(132 days)
This system is a Magnetic Resonance Medical Electrical Systems 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.
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 anatomy, 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 Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications
The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
The following modifications are covered compared to legally marketed predicate device:
- Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10);
- PerformanceBridge Protocol Manager Release 1.0;
- Introduction of new gradient system hardware with new gradient specifications;
- Introduction of new product name and covers.
The proposed Ingenia Elition S and Ingenia Elition X R5.4 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:
This document describes the 510(k) summary for the Philips Ingenia Elition S and Ingenia Elition X R5.4 Magnetic Resonance Diagnostic Devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3, K163116) rather than proving performance based on specific clinical outcomes for a novel application. Therefore, the details requested in the prompt, which are typically associated with performance studies for AI/CADe devices, are largely not present in this type of submission.
Based on the provided text, here's what can be extracted:
- Device: Ingenia Elition S and Ingenia Elition X R5.4 (Magnetic Resonance Diagnostic Device - MRDD)
- Submission Type: 510(k) Premarket Notification, Abbreviated 510(k)
- Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device due to modifications (new gradient system/specifications, software upgrades like Windows 10 compatibility and PerformanceBridge Protocol Manager, new product name/covers).
Here's an analysis of the provided text in relation to your specific questions:
1. A table of acceptance criteria and the reported device performance
The document states: "The verification and/or validation test results demonstrate that the proposed Ingenia Elition S and Ingenia Elition X R5.4: • Complies with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices - November 18, 2016" • Meets the acceptance criteria and is adequate for its intended use."
It further concludes: "The results of these tests demonstrate that the proposed Ingenia Elition S and Ingenia Elition X R5.4 meet the acceptance criteria and is adequate for its intended use."
However, the specific "acceptance criteria" (e.g., in terms of image quality metrics, diagnostic accuracy, or specific performance thresholds) and the "reported device performance" against those criteria are not detailed in this 510(k) summary. This type of submission relies on demonstrating compliance with recognized standards and that the modifications do not raise new questions of safety or effectiveness compared to the predicate device. The performance is implied to be equivalent to the predicate, which presumptively met certain performance standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission states, "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing." This indicates that formal clinical studies with distinct test sets, common for AI/CADe devices, were not performed or submitted for this 510(k). The "verification/validation testing" likely refers to engineering, phantom, and perhaps limited clinical image quality checks, rather than a full-scale clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no clinical study needing ground truth establishment was conducted for this 510(k) submission, there's no mention of experts or their qualifications for establishing ground truth on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As no clinical study needing a test set with ground truth was conducted for this 510(k) submission, there's no mention of an adjudication method.
5. 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 MRMC comparative effectiveness study was done as part of this submission. This device is a Magnetic Resonance Diagnostic Device (an MRI scanner itself), not an AI/CADe algorithm designed to assist human readers. The clearance is for the hardware and basic software functionality rather than an AI-driven interpretive aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. This is an MRI device, not a standalone algorithm. The "performance" relates to its ability to acquire images, not to automatically interpret them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Given that no clinical study was performed for this 510(k) submission (as stated: "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study..."), the concept of ground truth for a clinical validation set is not applicable here. The "ground truth" for the performance of an MR system typically relies on physical measurements in phantoms and comparison against established image quality metrics, rather than clinical outcomes or expert consensus for diagnosis.
8. The sample size for the training set
This information is not provided and is not relevant for this type of device submission. This is not an AI/ML device that requires a training set. The changes are hardware (gradient system) and basic software (OS upgrade, protocol manager).
9. How the ground truth for the training set was established
This information is not provided and is not relevant for this type of device submission, as there's no training set mentioned for an AI/ML model.
Summary of the Study Proving Acceptance (as implied by the document):
The "study" proving the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to demonstrate:
- Compliance with recognized standards: IEC 60601-1 (medical electrical equipment), IEC 60601-1-2 (EMC), IEC 62366 (usability), IEC 60601-1-8 (alarms), IEC 60601-2-33 (MR specific safety), IEC 62304 (software life cycle), NEMA MS-1, MS-4, MS-8, PS 3.1-3.20 (MR performance and DICOM standards), ISO 14971 (risk management).
