(31 days)
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.
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.
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.
The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four 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 9000 8-ch 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 is a 510(k) premarket notification for a medical device, specifically a "Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate" for Magnetic Resonance Imaging. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data to prove performance against specific acceptance criteria. Therefore, the document does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment in the way typically seen for new diagnostic algorithms or devices requiring extensive clinical validation.
The document primarily focuses on:
- Device Description and Intended Use: Detailing the physical characteristics and purpose of the breast coil.
- Comparison to Predicate Devices: Explicitly stating that the device is "Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate" (K001582) and other cleared devices, emphasizing similarities in features, intended use, indications for use, and safety aspects.
- Safety Features: Highlighting design aspects that mitigate risks like RF burns and resonant loops (e.g., receive-only coil, decoupling, non-conductive housing).
Given this context, I will address the requested points by explaining why the information is not present in the provided text for a 510(k) submission of this nature.
1. A table of acceptance criteria and the reported device performance
Information Not Available: This document does not present a table of acceptance criteria or reported device performance metrics in the way one would expect for a novel diagnostic algorithm or a device requiring new performance claims. As a 510(k) submission for a medical device accessory (an MRI coil), the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device, particularly in terms of safety and functionality. Performance is implicitly demonstrated by showing it functions similarly to the predicate for its intended use (obtaining MR images of the breast).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Available: No specific test set, patient data, or clinical study data (prospective or retrospective) from which performance metrics would be derived is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices, engineering design specifications, and safety assessments rather than new clinical trials with patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Information Not Available: Since no specific test set or clinical study is described, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Available: No test set or clinical study is described, so no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Information Not Available: This document describes an MRI breast coil, which is a hardware accessory, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Available: This device is an MRI coil, a hardware component, not a standalone algorithm. Thus, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information Not Available: As no clinical studies or test sets are described, there is no mention of the type of ground truth used.
8. The sample size for the training set
Information Not Available: This device is an MRI coil, not an AI-driven algorithm, so the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
Information Not Available: As the concept of a "training set" does not apply to this device, the establishment of ground truth for such a set is not mentioned.
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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 CoilProduct Features | Comparison to predicate device or other 510(k)cleared products |
|---|---|---|---|
| 2. Proprietary Name: | Liberty 9000 8-ch Breast Coil with DisposableBiopsy Plate | 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) |
| 3. Classification: | Class II | Indications for Use: Identical to routineMRI imaging. | -Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| 4. Establishment Registration #: | 1529041 | Coil Enclosure Material: FRPolyurethane Plastic, FR Royalite™R59 ABS/PVC, FR Acetyl Plastic, FRPolycarbonate, and FR Fiberglass | -Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate (K001582), Spirit IIITotalSENSE Cardiac Coil (K031172), and thePremier 7000 Phased Array CTL Spine Coil(K980157) manufactured by USA Instruments, Inc. |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422 | Coil Design: Phased Array, Receive-Only Coil | -Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. | Decoupling: RF Chokes with SwitchingDiodes | -Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| 7. Intended Use: | The Liberty 9000 8-ch Breast Coil with DisposableBiopsy Plate is a receive-only RF coil, used forobtaining MR images of the breast and axillarytissue. The biopsy plates allow access to the breastanatomy during biopsy procedures. No biopsyneedles are included with, or packaged with theLiberty 9000 8-ch Breast Coil with DisposableBiopsy Plate. The Liberty 9000 8-ch Breast Coilwith Disposable Biopsy Plate is designed for usewith the Excite 1.5T system, manufactured byGeneral Electric Healthcare. | 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) |
| 8. Device Description: | The Liberty 9000 8-ch Breast Coil with DisposableBiopsy Plate is a phased array, receive-only MRIcoil. The coil consists of a main supporting basewith a coil chamber in the middle section. Asternum bridge and two lateral wings divide thechamber into two segments, one to receive eachbreast. Each of the hollow coil segments housesfour coil elements that are insulated from thepatient by a ridged plastic housing. The coilhousing is made of plastic materials, which are firerated and have high impact and tensile strength.The Liberty 9000 8-ch Breast Coil with DisposableBiopsy Plate is designed to offer optimized imagingcapabilities and maximum lateral access to eachbreast for biopsy procedures. | Radio Frequency Absorption: Coil is areceive-only coil and does not transmitRF power; power deposition duringimaging is limited by SAR algorithm. | -Similar to Liberty 9000 Breast Coil withDisposable Biopsy Plate manufactured by USAInstruments, Inc. (K001582) |
| Formation of Resonant Loop:Decoupling isolates the coil elementsfrom RF 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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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 | (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. 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
§ 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.