(185 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 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 for diagnostic 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 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 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11.0 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems. This bundled abbreviated 510(k) submission will include modifications of the Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems as compared to our legally marketed devices Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020). In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor software enhancements to the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems when compared to the legally marketed predicate Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020): 1. SmartSpeed AI 2. SmartSpeed MotionFree 3. SmartSpeed 3D FreeBreathing 4. SmartSpeed Implant 5. SmartSpeed DWI 6. MR Workspace 7. ISP MR Packages 8. Extended functionality Options This 510(k) submission will also address the following minor hardware enhancements: 1. Introduction of a graphical processing unit in the host recon computer for image reconstruction 2. Additional monitor as part of the operating console The supporting documentation provided for the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems, includes software and hardware modifications that are addressed in test reports for system level development project, Voyager. The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition 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 provided text describes modifications to Philips MR systems, specifically the integration of "SmartSpeed AI" which combines previously cleared Compressed-SENSE with machine learning for improved image acquisition. The document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving a novel device's performance against clinical endpoints.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a formal "acceptance criteria table" with numerical targets. Instead, it describes the performance goals qualitatively, primarily focusing on "equivalent or better image quality" compared to images acquired without SmartSpeed AI but with longer scan times. The acceptance criteria essentially revolve around demonstrating that the new SmartSpeed AI feature does not negatively impact image quality and, ideally, improves it, especially at higher acceleration factors and lower SNR.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Comparable or better results than data reconstructed without SmartSpeed AI ("fully sampled ground truth data" and "data reconstructed without SmartSpeed AI" are used as benchmarks). | "SmartSpeed AI does provide comparable or better results than the data reconstructed without SmartSpeed AI." "SmartSpeed AI showed better alignment with the ground truth data for high acceleration factors and low SNR levels compared to the data reconstructed without SmartSpeed AI." |
| Does not negatively impact image quality measures when acquired with reduced scan time. | "In vivo images were analyzed to confirm that SmartSpeed AI does not negatively impact image quality measures when acquired with reduced scan time." |
| Images with equivalent or better image quality when comparing SmartSpeed AI images acquired with shorter scan times to images without SmartSpeed AI acquired with longer scan times. | "The combined results of the comparison described above confirmed that the SmartSpeed AI feature provides images with equivalent or better image quality." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The document does not specify a numerical sample size for the test set (number of images or patients). It mentions "a variety of datasets from different anatomies and image contrasts, varying SNR levels and acceleration factors" for pixel-wise comparison, and "in vivo images" for image quality analysis. For the reader evaluation study, it mentions "SmartSpeed AI images acquired across a variety of pulse sequences and anatomies."
- Data Provenance: Not explicitly stated. The phrase "in vivo images" and "a variety of datasets" implies real patient data, but the origin (e.g., country) is not mentioned, nor is whether the data was retrospective or prospectively collected for this study. Given it's a 510(k) for an upgrade, retrospective data is plausible.
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):
- Number of Experts: "A reader evaluation study with US board certified radiologists was performed." The exact number of radiologists is not specified, only that it was plural ("radiologists").
- Qualifications of Experts: "US board certified radiologists." No further details on their experience level (e.g., years of experience, subspecialty) are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document states: "Radiologists were asked to perform comparisons of SmartSpeed AI images acquired with shorter scan times and images without SmartSpeed AI acquired with longer scan times." It does not describe any specific adjudication method (e.g., consensus reading, majority vote) if there were multiple readers. It simply states "The combined results of the comparison described above confirmed..." suggesting an aggregation of individual reader opinions.
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:
- MRMC Study: A reader evaluation study was performed, which is a type of MRMC study. However, this study was not designed to measure "how much human readers improve with AI vs. without AI assistance." Instead, it was designed to compare the image quality of SmartSpeed AI images (shorter scan time) against non-SmartSpeed AI images (longer scan time), with human readers providing the comparison. The goal was to show non-inferiority or superiority in image quality, not an improvement in diagnostic performance of the human reader.
