(203 days)
No
The description focuses on "sparse data sampling and iterative reconstruction," which are established image processing techniques, not explicitly AI/ML. There is no mention of AI, ML, or related concepts like training or test sets for model development.
No
HyperSense is a software feature for MR systems that allows for faster imaging or increased resolution; it does not directly treat or diagnose a disease or condition.
No
HyperSense is a software feature that enhances the speed and resolution of MRI scans. It aids in image acquisition and quality, but it does not directly diagnose medical conditions.
No
The device is described as a "software feature intended for use on GE MR 1.5T and 3.0T Systems." This indicates it is a component of a larger hardware system (the MR scanner) and not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- HyperSense Function: HyperSense is a software feature for MR systems that focuses on image acquisition and processing. It accelerates the process of obtaining MR images by using sparse data sampling and iterative reconstruction.
- Lack of Specimen Analysis: The description of HyperSense does not involve the analysis of any biological specimens taken from the patient. It directly interacts with the MR scanner and the data acquired from the patient's body during the scan.
Therefore, HyperSense falls under the category of a medical imaging device software feature, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HyperSense is a software feature intended for use on GE MR 1.5T and 3.0T Systems. HyperSense is an acceleration technique based on sparse data sampling and iterative reconstruction that allows users to reduce scan times or increase scan resolution. HyperSense can be used for non-contrast enhanced imaging of the head, neck, spine, extremities, pelvis, and abdomen.
Product codes
LNH
Device Description
HyperSense is a software feature used on GE 1.5T and 3.0T MR systems. HyperSense is an acceleration technique based on sparse data sampling and iterative reconstruction, enabling faster imaging without the penalties commonly found with conventional parallel imaging. HyperSense is intended to be used with volumetric acquisitions, and can be combined with other methods of acceleration (ARC) for achieving high signal to noise ratio with shorter acquisition times. HyperSense can deliver higher spatial resolution images or reduced scan times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, neck, spine, extremities, pelvis, and abdomen
Indicated Patient Age Range
Not Found
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
A clinical study has been performed to evaluate the impact of HyperSense on image quality, as measured by the legibility of morphological features. Additionally, a peer reviewed journal article describing a study of the HyperSense technique has been provided in this submission as supporting evidence. The clinical results demonstrated that HyperSense maintains comparable imaging performance results as its predicate devices (K142085). Sample clinical images are included in this submission.
Key Metrics
Not Found
Predicate Device(s)
ARC (K142085)
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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
Ge Medical Systems, LLC Glen Sabin Regulatory Affairs Director 3200 Grandview Blvd Waukesha. Wisconsin 53188
Re: K162722
Trade/Device Name: HyperSense Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: March 15, 2017 Received: March 16, 2017
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.
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/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,
Michael O'Hara
For
Robert A. 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) K162722
Device Name HyperSense
Indications for Use (Describe)
HyperSense is a software feature intended for use on GE MR 1.5T and 3.0T Systems. HyperSense is an acceleration technique based on sparse data sampling and iterative reconstruction that allows users to reduce scan times or increase scan resolution. HyperSense can be used for non-contrast enhanced imaging of the head, neck, spine, extremities, pelvis, and abdomen.
| 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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue. The background is white.
| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||
|---|---|---|
| Date: | 19 April 2017 | |
| Primary Contact Person: | Glen Sabin | |
| Regulatory Affairs Director, MR | ||
| GE Healthcare, (GE Medical Systems, LLC) | ||
| Phone: 262-521-6848 | ||
| Fax: 414-908-9585 | ||
| Secondary Contact Person: | James McMahon | |
| Senior Director, Regulatory Affairs - MR | ||
| GE Healthcare, (GE Medical Systems, LLC) | ||
| Phone: 508-382-2858 | ||
| Device Trade Name: | HyperSense | |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device | |
| Classification Names: | 892.1000 | |
| Product Code: | LNH | |
| Predicate Devices: | Predicate Device: ARC (K142085) | |
| Device Description: | HyperSense is a software feature used on GE 1.5T and | |
| 3.0T MR systems. | ||
| HyperSense is an acceleration technique based on | ||
| sparse data sampling and iterative reconstruction, | ||
| enabling faster imaging without the penalties | ||
| commonly found with conventional parallel imaging. | ||
| HyperSense is intended to be used with volumetric | ||
| acquisitions, and can be combined with other methods | ||
| of acceleration (ARC) for achieving high signal to noise | ||
| ratio with shorter acquisition times. HyperSense can | ||
| deliver higher spatial resolution images or reduced | ||
| scan times. |
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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white water droplet shapes around the letters. The logo is simple and recognizable.
| Indications for Use: | HyperSense is a software feature intended for use on
GE MR 1.5T and 3.0T Systems. HyperSense is an
acceleration technique based on sparse data sampling
and iterative reconstruction that allows users to reduce
scan times or increase scan resolution. HyperSense
can be used for non-contrast enhanced imaging of the
head, neck, spine, extremities, pelvis, and abdomen. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of Intended
Use | Both HyperSense 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.
HyperSense and the predicate device are indicated for
the same patient population, and for the same clinical
setting. Both indications for use statements include a
range of intended anatomies.
Therefore, GE Healthcare believes that HyperSense 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
HyperSense and the predicate device is that HyperSense
adopts compressed sensing acquisition method based
on sparse data compressibility allowing scan time
reduction while maintaining appropriate image quality.
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 HyperSense compared to
the predicate device |
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are also some water droplet-like shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.
| Performance Data | Summary of Non-Clinical Tests: |
|---|---|
| HyperSense 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, HyperSense complies with NEMA PS3.1-3.18 for DICOM conformance. | |
| HyperSense complies with the same applicable standards as the software used in the predicate device. | |
| As with the predicate device, the following quality assurance measures were applied to the development of HyperSense: | |
| 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) | |
| Phantom testing has been conducted to evaluate the impact of HyperSense on Signal to Noise Ratio (SNR), and spatial resolution. | |
| The non-clinical testing was completed with passing results per the pass/fail criteria defined in the test cases. | |
| Summary of Clinical Tests: | |
| A clinical study has been performed to evaluate the impact of HyperSense on image quality, as measured by the legibility of morphological features. Additionally, a peer reviewed journal article describing a study of the HyperSense technique has been provided in this submission as supporting evidence. The clinical results demonstrated that HyperSense maintains comparable imaging performance results as its predicate devices (K142085). Sample clinical images are included in this submission. | |
| Conclusion: | GE Healthcare believes that the HyperSense software |
| feature has substantially the same intended use as the | |
| predicate ARC. This 510(k) submission includes | |
| information on the technological characteristics of the | |
| HyperSense feature, as well as performance data | |
| demonstrating that HyperSense 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 | |
| HyperSense feature is substantially equivalent to the | |
| predicate device. |
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are white swirls around the letters, creating a dynamic and recognizable design. The logo is simple, clean, and easily identifiable.