(140 days)
No
The description focuses on signal processing and reconstruction algorithms (SENSE) based on physics principles, not on learning from data. There is no mention of training data, models, or learning processes characteristic of AI/ML.
No
Explanation: The device is indicated for use in magnetic resonance imaging of the brain for BOLD fMRI, which is a diagnostic imaging technique, not a therapeutic treatment.
Yes
Explanation: The device is a software option for MR systems used in magnetic resonance imaging of the brain for BOLD fMRI. While it focuses on improving image acquisition and reconstruction, fMRI itself is a diagnostic tool used to observe brain activity, implying its use in diagnostic processes.
No
The device is described as a "software option intended for use on Achieva and Ingenia 1.5T & 3.OT MR Systems." While it is a software component, it is explicitly designed to function on existing MR hardware systems and modifies their operation (e.g., modulated RF pulses, blip-gradients). It is not a standalone software application that operates independently of specific medical device hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that MultiBand SENSE is used for magnetic resonance imaging (MRI) of the brain. MRI is an imaging technique that directly examines the human body, not specimens taken from it.
- The device processes MR signals to create images. This is a core function of an imaging device, not an IVD.
- The performance studies focus on image quality (SNR) and scan time reduction. These are relevant metrics for an imaging device, not for the analytical performance of an IVD.
Therefore, MultiBand SENSE is an imaging device, specifically a software option for MRI systems, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MultiBand SENSE is a software option intended for use on Achieva and Ingenia 1.5T & 3.OT MR Systems. It's indicated for use in magnetic resonance imaging of the brain for BOLD fMRI. MultiBand SENSE 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.
Product codes
LNH
Device Description
The MultiBand SENSE technique enables simultaneous 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 slices
- Blip-gradients to introduce a phase shift for improved unfolding ●
- New parameterization of the SENSE calculations ●
- Shifting coil sensitivities in reconstruction to correct for linear phase shift. ●
MultiBand SENSE is supported on the following systems:
- . 3.0T Ingenia
- 3.0T Achieva ●
- 1.5T Ingenia ●
- . 1.5T Achieva
The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. MultiBand SENSE is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the MultiBand SENSE pulse sequences and reconstructions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MR)
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)
Nonclinical tests: MultiBand SENSE has been verified to function with the Achieva and Ingenia 1.5T and 3.0T MR systems. The verification testing showed the MultiBand SENSE examcards could be loaded, the correct parameters were listed for each scan. MultiBand SENSE functioned properly together, the average SNR deviation was
§ 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines connecting them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
Philips Medical Systems, Nederland B.V. % Ms. Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K143606
Trade/Device Name: Multiband Sense Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: April 17, 2015 Received: April 20, 2015
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, 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 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.
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/Resourcesfor You/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.
Michael D.'Hara for
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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Services (301 ) 443-6741)
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3
PHILIF
Philips Medical Systems Nederland B.V.
510(k) Summary
MultiBand SENSE
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- I. 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 | |
| Tel: (440)-483-2291 | |
| Fax: (440)-483-4799 | |
| E-mail: susan.quick@philips.com | |
| Prepared (date): | 2014 December 12 |
| Trade Name of Device: | MultiBand SENSE |
| Classification: | Class II |
| Regulatory Section: | Magnetic Resonance Diagnostic Device. |
| 892.1000 | |
| Product Code: | 90LNH |
4
510(k) Summary MultiBand SENSE
21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:
| 1. Primary Predicate Device: SENSE | |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland BV |
| Predicate Device k#: | K110151 |
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 MultiBand SENSE technique enables simultaneous 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 slices
- Blip-gradients to introduce a phase shift for improved unfolding ●
- New parameterization of the SENSE calculations ●
- Shifting coil sensitivities in reconstruction to correct for linear phase shift. ●
MultiBand SENSE is supported on the following systems:
- . 3.0T Ingenia
- 3.0T Achieva ●
- 1.5T Ingenia ●
- . 1.5T Achieva
The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. MultiBand SENSE is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the MultiBand SENSE pulse sequences and reconstructions.
5
21 CFR 807.92(a)(5): Intended Use
MultiBand SENSE is a software option intended for use on Achieva and Ingenia 1.5T & 3.OT MR Systems. It's indicated for use in magnetic resonance imaging of the brain for BOLD fMRI. MultiBand SENSE 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.
21 CFR 807.92(a)(6): Technological Characteristics:
The main functional units in the software are:
- Methods (acquisition of MR signals by means of MR pulse sequences) -
- Reconstruction (transforming the MR signals to images) -
- -Patient Administration (storing of the images in the database and providing access)
- Viewing (display of images) -
The technical impact of the feature MultiBand SENSE comprises:
- -Methods: Introduction of a modulated RF pulse. Apply blipped gradients. Provide new parameterization for SENSE reconstruction.
- Reconstruction: Read new parameterization of SENSE calculations. Shift coil sensitivities before SENSE calculations.
No off-the-shelf software is used for the feature MultiBand SENSE. The off-the-shelf software used in the basic MR system is cleared. MultiBand SENSE is not designed to be connected to an external network.
MultiBand SENSE does not require any change of the hardware platform. The extension introduced by Multiband SENSE, are in methods pulse sequence code, and in reconstruction only for a new parameterization of a cleared SENSE unfolding calculation. Those run on the host computer characteristics :
- Manufacturer: HP; Model: Z420; Processor clock: 3.5 GHz; RAM: 64 GB RAM; -Processors: six core with hyper threading
- Operating system: Windows 7, 64 bits -
The only new element for the operator of the Multiband SENSE feature in this clinical routine workflow is:
- Protocol selection: The operator selects an ExamCard with Multiband SENSE protocols -
- Planscan phase: Optionally the operator may want to change the predefined Multiband acceleration factor.
All other steps are not changed. The generated image types can be viewed, post-processed, printed and archived as any other image type.
6
21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced or relied on in this premarket notification:
MultiBand SENSE has been verified to function with the Achieva and Ingenia 1.5T and 3.0T MR systems.
The verification testing showed the MultiBand SENSE examcards could be loaded, the correct parameters were listed for each scan. MultiBand SENSE functioned properly together, the average SNR deviation was