(70 days)
Not Found
No
The description focuses on established signal processing and reconstruction techniques (SENSE algorithm, k-space manipulation, Bo map correction) and does not mention AI or ML terms or concepts.
No
The device is described as an acquisition and reconstruction technique for magnetic resonance imaging of the brain, designed to accelerate imaging acquisition times or increase coverage/diffusion directions without increasing scan time. Its purpose is to enhance image acquisition, not to treat a disease, injury, or condition.
No
The device is a software option for an MR system, designed to accelerate imaging acquisition or increase coverage/diffusion directions. It aids in image acquisition and reconstruction, not in interpreting or diagnosing medical conditions from the acquired images.
No
The device is described as a "software option intended for use on Ingenia 3.0T CX MR Systems." While it is a software feature, it is explicitly tied to and operates on a specific hardware system (MR Systems). The description details how the software interacts with the hardware (multiband RF pulse, image unfolding using SENSE algorithm, k-space shifts, Bo map information) to achieve its function. It is not a standalone software application independent of a medical device hardware platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that MultiBand SENSE is a software option for an MRI system used for magnetic resonance imaging of the brain. This is an in vivo imaging technique, meaning it is performed on a living organism, not on samples taken from the body.
- Intended Use: The intended use is for accelerating or improving the acquisition of MRI images of the brain, not for analyzing biological samples.
Therefore, MultiBand SENSE falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MultiBand SENSE is a software option intended for use on Ingenia 3.0T CX MR Systems. It's indicated for use in magnetic resonance imaging of the brain for diffusion weighted imaging. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times, or increasing coverage or number of diffusion directions without increasing scan time.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Multiband SENSE feature enables simultaneous excitation and acquisition of multiple volumes for spin echo and gradient echo MR sequences for the purpose of speeding up acquisition times or increasing coverage or resolution without increasing scan time. The simultaneous volume excitation is achieved using a multiband RF pulse. The image unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The image unfolding is improved by introducing a shift in k-space in the phase direction which is dependent on the volume spatial location, resulting in a spatial shift of the aliased pixels. Artifacts related to mismatch between SENSE reference scan and the clinical scan are minimized using information from a previously acquired Bo map. The MultiBand SENSE feature is available on Ingenia 3.0T and Ingenia 3.0T CX systems, and is compatible with the 32 channel head coil.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging
Anatomical Site
brain
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)
The proposed MultiBand SENSE did not require a clinical study since substantial equivalence to the primary predicate device was demonstrated with the following attributes:
• Design features;
• Indication for use;
• Fundamental scientific technology;
• Non-clinical performance testing; and
• Safety and effectiveness.
Non-Clinical verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.
The verification and validation test results demonstrate that the proposed MultiBand SENSE:
• Complies with the aforementioned international and FDA recognized consensus standards and device specific guidance document
• Meets the acceptance criteria and is adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 U.S. Department of Health & Human Services. 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 image of three human profiles facing right, stacked on top of each other, with a wing-like shape extending from the top profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems Nederland B.V. % Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Rd CLEVELAND, OH 44094
December 30, 2016
Re: K162940
Trade/Device Name: MultiBand SENSE Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 20, 2016 Received: October 21, 2016
Dear Susan 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. 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
1
the quality systems (OS) 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 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 D'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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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) K162940
Device Name
MultiBand SENSE
Indications for Use (Describe)
MultiBand SENSE is a software option intended for use on Ingenia 3.0T CX MR Systems. It's indicated for use in magnetic resonance imaging of the brain for diffusion weighted imaging. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times, or increasing coverage or number of diffusion directions without increasing scan time.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | October 14, 2016 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Veenpluis 4-6, 5684 PC, Best, The Netherlands | |
| Establishment Registration Number: 3003768277 | |
| Primary Contact Person: | Jan van de Kerkhof |
| Regulatory Affairs Manager | |
| Phone: +31 6 13300542 | |
| E-mail: jan.van.de.kerkhof@philips.com | |
| Secondary Contact Person | Susan Quick |
| Regulatory Affairs Specialist | |
| Phone: (440) 483-2291 | |
| E-mail: susan.quick@philips.com | |
| Device Name: | |
| Classification: | MultiBand SENSE (MBSENSE) |
