(120 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 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, 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.
The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are provided on the 60 cm and 70 cm bore 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices.
This bundled abbreviated 510(k) submission will include modifications of the 3.0T systems, included in the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).
This 510(k) submission will address the following HW and SW modifications for the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 since the clearance of the last submission for each of the systems: New system MR 7700 which contains modified gradient system compared to Ingenia Elition X Modified Multi Nuclei option, now available for all 3.0T systems
This 510(k) submission will also address minor hardware and software enhancements: Universal Mains Distribution Unit (uMDU) 3.0T 1H RF Amplifier Extended Functionality Options
The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: mDIXON (K102344) SWIp (K131241) mDIXON-Quant (K133526) mDIXON XD (K143128) O-MAR K143253 3D APT (K172920) Coils compatible with Ingenia 3.0T, Ingenia 3,0T CX, Ingenia Elition and MR 7700
The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are substantially equivalent to the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).
The provided text describes modifications to existing Philips Magnetic Resonance (MR) systems (Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700) with the addition of "Distributed Multi Nuclei" functionality. The submission argues for substantial equivalence to a legally marketed predicate device (Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7, K193215).
However, the document does not describe a study that proves the device meets specific performance acceptance criteria in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence through non-clinical verification and validation testing, and compliance with recognized standards.
Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as a quantitative table of performance metrics. The document states: "Test results demonstrate that the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 meet the acceptance criteria and are adequate for its intended use." However, it does not specify what those acceptance criteria are nor what the reported performance values against those criteria are for the functional enhancements (Modified Gradient System, Distributed Multi Nuclei, uMDU, 3.0T 1H RF Amplifier).
The "acceptance criteria" appear to be related to compliance with international, FDA recognized consensus standards, and the intended use of the MR system as a diagnostic device. The performance is implied to be equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of a clinical study for a diagnostic algorithm. The document describes "non-clinical verification and/or validation tests." These would typically involve engineering tests, phantom studies, and system-level performance checks rather than a test set of patient data with ground truth for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Since no clinical study or diagnostic accuracy study with a "test set" in the context of expert-established ground truth is described, this detail is not present. The device enables physicians to obtain images and spectra; the interpretation by a "trained physician" is mentioned as part of the intended use, but not as part of a ground truth establishment process for the device's own performance evaluation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as points 2 and 3.
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. The document explicitly states: "The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing." Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an MR imaging system itself, not a standalone diagnostic algorithm that would typically undergo such testing. Its function is to acquire images and spectra for human interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the context of evaluating diagnostic accuracy using a test set of patient data. The "ground truth" for the non-clinical tests would have been established through engineering specifications, physical measurements, and compliance with recognized standards for MR system performance.
8. The Sample Size for the Training Set
This information is not applicable. The document does not describe an AI or machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The modifications are to the physical and software components of an MR system for image acquisition and processing capabilities.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
Summary of what the document does provide regarding acceptance criteria and proof:
The document establishes "substantial equivalence" to a predicate device (K193215) by demonstrating that the modifications (Modified Gradient System, Distributed Multi Nuclei, uMDU, 3.0T 1H RF Amplifier, and minor software enhancements) do not raise different questions of safety and effectiveness, and that the device continues to meet its intended use.
The proof described is through:
- Non-clinical verification and validation tests: These tests were performed "with regards to the intended use, the technical claims, the requirement specifications and the risk management results."
- Compliance with international and FDA recognized consensus standards: A list of standards (e.g., IEC60601 series, IEC62366-1, IEC 62304, NEMA MS series, ISO 14971, and various FDA guidance documents) is provided.
- Risk management activities: To ensure all identified risks are sufficiently mitigated and overall residual risk is acceptable.
The acceptance criteria implicitly refer to successfully passing these non-clinical tests, complying with all listed standards, adequately mitigating risks, and maintaining the same safety and effectiveness profile as the predicate device such that no new clinical study was deemed necessary. The "reported device performance" is the successful fulfillment of these criteria, leading to the conclusion of substantial equivalence.
{0}------------------------------------------------
March 3, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle and text around it, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Philips Medical Systems Nederland, B.V. % Jan van de Kerkhof Sr. Manager Regulatory Affairs Veenpluis 4-6 Best. 5684PC NETHERLANDS
Re: K213516
Trade/Device Name: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: January 31, 2022 Received: February 1, 2022
Dear Jan van de Kerkhof:
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
{1}------------------------------------------------
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,
For
CAPT Patrick Hintz, MSIH, CIH, USPHS Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213516
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Device Name
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700
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 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, 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.
