(26 days)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing 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, and presence of contrast agents. The use of contrast imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust 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.
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.
This Special 510(k) submission will include modifications of the proposed Ingenia Elition R5.7.1 SP4 MR Systems as compared to Philips legally marketed predicate device Ingenia Elition of the 510(k) submission Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K193215, 04/10/2020).
In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor software enhancements for the proposed Ingenia Elition R5.7.1 SP4 MR Systems:
- Introduction of a persistence latch which will prevent the currently available Interlock of SmokeDetector to be reset by customer, which is against the current labeling (abnormal use).
- The UI (User Interface) and IfU (Instructions for Use) are also updated to provide clear instructions for the user in case the currently available SmokeDetector Alarm Interlock is activated and to further clarify current instructions to prevent powercycling the system (abnormal use).
- SW Compatibility with the PD-Break Heat Detector
Identical to the predicate device, the proposed Ingenia Elition R5.7.1 SP4 MR Systems is intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA:
The provided document, a 510(k) Summary for Philips Medical Systems Nederland B.V.'s Ingenia Elition R5.7.1 SP4 MR Systems, focuses on demonstrating substantial equivalence to a predicate device. It addresses minor software enhancements, specifically related to a persistence latch for a SmokeDetector interlock, UI/IfU updates for the SmokeDetector alarm, and SW compatibility with a PD-Break Heat Detector.
Crucially, this document states that "The proposed Ingenia Elition R5.7.1 SP4 MR Systems did not introduce any modification to the indication for use or technological characteristics relative to the predicate devices that would require clinical testing." This implies that the device is not an AI/ML-powered medical device that would involve a study proving how AI-assistance improves human reader performance or the standalone performance of an AI algorithm.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/ML performance, cannot be extracted from this document, as it describes a non-AI/ML device undergoing a Special 510(k) for minor software changes. The "acceptance criteria" discussed are related to compliance with consensus standards and general safety/performance, not AI/ML specific metrics.
However, based on the non-clinical performance data and the conclusion, we can infer the acceptance criteria for the software changes and how the device (with these changes) meets them.
Inferred Acceptance Criteria and Device Performance (for software changes)
Since the submission is a "Special 510(k)" for minor software enhancements, the acceptance criteria are primarily related to maintaining the safety and effectiveness of the existing, cleared device, and ensuring compliance with updated standards.
| Acceptance Criteria (inferred for software modifications) | Reported Device Performance (from document) |
|---|---|
| Safety and Effectiveness Equivalence: | "Therefore, the proposed Ingenia Elition R5.7.1 SP4 MR Systems are substantially equivalent to the legally marketed predicate device Ingenia Elition of the 510(k) submission... in terms of safety and effectiveness." |
| Compliance with Consensus Standards: | "Identical to the predicate device, the proposed Ingenia Elition R5.7.1 SP4 MR Systems are in compliance with the following international and FDA-recognized consensus standards:" (list includes IEC60601-2-33, ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC 60601-1-8, ISO 14971, IEC 62366-1, IEC 62304). The document implies that new software hasn't caused non-compliance issues. |
| Risk Mitigation: | "Additionally, the risk management activities show that all risks are sufficiently mitigated; that new risks that were identified are mitigated to an acceptable level; and that the overall residual risk is acceptable." |
| Functional Verification of Changes: | "Non-Clinical verification tests were deemed necessary with regards to the requirement specifications and the risk management results. The verification test results demonstrate that the proposed Ingenia Elition R5.7.1 SP4 MR Systems meet the acceptance criteria and are adequate for the intended use." (Specifically for persistence latch, UI/IfU updates related to SmokeDetector, and PD-Break Heat Detector compatibility). "The validation testing performed with the predicate device remain valid for the changes introduced with the proposed device Ingenia Elition R5.7.1 SP4 MR Systems." |
Information Not Applicable/Provided for an AI/ML Device
The following points are specifically requested for AI/ML-powered medical devices and are not applicable to this 510(k) summary, as it describes a conventional MR system with minor software updates.
