(187 days)
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.
Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.
MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature is applicable for the 60 cm (CX) and 70 cm magnet systems. The systems and control software are substantially equivalent to the legally marketed primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017).
The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature also includes minor software changes since the clearance of the legally marketed primary predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017).
The following modifications are covered in this submission:
- Upgrade software platform to Windows 10
- Compressed SENSE feature allows ultra-high acceleration factors for shorter scan times and higher resolution in 2D and 3D imaging based on the principle of Compressed sensing in combination with SENSE.
- PerformanceBridge Protocol Manager Release 1.0 offering intended to help customers increase collaboration within a healthcare facility group. Customers will enter the Protocol Manager cloud functionality via the PerformanceBridge portal. Protocol Manager is a subscription service to a cloud based protocol repository that will allow a user to standardize protocols over the various connected MRI systems, enable editing of protocols and scan parameters and make central protocols available for use on local MRI systems.
The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T, Ingenia 1.5T CX, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature is intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:
The Philips Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature did not involve an AI algorithm in the typical sense of machine learning for diagnosis or prediction. Instead, "Compressed SENSE" refers to an image acquisition and reconstruction technique for Magnetic Resonance Imaging (MRI) that uses compressed sensing principles to achieve faster scan times and/or higher resolution. Therefore, the device's performance acceptance criteria and study design are related to image quality and system functionality rather than AI diagnostic performance.
Here's an analysis of the provided information based on your request, with the understanding that the "device" in question is an MRI system with an advanced imaging feature:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for a "device performance" in terms of diagnostic accuracy, sensitivity, or specificity, as would be expected for an AI-powered diagnostic tool. Instead, the acceptance criteria are generally stated as compliance with regulatory standards and the demonstration of substantial equivalence to a predicate device. The performance is assessed based on a comparison of images produced by the new feature to those from the predicate device and established imaging principles.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Regulatory Compliance | Complies with IEC60601-1-2 Edition 3, IEC60601-1-6 Edition 3, IEC62366 (2015), IEC60601-1-8 Edition 2, IEC60601-2-33 Edition 3, IEC 62304 (2006), ISO 14971 (2007), Device specific guidance document ("Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 18, 2016"), "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005), "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016), and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014). |
| Functional Equivalence | The new device with Compressed SENSE feature is substantially equivalent to the legally marketed primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. |
| Intended Use Adequacy | The verification and validation test results, combined with sample clinical images, demonstrate that the proposed device: "Meets the acceptance criteria and is adequate for its intended use." This intended use is: "a Magnetic Resonance Medical Electrical System indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning." Compressed SENSE enables scan time reduction or improved spatial resolution. |
| Safety and Effectiveness | The device does not raise "different questions of safety and effectiveness" compared to the predicate device. Non-clinical performance (verification and validation) tests demonstrated compliance with requirements. |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document states that "sample clinical images" were used. However, it does not specify a numerical sample size for a test set in the context of an analytical or clinical performance study.
- Data provenance: Not explicitly stated, but given Philips' global operations, it's likely a combination of internal data or data from clinical sites where their systems are installed. The study is described as "non-clinical verification and or validation tests" combined with sample clinical images, suggesting a retrospective evaluation of existing images or images acquired during validation protocols.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document, as the submission focuses on the technical equivalence and safety of the MRI system and its new imaging feature (Compressed SENSE), rather than a diagnostic performance study requiring expert ground truth establishing for a specific pathology. The "ground truth" for an MRI system's image reconstruction capability is typically evaluated against physical phantoms (known objects) and expert review of image quality (e.g., signal-to-noise ratio, spatial resolution, artifact levels, anatomical depiction) by MR physicists and radiologists.
-
Adjudication method for the test set:
- This information is not applicable/provided as there was no formal diagnostic performance study described that would require an adjudication method for ground truth establishment by multiple experts.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
- Furthermore, the "Compressed SENSE" feature is an imaging technique, not an AI diagnostic tool, so improving human readers with AI assistance is not the objective here. The goal is to produce images of comparable diagnostic quality with faster acquisition or higher resolution.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI diagnostic algorithm. The "Compressed SENSE" is an image reconstruction algorithm that operates intrinsically within the MRI system to produce images for interpretation by a human. Its performance is effectively its ability to produce diagnostically acceptable images.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical validation of Compressed SENSE, the "ground truth" would likely involve:
- Physical phantoms: Objects with known properties used to objectively measure image quality metrics (e.g., spatial resolution, signal-to-noise ratio, uniformity).
