(80 days)
No
The document describes standard MRI technology and image reconstruction techniques (Fourier transformation) without mentioning AI or ML.
No.
The device is described as a "diagnostic imaging device" used to produce images that "may assist in diagnosis," not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa Infinity System is indicated for use as a diagnostic imaging device to produce... images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description clearly states it is a "Magnetic Resonance System" which includes a superconducting magnet and other hardware components for acquiring images. It is a physical imaging device, not solely software.
Based on the provided text, the GE Signa Infinity line of products is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The Signa Infinity is a magnetic resonance scanner that images the internal structures and organs of the body in vivo (within the body).
- The intended use clearly states it's a "diagnostic imaging device" to produce images of internal structures. This is the core function of an imaging system, not an IVD.
- The device description details a superconducting magnet and imaging techniques. These are characteristic of an MRI system, not an IVD.
Therefore, the GE Signa Infinity is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Signa Infinity Magnetic Resonance System is a modification to the Signa TwinSpeed Magnetic Resonance System (K012200) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa Infinity Magnetic Resonance System features a superconducting magnet operating at 1.5T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and short scan times. Previously cleared software options, coils, and other accessories may · be used with the Signa Infinity Magnetic Resonance System.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
whole body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / 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)
The Signa Infinity Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa Infinity Magnetic Resonance System is comparable to the currently marketed Signa TwinSpeed Magnetic Resonance System.
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.
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
KOI 3636
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.
JAN 2 4 2002
GE Medical Systems
Page 1 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
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: | 262-544-3863 |
| Date Prepared: | November 1, 2001 |
Device Name:
GE Signa Infinity Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The Signa Infinity System is substantially equivalent to the currently marketed Signa TwinSpeed MR system (K012200) with the main differences being an addition of eight independent receive channels and an update of the technology used for the Computer subsystem as well as the RF Pulse Control subsystem. In addition, ASSET imaging (K012970) is now offered for eight receive channels.
Device Description:
The Signa Infinity Magnetic Resonance System is a modification to the Signa TwinSpeed Magnetic Resonance System (K012200) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa Infinity Magnetic Resonance System features a superconducting magnet operating at 1.5T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and short scan times. Previously cleared software options, coils, and other accessories may · be used with the Signa Infinity Magnetic Resonance System.
Indications for Use:
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that
1
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border appearing in black against a white background.
Page 2 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
may assist in diagnosis.
Comparison with Predicate Device:
The Signa Infinity System is a modification of the Signa TwinSpeed MR system (K012200) with the main differences being the addition of eight independent receive channels and an update of the technology used for the Computer subsystem as well as the RF Pulse Control subsystem. Whereas these modifications are generally applicable across a range of field strengths, gradient and RF subsystems, the initial scope is limited to systems comparable to the currently marketed Signa TwinSpeed (K012200) 1.5T Magnetic Resonance Systems.
Summary of Studies:
The Signa Infinity Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa Infinity Magnetic Resonance System is comparable to the currently marketed Signa TwinSpeed Magnetic Resonance System.
Conclusion:
It is the opinion of GE that the Signa Infinity Magnetic Resonance System is substantially equivalent to the Signa TwinSpeed Magnetic Resonance System. Usage of the Signa Infinity Magnetic Resonance System 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 is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle with three lines extending from its back, representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Larry A. Kroger, Ph.D. Regulatory Affairs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K013636
Trade/Device Name: Signa Infinity MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 1, 2001 Received: November 5, 2001
Dear Dr. Kroger:
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 nanufacturing 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 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 rr you debile 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. Brogdon
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): _ Ko / 36 36
Device Name: Signa Infinity Magnetic Resonance System
Indications For Use:
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support The Off Siglia Inimity mic of products are misses. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire spectosopic miages, andror spoona, cymained to, head, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protors (fiydrogen nucle) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| ption Use | |
|---|---|
| (1 CFR 801.109) |
OR Over-The-Counter Use
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K013636 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescrip (Per 21