- Sample size used for the test set and the data provenance: Not applicable. No specific test set data for AI/ML performance is presented. The testing pertains to software verification and compliance with standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment for AI/ML performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not AI-assisted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) document indicates that the device is a Philips MR system with minor software changes and not an AI/ML-powered device. Therefore, the detailed AI/ML-specific study information requested is not present. The acceptance criteria and performance data are related to general device safety, effectiveness, and compliance with established medical device standards for MR systems.
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Philips Medical Systems Nederland B.V. % Ioana Ulea Senior Regulatory Affairs Specialist Veenpluis 6 Best. 5684 PC Netherlands
Re: K232030
Trade/Device Name: Ingenia Elition R5.7.1 SP4 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: July 6, 2023 Received: July 7, 2023
Dear Ioana Ulea:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
August 2nd, 2023
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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for
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232030
Device Name Ingenia Elition R5.7.1 SP4 MR Systems
Indications for Use (Describe)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing 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, and presence of contrast agents. The use of contrast imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust 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.
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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Special 510(k)
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: | July 06, 2023 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Ioana UleaSenior Regulatory Affairs SpecialistPhone: +31 618345875E-mail: ioana.ulea@philips.com |
| Secondary ContactPerson | Jan van de KerkhofAssociate Director Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Device Name: | Ingenia Elition R5.7.1 SP4 MR Systems |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Regulation: 21CFR 892.1000 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: 90LNH | |
| 90LNI | |
| Primary PredicateDevice: | Trade name: Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K193215, 04/10/2020 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class IIProduct Code: 90LNH90LNI |
| DeviceDescription: | This Special 510(k) submission will include modifications of the proposedIngenia Elition R5.7.1 SP4 MR Systems as compared to Philips legallymarketed predicate device Ingenia Elition of the 510(k) submissionAchieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia AmbitionMR Systems (K193215, 04/10/2020). |
|---|---|
| In this 510(k) submission, Philips Medical Systems Nederland B.V. will beaddressing the following minor software enhancements for the proposedIngenia Elition R5.7.1 SP4 MR Systems: | |
| 1. | Introduction of a persistence latch which will prevent the currentlyavailable Interlock of SmokeDetector to be reset by customer, which isagainst the current labeling (abnormal use). |
| 2. | The UI (User Interface) and IfU (Instructions for Use) are also updatedto provide clear instructions for the user in case the currently availableSmokeDetector Alarm Interlock is activated and to further clarifycurrent instructions to prevent powercycling the system (abnormaluse). |
| 3. | SW Compatibility with the PD-Break Heat Detector |
| Identical to the predicate device, the proposed Ingenia Elition R5.7.1 SP4MR Systems is intended to be marketed with the following pulsesequences and coils that are previously cleared by FDA: | |
| 1. mDIXON (K102344)2. SWIp (K131241)3. mDIXON-Quant (K133526)4. MRE (K140666)5. mDIXON XD (K143128)6. O-MAR (K143253)7. 3D APT (K172920)8. Compatible System Coils (identical to the predicate devices) | |
| Indications for Use: | There are no changes to the indications for use statement, provided below,of the proposed Ingenia Elition R5.7.1 SP4 MR Systems when comparedto the predicate device Ingenia Elition of the 510(k) submission Achieva,Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRSystems (K193215, 04/10/2020):"Philips Magnetic Resonance (MR) systems are Medical ElectricalSystems indicated for use as a diagnostic device.This MR system enables trained physicians to obtain cross-sectionalimages, spectroscopic images and/or spectra of the internal structure ofthe head, body or extremities, in any orientation, representing the spatialdistribution of protons or other nuclei with spin.Image appearance is determined by many different physical properties ofthe tissue and the anatomy, the MR scan technique applied, and presenceof contrast agents.The use of contrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent. |
