(86 days)
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 the SIGNA Voyager reflect the spatial distribution and/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.
The SIGNA Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system uses a combination of time-varying magnetic 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 and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features A 1.5T superconducting magnet with a 70cm bore size.
The document describes the SIGNA Voyager, a Magnetic Resonance Diagnostic Device. However, it does not provide specific acceptance criteria in a table format with reported device performance or details of a dedicated study to prove it meets acceptance criteria as might be expected for an AI/CADe device.
Instead, the document focuses on substantial equivalence to predicate devices (SIGNA Pioneer and Optima MR450w 1.5T). The "Performance Data" section primarily discusses non-clinical tests and a summary of clinical images, rather than a detailed clinical study with quantifiable acceptance criteria.
Based on the provided text, here is an attempt to answer your questions, highlighting where information is not available:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria with corresponding device performance metrics is provided for the SIGNA Voyager in this document. The document states:
"The sample clinical images demonstrate the acceptable diagnostic imaging performance of the SIGNA Voyager including the additional enhanced software features and all coils. The image quality of SIGNA Voyager is substantially equivalent to that of the predicate device."
This statement implies that the acceptance criterion was "acceptable diagnostic imaging performance" and "substantially equivalent image quality to the predicate device", which was demonstrated through clinical images. However, specific quantitative metrics for "acceptable diagnostic imaging performance" are not defined.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "The sample clinical images," but does not specify the sample size for these images, nor does it provide details about data provenance (country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. It states that images are "interpreted by a trained physician," but does not detail the number or qualifications of experts involved in establishing ground truth for any test set mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A MRMC comparative effectiveness study, especially concerning AI assistance, is not mentioned. The SIGNA Voyager is a magnetic resonance diagnostic device, not an AI/CADe device in the context typically requiring such studies for performance evaluation. The "enhanced software features" are not characterized as AI for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for the SIGNA Voyager, as it is a diagnostic imaging device, not a standalone algorithm. Its performance inherently involves human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states that images and/or spectra, "when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the basis for "acceptable diagnostic imaging performance" would be physician interpretation, acting as a form of expert consensus or clinical judgment. However, the exact methodology for establishing ground truth for the "sample clinical images" is not explicitly detailed.
8. The sample size for the training set
The document discusses "The sample clinical images" for demonstrating performance, but it does not mention any training set or details regarding the development process that would involve a training set (which would be typical for an AI/ML device, but not explicitly stated for this MR device).
9. How the ground truth for the training set was established
As no training set is mentioned in the context of device performance evaluation, this information is not applicable/provided.
Summary of Device Performance (as stated in the document, without specific metrics):
- Intended Use: Produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body.
- Performance Claim: "The sample clinical images demonstrate the acceptable diagnostic imaging performance of the SIGNA Voyager including the additional enhanced software features and all coils."
- Equivalence Claim: "The image quality of SIGNA Voyager is substantially equivalent to that of the predicate device."
In essence, this 510(k) summary focuses on demonstrating substantial equivalence through descriptions of technological characteristics, adherence to voluntary standards, quality assurance measures during development, and a general statement about clinical image quality compared to predicates, rather than extensive clinical study results with detailed acceptance criteria and quantitative performance metrics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Ge Healthcare Glen Sabin Regulatory Affairs Director 3200 N. Grandview Blvd Waukesha. Wisconsin 53188
Re: K161567
Trade/Device Name: Signa Voyager Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: June 3, 2016 Received: June 7, 2016
Dear Glen Sabin:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'Hara
For
Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
SIGNA Voyager
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161567
Device Name SIGNA Voyager
Indications for Use (Describe)
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-tonoise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 the SIGNA Voyager reflect the spatial distribution and/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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (8/14)
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Section 5: 510(k) Summary
SIGNA Voyager
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Section 5: 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 03, 2016 |
|---|---|
| Submitter: | GE Healthcare3200 N. Grandview Blvd.Waukesha, WI 53188. USA |
| Primary Contact Person: | Glen SabinRegulatory Affairs DirectorGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848 |
| Secondary Contact Person: | Steve KachelmeyerRegulatory Affairs Director - MRGE Healthcare, (GE Medical Systems, LLC)Phone: (262) 548-2432 |
| Device Trade Name: | SIGNA Voyager |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 |
| Product Code: | LNH, MOS |
| Predicate Device: | SIGNA Pioneer (K160621)Optima MR450w 1.5T (DV25) (K142085) |
| Device Description: | The SIGNA Voyager system is a whole body magneticresonance scanner designed to support high resolution, highsignal-to-noise ratio, and short scan times. The system uses acombination of time-varying magnetic fields (gradients) and RFtransmissions to obtain information regarding the density andposition of elements exhibiting magnetic resonance. The systemcan image in the sagittal, coronal, axial and oblique planes, usingvarious pulse sequences and reconstruction algorithms. Thesystem is offered as a new system installation, in either a fixed ora mobile configuration. The system features A 1.5Tsuperconducting magnet with a 70cm bore size. |
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510(k) Premarket Notification Submission
| Intended Use: | The SIGNA Voyager is a whole body magnetic resonancescanner designed to support high resolution, high signal-to-noiseratio, and short scan time imaging. The SIGNA Voyager isindicated for use as a diagnostic imaging device to produce axial,sagittal, coronal, and oblique images, spectroscopic imagesand/or spectra, dynamic images, and parametric maps of theinternal structures and organs of the entire body. Body structuresfor evaluation include, but are not limited to: head, neck, TMJ,spine, breast, heart, abdomen, pelvis, joints, prostate, bloodvessels, and musculoskeletal regions of the body. Depending onthe region of interest being imaged, contrast agents may be used.The images produced by the SIGNA Voyager reflect the spatialdistribution and/or molecular environment of nuclei exhibitingmagnetic resonance. These images and/or spectra wheninterpreted by a trained physician yield information that mayassist in diagnosis. |
|---|---|
| TechnologicalCharacteristics: | The SIGNA Voyager employs the same fundamental scientifictechnology as its predicate devices.The following is a summary of the different technologycharacteristics from the predicate devices:Updated RF Receive Chain New version of software Modified magnet and RF body coil Updated TDI Coil Suite New Computers |
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| Performance Data: | Summary of Non-Clinical Tests:Like the predicate device, the SIGNA Voyager complies with thefollowing voluntary standards:• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-33• ISO 10993-1In addition, the SIGNA Voyager complies with the applicableNEMA MS standards for MRI and NEMA PS3 standard forDICOM, as does the predicate device.The following quality assurance measures were applied to thedevelopment of the system, as they were for the predicates:• Risk Analysis• Requirements Reviews• Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Performance testing (Verification)• Safety testing (Verification)• Simulated use testing (Validation) |
|---|---|
| Summary of Clinical Tests:The sample clinical images demonstrate the acceptablediagnostic imaging performance of the SIGNA Voyagerincluding the additional enhanced software features and all coils.The image quality of SIGNA Voyager is substantially equivalentto that of the predicate device. | |
| Conclusion: | The SIGNA Voyager has the same intended use as the predicatedevices. The differences in technological characteristics betweenthe SIGNA Voyager and the predicate devices do not raise anydifferent questions of safety or effectiveness. Performance dataprovided in this submission demonstrate that the SIGNAVoyager is as safe, as effective, and performs as well as or betterthan the predicate devices.GE Healthcare considers the SIGNA Voyager to be substantiallyequivalent to the SIGNA Pioneer and Optima MR450w devices. |
§ 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.