(81 days)
No
The description focuses on acquisition and reconstruction techniques for accelerating MRI, not on AI/ML for image analysis or processing. There is no mention of AI, DNN, or ML, nor any description of training or test sets typically associated with AI/ML development.
No.
HyperBand is a software option for GE MR systems that accelerates imaging acquisition and increases slice coverage; it does not treat or cure any medical condition.
No.
HyperBand is a software intended to accelerate imaging acquisition times or increase slice coverage, not to diagnose a condition. It is used on MR systems for image acquisition.
No
The device is described as a "software option intended for use on GE MR 1.5T and 3T Systems" and an "optional feature for GE Healthcare's 1.5T and 3T MR systems." While it is a software feature, it is explicitly designed to operate on existing MR hardware systems, and its function is directly tied to the acquisition and reconstruction of MR images generated by that hardware. It is not a standalone software application that performs a medical function independent of specific hardware.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that HyperBand is a software option for GE MR systems used for imaging the head and breast. This is an in vivo (within a living organism) imaging technique, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description reinforces that it's a software application for MR systems to improve scan time and image acquisition.
- Input Imaging Modality: The input is Magnetic Resonance (MR), which is an in vivo imaging modality.
- Anatomical Site: The specified anatomical sites (head and breast) are parts of the human body being imaged directly.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information for diagnosis, monitoring, or screening. HyperBand does not perform this function. It is a tool to enhance the acquisition of in vivo MR images.
N/A
Intended Use / Indications for Use
HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple slices at multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.
Product codes
LNH
Device Description
HyperBand is a clinical software application which is offered as an optional feature for GE Healthcare's 1.5T and 3T MR systems. It provides a reduction in scan time by simultaneously exciting multiple slices at multiple locations. It can lead to higher acceleration reduction factors when combined to other methods of parallel imaging. The benefits of HyperBand acceleration include enhancements on productivity and patient experience by shortened breath holds, increased anatomy coverage and higher resolution image acquisition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR 1.5T and 3T Systems
Anatomical Site
head and breast
Indicated Patient Age Range
all patients not otherwise contraindicated for MRI examination
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)
Summary of Non-Clinical Tests:
HyperBand is a software only feature and complies with the following voluntary standards:
AAMI/ANSI 62304 AAMI/ANSI ES60601-1 IEC 60601-2-33
In addition, HyperBand complies with NEMA PS3.1-3.18 for DICOM conformance.
The following quality assurance measures were applied to the development of the device:
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)
Signal to Noise Ratio (SNR) testing was performed with and without the HyperBand feature, and provided to support substantial equivalence.
The non-clinical tests have been summarized in the verification and validation testing for HyperBand. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicates because it was also developed under quality assurance Design Controls. In addition, the software complies with the same applicable Standards.
Summary of Clinical Tests:
The subject of this premarket submission, HyperBand, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features. The clinical results demonstrated that HyperBand maintain the same imaging performance results as its predicate devices (K012970). Sample clinical images are included in this submission.
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
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
GE Medical Systems, LLC % Mr. Glen Sabin Regulatory Affairs Leader 3200 North Grandview Blvd. WAUKESHA WI 53188
Re: K162403 Trade/Device Name: HyperBand Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 26, 2016 Received: August 29, 2016
Dear Mr. 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 device-related 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.
1
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/Resourcesfor You/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.
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162403
Device Name
HyperBand
Indications for Use (Describe)
HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consistion and reconstruction technique allowing simultaneous excitation of multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.
