(247 days)
MR-Touch™, is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body.
MR-Touch™ generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-Touch™ acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the timeseries of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images.
When used with a GE Signa® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver.
When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.
MR-Touch™ is a combined software and hardware accessory for use with a GE Signa® MR System. It is an evolutionary improvement of the existing phase-contrast imaging feature included with existing GE Signa® MR Systems. The Resoundant hardware component consists of an acoustic wave generator coupled through a length of flexible tubing with a passive transducer to induce small vibrations in the scan subject. The software includes both image acquisition and reconstruction components. The acquisition software is a gradient echo sequence that acquires a series of phase-contrast images over time. It also synchronizes the low frequency and low magnitude induced vibrations generated by Resoundant. The phase-contrast imaging technique measures motion or displacement. During reconstruction, the displacement from the induced vibrations is detected using the timeseries of phase-contrast images. MR-Touch™ then presents the reconstructed displacement information as strain wave and relative stiffness images (referred to as Elastograms).
The GE Healthcare MR-Touch™ Option for GE Signa® MR Systems is an accessory designed to generate transverse sectional information related to the relative stiffness of soft tissue. It comprises hardware for inducing vibrations and software for image acquisition and reconstruction. The primary claim is substantial equivalence to existing MR systems and elastography ultrasound systems.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the MR-Touch™ Option in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices and verifying certain functional aspects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Existing Phase-Contrast Imaging | MR-Touch™ is described as an "evolutionary improvement of the existing phase-contrast imaging feature included with existing GE Signa® MR Systems." It offers a "more convenient method to visualize a time-series of phase-contrast images and the ability to induce synchronized vibrations in the scan subject during acquisition." This implies it performs at least as well as, if not better than, the predicate in its core imaging function. |
| Elastography Output Equivalence to Cleared Ultrasound System | The "Elastography relative-stiffness images (Elastograms)" are stated to be "substantially equivalent to the output of the previously cleared Ultrasonix SonixTouch Elastography imaging mode, which provides color-coded images to differentiate between tissues based on stiffness." |
| Repeatability of Results | "Confidence studies prove that MR-Touch™ produces repeatable results." (No specific quantitative metric or range for repeatability is provided). |
| Ability to Differentiate Tissues of Different Stiffness | "Confidence studies prove that MR-Touch™... can reliably differentiate between tissues of different stiffness." (No specific quantitative metric or threshold for differentiation is provided). |
| Safety and Electromagnetic Compatibility (EMC) | The Resoundant hardware was evaluated against IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety standard) and IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - Second Edition with Amendment 1). The conclusion of substantial equivalence implies it met these safety and EMC standards. |
| Image Quality and Visualization | "Sample images demonstrate the strain wave and Elastogram outputs." "When used with a GE Signa® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver." (This implies adequate image quality for diagnostic interpretation by a trained physician, though specific metrics are absent). |
| Regulatory Substantial Equivalence | The FDA's 510(k) clearance letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the ultimate acceptance criterion for a 510(k) submission. |
2. Sample Size and Data Provenance (for test set)
The document is unclear regarding a dedicated "test set" in the context of clinical performance evaluation. The "Summary of Studies" mentions "Sample images" and "confidence studies" but gives no specifics on:
- Sample Size: Not specified for any performance evaluation.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is common for 510(k) submissions, especially for accessories and evolutionary improvements, to rely on internal testing, phantoms, and existing predicate device performance rather than large-scale clinical studies.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: The document does not describe how ground truth was established for any "test set." The statement "When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis" suggests diagnostic interpretation by a physician is the intended clinical use, but this is not defined as a ground truth mechanism for device validation.
4. Adjudication Method
Not discussed or specified. Given the nature of the submission (substantial equivalence based on technical and functional similarity rather than a new clinical claim requiring high-stakes diagnostic accuracy), a formal adjudication method for a test set is unlikely to have been implemented or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on the device's technical performance and equivalence to existing technologies, not on improving human reader performance with or without AI assistance. The "AI" component here is the image processing and reconstruction software, not a diagnostic AI intended to aid human readers.
6. Standalone Performance Study
The "Summary of Studies" section describes "confidence studies" that "prove that MR-Touch™ produces repeatable results and can reliably differentiate between tissues of different stiffness." This inherently evaluates the standalone performance of the algorithm in generating the strain wave and elastogram outputs. However, specific performance metrics (e.g., accuracy against a known stiffness standard, precision) are not provided. The study does not describe a "human-in-the-loop" component for these specific tests, making them standalone evaluations of the device's ability to produce consistent and differentiate images.
7. Type of Ground Truth Used
For the "confidence studies" demonstrating repeatability and differentiation of stiffness, the ground truth would most likely have been:
- Phantom Studies: Using materials with known and varied stiffness properties.
- Known Physical Properties: Measuring the physical properties of the materials used in the "confidence studies" (e.g., using a mechanical testing device to confirm differences in stiffness).