- Effect Size: No effect size regarding human reader improvement is reported because that was not the objective of the study. The study aimed to assess equivalent or better image quality of the AI-processed images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was done. The document states:
- "A pixel-wise comparison was performed to confirm that SmartSpeed AI does provide comparable or better results than the data reconstructed without SmartSpeed AI."
- "SmartSpeed AI showed better alignment with the ground truth data for high acceleration factors and low SNR levels compared to the data reconstructed without SmartSpeed AI."
- "In vivo images were analyzed to confirm that SmartSpeed AI does not negatively impact image quality measures when acquired with reduced scan time."
These directly assess the algorithm's output (image quality) without human interpretation in the loop as the primary endpoint for these specific analyses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the pixel-wise comparison was "fully sampled ground truth data." This implies a reference image acquired with conventional, unaccelerated scanning techniques, which is considered the "true" or ideal image without any AI reconstruction. For the in vivo image quality assessment and reader study, the ground truth was essentially the "image quality" as perceived by "US board certified radiologists" in comparison to the non-AI enhanced, longer-scan-time images. It's a comparative ground truth based on expert perception rather than a definitive clinical diagnosis or pathology.
8. The sample size for the training set:
The document does not specify the sample size for the training set used for the "SmartSpeed AI" machine learning component.
9. How the ground truth for the training set was established:
The document mentions that SmartSpeed AI "combining the previously cleared and legally marketed feature Compressed-SENSE... with machine learning." Given the context of image reconstruction and enhancement, it's highly probable the training ground truth involved pairs of unaccelerated (or conventionally accelerated) MR images and corresponding undersampled or noisy MR data, allowing the AI to learn to reconstruct high-quality images from suboptimal inputs. However, the exact method for establishing this ground truth (e.g., specific image acquisition protocols, expert annotation for quality metrics) is not detailed in the provided text.
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May 16, 2022
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Philips Medical Systems Nederland, B.V. % Susan Quick Sr. Manager Regulatory Affairs Veenpluis 4-6 5684PC Best NETHERLANDS
Re: K213583
Trade/Device Name: Achieva, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: April 14, 2022 Received: April 15, 2022
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 mediation-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.
For
Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition 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 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 for diagnostic 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 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 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 Drug (21 CFR 201.2 Subpart D) |
|---|
| Compounding Use (21 CFR 201.2 Subpart G) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k)
Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
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: | Nov. 10, 2021 |
|---|---|
| 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 AffairsTelephone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary ContactPerson | Susan QuickRegulatory Affairs SpecialistTelephone: (440) 8694612E-mail: susan.quick@philips.com |
| Device Name: | Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI |
| Primary PredicateDevice: | Trade name: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems R5.7Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K193215Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class IIProduct Code: 90LNH90LNI |
| Device Description: | The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems R11.0 are 60 cm and 70 cm bore 1.5and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance DiagnosticDevices, hereafter to be known as Achieva, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR Systems. |
| This bundled abbreviated 510(k) submission will include modificationsof the Achieva, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems as compared to our legally marketed devicesAchieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems R5.7 (K193215, 04/10/2020). | |
| In this 510(k) submission, Philips Medical Systems Nederland B.V. willbe addressing the following minor software enhancements to theproposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems when compared to the legally marketedpredicate Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems R5.7 (K193215, 04/10/2020): | |
| 1. SmartSpeed AI2. SmartSpeed MotionFree3. SmartSpeed 3D FreeBreathing4. SmartSpeed Implant5. SmartSpeed DWI6. MR Workspace7. ISP MR Packages8. Extended functionality Options | |
| This 510(k) submission will also address the following minor hardwareenhancements:1. Introduction of a graphical processing unit in the host reconcomputer for image reconstruction2. Additional monitor as part of the operating console | |
| The supporting documentation provided for the proposed Achieva,Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRSystems, includes software and hardware modifications that areaddressed in test reports for system level development project,Voyager. | |
| The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems are intended to be marketed with thefollowing pulse sequences and coils that are previously cleared byFDA: | |
