(31 days)
No
The device description focuses on the physical components and function of an MRI coil and biopsy plate. There is no mention of software, algorithms, or any technology that would process images or data using AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is used for obtaining MR images and facilitating biopsy procedures by providing access, not for treating any condition or disease.
Yes
The device aids in obtaining MR images of the breast and axillary tissue. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis, which is the definition of a diagnostic device.
No
The device is described as a physical RF coil with a supporting base, coil chamber, sternum bridge, lateral wings, and coil elements, all made of plastic materials. This clearly indicates a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis.
- The Liberty 9000 8-ch Breast Coil is a receive-only RF coil used for obtaining MR images of the breast and axillary tissue. This is an in vivo imaging technique, not an in vitro diagnostic test.
- The device facilitates biopsy procedures, which involve obtaining tissue samples, but the device itself is not performing the diagnostic test on those samples. The biopsy plates provide access for the biopsy, and the MR images guide the procedure.
- The intended use clearly states it's for producing images that, when interpreted by a trained physician, can be useful in determining a diagnosis. This describes an imaging device, not an IVD.
Therefore, the Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a medical device used for imaging and guiding procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
90 LNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
breast and axillary tissue, Breast anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
Product Features | Comparison to predicate device or other 510(k)
cleared products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Liberty 9000 8-ch Breast Coil with Disposable
Biopsy Plate | 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) |
| 3. Classification: | Class II | Indications for Use: Identical to routine
MRI imaging. | -Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) |
| 4. Establishment Registration #: | 1529041 | Coil Enclosure Material: FR
Polyurethane Plastic, FR Royalite™
R59 ABS/PVC, FR Acetyl Plastic, FR
Polycarbonate, and FR Fiberglass | -Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate (K001582), Spirit III
TotalSENSE Cardiac Coil (K031172), and the
Premier 7000 Phased Array CTL Spine Coil
(K980157) manufactured by USA Instruments, Inc. |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,
1515 Danner Drive
Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422 | Coil Design: Phased Array, Receive-
Only Coil | -Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) |
| 6. Performance Standard: | No applicable performance standards have been
issued under Section 514 of the Food, Drug and
Cosmetic Act. | Decoupling: RF Chokes with Switching
Diodes | -Similar to Liberty 9000 Breast Coil with
Disposable Biopsy Plate manufactured by USA
Instruments, Inc. (K001582) |
| 7. 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. | 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) |
| 8. Device Description: | 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. | 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 Loop:
Decoupling isolates the 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) | | |
1
9. Safety and Effectiveness
2
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.
3
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
4
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