(25 days)
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.
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.
The indications for use are the same as for standard imaging:
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.
The Liberty 5000 Breast Coil with Disposable Biopsy Plates 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 Plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
The provided text describes a 510(k) premarket notification for a medical device, the "Liberty 5000 Breast Coil with Disposable Biopsy Plates." This submission is based on substantial equivalence to a predicate device, rather than a de novo clinical study establishing new safety and effectiveness. Therefore, the information requested about acceptance criteria, detailed study design, and performance metrics in the context of a new efficacy study might not be directly applicable or available in this document.
However, based on the principle of substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The "study" that proves this involves comparing the new device's features, intended use, and technical characteristics to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or image quality scores) for a new clinical study are not provided. Instead, the acceptance criteria are satisfied by demonstrating similarity to the predicate device.
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Breast Imaging for diagnostic purposes, with biopsy access. | Similar to predicate: Intended Use for breast imaging for diagnostic purposes, with a biopsy plate that allows breast access. (K022007) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate: Identical to routine MRI imaging. (K022007) |
| Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate, and Delrin. | Similar to predicate: Uses similar materials. (K022007) |
| Coil Design: Receive-only phased array. | Similar to predicate: Receive-only phased array design. (K022007) |
| Decoupling mechanism: RF Chokes with Switching Diodes. | Similar to predicate: RF Chokes with Switching Diodes. (K022007) |
| Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, non-conductive housing. | Similar to predicate: Does not transmit RF power; decoupling isolates coil elements from RF fields; coil elements and circuitry are enclosed in a non-conductive housing. (K0222007) |
| Radio Frequency Absorption: Receive-only coil, SAR algorithm limits power deposition. | Similar to predicate: Coil is a receive-only coil; power deposition during imaging is limited by SAR algorithm. (K022007) |
| Formation of Resonant Loops: Decoupling isolates coil elements, cable length/stiffness prevents looping. | Similar to predicate: Decoupling isolates coil elements; length of cable and stiffness does not permit looping. (K022007) |
| Compatibility: Designed for use with the 0.3T Airis MRI scanner. | Specified: Designed for use with the 0.3T Airis MRI scanner (Hitachi Medical Systems). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of a new, independent study to establish safety and effectiveness. The comparison is made to a legally marketed predicate device (K022007) by comparing technical and functional characteristics. Therefore, there is no specific sample size or data provenance provided for a test set for a new study. The "data provenance" for the comparison is regulatory documentation of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As explained above, no independent test set with expert-established ground truth was created for this 510(k) submission based on the provided text. The assessment relies on a comparison to the established safety and effectiveness of a predicate device.
4. Adjudication Method for the Test Set
Not applicable. There was no independent test set requiring adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The document relies on substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical MRI coil accessory, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. Its performance is integrated with the MRI scanner and human interpretation.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance of this device is its substantial equivalence to a legally marketed predicate device (Liberty 5000 Breast Coil with Disposable Biopsy Plate, K022007), which has already been determined by the FDA to be safe and effective. This is achieved by demonstrating that the new device has the same intended use, indications for use, technological characteristics, and performance principles as the predicate.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve an AI/algorithm with a training set.
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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 BiopsyPlates |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,Aurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Liberty 5000 Breast Coil with Disposable BiopsyPlates is a receive-only RF coil, used for obtainingMR images of the breast and axillary tissue. Thebiopsy plate allows access to the breast anatomyduring biopsy procedures. No biopsy needles areincluded with, or packaged with the Liberty 5000Breast Coil with Disposable Biopsy Plates. Theindications for use are the same as for standard MRImaging. The Liberty 5000 Breast Coil withDisposable Biopsy Plates is designed for use withthe 0.3T Airis MRI scanner manufactured by HitachiMedical Systems. |
| 8. Device Description: | The Liberty 5000 Breast Coil with Disposable BiopsyPlates is a phased array, receive-only MRI coil. Thecoil consists of three sections: a supporting baseand two insulating coil chambers, one for eachbreast. Each of the hollow coil chambers housestwo coil elements that are insulated from the patientby a ridged plastic housing. The coil housing ismade of plastic materials, which are fire rated andhave high impact and tensile strength. The Liberty5000 Breast coil with Disposable Biopsy Plates isdesigned to offer optimized imaging capabilities andmaximum lateral access to each breast for biopsyprocedures. |
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9. Safety and Effectiveness
| Liberty 5000 Breast Coil withDisposableBiopsy Plates Product Features | Comparison to predicate device or other510(k) Cleared Products |
|---|---|
| Intended Use: Breast Imaging fordiagnostic purposes. The coil has abiopsy plate that allows access to thebreast. | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Indications for Use: Identical toroutine MRI imaging | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Coil Enclosure Material:Polyurethane Plastic, ABS Plastic,Polycarbonate, and Delrin. | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Coil Design: Receive-only phasedarray design | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Decoupling: RF Chokes withSwitching Diodes | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Prevention of RF Burns: Does nottransmit RF power; decoupling isolatesthe coil elements from RF fields duringRF transmission; coil elements andcircuitry are enclosed in a non-conductive housing. | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Radio Frequency Absorption: Coil isa receive only coil and does nottransmit RF power; power depositionduring imaging is limited by SARalgorithm | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K022007) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission:length of cable and stiffness does notpermit looping | - Similar to Liberty 5000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, 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 | (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" (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 (800) 638-2041 or (301) 443-6597 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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.