(87 days)
No
The description mentions an "algorithm" for image processing and stiffness map creation, but there is no mention of AI, ML, deep learning, or any related terms. The focus is on a specific acquisition sequence and a deterministic algorithm based on physical principles (vibration and MR signal response).
No
The device is described as a software option for MR systems used to produce images representing tissue stiffness. It is an imaging and diagnostic tool, not one that delivers therapy.
Yes
The device is described as producing images representing tissue stiffness and reliability, and creating confidence maps and wave images, all of which are used to evaluate parametric images, indicating its use in assessing the state of tissues. The intended use also mentions producing images representing tissue stiffness of the abdomen area such as liver and muscle, which is a diagnostic purpose.
No
The device description explicitly states that the MR Elastography feature includes "a source of acoustic frequency vibration and means to impart that vibration to the scan subject," which are hardware components provided by a third party.
Based on the provided text, this device is likely an IVD (In Vitro Diagnostic), although it's not explicitly stated as such. Here's why:
- Intended Use: The device is intended for "producing images representing tissue stiffness of the abdomen area such as liver and muscle." While this isn't a direct diagnostic claim like "diagnosing liver fibrosis," measuring tissue stiffness (elastography) is a well-established technique used to aid in the diagnosis and assessment of various medical conditions, particularly those affecting the liver (like fibrosis or cirrhosis). The output (stiffness in kPa) is a quantitative measurement used in clinical decision-making.
- Device Description: The description details a process that involves acquiring data from the patient (MR acquisition synchronized with vibration), processing that data (image processing to produce stiffness maps, confidence maps, and wave images), and providing an analysis tool. This aligns with the typical workflow of an IVD, which involves analyzing a sample (in this case, the tissue's response to vibration captured by MR) to provide information for diagnosis or assessment.
- Predicate Devices: The predicate devices listed (K083421 MR-Touch Option and K121434 syngo MR K13A) are also related to MR imaging and likely include features or functionalities that are considered medical devices, and potentially IVDs depending on their specific intended use. MR-Touch is a known MR elastography system.
- Performance Studies: The summary of performance studies mentions "clinical validation" and testing of "clinical user needs," which are common requirements for medical devices, including IVDs. The focus on repeatability and differentiation between tissues of different stiffness further supports its use in a diagnostic context.
Why it's not definitively stated as an IVD:
- The text doesn't explicitly use the term "In Vitro Diagnostic" or state that it's intended for use on "in vitro diagnostic specimens." However, the definition of an IVD can be broad and include devices that analyze data derived from the human body to provide diagnostic information.
In conclusion, while the text doesn't explicitly label it as an IVD, the intended use of providing quantitative tissue stiffness measurements for clinical assessment, the processing of data derived from the patient, and the context of its predicate devices strongly suggest that this device falls under the category of an In Vitro Diagnostic medical device.
N/A
Intended Use / Indications for Use
MR Elastography is a software and hardware option intended for use on Achieva and Ingenia 1.5T and 3.0T MR Systems for producing images representing tissue stiffness of the abdomen area such as liver and muscle. MR Elastography applies an MR acquisition sequence synchronized with an external source of vibration to produce images representing tissue stiffness (in kiloPascals, kPa). The stiffness image production technique also creates an overlay representing the reliability of the stiffness image production algorithm.
Product codes
LNH
Device Description
The MR Elastography feature consists of a specialized acquisition: a source of acoustic frequency vibration and means to impart that vibration to the scan subject: an image processing step to produce stiffness maps, confidence maps, and wave images; and an analysis tool to evaluate the parametric images created.
The acquisition is based on the Phase Contrast FFE sequence acquired while imparting a known frequency of vibration into the patient. A set of images with controlled phase differences between the acquisition and the mechanical oscillation is created by synchronizing the mechanical driver with the acquisition at different time delays. The vibration source and connecting equipment are provided by Resoundant Inc. as a complete set. Elasticity images are created from the image data generated by this acquisition strategy using an algorithm developed by Resoundant Inc. and The Mayo Clinic. In addition, wave images and confidence overlays are also produced to provide data quality assurance.
The following elements of MR Elastography are similar to previously cleared devices (refs [2] and [3]):
- The MR Elastography sequence acquires a PC FFE image for each required . acoustic phase difference for each slice.
- The scan execution of the MR Elastography acquisition produces a TTL trigger . for each TR.