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 of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
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: | Jan. 20, 2022 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary ContactPerson | Ioana UleaSenior Regulatory Affairs SpecialistTelephone: +31 618345875E-mail: ioana.ulea@philips.com |
| Device Name: | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed MultiNuclei |
| 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, Ingenia 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 |
| DeviceDescription: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700with Distributed Multi Nuclei R5.9 are provided on the 60 cm and 70 cm bore3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices. |
| This bundled abbreviated 510(k) submission will include modifications of the3.0T systems, included in the legally marketed predicate device Achieva, Intera,Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7(K193215, 04/10/2020). | |
| This 510(k) submission will address the following HW and SW modifications forthe proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700with Distributed Multi Nuclei R5.9 since the clearance of the last submissionfor each of the systems: New system MR 7700 which contains modified gradient system compared to Ingenia Elition X Modified Multi Nuclei option, now available for all 3.0T systems | |
| This 510(k) submission will also address minor hardware and softwareenhancements: Universal Mains Distribution Unit (uMDU) 3.0T 1H RF Amplifier Extended Functionality Options | |
| The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 are intended to be marketed with the followingpulse sequences and coils that were previously cleared by FDA:mDIXON (K102344) SWIp (K131241) mDIXON-Quant (K133526) mDIXON XD (K143128) O-MAR K143253 3D APT (K172920) Coils compatible with Ingenia 3.0T, Ingenia 3,0T CX, Ingenia Elition and MR 7700 | |
| The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 are substantially equivalent to the legally marketedpredicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems R5.7 (K193215, 04/10/2020). | |
| Indications forUse: | There are no changes to the indications for use statement for the proposedIngenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with DistributedMulti Nuclei R5.9. |
| Philips Magnetic Resonance (MR) systems are Medical Electrical Systemsindicated 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 orextremities, in any orientation, representing the spatial distribution of protons orother nuclei with spin. | |
| Image appearance is determined by many different physical properties of thetissue and the anatomy, the MR scan technique applied, and presence of contrastagents. 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 customize imageappearance, accelerate image acquisition, and synchronize with the patient'sbreathing or cardiac cycle. | |
| The systems can use combinations of images to produce physical parameters,and related derived images, spectra, and measurements of physicalparameters, when interpreted by a trained physician, provide information that mayassist diagnosis and therapy planning. The accuracy of determined physicalparameters depends on system and scan parameters, and must be controlled andvalidated by the clinical user. | |
| In addition the Philips MR systems provide imaging capabilities, such as MRfluoroscopy, to guide and evaluate interventional and minimally invasiveprocedures in the head, body and extremities. | |
| MR Interventional procedures, performed inside or adjacent to the Philips MRsystem, must be performed with MR Conditional or MR Safe instrumentation asselected and evaluated by the clinical user for use with the specific MR systemconfiguration in the hospital. The appropriateness and use of information from aPhilips MR system for a specific interventional procedure and specific MR systemconfiguration must be validated by the clinical user. | |
| Design Features/FundamentalScientificTechnology: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 are based on the principle that certain atomicnuclei present in the human body will emit a weak relaxation signal when placedin a strong magnetic field and excited by a radio signal at the precessionfrequency. The emitted relaxation signals are analyzed by the system and acomputed image reconstruction is displayed on a video screen. |
| The table below lists the main changes between the devices from the proposedIngenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with DistributedMulti Nuclei R5.9 and devices from the legally marketed predicate deviceAchieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MRSystems R5.7 (K193215, 04/10/2020). | |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and fills most of the frame. The color of the letters is a bright, saturated blue.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
| Device frompredicate device . | Device from thissubmission | Main differences |
|---|---|---|
| Ingenia Elition S/X | MR 7700 | Modified gradient systemAddition of Distributed MultiNuclei |
| Ingenia Elition S/X | Ingenia Elition S/X | Addition of Distributed MultiNuclei |
| Ingenia 3.0TIngenia 3.0T CX | Ingenia 3.0TIngenia 3.0T CX | Change in Multi Nucleifunctionality |
The following are descriptions of the modified or minor enhanced hardware and software features.
