(14 days)
Not Found
No
The summary describes a physical MR coil and does not mention any software or algorithms that would utilize AI/ML for image processing or analysis.
No
The device is described as an accessory to produce images, and its primary applications are associated with "evaluation of the anatomy." It is a receive-only MR coil, which means it aids in imaging rather than directly treating a condition.
No
Explanation: The device is described as an accessory for producing images. While these images may be used for diagnostic purposes, the device itself is a tool for image acquisition, not for diagnosis. It does not analyze data or provide diagnostic conclusions.
No
The device description explicitly states it is a "four-channel phased array receive only MR coil," which is a hardware component used in conjunction with an MR system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the coil is used "to produce images of the abdominal and pelvic regions in 2D and 3D" in conjunction with an MR scanner. This is a device used for imaging, not for performing tests on biological samples (like blood, urine, tissue) outside of the body to diagnose or monitor a condition.
- Device Description: The description confirms it's an "MR coil," which is a component of an imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) as part of an imaging procedure.
N/A
Intended Use / Indications for Use
The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.
The primary applications associated with evaluation of the anatomy are as follows:
- Thorax
- Abdomen
- Male and Female Pelvis
- Prostate
Product codes (comma separated list FDA assigned to the subject device)
90-MOS
Device Description
The 3.0T Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction with the GE 3.0T MR system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
abdominal and pelvic regions, Thorax, Abdomen, Male and Female Pelvis, Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 of the 4 channel 3.0T Torso Phased Array Coil meet predetermined acceptance criteria.
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
Image /page/0/Picture/0 description: The image shows a series of handwritten numbers. The numbers are 103 0495. The numbers are written in black ink on a white background.
MAR 0 5 2003
510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | January 31, 2003 |
Device Name:
3.0T Torso Phased Array Coil Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-MOS
Marketed Device:
The 3.0T Torso Phased Array Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209).
Device Description:
The 3.0T Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction with the GE 3.0T MR system.
Indications for Use:
The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.
The primary applications associated with evaluation of the anatorny are as follows:
- u Thorax
- . Abdomen
- 트 Male and Female Pelvis
- . Prostate
Comparison with Predicate Device:
The 3.0T Torso Phased Array Coil is a modification of the GE Medical Systems 1.5T Cardiac Phased Array Coil (K971667) with the main differences being that the 3.0T
1
Torso Phased Array Coil is tuned to 127.72MHz for operation at 3.0T instead of 63.86MHz for operation at 1.5T. In addition the dimensions of the 3.0T Torso Phased Array Coil (34cm wide and 32cm long) are larger than the dimensions of the 1.5T Cardiac Phased Array Coil for a higher FOV coverage requirement in case of the 3.0T Torso Phased Array coil. The technological similarities to the USA Instruments Torso and Pelvis Phased Array Coil (K001209) include similar applications and indications for use.
Summary of Studies:
Testing was performed to demonstrate that the design of the 4 channel 3.0T Torso Phased Array Coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the 3.0T Torso Phased Array Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array Coil (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209). Usage of the 3.0T Torso Phased Array Coil does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems % Mr. Heinz Joerg Steneberg TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K030495
MAR 0 5 2003
Trade/Device Name: 3.0T Torso Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 14, 2003 Received: February 19, 2003
Dear Mr. Steneberg:
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 (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
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 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 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Ko30495 510(k) Number (if known):
Device Name: 3.0T Torso Phased Array Coil
Indications For Use:
The coil is indicated for use, on the order of a physician in conjunction with a 3.0T MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.
The primary applications associated with evaluation of the anatomy are as follows:
- Thorax 비
- 트 Abdomen
- 미 Male and Female Pelvis
- Prostate
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broadon
informati 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use