- After reconstruction, the MR Elastography acquisition magnitude and phase . images are used in the MR Elastography post-processing package to generate wave images and elasticity images using an algorithm based on those developed by The Mayo Clinic and Resoundant Incorporated.
- Confidence overlays are generated by the MR Elastography image post-. processing package as a guide indicating which voxels may not yield dependable computational results.
- An MR Elastography image analysis tool is available to view images, draw . ROI's, and display stiffness information, and provide overlays of the confidence map on the images and overlays of the stiffness map on the anatomical images.
Hardware as part of the MR Elastography feature
The MR Elastography feature includes hardware supplied by Resoundant Incorporated. This hardware consists of an active driver outside of the magnet room and a passive (MR compatible) driver positioned next to the scan subject connected by a length of plastic hose. The vibration from the active driver is transmitted to the passive driver pneumatically through the hose connecting the two drivers. The passive driver is held in place by an elastic belt that is wrapped around the patient. The active driver is a self-contained metal and plastic box that generates the mechanical waves necessary for the MR Elastography examination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
abdomen area such as liver and muscle
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
MR Elastography has been verified to function with the Achieva and Ingenia MR systems. Sample images demonstrate the wave and elastogram outputs. Additionally, included confidence studies prove that MR Elastography produces repeatable results and can reliably differentiate between tissues of different stiffness.
All the tests performed for MR Elastography were successful.
The clinical user needs are tested as part of the validation testing. The clinical validation of MR Elastography is completed successfully. All clinical user needs have passed for Achieva and Ingenia 1.5T and 3T systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word, there is some handwritten text that appears to be a document number or page identifier. The handwritten text includes the characters "K140666" and "Page 1 of 4".
Philips Medical Systems Nederland B.V.
l.
JUN 1 3 2014
510(k) Summary
MR Elastography
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| General Information
21 CFR 807.92 (a)(1),
| (2) | |
|---|---|
| Company Name: | Philips Medical Systems Nederland B.V. |
| Address: | Veenpluis 4-6 |
| 5684 PC Best | |
| The Netherlands | |
| Registration No.: | 3003768277 |
| Contact Person: | Susan Quick |
| 595 Miner Rd | |
| Cleveland, Oh 44143 | |
| Fax: (440)-483-4799 | |
| E-mail: susan.quick@philips.com | |
| Prepared (date): | 2014 March 14 |
| Trade Name of Device: | MR Elastography |
| Common Name | Software Option for Magnetic Resonance |
| Diagnostic Device | |
| Classification: | Class II. |
| Regulatory Section: | Magnetic Resonance Diagnostic Device. |
| 892.1000 | |
| Product Code: | 90LNH |
1
510(k) Summarv MR Elastography
21 CFR 807.92(a)(3): Legally marketed predicate device to which substantial equivalence is claimed:
| 1. Predicate Device: | MR-Touch Option |
|---|---|
| Manufacturer: | GE |
| Predicate Device K#: | K083421 |
| Product Code: | LNH |
| 2. Predicate Device: | syngo MR K13A for the MAGNETOM Systems |
| Aera/Skyra/Avanto/Verio | |
| Manufacturer: | Siemens |
| Predicate Device K#: | K121434 |
| Product Code: | LNH |
21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification:
Summary of functions of the device and its major components
The MR Elastography feature consists of a specialized acquisition: a source of acoustic frequency vibration and means to impart that vibration to the scan subject: an image processing step to produce stiffness maps, confidence maps, and wave images; and an analysis tool to evaluate the parametric images created.
The acquisition is based on the Phase Contrast FFE sequence acquired while imparting a known frequency of vibration into the patient. A set of images with controlled phase differences between the acquisition and the mechanical oscillation is created by synchronizing the mechanical driver with the acquisition at different time delays. The vibration source and connecting equipment are provided by Resoundant Inc. as a complete set. Elasticity images are created from the image data generated by this acquisition strategy using an algorithm developed by Resoundant Inc. and The Mayo Clinic. In addition, wave images and confidence overlays are also produced to provide data quality assurance.
The following elements of MR Elastography are similar to previously cleared devices (refs [2] and [3]):
- The MR Elastography sequence acquires a PC FFE image for each required . acoustic phase difference for each slice.
- The scan execution of the MR Elastography acquisition produces a TTL trigger . for each TR.