| Classification name: Magnetic Resonance Diagnostic device (MRDD) | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: LNH | |
| Primary Predicate Device: | Trade name: MultiBand SENSE |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K143606, May 08, 2015 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class II | |
| Product Code: LNH | |
| Reference Predicate Device: | Trade name: ACHIEVA R4 1.5T AND |
| ACHIEVA R4 3.0T | |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K110151, March 22, 2011 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class II |
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Device Description: The Multiband SENSE feature enables simultaneous excitation and acquisition of multiple volumes for spin echo and gradient echo MR sequences for the purpose of speeding up acquisition times or increasing coverage or resolution without increasing scan time. The simultaneous volume excitation is achieved using a multiband RF pulse. The image unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The image unfolding is improved by introducing a shift in k-space in the phase direction which is dependent on the volume spatial location, resulting in a spatial shift of the aliased pixels. Artifacts related to mismatch between SENSE reference scan and the clinical scan are minimized using information from a previously acquired Bo map. The MultiBand SENSE feature is available on Ingenia 3.0T and Ingenia 3.0T CX systems, and is compatible with the 32 channel head coil. Indications for Use: MultiBand SENSE is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. It's indicated for use in magnetic resonance imaging of the brain for BOLD fMRI and for diffusion weighted imaging. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times, or increasing coverage or number of diffusion directions without increasing scan time. Fundamental Scientific The MultiBand SENSE feature enables simultaneous Technology: excitation and acquisition of multiple volumes or slices for the purpose of speeding up acquisition times or increasing coverage or resolution at constant scan time. The simultaneous excitation is done using a multi-band radiofrequency pulse. The unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The unfolding process (solving the linear equation of the SENSE algorithm) is improved by introducing a linear phase over k-space in the volume direction resulting in a spatial shift of the aliased pixels. The phase shift is applied by additional blip-gradients in the slice direction or switching between different RF pulses, and compensated for in reconstruction by a translation of the coil sensitivity data before the SENSE unfolding. The feature consists of: ● Modulated RF pulses exciting 2 or more spatial slice locations Blip-gradients to introduce a phase shift on slices for . improved unfolding . Shifting coil sensitivities in reconstruction to correct for linear phase shift. Automatic use of Bo inhomogeneity information to . correct geometric distortions in the SENSE calculation
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| Summary of Non-Clinical
Performance Data: | The proposed MultiBand SENSE complies with the following
international and FDA-recognized consensus standards:
• IEC 62304 Medical device software - Software life cycle
processes
• ISO 14971 Application of risk management to medical
devices (2012)
• Device specific guidance document, entitled "Guidance for
the Submission Of Premarket Notifications for Magnetic
Resonance Diagnostic Devices - November 14, 1998"
• Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices
Non-Clinical verification and validation tests have been
performed with regards to the intended use, the technical
claims, the requirement specifications and the risk
management results.
The verification and validation test results demonstrate that
the proposed MultiBand SENSE:
• Complies with the aforementioned international and FDA
recognized consensus standards and device specific
guidance document
• Meets the acceptance criteria and is adequate for its
intended use.
Therefore, the proposed MultiBand SENSE is substantially
equivalent to the primary predicate device, MultiBand SENSE
(K143606, 05/08/2015) and the reference predicate device
Achieva R4 1.5T and Achieva R4 3.0T (K110151, 03/22/2011)
in terms of safety and effectiveness. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Clinical Data: | The proposed MultiBand SENSE did not require a clinical
study since substantial equivalence to the primary predicate
device was demonstrated with the following attributes:
• Design features;
• Indication for use;
• Fundamental scientific technology;
• Non-clinical performance testing; and
• Safety and effectiveness. |
| Substantial Equivalence
Conclusion: | The proposed MultiBand SENSE and the primary predicate device, MultiBand SENSE (K143606, 05/08/2015) and reference predicate device Achieva R4 1.5T and Achieva R4 3.0T (K110151, 03/22/2011) have the same primary indications for use with respect to the following:
• Software option intended for use on the Ingenia 3.0T and Ingenia 3.0T CX MR Systems
• Use in magnetic resonance imaging of the brain for BOLD fMRI
• Consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times or increasing coverage or resolution without increasing scan time
The proposed MultiBand SENSE is substantially equivalent to the primary predicate device, MultiBand SENSE (K143606, 05/08/2015) and reference predicate device Achieva R4 1.5T and Achieva R4 3.0T (K110151, 03/22/2011) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards and device-specific guidance. The results of these tests demonstrate that the proposed MultiBand SENSE met the acceptance criteria and is adequate for its intended use |
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