(203 days)
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.
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.
HyperSense Device Acceptance Criteria and Study Details
The provided document describes the GE HyperSense, a software feature for MR systems that uses sparse data sampling and iterative reconstruction to reduce scan times or increase resolution.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Reported Device Performance (HyperSense with predicate) |
|---|---|
| Image quality (legibility of morphological features) | Comparable imaging performance |
| Signal to Noise Ratio (SNR) | Evaluated (results not explicitly stated, but "passing results" generally imply meeting predetermined criteria) |
| Spatial Resolution | Evaluated (results not explicitly stated, but "passing results" generally imply meeting predetermined criteria) |
Note: The document states that "the non-clinical testing was completed with passing results per the pass/fail criteria defined in the test cases" for SNR and spatial resolution. For clinical testing, it states "The clinical results demonstrated that HyperSense maintains comparable imaging performance results as its predicate devices."
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for either phantom or clinical studies.
- Data Provenance: Not explicitly stated for the clinical study. It mentions "sample clinical images are included in this submission," suggesting the data was likely from relevant GE MR systems. The study is referred to as "A clinical study has been performed," implying a prospective nature, though not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The clinical study focused on evaluating the impact of HyperSense on image quality compared to its predicate devices, not on human reader improvement with AI assistance.
6. Standalone Performance Study
- Standalone Study: Yes, a standalone performance study in the form of phantom testing was conducted to evaluate the impact of HyperSense on Signal to Noise Ratio (SNR) and spatial resolution. The "clinical study" also appears to be a standalone assessment of the device's image quality. The device is a "software only feature" that enhances image acquisition and reconstruction, implying its direct impact on the image itself, which is a standalone performance by the algorithm.
7. Type of Ground Truth Used
- Phantom Testing: Objective measurements of SNR and spatial resolution.
- Clinical Study: "Legibility of morphological features," which implies a qualitative assessment by experts (implicitly radiologists or medical professionals experienced with MRI interpretations). This would typically involve expert consensus or assessment against established diagnostic criteria. The document also mentions a "peer reviewed journal article describing a study of the HyperSense technique as supporting evidence," which would also likely rely on similar ground truth methodologies.
8. Sample Size for Training Set
- Sample Size for Training Set: Not mentioned. HyperSense is an acceleration technique and iterative reconstruction method. While it's a software feature, the process of developing and tuning such algorithms often involves various datasets for training and validation, but these details are not provided in the summary.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set was Established: Not mentioned. Given the nature of an iterative reconstruction algorithm, "ground truth" for training would typically involve high-quality, fully sampled MR images that the algorithm aims to replicate or improve upon from undersampled data. The process would likely involve various forms of quantitative image metrics and expert review to optimize the reconstruction parameters.
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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.
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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,
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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| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||
|---|---|---|
| Date: | 19 April 2017 | |
| Primary Contact Person: | Glen SabinRegulatory Affairs Director, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848Fax: 414-908-9585 | |
| Secondary Contact Person: | James McMahonSenior Director, Regulatory Affairs - MRGE 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 and3.0T MR systems.HyperSense is an acceleration technique based onsparse data sampling and iterative reconstruction,enabling faster imaging without the penaltiescommonly found with conventional parallel imaging.HyperSense is intended to be used with volumetricacquisitions, and can be combined with other methodsof acceleration (ARC) for achieving high signal to noiseratio with shorter acquisition times. HyperSense candeliver higher spatial resolution images or reducedscan times. |
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| Indications for Use: | HyperSense is a software feature intended for use onGE MR 1.5T and 3.0T Systems. HyperSense is anacceleration technique based on sparse data samplingand iterative reconstruction that allows users to reducescan times or increase scan resolution. HyperSensecan be used for non-contrast enhanced imaging of thehead, neck, spine, extremities, pelvis, and abdomen. |
|---|---|
| Comparison of IntendedUse | Both HyperSense and the predicate device aremagnetic resonance imaging devices intended fordiagnostic use.Both indications for use statements are functional innature, and do not list specific diseases or conditions.HyperSense and the predicate device are indicated forthe same patient population, and for the same clinicalsetting. Both indications for use statements include arange of intended anatomies.Therefore, GE Healthcare believes that HyperSense hasthe same intended use as the predicate device inaccordance with the FDA's guidance document "The510(k) Program: Evaluating Substantial Equivalence inPremarket Notifications [510(k)]", dated 28 July 2014. |
| Comparison ofTechnologicalCharacteristics: | The most notable technological difference betweenHyperSense and the predicate device is that HyperSenseadopts compressed sensing acquisition method basedon sparse data compressibility allowing scan timereduction while maintaining appropriate image quality.Per bench and clinical data collected to validate theindications for use, this technological difference doesnot raise any different questions of safety andeffectiveness. Both devices must address questions ofwhether they provide an adequate level of imagequality appropriate for diagnostic use. The performancedata described in this submission include results ofboth bench testing and clinical testing that show theimage quality performance of HyperSense compared tothe predicate device |
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| 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 softwarefeature has substantially the same intended use as thepredicate ARC. This 510(k) submission includesinformation on the technological characteristics of theHyperSense feature, as well as performance datademonstrating that HyperSense is as safe and effectiveas the predicate, and does not raise different questionsof safety and effectiveness.In conclusion, GE Healthcare believes that theHyperSense feature is substantially equivalent to thepredicate device. |
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§ 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.