(91 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard MRI technology and image processing techniques.
No.
The device is indicated for use as a diagnostic imaging device to produce images and/or spectra that, when interpreted by a trained physician, may assist in diagnosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device."
No
The device description explicitly states it is a "whole body magnetic resonance scanner" and details hardware components like a "1.5T superconducting magnet with 60cm bore size." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the SIGNA Victor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body. They are used to provide information about a person's health status.
- SIGNA Victor's Function: The SIGNA Victor is a Magnetic Resonance (MR) scanner. It produces images of the internal structures and functions of the entire body in vivo (within the living body) using magnetic fields and radio waves. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is a "diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body". This describes an imaging modality, not an IVD.
Therefore, the SIGNA Victor falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIGNA Victor is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Victor reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.
These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
LNH
Device Description
SIGNA™ Victor is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, neck, TMI, spine, breast, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. (From Indications for Use on page 4)
head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. (From Device Description on page 6)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained 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)
Summary of Non-Clinical Tests:
The SIGNA™ Victor and the predicate devices were subject to similar risk management testing to demonstrate substantial equivalence of safety and performance.
Testing to the following voluntary standards included:
- ANSI AAMI ES60601-1
- IEC 60601-1-2
- IEC 60601-2-33
- IEC 62304
- IEC 60601-1-6
- IEC 62366-1
- ISO 10993-1
In addition, the SIGNA™ Victor complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate devices.
Both the SIGNA™ Victor and the predicate devices have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices.
The following quality assurance measures were applied to the development of the subject device, as they were for the predicate devices: - Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, the SIGNA™ Victor, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Victor in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on November 18, 2016. The image quality of the SIGNA™ Victor is substantially equivalent to that of the predicate devices.
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.
SIGNA™ Explorer (K143251), SIGNA™ Prime (K211980)
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.
SIGNA Voyager (K161567), SIGNA Artist Evo (K213603)
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.
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February 13, 2023
GE Healthcare (Tianjin) Company Limited % Huande Li Regulatory Affairs Manager No. 266 Jingsan Road, Tianjin Airport Economic Area Tianjin, Tianjin 300308 CHINA
Re: K223439
Trade/Device Name: SIGNA™ Victor Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 15, 2022 Received: November 17, 2022
Dear Huande Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D. K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Section 4 Indications for Use
3
Indications for Use
510(k) Number (if known)
K223439
Device Name SIGNA™ Victor
Indications for Use (Describe)
The SIGNA Victor is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Victor reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.
These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SIGNA Victor 510(k) Premarket Notification
Section 5 510(K) Summary
Section 5 Page 1 of 6
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 10, 2022 |
|---|---|
| Submitter: | GE Healthcare (Tianjin) Company Limited |
| No. 266 Jingsan Road, Tianjin Airport Economic Area | |
| Tianjin, P.R. China 300308 | |
| Distributor | GE Medical Systems, LLC |
| 3200 N Grandview BLVD. Waukesha, WI USA 53188 | |
| Primary Contact | |
| Person: | Huande Li |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 86-18101131237 | |
| E-mail: huande.li@ge.com | |
| Secondary | |
| Contact Person: | Glen Sabin |
| Director, Regulatory Affairs | |
| GE Healthcare | |
| Phone: 262- 5216848 | |
| E-mail: glen.sabin@ge.com | |
| Device Trade | |
| Name: | SIGNA™ Victor |
| Common/Usual | |
| Name: | Magnetic Resonance Diagnostic Device |
| Classification | |
| Names: | Magnetic Resonance Diagnostic Device per 21 CFR |
| 892.1000 | |
| Product Code: | LNH |
| Predicate | |
| Device(s): | SIGNA™ Explorer (K143251) |
| SIGNA™ Prime (K211980) | |
| Reference | |
| Device(s): | SIGNA Voyager (K161567) |
| SIGNA Artist Evo (K213603) | |
| Device | |
| Description: | SIGNA™ Victor is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine). |
| Indications for | |
| Use | The SIGNA Victor is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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 body. |
| Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Victor reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. | |
| Technology: | The SIGNA™ Victor employs the same fundamental scientific technology as its predicate devices. |
| SIGNA™ Victor is built with superconducting magnet, RF transmit architecture, RF receive chain and software application suite. | |
| Comparison of | |
| Indications | |
| for Use | The changes in technology do not impact the indications for use. |
| The indications for use have not been changed, other than to | |
| reflect the SIGNA™ Victor product name. | |
| Therefore, the intended use is the same as the predicate devices | |
| in accordance with the FDA's guidance document "The 510(k) | |
| Program: Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)]", dated 28 July 2014. | |
| Comparison of | |
| Technological | |
| Characteristics | Overall, the SIGNA™ Victor employs the same fundamental |
| scientific technology as the predicate devices. | |
| System Design: Both SIGNA™ Victor and the predict devices | |
| includes the 1.5T magnets, RF transmit architecture, RF receive | |
| chain and software application suite. | |
| Operating Principles: The SIGNA™ Victor functions using the | |
| same operating principles as the predicate devices. | |
| Materials: The SIGNA™ Victor and the predicate devices both | |
| use flame retardant materials. | |
| Safety and Performance Testing: Both the SIGNA™ Victor and | |
| the predicate devices comply with the same safety and | |
| performance testing (see Determination of Substantial | |
| Equivalence, below). | |
| These technological differences do not raise any different | |
| questions regarding safety and effectiveness. Both devices must | |
| address questions of whether they provide an adequate level of | |
| image quality appropriate for diagnostic use. The performance | |
| data described in this submission include results of both bench | |
| testing and clinical testing that show the image quality | |
| performance of SIGNA™ Victor compared to the predicate | |
| devices. | |
| Determination of | |
| Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The SIGNA™ Victor and the predicate devices were subject to | |
| similar risk management testing to demonstrate substantial | |
| equivalence of safety and performance. |
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Testing to the following voluntary standards included:
- ANSI AAMI ES60601-1
- IEC 60601-1-2 ●
- IEC 60601-2-33
- IEC 62304
- IEC 60601-1-6
- IEC 62366-1
- ISO 10993-1
In addition, the SIGNA™ Victor complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate devices.
Both the SIGNA™ Victor and the predicate devices have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices.
The following quality assurance measures were applied to the development of the subject device, as they were for the predicate devices:
- Risk Analysis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- . Integration testing (System verification)
- Performance testing (Verification) ●
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, the SIGNA™ Victor, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Victor in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on November 18,
9
Image /page/9/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.
| 2016. The image quality of the SIGNAT™ Victor is substantially | |
|---|---|
| equivalent to that of the predicate devices. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed device are comparable to | |
| the claimed predicate devices. The SIGNAT™ Victor employs | |
| equivalent technology to the claimed predicate devices. | |
| Additionally, the results from the above non-clinical tests | |
| demonstrate that the device performs as intended. Therefore, the | |
| SIGNAT™ Victor is substantially equivalent to the predicate devices | |
| to which it has been compared. | |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNAT™ |
| Victor to be as safe, as effective, with performance that | |
| is substantially equivalent to the predicate devices. |