- Comparison to gold standard MRI sequences: Images acquired with conventional, fully sampled sequences (considered the "gold standard" for image quality, though slower) would serve as a reference for images reconstructed using Compressed SENSE.
- Expert review of image quality: Radiologists and MR physicists would qualitatively assess the images for diagnostic acceptability, presence of artifacts, depiction of anatomical structures, and comparability to predicate device images.
- The document mentions "sample clinical images" were part of the validation, implying expert review of these images for diagnostic acceptability.
- For the technical validation of Compressed SENSE, the "ground truth" would likely involve:
-
The sample size for the training set:
- Not applicable/provided. Compressed SENSE, while employing sophisticated mathematics (compressed sensing), is primarily a signal processing and image reconstruction technique rather than a machine learning algorithm that requires a separate "training set" for diagnostic classification. The parameters for compressed sensing reconstruction are typically derived from theoretical principles and validated through experimentation, rather than trained from a large labeled dataset in the same way a deep learning model would be.
-
How the ground truth for the training set was established:
- Not applicable/provided as there was no distinct "training set" in the context of an AI diagnostic model. The development of Compressed SENSE relies on mathematical principles and engineering validation.
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April 4, 2018
Philips Medical Systems Nederland B.V. % Susan Ouick Regulatory Affairs Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland, Ohio 44143
Re: K173079
Trade/Device Name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: March 20, 2018 Received: March 22, 2018
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
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801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K173079
Device Name
Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.
Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.
MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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: | September 27, 2017 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary ContactPerson | Susan QuickRegulatory Affairs SpecialistPhone: (440) 483-2291E-mail: susan.quick@philips.com |
| Device Name: | Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, andIngenia 3.0T CX R5.4 |
| Classification: | Classification name: Magnetic Resonance Diagnostic device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI |
| Primary Predicate Device: | Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 3T R5.3Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K163116Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class IIProduct Code: 90LNH90LNI |
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| Device Description: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature isapplicable for the 60 cm (CX) and 70 cm magnet systems. The systemsand control software are substantially equivalent to the legally marketedprimary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3TR5.3 (K163116, 01/06/2017). |
|---|---|
| The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featurealso includes minor software changes since the clearance of the legallymarketed primary predicate device, Ingenia 1.5T, Ingenia 1.5T S andIngenia 3T R5.3 (K163116, 01/06/2017). | |
| The following modifications are covered in this submission: | |
| 1. Upgrade software platform to Windows 10 | |
| 2.Compressed SENSE feature allows ultra-high accelerationfactors for shorter scan times and higher resolution in 2D and 3Dimaging based on the principle of Compressed sensing incombination with SENSE. | |
| 3.PerformanceBridge Protocol Manager Release 1.0 offeringintended to help customers increase collaboration within ahealthcare facility group. Customers will enter the ProtocolManager cloud functionality via the PerformanceBridge portal. | |
| Protocol Manager is a subscription service to a cloud basedprotocol repository that will allow a user to standardize protocolsover the various connected MRI systems, enable editing ofprotocols and scan parameters and make central protocolsavailable for use on local MRI systems. | |
| The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T, Ingenia1.5T CX, and Ingenia 3.0T CX R5.4 with Compressed SENSE featureis intended to be marketed with the following pulse sequences and coilsthat were previously cleared by FDA: | |
| 1. mDIXON K1023442. SWIp K1312413. mDIXON-Quant K1335264. MRE K1406665. mDIXON XD K1431286. O-MAR K1432537. MultiBand SENSE K1436068. Ingenia Coils See Appendix 004 and Appendix 007 |
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| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systemsindicated for use as a diagnostic device. The system can producecross-sectional images, spectroscopic images and/or spectra in anyorientation of the internal structure of the head, body or extremities. |
|---|---|
| Magnetic Resonance images represent the spatial distribution ofprotons or other nuclei with spin. Image appearance is determined bymany different physical properties of the tissue and the anatomy, andthe MR scan technique applied. The image acquisition process can besynchronized with the patient's breathing or cardiac cycle. Thesystems can use combinations of images to produce physicalparameters, and related derived images. | |
| Images, spectra, and measurements of physical parameters, wheninterpreted by a trained physician, provide information that may assistthe diagnosis and therapy planning. The accuracy of determinedphysical parameters depends on system and scan parameters, andmust be controlled and validated by the clinical user. The use ofcontrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent. | |