| 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 CoilsIndications for Use:There are no changes to the indications for use statement, provided below, of the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems.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 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. 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: | The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems are based on the principle that certainatomic nuclei present in the human body will emit a weak relaxationsignal when placed in a strong magnetic field and excited by a radiosignal at the precession frequency. The emitted relaxation signals areanalyzed by the system and a computed image reconstruction isdisplayed on a video screen.The principal technological components (magnet, transmit body coil,gradient coil, gradient amplifier, RF amplifier and patient support) of theproposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR Systems are identical to those used in the legallymarketed predicate device Achieva, Intera, Ingenia, Ingenia CX,Ingenia Elition and Ingenia Ambition MR systems R5.7 (K193215,04/10/2020).The software R11 used on the proposed Achieva, Ingenia, IngeniaCX, Ingenia Elition and Ingenia Ambition MR Systems has beenmodified to include the SmartSpeed AI feature combining thepreviously cleared and legally marketed feature Compressed-SENSE(K193215, 04/10/2020) with machine learning to allow for higheraccelerations with equal or better image quality. |
| Summary of Non-ClinicalPerformance Data: | The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems are compliance with the followinginternational and FDA-recognized consensus standards:IEC60601-1 Edition 3 IEC60601-1-2 Edition 4 IEC60601-1-6 Edition 3 IEC62366-1 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" (issued November 18, 2016 – documentnumber 340) Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Contained inMedical Devices (issued May 11, 2005 – document number337) Guidance for Industry and FDA Staff – Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices (issued October 2, 2014 – document number 1825) |
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Guidance for Industry and FDA Staff - Applying Human Factors ● and Usability Engineering to Medical Devices (issued February 3, 2016 - document number 1757) Guidance for Industry and FDA Staff - Use of International . Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016 - document number 1811) Guidance for Industry and FDA Staff - Information to Support a ● Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 - document number 1400057) . Guidance for Industry and FDA Staff - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017 - document number 1500015) Non-Clinical verification and or validation tests have been performed with reqards to the intended use, the technical claims, the requirement specifications and the risk management results. The SmartSpeed AI feature has undergone performance testing on component and system level. A variety of datasets from different anatomies and image contrasts, varying SNR levels and acceleration factors were reconstructed with and without SmartSpeed AI and compared to fully sampled ground truth data. A pixel-wise comparison was performed to confirm that SmartSpeed Al does provide comparable or better results than the data reconstructed without SmartSpeed AI. SmartSpeed AI showed better alignment with the ground truth data for high acceleration factors and low SNR levels compared to the data reconstructed without SmartSpeed AI. In vivo images were analyzed to confirm that SmartSpeed AI does not neqatively impact image quality measures when acquired with reduced scan time. A reader evaluation study with US board certified radiologists was performed on SmartSpeed AI images acquired across a variety of pulse sequences and anatomies. Radiologists were asked to perform comparisons of SmartSpeed Al images acquired with shorter scan times and images without SmartSpeed AI acquired with longer scan times. The combined results of the comparison described above confirmed that the SmartSpeed AI feature provides images with equivalent or better image quality. The verification and/or validation test results demonstrate that the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
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| Ambition MR Systems meet the acceptance criteria and are adequatefor the intended use.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 Achieva, Ingenia, Ingenia CX, IngeniaElition and Ingenia Ambition MR Systems are substantiallyequivalent to the legally marketed predicate devices Achieva, Intera,Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRsystems R5.7 (K193215, 04/10/2020), in terms of safety andeffectiveness. | |
| Summary ofClinical Data: | The proposed Ingenia Achieva, Ingenia, Ingenia CX, Ingenia Elitionand Ingenia Ambition MR Systems did not require a clinical studysince substantial equivalence to the legally marketed predicate devicewas proven with the verification/validation testing. |
| SubstantialEquivalence: | The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems and the legally marketed predicatedevice Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR systems R5.7 (K193215, 04/10/2020), have thesame 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition andIngenia Ambition MR Systems are substantially equivalent to thelegally marketed predicate device Achieva, Intera, Ingenia, IngeniaCX, Ingenia Elition and Ingenia Ambition MR systems R5.7(K193215, 04/10/2020), in terms of design features, fundamentalscientific 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 Achieva,Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MRSystems meet the acceptance criteria and are adequate for the intended |
§ 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.