operated by MRI technicians/radiologists. Device does not transmit RF power; decoupling via RF chokes and switching diodes isolates elements during transmission. Provides high-resolution images to radiologists for diagnostic interpretation and biopsy guidance. Benefits include optimized imaging and lateral access for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technological characteristics, materials, and performance specifications to legally marketed predicate devices.

Technological Characteristics

Phased array, receive-only RF coil. Materials: FR Polyurethane Plastic, FR Royalite R59 ABS/PVC, FR Acetyl Plastic, FR Polycarbonate, FR Fiberglass. Decoupling: RF chokes with switching diodes. Form factor: Main base with sternum bridge and two lateral wings. Connectivity: Dedicated interface for GE Excite 1.5T MRI system. Non-conductive housing.

Indications for Use

Indicated for diagnostic MRI imaging of breast and axillary tissue in patients requiring breast anatomy visualization or biopsy procedures. Compatible with GE Signa Excite 1.5T MRI systems. Contraindications: None stated beyond standard MRI safety precautions.

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 9000 Breast Coil with Disposable Biopsy Plate (K001582)
• OBC-300 Breast Array Coil (K993776)
• MR Guided Procedures (MRGP) Basic Package (K983342)

Reference Devices

• Spirit III TotalSENSE Cardiac Coil (K031172)
• Premier 7000 Phased Array CTL Spine Coil (K980157)

Submission Summary (Full Text)

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KD41695

## JUL 2 3 2004

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory | Liberty 9000 8-ch Breast Coil<br>Product Features | Comparison to predicate device or other 510(k)<br>cleared products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Liberty 9000 8-ch Breast Coil with Disposable<br>Biopsy Plate | 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 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582)<br>-Similar to OBC-300 Breast Array Coil<br>manufactured by MRI Devices, Inc. (K993776)<br>-Similar to the Biopsy Plate included in the MR<br>Guided Procedures (MRGP) Basic Package<br>manufactured by Picker International Inc.<br>(K983342) |
| 3. Classification: | Class II | Indications for Use: Identical to routine<br>MRI imaging. | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) |
| 4. Establishment Registration #: | 1529041 | Coil Enclosure Material: FR<br>Polyurethane Plastic, FR Royalite™<br>R59 ABS/PVC, FR Acetyl Plastic, FR<br>Polycarbonate, and FR Fiberglass | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate (K001582), Spirit III<br>TotalSENSE Cardiac Coil (K031172), and the<br>Premier 7000 Phased Array CTL Spine Coil<br>(K980157) manufactured by USA Instruments, Inc. |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,<br>1515 Danner Drive<br>Aurora, Ohio 44202, USA<br>Telephone: [phone]; Fax: [phone] | Coil Design: Phased Array, Receive-<br>Only Coil | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) |
| 6. Performance Standard: | No applicable performance standards have been<br>issued under Section 514 of the Food, Drug and<br>Cosmetic Act. | Decoupling: RF Chokes with Switching<br>Diodes | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) |
| 7. Intended Use: | The Liberty 9000 8-ch Breast Coil with Disposable<br>Biopsy Plate is a receive-only RF coil, used for<br>obtaining MR images of the breast and axillary<br>tissue. The biopsy plates allow access to the breast<br>anatomy during biopsy procedures. No biopsy<br>needles are included with, or packaged with the<br>Liberty 9000 8-ch Breast Coil with Disposable<br>Biopsy Plate. The Liberty 9000 8-ch Breast Coil<br>with Disposable Biopsy Plate is designed for use<br>with the Excite 1.5T system, manufactured by<br>General Electric Healthcare. | 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 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) |
| 8. Device Description: | The Liberty 9000 8-ch Breast Coil with Disposable<br>Biopsy Plate is a phased array, receive-only MRI<br>coil. The coil consists of a main supporting base<br>with a coil chamber in the middle section. A<br>sternum bridge and two lateral wings divide the<br>chamber into two segments, one to receive each<br>breast. Each of the hollow coil segments houses<br>four coil elements that are insulated from the<br>patient by a ridged plastic housing. The coil<br>housing is made of plastic materials, which are fire<br>rated and have high impact and tensile strength.<br>The Liberty 9000 8-ch Breast Coil with Disposable<br>Biopsy Plate is designed to offer optimized imaging<br>capabilities and maximum lateral access to each<br>breast for biopsy procedures. | Radio Frequency Absorption: Coil is a<br>receive-only coil and does not transmit<br>RF power; power deposition during<br>imaging is limited by SAR algorithm. | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) |
| Formation of Resonant Loop:<br>Decoupling isolates the coil elements<br>from RF fields during RF transmission;<br>length of cable and stiffness does not<br>permit looping | -Similar to Liberty 9000 Breast Coil with<br>Disposable Biopsy Plate manufactured by USA<br>Instruments, Inc. (K001582) | | |

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## 9. Safety and Effectiveness

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Mr. James Wrenn Manager, OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K041695

Trade/Device Name: Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH

Dated: June 16, 2004 Received: June 23, 2004

Dear Mr. Wrenn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we never over 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 I ou may , who spovisions 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 (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 that 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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Page 2

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 premaince nevice 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. Bryden

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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42 KO41695 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate

Indications for Use: The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner.

> Anatomic Regions: Breast anatomy Hydrogen Nuclei Excited:

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

The Signa Excite 1.5T 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 reluxation 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)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0411695