| In addition the Philips MR systems provide imaging capabilities, suchas MR fluoroscopy, to guide and evaluate interventional and minimallyinvasive procedures in the head, body and extremities. | |
| MR Interventional procedures, performed inside or adjacent to thePhilips MR system, must be performed with MR Conditional or MRSafe instrumentation as selected and evaluated by the clinical user foruse with the specific MR system configuration in the hospital. Theappropriateness and use of information from a Philips MR system for aspecific interventional procedure and specific MR system configurationmust be validated by the clinical user. |
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| Design Features/Fundamental ScientificTechnology: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featureare based on the principle that certain atomic nuclei present in thehuman body will emit a weak relaxation signal when placed in a strongmagnetic field and excited by a radio signal at the precession frequency.The emitted relaxation signals are analyzed by the system and acomputed image reconstruction is displayed on a video screen. |
|---|---|
| The principal technological components (magnet, transmit bodycoil, gradient coil, receive coils and patient support) of the proposedIngenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, andIngenia 3.0T CX R5.4 with the Compressed SENSE feature areidentical to those used in the legally marketed primary predicate deviceIngenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116,01/06/2017). | |
| Compressed SENSE enables scan time reduction or improved spatialresolution through non-equidistant k-space sampling and regularizedreconstruction methods with automatic parameter tuning. TheCompressed SENSE feature allows ultra-high acceleration factors forshorter scan times and higher resolution in 2D and 3D imaging based onthe principle of Compressed sensing in combination with SENSE. Theuse of Compressed SENSE is limited to non-contrast enhanced exams. | |
| Based on the information provided above, the proposed Ingenia 1.5T,Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CXR5.4 with the Compressed SENSE feature does not raise differentquestions of safety and effectiveness compare to the legally marketedprimary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3TR5.3 (K163116, 01/06/2017). | |
| Summary of Non-ClinicalPerformance Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featurecomply with the following international and FDA-recognized consensusstandards:• IEC60601-1-2 Edition 3• IEC60601-1-6 Edition 3• IEC62366 (2015)• IEC60601-1-8 Edition 2• IEC60601-2-33 Edition 3• IEC 62304 (2006)• ISO 14971 Application of risk management to medical devices (2007)• Device specific guidance document, entitled "Guidance for theSubmission Of Premarket Notifications for Magnetic ResonanceDiagnostic Devices – November 18, 2016"• Guidance for Industry and FDA Staff - Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices(issued May 11, 2005)• Guidance for Industry and FDA Staff - Applying Human Factors andUsability Engineering to Medical Devices 9 issued February 3, 2016)• Guidance for Industry and FDA Staff – Content of PremarketSubmissions for Management of Cybersecurity in Medical Devicesissued October 2, 2014 |
| Non-Clinical verification and or validation tests have been performedwith regards to the intended use, the technical claims, the requirementspecifications and the risk management results. | |
| The verification and or validation test results, combined with sampleclinical images demonstrate that the proposed Ingenia 1.5T, Ingenia1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 withthe Compressed SENSE feature:• Complies with the aforementioned international and FDArecognized consensus standards and Device specific guidancedocument, entitled "Guidance for the Submission Of PremarketNotifications for Magnetic Resonance Diagnostic Devices –November 18, 2016"• Meets the acceptance criteria and is adequate for its intendeduse. | |
| Therefore, the proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5TCX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the CompressedSENSE feature are substantially equivalent to the legally marketedprimary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T | |
| Summary of Clinical Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featuredid not require a clinical study since substantial equivalence to thelegally marketed predicate device was proven with theverification/validation testing. |
| Substantial Equivalence: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featureand the legally marketed primary predicate device Ingenia 1.5T, Ingenia1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017) have the sameindications for use with respect to the following:Providing cross-sectional images based on the magneticresonance phenomenon Interpretation of the images is the responsibility of trainedphysicians Images can be used for interventional and treatment planningpurposes The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE featureare substantially equivalent to the legally marketed primary predicatedevice Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116,01/06/2017) in terms of design features, fundamental scientifictechnology, indications for use, and safety and effectiveness.Additionally, substantial equivalence was demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognizedconsensus standards and device-specific guidance. |
| Conclusion: | The results of these tests demonstrate that the proposed Ingenia 1.5T,Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CXR5.4 with the Compressed SENSE feature meet the acceptance criteriaand 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.