- After reconstruction, the MR Elastography acquisition magnitude and phase . images are used in the MR Elastography post-processing package to generate wave images and elasticity images using an algorithm based on those
1
2
developed by The Mayo Clinic and Resoundant Incorporated.
- Confidence overlays are generated by the MR Elastography image post-. processing package as a guide indicating which voxels may not yield dependable computational results.
- An MR Elastography image analysis tool is available to view images, draw . ROI's, and display stiffness information, and provide overlays of the confidence map on the images and overlays of the stiffness map on the anatomical images.
Hardware as part of the MR Elastography feature
The MR Elastography feature includes hardware supplied by Resoundant Incorporated. This hardware consists of an active driver outside of the magnet room and a passive (MR compatible) driver positioned next to the scan subject connected by a length of plastic hose. The vibration from the active driver is transmitted to the passive driver pneumatically through the hose connecting the two drivers. The passive driver is held in place by an elastic belt that is wrapped around the patient. The active driver is a self-contained metal and plastic box that generates the mechanical waves necessary for the MR Elastography examination.
21 CFR 807.92(a)(5): Intended Use
MR Elastography is a software and hardware option intended for use on Achieva and Ingenia 1.5T and 3.0T MR Systems for producing images representing tissue stiffness of the abdomen area such as liver and muscle. MR Elastography applies an MR acquisition sequence synchronized with an external source of vibration to produce images representing tissue stiffness (in kiloPascals, kPa). The stiffness image production technique also creates an overlay representing the reliability of the stiffness image production algorithm.
21 CFR 807.92(a){6): Technological Characteristics:
MR Elastography contains both hardware and software elements. The hardware elements are supplied by Resoundant, Inc. and consist of an active driver positioned outside the magnet room and a passive driver positioned on the scan subject. The MR Elastography software post-processing package was based on an estimation algorithm provided by The Mayo Clinic and Resoundant, Inc and the final MR Elastography software was developed in conjunction with The Mayo Clinic and Resoundant, Inc. Both the GE MR-Touch (K083421) and the Siemens MR Elastography (K121434) contain the same hardware elements provided by Resoundant, Inc. and both predicates used the same estimation algorithm and worked in conjunction with The Mayo Clinic and Resoundant, Inc. to develop their final software.
MR Elastography acquisitions are substantially equivalent to the existing phasecontrast imaging feature of the previously cleared Achieva and Ingenia1.5T and 3.0T MR systems (K110151). The acquisition, processing and output images are substantially equivalent to the previously cleared predicates, GE MR-Touch (K083421)
3
K140666
Page 4 of 4
and the Siemens MR Elastography (K121434) used in the MAGNETOM Aera and MAGNETOM Skyra. As with the above predicates, the MR Elastography option provides for a sensitive phase-contrast acquisition synchronized with the vibration supplied by the Resoundant hardware. This captures images of the tissue displacements, which are then input to an algorithm to estimate relative stiffness.
21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:
MR Elastography has been verified to function with the Achieva and Ingenia MR systems. Sample images demonstrate the wave and elastogram outputs. Additionally, included confidence studies prove that MR Elastography produces repeatable results and can reliably differentiate between tissues of different stiffness.
All the tests performed for MR Elastography were successful.
21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:
The clinical user needs are tested as part of the validation testing. The clinical validation of MR Elastography is completed successfully. All clinical user needs have passed for Achieva and Ingenia 1.5T and 3T systems.
21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe. as effective, and performs as well as the legally marketed device identified in paragraph (a)(3) of this section:
The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.
MR Elastography does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers MR Elastography to be substantially equivalent to the above mentioned predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems. Nederland B.V. % Ms. Susan Quick Regulatory Affairs Speciālist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K140666
Trade/Device Name: MR Elastography Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 7, 2014 Received: April 9, 2014
Dear Ms. Quick:
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. Iisting 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.
June 13, 2014
5
Page 2—Ms. Quick
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,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
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) K140666
Device Name
MR Elastography-
Indications for Use (Describe)
MR Elastography is a software option intended for use on Achieva and Ingenia 1.5T and 3.0T MR Systems for producing images representing tissue stiffness of the abdomen area such as liver and muscle. MR Elastography applies " an MR acquisition sequence synchronized with an external source of vibration to produce images representing tissue stiffness (in kiloPascals, kPa). The stiffness image production technique also creates an overlay the reliability of the stiffness image production algorithm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ل Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR USE ONLY ・・・ *****************************************************************************************************************************************************************************
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Robert A Ochs
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."