(70 days)
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.
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.
The provided text describes the regulatory clearance of MultiBand SENSE and mentions that "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." It further states that these tests "demonstrate that the proposed MultiBand SENSE... Meets the acceptance criteria and is adequate for its intended use."
However, the specific details of the acceptance criteria, the study demonstrating compliance, reported device performance, sample sizes, ground truth establishment, expert qualifications, or adjudication methods are not provided in the given document. The document summarizes that adherence to international and FDA-recognized consensus standards and device-specific guidance formed the basis for demonstrating substantial equivalence, rather than a detailed comparative effectiveness study of the MultiBand SENSE itself against a "without AI" baseline or a standalone performance study.
Therefore, based on the provided text, I cannot provide the requested information in detail. The document indicates that a clinical study was not required for this 510(k) submission, and the focus was on demonstrating substantial equivalence through design features, indications for use, fundamental scientific technology, and non-clinical performance testing.
There is no information in the provided document to fill out the table and answer the specific questions about the study that proves the device meets the acceptance criteria.
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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
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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)
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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 |
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| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary Contact Person: | Jan van de KerkhofRegulatory Affairs ManagerPhone: +31 6 13300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary Contact Person | Susan QuickRegulatory Affairs SpecialistPhone: (440) 483-2291E-mail: susan.quick@philips.com |
| Device Name:Classification: | MultiBand SENSE (MBSENSE)Classification name: Magnetic Resonance Diagnostic device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: LNH |
| Primary Predicate Device: | Trade name: MultiBand SENSEManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K143606, May 08, 2015Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class IIProduct Code: LNH |
| Reference Predicate Device: | Trade name: ACHIEVA R4 1.5T ANDACHIEVA R4 3.0TManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K110151, March 22, 2011Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice 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-ClinicalPerformance Data: | The proposed MultiBand SENSE complies with the followinginternational and FDA-recognized consensus standards:• IEC 62304 Medical device software - Software life cycleprocesses• ISO 14971 Application of risk management to medicaldevices (2012)• Device specific guidance document, entitled "Guidance forthe Submission Of Premarket Notifications for MagneticResonance Diagnostic Devices - November 14, 1998"• Guidance for the Content of Premarket Submissions forSoftware Contained in Medical DevicesNon-Clinical verification and validation tests have beenperformed with regards to the intended use, the technicalclaims, the requirement specifications and the riskmanagement results.The verification and validation test results demonstrate thatthe proposed MultiBand SENSE:• Complies with the aforementioned international and FDArecognized consensus standards and device specificguidance document• Meets the acceptance criteria and is adequate for itsintended use.Therefore, the proposed MultiBand SENSE is substantiallyequivalent to the primary predicate device, MultiBand SENSE(K143606, 05/08/2015) and the reference predicate deviceAchieva R4 1.5T and Achieva R4 3.0T (K110151, 03/22/2011)in terms of safety and effectiveness. |
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| Summary of Clinical Data: | The proposed MultiBand SENSE did not require a clinicalstudy since substantial equivalence to the primary predicatedevice was demonstrated with the following attributes:• Design features;• Indication for use;• Fundamental scientific technology;• Non-clinical performance testing; and• Safety and effectiveness. |
| Substantial EquivalenceConclusion: | 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 timeThe 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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§ 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.