(138 days)
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.
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.
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the Liberty 5000 Breast Coil with Disposable Biopsy Plate. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new diagnostic algorithm.
Here's an analysis based on the information provided, addressing your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain a table of explicit acceptance criteria or quantitative performance metrics in the way a diagnostic algorithm's accuracy (e.g., sensitivity, specificity, AUC) would be evaluated. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The "reported device performance" is descriptive, comparing the features and intended use of the new device to existing cleared devices.
| Feature/Criterion (Implied Acceptance) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Breast Imaging for diagnostic purposes with biopsy access. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582), OBC-300 Breast Array Coil (K993776), and MR Guided Procedures (MRGP) Basic Package Biopsy Plate (K983342). |
| Indications for Use: Identical to routine MRI imaging (providing images corresponding to proton distribution, NMR parameters, and soft tissue structure, useful for diagnosis when interpreted by a trained physician). | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). The indications for use are the same as for the Hitachi Altaire 0.7T system, which is indicated for use as an NMR device that produces images of soft tissue structure of the head and whole body, useful for diagnosis when interpreted by a trained physician. |
| Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate, and Delrin. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Coil Design: Receive-only phased array design. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Decoupling: RF Chokes with Switching Diodes. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Prevention of RF Burns: Does not transmit RF power; decoupling isolates elements; elements/circuitry in non-conductive housing. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Radio Frequency Absorption: Receive-only coil; power deposition limited by SAR algorithm. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
| Formation of Resonant Loops: Decoupling isolates elements; cable length/stiffness prevents looping. | Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate (K001582). |
The core "study" here is the comparison of the device's features and performance characteristics to those of predicate devices that have already received 510(k) clearance. The FDA's determination of "substantial equivalence" is the "proof" that the device meets the implied "acceptance criteria" of being as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance for a performance study in the context of an AI/algorithm-driven device. The safety and effectiveness are established through the comparison of the device's physical and functional attributes to predicate devices, and an analysis of potential risks (like RF burns, resonant loops, etc.) based on its design. This is a hardware device, not an algorithm, so data provenance, retrospective/prospective studies, and test sets with patient data are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this submission is for a physical medical device (an MRI coil), not a diagnostic algorithm that requires expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done, and it would not be applicable for this type of device (an MRI coil). MRMC studies are typically performed to evaluate the diagnostic accuracy of image interpretation, often comparing human readers with and without AI assistance. This device is an accessory for image acquisition, not an image interpretation tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an algorithm's performance was not done. The concept of "standalone performance" refers to the accuracy of an AI algorithm operating without human intervention for diagnostic tasks, which is not relevant to an MRI coil.
7. The Type of Ground Truth Used
Not applicable. Ground truth (e.g., pathology, outcomes data) is used to validate diagnostic algorithms or tests against a definitive standard. This document focuses on the physical and functional equivalence of an MRI accessory.
8. The Sample Size for the Training Set
Not applicable. This device is an MRI coil, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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NOV 4 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Liberty 5000 Breast Coil with Disposable BiopsyPlate |
| 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 BiopsyPlate 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 Plate. Theindications for use are the same as for standard MRImaging. The Liberty 5000 Breast Coil withDisposable Biopsy Plate is designed for use with the0.7T Altaire MRI scanner manufactured by HitachiMedical Systems. |
| 8. Device Description: | The Liberty 5000 Breast Coil with Disposable BiopsyPlate 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 Plate 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 Plate 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 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582)-Similar to OBC-300 Breast Array Coilmanufactured by MRI Devices, Inc. (K993776)-Similar to the Biopsy Plate included in the MRGuided Procedures (MRGP) Basic Packagemanufactured by Picker International Inc.(K983342) |
| Indications for Use: Identical toroutine MRI imaging | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Coil Enclosure Material:Polyurethane Plastic, ABS Plastic,Polycarbonate, and Delrin. | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Coil Design: Receive-only phasedarray design | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Decoupling: RF Chokes withSwitching Diodes | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| 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 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Radio Frequency Absorption: Coil isa receive only coil and does nottransmit RF power; power depositionduring imaging is limited by SARalgorithm | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission;length of cable and stiffness does notpermit looping | - Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
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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.
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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
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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.
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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 |
§ 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.