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| The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize 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 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. 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”. | ||||
|---|---|---|---|---|
| Design Features/FundamentalScientificTechnology: | Same as the predicate device, the proposed Ingenia Elition R5.7.1 SP4 MR Systems are based on the principle that certain atomic nuclei present in the human body will emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency. The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen.The principal technological components (magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier and patient support) of the proposed Ingenia Elition R5.7.1 SP4 MR Systems are fundamentally the same as those used in the legally marketed predicate device Ingenia Elition of the 510(k) submission Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K193215, 04/10/2020). | |||
| Summary ofNon-ClinicalPerformanceData: | Identical to the predicate device, the proposed Ingenia Elition R5.7.1 SP4 MR Systems are in compliance with the following international and FDA-recognized consensus standards: | |||
| No. | RecognitionNumber | StandardNumber andDate | Standard Name | |
| 1 | 12-295 | IEC60601-2-33Ed. 3.2:2010 +Amd 1:2013 +Amd 2:2015 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | |
| 2 | 19-4 | ANSI / AAMIES60601-1:2005/(R)2012and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2006, MOD). | |
| 3 | 19-8 | IEC60601-1-2Ed. 4.0:2014 | Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral standard:Electromagnetic disturbances -Requirements and tests | |
| 4 | 5-89 | IEC 60601-1-6Ed. 3.1:2010 +Amd 1:2013 | Medical electrical equipment - Part1-6: General requirements for basicsafety and essential performance -Collateral Standard: Usability | |
| 5 | 5-76 | IEC 60601-1-8Ed. 2.1:2006 +Amd 1:2012(Ed.2.1) | Medical electrical equipment - Part1-8: General requirements for basicsafety and essential performance -Collateral Standard: Generalrequirements, tests and guidancefor alarm systems in medicalelectrical equipment and medicalelectrical systems | |
| 6 | 5-125 | ISO 14971 ThirdEdition 2019 | Medical devices – Application of riskmanagement to medical devices. | |
| 7 | 5-114 | IEC 62366-1 Ed.1.0:2015 | Medical devices – Part 1:Application of usability engineeringto medical devices | |
| 8 | 13-79 | IEC 62304 Ed.1.1:2015 | Medical device software - Softwarelife cycle processes. | |
| Non-Clinical verification tests were deemed necessary with regards to therequirement specifications and the risk management results. | ||||
| The verification test results demonstrate that the proposed Ingenia ElitionR5.7.1 SP4 MR Systems meet the acceptance criteria and are adequatefor the intended use.The validation testing performed with the predicate device remain valid forthe changes introduced with the proposed device Ingenia Elition R5.7.1SP4 MR Systems. | ||||
| Additionally, the risk management activities show that all risks aresufficiently mitigated; that new risks that were identified are mitigated toan acceptable level; and that the overall residual risk is acceptable. | ||||
| Therefore, the proposed Ingenia Elition R5.7.1 SP4 MR Systems aresubstantially equivalent to the legally marketed predicate device IngeniaElition of the 510(k) submission Achieva, Intera, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR Systems (K193215, 04/10/2020)in terms of safety and effectiveness. | ||||
| Summary ofClinical Data: | The proposed Ingenia Elition R5.7.1 SP4 MR Systems did not introduceany modification to the indication for use or technological characteristicsrelative to the predicate devices that would require clinical testing. | |||
| SubstantialEquivalence: | The proposed Ingenia Elition R5.7.1 SP4 MR Systems and the legallymarketed predicate device Ingenia Elition of the 510(k) submissionAchieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition |
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| Conclusion: | MR Systems (K193215, 04/10/2020), have the same indications for use with respect to the following:Providing cross-sectional images based on the magnetic resonance phenomenon Interpretation of the images is the responsibility of trained physicians Images can be used for interventional and treatment planning purposes The proposed Ingenia Elition R5.7.1 SP4 MR Systems are substantially equivalent to the legally marketed predicate device Ingenia Elition of the 510(k) submission Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K193215, 04/10/2020), in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.Additionally, substantial equivalence is demonstrated with non-clinical performance tests and compliance 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 Ingenia Elition R5.7.1 SP4 MR Systems meet the acceptance criteria and are adequate for the 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.