- Compliance with FDA guidance documents: Specifically, "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 18, 2016" and other relevant guidances for software, human factors, cybersecurity, biocompatibility, and EMC.
- Equivalence to the predicate device: The new gradient system and software changes were evaluated to ensure they did not negatively impact the imaging performance (image quality, safety parameters) or introduce new risks compared to the predicate device.
The document states that these tests demonstrate the device "Meets the acceptance criteria and is adequate for its intended use." The "acceptance criteria" are intrinsically tied to meeting these regulatory standards and demonstrating that the modifications do not alter the substantial equivalence to the predicate. The document does not provide quantitative performance metrics from these tests.
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Philips Medical Systems Nederland B.V. Henrie Daniels Regulatory Affairs Specialist Veenpluis 4-6 Best, 5684PC N1
Re: K173356
Trade/Device Name: Ingenia Elition S and Ingenia Elition X R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: January 30, 2018 Received: February 2, 2018
Dear Henrie Daniels:
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 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);
March 6, 2018
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Page 2 - Henrie Daniels
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 medical devices and radiation-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) K173356
Device Name Ingenia Elition S and Ingenia Elition X R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical Systems 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.
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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
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Premarket Notification [510(k)] Submission Philips Medical Systems Nederland B.V. Ingenia Elition S and Ingenia Elition X R5.4 ട് 4
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k)
Ingenia Elition S and Ingenia Elition X R5.4
Section 5
510(k) Summary
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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 20, 2017 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary Contact Person: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com | |
| Secondary Contact Person | Henrie DanielsRegulatory Affairs SpecialistTelephone: +31 643837374E-mail: henrie.daniels@philips.com | |
| Device Name: | Ingenia Elition S and Ingenia Elition X R5.4 | |
| Classification: | Classification name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | 90LNH90LNI | |
| Primary Predicate Device: | Trade name: | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K163116 | |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH90LNI | |
| Device Description: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specificationsThe proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).The following modifications are covered compared to legally marketed predicate device:1. Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10);2. PerformanceBridge Protocol Manager Release 1.0;3. Introduction of new gradient system hardware with new gradient specifications;4. Introduction of new product name and covers.The proposed Ingenia Elition S and Ingenia Elition X R5.4 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:1. mDIXON K1023442. SWIp K1312413. mDIXON-Quant K1335264. MRE K1406665. mDIXON XD K1431286. O-MAR K1432537. MultiBand SENSE K143606 | |
| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systems | |
| indicated for use as a diagnostic device. The system can producecross-sectional images, spectroscopic images and/or spectra inany orientation of the internal structure of the head, body orextremities. | ||
| Magnetic Resonance images represent the spatial distribution ofprotons or other nuclei with spin. Image appearance is determinedby many different physical properties of the tissue and theanatomy, and the MR scan technique applied. The imageacquisition process can be synchronized with the patient'sbreathing or cardiac cycle. The systems can use combinations ofimages to produce physical parameters, and related derivedimages. | ||
| Images, spectra, and measurements of physical parameters,when interpreted by a trained physician, provide information thatmay assist the diagnosis and therapy planning. The accuracy ofdetermined physical parameters depends on system and scanparameters, and must be controlled and validated by the clinicaluser. The use of contrast agents for diagnostic imagingapplications should be performed consistent with the approvedlabeling for the contrast agent. | ||
