(14 days)
Not Found
No
The document describes a passive RF coil for MRI and does not mention any software or processing capabilities, let alone AI/ML.
No
The device is described as an RF coil used for obtaining MR images and facilitating biopsy procedures, not for treating any condition or disease.
No
The device is an RF coil used for obtaining MR images. While MR imaging is often used for diagnostic purposes, the device itself is a component for image acquisition, not a diagnostic device that interprets or analyzes data to diagnose a condition. Its function is to facilitate imaging, and the "indications for use are the same as for standard MR Imaging," which is a modality, not a diagnostic claim for the device itself.
No
The device description explicitly details physical hardware components (RF coil, supporting base, coil chamber, sternum bridge, lateral wings, coil elements, plastic housing) and their function in obtaining MR images.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The 3.0T HD Breast Array is an MRI coil. Its function is to receive radiofrequency signals during an MRI scan to create images of the breast and axillary tissue. It is a component of an imaging system, not a device that analyzes biological samples.
- Intended Use: The intended use is for obtaining MR images and facilitating biopsy procedures, which are clinical procedures performed on the patient, not laboratory tests on samples.
Therefore, based on the provided information, the 3.0T HD Breast Array is a medical device used for imaging and biopsy guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3.0T HD Breast Array 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 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.
Product codes
MOS
Device Description
The 3.0T HD Breast Array 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 rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The 3.0T HD Breast Array is designed to offer optimized imaging capabilities and maximum lateral and medial access to each breast for biopsy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images
Anatomical Site
breast and axillary tissue
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
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Summary of Performance Studies
Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| 1. Device Name: | Magnetic Resonance Imaging Accessory | |
|---|---|---|
| 2. Proprietary Name: | 3.0T HD Breast Array | |
| 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 3.0T HD Breast Array 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 3.0T HD Breast Array. The indications for use are the | ||
| same as for standard MR Imaging. The 3.0T HD Breast Array is | ||
| designed for use with the 3.0T Signa Excite MRI scanner, | ||
| manufactured by General Electric Healthcare. | ||
| 8. Device Description: | The 3.0T HD Breast Array 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 rigid plastic housing. The | ||
| coil housing is made of plastic materials, which are fire rated and | ||
| have high impact and tensile strength. The 3.0T HD Breast Array | ||
| is designed to offer optimized imaging capabilities and maximum | ||
| lateral and medial access to each breast for biopsy procedures. | ||
| 9. Marketed Device: |
- Comparison with Predicate: | 3.0T HD Breast Array
The 3.0T HD Breast Array is a modification of the existing cleared
1.5T Liberty 9000 8-channel Breast coil (K041695), with the main
difference being the coil has been retuned for operation in a 3.0T
magnetic field instead of a 1.5T field strength | |
| 11. Summary of Studies: | Testing was performed to demonstrate that the design
modifications to the 3.0T HD Breast Array meet predetermined
acceptance criteria. | |
1
Conclusion:
It is the opinion of USA Instruments that the 3.0T HD Breast Array is substantially equivalent to the USA Instruments 1.5T Liberty 9000 8 channel Breast Array (K041695). Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing protection and service. The eagle is a prominent symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Brown Manager, Quality Assurance/ Regulatory Affairs USA Instruments 1515 Danner Drive AURORA OH 44202
Re: K052585
OCT 4 - 2005
Trade/Device Name: 3,OT HD Breast Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 16, 2005 Received: September 20, 2005
Dear Mr. Brown:
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 (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premanted notificate 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 If you desire specific at ne of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 601:57). I Camay Coums Sturers, 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/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INTENDED USE
K052585 510(k) Number (if known): ___
Device Name: 3.0T HD Breast Array
Indications for Use:
The 3.0T HD Breast Array 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 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801-109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
David R. Ingram