← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K022007 # LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES (K022007) _Usa Instruments, Inc. · MOS · Nov 4, 2002 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K022007 ## Device Facts - **Applicant:** Usa Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Nov 4, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Liberty 5000 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 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 Plate. The indications for use are the same as for standard MR Imaging. The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed for use with the 0.7T Altaire MRI scanner manufactured by Hitachi Medical Systems. ## Device Story Phased array, receive-only MRI coil; consists of supporting base and two insulating chambers for breasts. Each chamber houses two coil elements within rigid plastic housing. Used in clinical MRI settings; operated by MRI technicians/physicians. Device receives RF signals from hydrogen nuclei; does not transmit RF power. Decoupling achieved via RF chokes and switching diodes to isolate elements during RF transmission. Provides lateral access to breast anatomy for biopsy procedures. Output is MR image data displayed on MRI scanner console; interpreted by physicians to aid diagnosis. Benefits include optimized imaging and biopsy access. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Phased array, receive-only RF coil. Materials: Polyurethane, ABS, Polycarbonate, Delrin. Decoupling: RF chokes with switching diodes. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated interface for Hitachi Altaire 0.7T MRI scanner. Form factor: Two-chamber breast coil with biopsy plate. ## 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 - Liberty 9000 Breast Coil with Disposable Biopsy Plate ([K001582](/device/K001582.md)) - OBC-300 Breast Array Coil ([K993776](/device/K993776.md)) - MR Guided Procedures (MRGP) Basic Package ([K983342](/device/K983342.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ### NOV 4 2002 # SUMMARY OF SAFETY AND EFFECTIVENESS K022007 | 1. Device Name : | Magnetic Resonance Imaging Accessory | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Proprietary Name : | Liberty 5000 Breast Coil with Disposable Biopsy
Plate | | 3. Classification : | Class II | | 4. Establishment Registration #: | 1529041 | | 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,
Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422. | | 6. Performance Standard: | No applicable performance standards have been
issued under Section 514 of the Food, Drug and
Cosmetic Act. | | 7. Intended Use: | The Liberty 5000 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 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 Plate. The
indications for use are the same as for standard MR
Imaging. The Liberty 5000 Breast Coil with
Disposable Biopsy Plate is designed for use with the
0.7T Altaire MRI scanner manufactured by Hitachi
Medical Systems. | | 8. Device Description: | The Liberty 5000 Breast Coil with Disposable Biopsy
Plate is a phased array, receive-only MRI coil. The
coil consists of three sections: a supporting base
and two insulating coil chambers, one for each
breast. Each of the hollow coil chambers houses
two coil elements that are insulated from the patient
by a ridged plastic housing. The coil housing is
made of plastic materials, which are fire rated and
have high impact and tensile strength. The Liberty
5000 Breast coil with Disposable Biopsy Plate is
designed to offer optimized imaging capabilities and
maximum lateral access to each breast for biopsy
procedures. | {1}------------------------------------------------ # 9. Safety and Effectiveness | Liberty 5000 Breast Coil with
Disposable
Biopsy Plate Product Features | Comparison to predicate device or other
510(k) Cleared Products | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: Breast Imaging for
diagnostic purposes. The coil has a
biopsy plate that allows access to the
breast. | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582)
-Similar to OBC-300 Breast Array Coil
manufactured by MRI Devices, Inc. (K993776)
-Similar to the Biopsy Plate included in the MR
Guided Procedures (MRGP) Basic Package
manufactured by Picker International Inc.
(K983342) | | Indications for Use: Identical to
routine MRI imaging | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Coil Enclosure Material:
Polyurethane Plastic, ABS Plastic,
Polycarbonate, and Delrin. | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Coil Design: Receive-only phased
array design | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Decoupling: RF Chokes with
Switching Diodes | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Prevention of RF Burns: Does not
transmit RF power; decoupling isolates
the coil elements from RF fields during
RF transmission; coil elements and
circuitry are enclosed in a non-
conductive housing. | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Radio Frequency Absorption: Coil is
a receive only coil and does not
transmit RF power; power deposition
during imaging is limited by SAR
algorithm | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | | Formation of Resonant Loops:
Decoupling isolates coil elements from
RF fields during RF transmission;
length of cable and stiffness does not
permit looping | - Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) | {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle-like symbol in the center. The text around the perimeter appears to say "DEPARTMENT OF HEALTH & HUMAN..." but is cut off. The central symbol consists of three parallel, curved lines that resemble a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Christie Shumaker Manager, QA and Regulatory Affairs. USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202 ## Re: K022007 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: September 20, 2002 Received: September 24, 2002 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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (sec 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); 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. {3}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 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: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known): _ K 0 2 2 0 2 2 0 0 Device Name: Liberty 5000 Breast Coil with Disposable Biopsy Plate Indications for Use: The Liberty 5000 Breast Coil with Disposable Biopsy Plate 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 Plate is designed for use with the Hitachi Altaire 0.7T scanner. > Anatomic Regions: Breast Anatomy Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Altaire 0.7T 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) | 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 | K022007 | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K022007](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K022007) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com