| In addition the Philips MR systems provide imaging capabilities,such as MR fluoroscopy, to guide and evaluate interventional andminimally invasive 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 clinicaluser for use with the specific MR system configuration in thehospital. The appropriateness and use of information from aPhilips MR system for a specific interventional procedure andspecific MR system configuration must be validated by the clinicaluser. | ||
| Design Features/Fundamental ScientificTechnology: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 arebased on the principle that certain atomic nuclei present in thehuman body will emit a weak relaxation signal when placed in astrong magnetic field and excited by a radio signal at theprecession frequency. The emitted relaxation signals are analyzedby the system and a computed image reconstruction is displayedon a video screen.The principal technological components (magnet, receive coilsand patient support) of the proposed Ingenia Elition S andIngenia Elition X R5.4 are identical to those used in the legallymarketed predicate device, Ingenia 1.5T, Ingenia 1.5T S andIngenia 3.0T R5.3 (K163116, 01/06/2017), except for the transmitbody coil and the gradient coil, which have been changed to adaptto the changed voltage levels of the gradient amplifier.Based on the information provided above, the proposed IngeniaElition S and Ingenia Elition X R5.4 does not raise differentquestions of safety and effectiveness compared to the legallymarketed predicate device Ingenia 1.5T, Ingenia 1.5T S andIngenia 3.0T R5.3 (K163116, 01/06/2017). | |
| Summary of Non-Clinical PerformanceData: | The proposed Ingenia Elition S and Ingenia Elition X R5.4comply with the following international and FDA-recognizedconsensus standards: | |
| • IEC60601-1 Edition 3 | ||
| • IEC60601-1-2 Edition 3 | ||
| • IEC60601-1-6 Edition 3 | ||
| • IEC62366 Edition 1 | ||
| • IEC60601-1-8 Edition 2 | ||
| • IEC60601-2-33 Edition 3 | ||
| • IEC 62304 Edition 1 | ||
| • NEMA MS-1 2008 | ||
| • NEMA MS-4 2010 | ||
| • NEMA MS-8 2008 | ||
| • NEMA PS 3.1-PS 3.20 | ||
| • ISO 14971 Edition 2 | ||
| • 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 Contentof Premarket Submissions for Software Contained in MedicalDevices (issued May 11, 2005) | ||
| • Guidance for Industry and FDA Staff - Applying Human Factorsand Usability Engineering to Medical Devices 9 issued February3, 2016) | ||
| • Guidance for Industry and FDA Staff - Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices issued October 2, 2014 | ||
| • Guidance for Industry and FDA Staff - Use of InternationalStandard ISO 10993-1, "Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process" (issued June 16, 2016) | ||
| • Guidance for Industry and FDA Staff – Information to Support aClaim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016) | ||
| Non-Clinical verification and or validation tests have beenperformed with regards to the intended use, the technical claims,the requirement specifications and the risk management results. | ||
| The verification and/or validation test results demonstrate that theproposed Ingenia Elition S and Ingenia Elition X R5.4: | ||
| • Complies with the aforementioned international and FDArecognized consensus standards and Device specificguidance document, entitled "Guidance for the Submission OfPremarket Notifications for Magnetic Resonance DiagnosticDevices - November 18, 2016"• Meets the acceptance criteria and is adequate for its intendeduse. | ||
| Therefore, the proposed Ingenia Elition S and Ingenia Elition XR5.4 are substantially equivalent to the legally marketed predicatedevice Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3(K163116, 01/06/2017) in terms of safety and effectiveness. | ||
| Summary of ClinicalData: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 didnot require a clinical study since substantial equivalence to thelegally marketed predicate device was proven with theverification/validation testing. | |
| SubstantialEquivalence: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 andthe legally marketed predicate device Ingenia 1.5T, Ingenia 1.5TS and Ingenia 3.0T 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 planningpurposesThe proposed Ingenia Elition S and Ingenia Elition X R5.4 aresubstantially equivalent to the legally marketed predicate deviceIngenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116,01/06/2017) 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, whichcomplied with the requirements specified in the international andFDA-recognized consensus standards and device-specificguidance. | ||
| Conclusion: | The results of these tests demonstrate that the proposed IngeniaElition S and Ingenia Elition X R5.4 meet the acceptance criteriaand is adequate for its intended use. |
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N/A