- The document implies the output (elastograms) themselves are the useful information, rather than a comparison to an external clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not mention any "training set" in the context of machine learning. The MR-Touch™ system is described as an "evolutionary improvement" to existing gradient echo sequences and phase-contrast imaging, implying traditional image processing and reconstruction algorithms rather than a deep learning model that requires a labeled training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set for machine learning is described.
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GE Healthcare
MR-Touch™ Option for GE Signa® MR Systems 510(k} Premarket Notification
510(k) Summary
This 510|k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.
JUL 2 4 2009
| Submitter: | GE Medical Systems, LLC |
|---|---|
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Contact Person: | Daniel T. Biank |
| Regulatory Affairs Leader | |
| Telephone: | 262 - 521 - 6467 |
| Fax: | 262 - 521 - 6379 |
| Email: | Daniel.Biank@med.ge.com |
| Date Prepared: | November 12, 2008 |
| Device Name: | |
| Proprietary Name: | MR-TouchTM Option |
Proprietary Name: MK-Touch™ Option
Common Name: Software and Hardware Accessory for Magnetic Resonance Imaging System
Classification Name: Magnetic Resonance Diagnostic Device, (21 C.F.R. 892.1000, LNH)
Predicate Devices:
GE 1.5T and 3.0T Signa® HDx MR System (K052293).
Ultrasonix SonixTouch Ultrasound Imaging System for Elastoaraphy (K083095),
Device Description:
MR-Touch™ is a combined software and hardware accessory for use with a GE Signa® MR System. It is an evolutionary improvement of the existing phase-contrast imaging feature included with existing GE Signa® MR Systems. The Resoundant hardware component consists of an acoustic wave generator coupled through a length of flexible tubing with a passive transducer to induce small vibrations in the scan subject. The software includes both image acquisition and reconstruction components. The acquisition software is a gradient echo sequence that acquires a series of phase-contrast images over time. It also synchronizes the low frequency and low magnitude induced vibrations generated by Resoundant. The phase-contrast imaging technique measures motion or displacement. During reconstruction, the displacement from the induced vibrations is detected using the timeseries of phase-contrast images. MR-Touch™ then presents the reconstructed displacement information as strain wave and relative stiffness images (referred to as Elastograms).
Intended Use:
MR-Touch™ is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body.
MR-Touch™ generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software components induce vibrations into the scan subject. The MR-Touch™ acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the time-series of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images.
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GE Healthcare
MR-Touch™ Option for GE Signa® MR Systems 510[k} Premarket Notification
When used with a GE Signo® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver.
When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.
Comparison with Predicate Devices:
MR-Touch™ is substantially equivalent to the existing phase-contrast imaging feature of the previously cleared GE 1.5T and 3.0T Signa® HDx MR System (K052293). The primary differences include a more convenient method to visualize a time-series of phase-contrast images and the ability to induce synchronized vibrations in the scan subject during acquisition. The Elastography relative-stiffness images (Elastograms) are substantially equivalent to the output of the previously cleared Ultrasonix SonixTouch Elastography imaging mode, which provides color-coded images to differentiate between tissues based on stiffness.
Summary of Studies:
MR-Touch™ has been verified to function with the GE Signa® HDx MR System. Sample images demonstrate the strain wave and Elastogram outputs. Additionally, included confidence studies prove that MR-Touch™ produces repeatable results and can reliably differentiate between tissues of different stiffness.
The Resoundant, new hardware introduced with MR-Touch™, has been evaluated to the appropriate clauses of IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety standard and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety 2001 - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - Second Edition with Amendment 1.
Conclusion:
It is the opinion of GE that MR-Touch™ when used with a GE Signa® MR System is substantially equivalent to the currently cleared and marketed GE 1.5T and 3.0T Signa® HDx MR Systems, providing Elastography image output that is substantially equivalent to the output provided by the Elastography imaging mode of the currently cleared Ultrasonix SonixTouch Ultrasound Imaaing System.
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Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or other bird with its wings spread. The bird is depicted in a simple, abstract manner with three curved lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel Biank Regulatory Affairs Leader GE Healthcare, MR 3200 N. Grandview Blvd. WAUKESHA WI 53188
JUL 24 2009
Re: K083421
Trade/Device Name: MR-Touch™ Option Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 23, 2009 Received: June 25, 2009
Dear Mr. Biank:
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.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours willy
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Healthcare
Indications for Use
510(k) Number (if known):
Device Name:
MR-Touch™ Option
Indications for Use:
MR-Touch™, is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for maqnetic resonance imaging of the human body.
MR-Touch™ generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-Touch™ acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the timeseries of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images.
When used with a GE Signa® MR system, MR-Touch™ is capable of producing transverse images of internal body structures such as muscle and liver.
When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.
Prescription Use × AND/OR Over-the-Counter Use (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hogart M. Thag
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Section 4
MR-Touch™ Option
§ 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.