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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GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary HyperBand
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GE Healthcare 510(k) Premarket Notification Submission
| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||
|---|---|---|
| Date: | November 16, 2016 | |
| Primary Contact Person: | Glen Sabin | |
| Requlatory Affairs Director, MR | ||
| GE Healthcare, (GE Medical Systems, LLC) | ||
| Phone: 262-521-6848 | ||
| Fax: 414-908-9585 | ||
| Device Trade Name: | HyperBand | |
| Common/Usual Name: | MR Software Application | |
| Classification Names: | Magnetic Resonance Diagnostic Device | |
| (21 CFR 892.1000) | ||
| Product Code: | LNH | |
| Predicate Devices: | Predicate Device: ASSET (K012970) | |
| Device Description: | HyperBand is a clinical software application which is | |
| offered as an optional feature for GE Healthcare's 1.5T | ||
| and 3T MR systems. It provides a reduction in scan | ||
| time by simultaneously exciting multiple slices at | ||
| multiple locations. It can lead to higher acceleration | ||
| reduction factors when combined to other methods of | ||
| parallel imaging. The benefits of HyperBand | ||
| acceleration include enhancements on productivity and | ||
| patient experience by shortened breath holds, | ||
| increased anatomy coverage and higher resolution | ||
| image acquisition. | ||
| Indications for Use: | HyperBand is a software option intended for use on GE | |
| MR 1.5T and 3T Systems. HyperBand consists of an | ||
| acquisition and reconstruction technique allowing | ||
| simultaneous excitation of multiple slices at multiple | ||
| locations to accelerate imaging acquisition times or | ||
| increase slice coverage without increasing scan time. | ||
| HyperBand is indicated for echo-planar imaging (EPI) of | ||
| the head and breast. | ||
| HyperBand is indicated for imaging all patients not | ||
| otherwise contraindicated for MRI examination. | ||
| Comparison of Intended | ||
| Use | Both HyperBand and the predicate device are magnetic | |
| resonance imaging devices intended for diagnostic use. | ||
| Both indications for use statements are functional in | ||
| nature, and do not list specific diseases or conditions. | ||
| HyperBand and the predicate device are indicated for | ||
| the same patient population, and for the same clinical | ||
| setting. HyperBand and the predicate device are | ||
| indicated for similar anatomical regions: HyperBand | ||
| for the head and breast, and ASSET for the head or | ||
| body. | ||
| Therefore, GE Healthcare believes that HyperBand has | ||
| the same intended use as the predicate device 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: | The most notable technological difference between | |
| HyperBand and the predicate device is that HyperBand | ||
| is capable of simultaneously exciting multiple slices | ||
| leading to higher acceleration reduction factors when | ||
| combined with other methods of parallel imaging. The | ||
| predicate device acquires one slice or one slab at a time. | ||
| However, per bench and clinical data collected to | ||
| validate the indications for use, this technological | ||
| difference does not raise any different questions of | ||
| 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 HyperBand | ||
| compared to the predicate device. | ||
| Performance Data: | Summary of Non-Clinical Tests: | |
| HyperBand is a software only feature and complies | ||
| with the following voluntary standards: | ||
| AAMI/ANSI 62304 AAMI/ANSI ES60601-1 IEC 60601-2-33 | ||
| In addition, HyperBand complies with NEMA PS3.1-3.18 | ||
| for DICOM conformance. | ||
| The following quality assurance measures were applied | ||
| to the development of the device: | ||
| 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) | ||
| Signal to Noise Ratio (SNR) testing was performed with | ||
| and without the HyperBand feature, and provided to | ||
| support substantial equivalence. | ||
| The non-clinical tests have been summarized in the | ||
| verification and validation testing for HyperBand. The | ||
| testing was completed with passing results per the | ||
| pass/fail criteria defined in the test cases. This supports | ||
| substantial equivalence to its predicates because it was | ||
| also developed under quality assurance Design | ||
| Controls. In addition, the software complies with the | ||
| same applicable Standards. | ||
| Summary of Clinical Tests: | ||
| The subject of this premarket submission, HyperBand, | ||
| did not require external clinical studies to support | ||
| substantial equivalence. Internal scans were conducted | ||
| as part of validation for workflow and image quality for | ||
| the addition of the new features. The clinical results | ||
| demonstrated that HyperBand maintain the same | ||
| imaging performance results as its predicate devices | ||
| (K012970). Sample clinical images are included in this | ||
| submission. | ||
| Conclusion: | GE Healthcare believes that the HyperBand software | |
| feature has substantially the same intended use as the | ||
| predicate ASSET. This 510(k) submission includes | ||
| information on the technological characteristics of the | ||
| HyperBand feature, as well as performance data | ||
| demonstrating that HyperBand is as safe and effective | ||
| as the predicate, and does not raise different questions | ||
| of safety and effectiveness | ||
| In conclusion, GE Healthcare believes that the | ||
| HyperBand feature is substantially equivalent to the | ||
| predicate device. |
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GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare
510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission