(141 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.
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems.
This bundled abbreviated 510(k) submission, is prompted by the introduction of a new optional software feature called Precise Image contained in software R12 for the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, as compared to our legally marketed primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) and the secondary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442).
Precise Image is a deep learning based reconstruction technique designed to increase signal-to-noise ratio (SNR), increase sharpness and decrease ringing artefacts from MR images.
The introduction of Precise Image only required updates to the MR System Software.
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA:
- mDIXON (K102344)
- SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR (K143253)
- 3D APT (K172920)
- Compatible System Coils
The accessories to be used with the proposed device Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems have not changed compared to the primary predicate device and secondary predicate device and can be found in the Instructions for Use accompanying the device:
System coils PPU Sensor for wireless physiology Pediatric PPU Sensor FlexTrak trolleys (FlexTrak / HA FlexTrak II) Acoustic Hood MR Elastography
When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply:
Flextrak OR MR-RT CouchTop RT CouchTop XD
The provided text describes the acceptance criteria and the study conducted for the Philips Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300, and MR 7700 MR Systems, specifically focusing on the new "Precise Image" software feature.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain equivalence for diagnosis | Assessed as equivalent for diagnosis compared to predicate reconstruction technology |
| Improve Signal-to-Noise Ratio (SNR) | Significantly better SNR compared to predicate reconstruction technology |
| Improve sharpness | Significantly better sharpness compared to predicate reconstruction technology |
| Manage artifact level | Artifact levels were analyzed |
| Manage contrast-to-noise ratio (CNR) | CNR was analyzed |
| Maintain quality of visualization of abnormalities and pathologies | Assessed as equivalent for diagnosis and showed significantly better SNR and sharpness in the presence of (subtle) abnormalities and pathology. |
| Sufficient quality for diagnostic purposes | Images were assessed to be of sufficient quality for diagnostic purposes. |
| Reproducibility of Precise in comparison to predicate device reconstruction technique | Considered established. |
2. Sample size used for the test set and the data provenance
The document mentions "a reader evaluation by ABR board certified radiologists was performed" and refers to "MR images," but does not explicitly state the sample size (number of images or cases) used for the test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states "ABR board certified radiologists" were used for the reader evaluation. It does not specify the exact number of experts or their years of experience.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify the adjudication method used for the reader evaluation. It only mentions that radiologists performed the evaluation.
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
The study was a reader evaluation comparing MR images reconstructed with the new "Precise Image" feature (deep learning-based) to images from the predicate device reconstruction technology. While it involved multiple readers (radiologists) and multiple cases (implied by "MR images" and "abnormalities and pathologies"), it was primarily an evaluation of the image quality and diagnostic equivalence of the algorithm's output rather than a direct MRMC comparative effectiveness study measuring human reader improvement with AI assistance versus without.
Therefore, the document does not provide an effect size of how much human readers improve with AI vs without AI assistance. The focus was on the performance of the algorithm's output itself in comparison to existing technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation was implicitly done through the "reader evaluation by ABR board certified radiologists." The radiologists assessed the properties of the images generated by the new Precise Image technique against images from the predicate reconstruction technology. This assesses the algorithm's output quality and diagnostic value in a standalone capacity, even though humans are interpreting its output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the reader evaluation seems to be based on expert assessment/consensus by the ABR board-certified radiologists, who evaluated image properties (SNR, artifact level, sharpness, CNR) and the visualization of abnormalities/pathologies. The document doesn't explicitly mention external pathology or outcomes data as the primary ground truth for this specific evaluation, rather the expert interpretation of the images.
8. The sample size for the training set
The document does not mention the sample size used for the training set of the deep learning-based "Precise Image" reconstruction technique.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established for the deep learning-based "Precise Image" technique. It only describes the nature of the technique as "deep learning based reconstruction."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 6, 2023
Philips Medical Systems Nederland B.V. % Ioana Ulea Senior Regulatory Affairs Specialist Veenpluis 6 5684 PC Best NETHERLANDS
Re: K223458
Trade/Device Name: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: March 6, 2023 Received: March 6, 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.
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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) 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.
D. Ray Kerlick
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)
Device Name
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 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) | |
|---|---|
|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: | Apr. 05, 2023 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary Contact Person: | Ioana UleaSenior Regulatory Affairs SpecialistPhone: +31 618345875E-mail: ioana.ulea@philips.com | |
| Secondary Contact Person | Jan van de KerkhofAssociate Director Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com | |
| Device Name: | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | |
| 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: Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (R11)Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K213583Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class: Class IIProduct Code: 90LNH90LNI | |
| Trade name: MR 5300 and MR 7700 R11 MR Systems | ||
| SecondaryPredicate Device: | Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) Clearance: | K223442 | |
| ClassificationRegulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device(MRDD) | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH90LNI | |
| ReferenceDevice | Trade name: | SIGNA Premier |
| Manufacturer: | GE Medical Systems, LLC | |
| 510(k) Clearance: | K193282 | |
| ClassificationRegulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device(MRDD) | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH90LNI |
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| Device | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices,hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, IngeniaAmbition, MR 5300 and MR 7700 MR Systems. |
|---|---|
| Description: | This bundled abbreviated 510(k) submission, is prompted by theintroduction of a new optional software feature called Precise Imagecontained in software R12 for the proposed Ingenia, Ingenia CX, IngeniaElition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, ascompared to our legally marketed primary predicate device Achieva,Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems(R11) (K213583) and the secondary predicate device MR 5300 and MR7700 R11 MR Systems (K223442). |
| Precise Image is a deep learning based reconstruction techniquedesigned to increase signal-to-noise ratio (SNR), increase sharpness anddecrease ringing artefacts from MR images. | |
| The introduction of Precise Image only required updates to the MR SystemSoftware. | |
| The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,MR 5300 and MR 7700 MR Systems are intended to be marketed with | |
| the following pulse sequences 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 | |
| The accessories to be used with the proposed device Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems have not changed compared to the primary predicate device and secondary predicate device and can be found in the Instructions for Use accompanying the device: | |
| System coils PPU Sensor for wireless physiology Pediatric PPU Sensor FlexTrak trolleys (FlexTrak / HA FlexTrak II) Acoustic Hood MR Elastography | |
| When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply: | |
| Flextrak OR MR-RT CouchTop RT CouchTop XD | |
| Indications for Use: | The indications for Use statement provided below for the proposed device is identical to the one of the primary and secondary predicate devices. The intended use is also not impacted by the introduction of Precise Image feature. |
| 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 anatomy, the MR scan technique applied, and presence of contrast agents. | |
| The use of contrast agents for diagnostic imaging applications should beperformed consistent with the approved labeling for the contrast agent. | |
| The trained clinical user can adjust the MR scan parameters to customizeimage appearance, accelerate image acquisition, and synchronize withthe patient's breathing or cardiac cycle. The systems can usecombinations of images to produce physical parameters, and relatedderived images. Images, spectra, and measurements of physicalparameters, when interpreted by a trained physician, provide informationthat may assist diagnosis and therapy planning. The accuracy ofdetermined physical parameters depends on system and scan parametersand must be controlled and validated by the clinical user. | |
| In addition, the Philips MR systems provide imaging capabilities, such asMR fluoroscopy, to guide and evaluate interventional and minimallyinvasive procedures in the head, body and extremities. MR Interventionalprocedures, performed inside or adjacent to the Philips MR system, mustbe performed with MR Conditional or MR Safe instrumentation as selectedand evaluated by the clinical user for use with the specific MR systemconfiguration in the hospital. The appropriateness and use of informationfrom a Philips MR system for a specific interventional procedure andspecific MR system configuration must be validated by the clinical user. | |
| Design Features/FundamentalScientificTechnology: | Just as the primary and secondary predicate devices, the proposedIngenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 andMR 7700 MR Systems are based on the principle that certain atomicnuclei present in the human body will emit a weak relaxation signal whenplaced in a strong magnetic field and excited by a radio signal at theprecession frequency. The emitted relaxation signals are analyzed by thesystem and a computed image reconstruction is displayed on a videoscreen.The principal technological components (magnet, transmit body coil,gradient coil, gradient amplifier, RF amplifier and patient support) of theproposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR5300 and MR 7700 MR Systems are unchanged compared to primarypredicate (K213583) and the secondary predicate device (K223442). |
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| No. | Recognition Number | Standard Number and Date | 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 / AAMI ES60601-1:2005/(R)2012and A1:2012 | Medical Electrical Equipment -Part 1: General RequirementsFor Basic Safety And EssentialPerformance (IEC 60601-1:2006, MOD). |
| 3 | 19-8 | IEC60601-1-2Ed. 4.0:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety 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 - Part 1-6: General requirements for basic safety 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 - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 6 | 5-125 | ISO 14971 ThirdEdition 2019 | Medical devices – Application of risk management to medical devices. |
| 7 | 5-114 | IEC 62366-1 Ed.1.0:2015 | Medical devices – Part 1: Application of usability engineering to medical devices |
| 8 | 13-79 | IEC 62304 Ed.1.1:2015 | Medical device software - Software life cycle processes. |
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| review, reproducibility of Precise in comparison to predicate devicereconstruction technique can be considered established. Additionally, areader evaluation by ABR board certified radiologists was performed,where following properties have been analyzed as part of the comparison:signal-to-noise ratio (SNR), artifact level, sharpness, and contrast-to-noiseratio (CNR). Furthermore, the radiologists have assessed the quality of thevisualization of abnormalities and pathologies in case they were presentin the images as well as if the images were of sufficient quality fordiagnostic purposes. The review evaluation shows that the proposeddevice is assessed as equivalent for diagnosis and holds significantlybetter SNR and sharpness compared to the predicate reconstructiontechnology, also in the presence of (subtle) abnormalities and pathology. | |
|---|---|
| The verification and/or validation test results demonstrate that theproposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR5300 and MR 7700 MR Systems meet the acceptance criteria and areadequate for the intended use. | |
| The risk management activities show that all risks are sufficientlymitigated, that no new risks are introduced, and that the overall residualrisks are acceptable. | |
| Therefore, the proposed Ingenia, Ingenia CX, Ingenia Elition, IngeniaAmbition, MR 5300 and MR 7700 MR Systems are substantiallyequivalent to the legally marketed primary predicate device Achieva,Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems(R11) (K213583, 16/05/2022) and the secondary predicate device MR5300 and MR 7700 R11 MR Systems (K223442) in terms of safety andeffectiveness. | |
| Summary ofClinical Data: | With the proposed Ingenia, Ingenia CX, Ingenia Elition, IngeniaAmbition, MR 5300 and MR 7700 MR Systems the indications for useremain unchanged and there were no technological characteristics relativeto the primary and secondary predicate device that would require clinicaltesting. |
| SubstantialEquivalence: | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,MR 5300 and MR 7700 MR Systems and the legally marketed primarypredicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems (R11) (K213583, 16/05/2022) and thesecondary predicate device MR 5300 and MR 7700 R11 MR Systems(K223442), 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 |
| Conclusion: | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,MR 5300 and MR 7700 MR Systems are substantially equivalent to thelegally marketed primary predicate device Achieva, Ingenia, Ingenia CX,Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) andthe secondary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442) in terms of safety and effectiveness. |
| (K223442), in terms of design features, fundamental scientific technology,indications for use, and safety and effectiveness. | |
| Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognizedconsensus standards and device-specific guidance. | |
| The results of these tests demonstrate that the proposed Ingenia, IngeniaCX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MRSystems meet the acceptance criteria and are adequate for the intendeduse. |
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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.