(138 days)
Not Found
No
The description focuses on the physical components and function of an MRI coil and biopsy plate, with no mention of AI or ML for image processing, analysis, or any other function.
No.
The device is used for obtaining diagnostic images and guiding biopsy procedures, not for treating a condition or disease.
Yes
The device aids in obtaining MR images and guidance during biopsy procedures, and these images, when interpreted by a trained physician, provide information useful in diagnosis.
No
The device description explicitly states it is a "phased array, receive-only MRI coil" and describes physical components like a supporting base, coil chambers, coil elements, and plastic housing. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Liberty 5000 Breast Coil with Disposable Biopsy Plate is a medical device used in conjunction with an MRI scanner to obtain images of the breast and aid in biopsy procedures. It is a physical component used during an imaging and interventional procedure.
- No Sample Analysis: The device itself does not analyze biological samples. It facilitates the acquisition of images and provides access for a biopsy, but the diagnostic information comes from the interpretation of the MR images and potentially the analysis of the tissue sample obtained during the biopsy (which would be a separate process).
- Intended Use: The intended use is to provide MR images and aid in guidance during biopsy procedures, not to perform diagnostic tests on biological samples.
Therefore, the Liberty 5000 Breast Coil with Disposable Biopsy Plate falls under the category of a medical device used for imaging and interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) / NMR
Anatomical Site
Breast and axillary tissue, Breast Anatomy, head and whole body
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
NOV 4 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| 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 |