(17 days)
Not Found
No
The summary describes a passive MRI coil and does not mention any software or processing capabilities that would suggest the use of AI/ML.
No.
The device is described as an "Array" or "Torso Coil" for 2D and 3D Magnetic Resonance imaging and Parallel body imaging, indicating it is used for diagnostic purposes rather than treating a condition.
No
The device is a coil for an MRI machine, which is an imaging device used to produce images of the body. While MRI is used for diagnostic purposes, the coil itself is a component that facilitates imaging, not a diagnostic device that interprets data or provides a diagnosis. Its function is to acquire image data, not analyze it for diagnostic conclusions.
No
The device description clearly states it is a "12- element coil with integrated preamplifiers," which is a hardware component used in MRI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "2D and 3D Magnetic Resonance imaging and Parallel body imaging" of specific anatomical regions (abdomen, pelvis, chest). This describes an imaging device used on the patient, not a device used to examine samples from the patient (which is the core of IVD).
- Device Description: The description details a "coil" for an MRI scanner, which is a component used to generate and receive radiofrequency signals for imaging the body. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
In summary, the device is clearly described as an accessory for an MRI scanner used for medical imaging of the human body, which falls under the category of in-vivo diagnostic devices, not in-vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
Product codes
MOS
Device Description
The USA Instruments 1.5T 12 Channel Torso Coil is a 12-element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. This coil designed for use with the 1.5T Signa Excite MRI scanner, manufactured by General Electric Healthcare. The coil will be available with different connector configurations depending on the configuration of the scanner it will be used with.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance imaging
Anatomical Site
abdomen, pelvis and chest regions
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)
Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
OCT 7 - 2005
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: | 1.5T 12 Channel Body Array |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc. (A GE company) |
| 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 USA Instruments 1.5T 12 Channel Body Array is intended to |
| be used in the abdomen, pelvis and chest regions for 2D and 3D | |
| Magnetic Resonance imaging and Parallel body imaging. | |
| 8. Device Description: | The USA Instruments 1.5T 12 Channel Torso Coil is a 12- |
| element coil with integrated preamplifiers that provides | |
| optimized geometry for parallel imaging. The coil is designed to | |
| provide imaging of the abdomen, pelvis and chest regions. This | |
| coil designed for use with the 1.5T Signa Excite MRI scanner, | |
| manufactured by General Electric Healthcare. The coil will be | |
| available with different connector configurations depending on | |
| the configuration of the scanner it will be used with. | |
| 9. Marketed Device: | 1.5T 12 Channel Body Array |
| 10. Comparison with Predicate: | The 1.5T 12 Channel Body Array is a modification of the existing |
| cleared GE Healthcare 1.5T 8 Channel Torso Coil (K031209), with | |
| the main difference being the separation of the 12 individual | |
| elements into separate channels and a redesign of the coil | |
| connector to make it compatible with magnetic resonance scanners | |
| that have more then an 8 channel receive chain. | |
| 11. Summary of Studies: | Testing was performed to demonstrate that the design |
| modifications to the 1.5T 12 Channel Body Array meet | |
| predetermined acceptance criteria. |
1
Conclusion:
It is the opinion of USA Instruments that the 1.5T 12 Channel Body Array is substantially equivalent to the GE Healthcare 1.5T 8 Channel Torso Coil (K031209). Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards.
2
OCT 7 - 2005
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert B. Smith Ouality Assurance/Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K052584 Trade/Device Name: 1.5T 12 Channel Body 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. Smith:
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) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics nedicate 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 11 you atter Office of Compliance at one 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 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/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
510(k) Number (if known): K052584
Device Name: 1.5T 12 Channel Body Array
Indications for Use:
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
(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 h. Segrom
510(k) Num