MR 7700 – Modified Gradient System
- · Gradient Amplifier to achieve the higher maximum amplitude, a new gradient amplifier was needed. The new gradient amplifier has the same principle of operation as the predecessor gradient amplifier found in the legally marketed predicate device, Ingenia Elition X.
- · Gradient Coil same as the gradient coil used in the legally marketed predicate device Ingenia Elition X.
Distributed Multi Nuclei
The Multi Nuclei function is available as a commercial option on the predicate devices Inqenia 3.0T and Ingenia 3.0T CX from the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).
Currently the legally marketed predicate devices, Ingenia 3.0T and Ingenia 3.0T CX, have the Multi Nuclei option 31P supported as fully integrated. The modified Multi Nuclei option consists of additional nuclei to the MR system to transmit and receive on frequencies other than the frequency used for phosphor (31P). For the Ingenia 3.0T and Ingenia 3.0T CX this gives the possibility to create Spectra and Images for additional nuclei 13C, 23Na, next to being technical prepared for other nuclei. For Ingenia Elition S/X and the MR 7700 the modified Multi Nuclei option is newly introduced.
Universal Mains Distribution Unit (uMDU)
The universal Mains Distribution Unit (uMDU) is a unit that connects to the hospital mains inlet. The unit consists of circuit breakers / switches for the different parts of the MRI system. The switch for the gradient amplifier cabinet is changed to a higher rated switch due to the increased input power requirement of the new gradient amplifier for the proposed MR 7700. The modified uMDU is used in Ingenia Elition S, Ingenia Elition X and MR 7700 of the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9.
3.0T 1H RF Amplifier
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
| Summary of Non-ClinicalPerformance Data: | The 1H RF Amplifier is a unit that delivers high power RF to theTransmit/Receive coils (either the system Body coil or local Transmit/Receivecoils. A new 3.0T 1H RF Amplifier has been designed with same specificationsand characteristics as the 3.0T 1H RF Amplifier which is part of the 3.0T devicesof the legally marketed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, andIngenia Ambition MR Systems R5.7 (K193215, 04/10/2020).Extended Functionality OptionsMinor software enhancements regarding extended functionality options. Theseminor software enhancements are related to parameter extensions for advancedusers, and do not pose any risk, nor have impact on safety and efficacy.ased onthe information provided above, the proposed Ingenia 3.0T, Ingenia 3.0T CX,Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 do not raisedifferent questions of safety and effectiveness compared to the legally marketedpredicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems R5.7 (K193215, 04/10/2020), therefore demonstratingsubstantial equivalence.Philips Medical Systems Nederland B.V. declares that the proposed Ingenia 3.0T,Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NucleiR5.9 are in compliance with all applicable requirements of the followinginternational and FDA recognized consensus standards:Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition |
|---|---|
| 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 the SubmissionOf Premarket Notifications for Magnetic Resonance Diagnostic Devices"(issued November 18, 2016) Guidance for Industry and FDA Staff – Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices(issued May 11, 2005) Guidance for Industry and FDA Staff – Content of Premarket Submissionsfor Management of Cybersecurity in Medical Devices (issued October 022014) Guidance for Industry and FDA Staff – Applying Human Factors andUsability Engineering to Medical Devices (issued February 3, 2016) | |
| Guidance for Industry and FDA Staff – Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" (issued September 04, 2020 Guidance for Industry and FDA Staff – Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered MedicalDevices (issued July 11, 2016) Guidance for Industry and FDA Staff -Design Considerations andPremarket Submission Recommendations for Interoperable MedicalDevices (issued September 6, 2017) | |
| Non-Clinical verification and or validation tests have been performed with regardsto the intended use, the technical claims, the requirement specifications and therisk management results. | |
| Test results demonstrate that the proposed Ingenia 3.0T, Ingenia 3.0T CX,Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 meet theacceptance criteria and are adequate for its intended use. Additionally, the riskmanagement activities show that all risks are sufficiently mitigated; that new risksthat were identified are mitigated to an acceptable level; and that the overallresidual risk is acceptable. | |
| Therefore, the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR7700 with Distributed Multi Nuclei R5.9 are substantially equivalent to the legallymarketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition,and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020) in terms of safetyand effectiveness. | |
| Summary ofClinical Data: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 did not require a clinical study since substantialequivalence to the legally marketed predicate device was proven with theverification/validation testing. |
| SubstantialEquivalence: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 and the legally marketed predicate Achieva, Intera,Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7(K193215, 04/10/2020) have the same indications for use with respect to thefollowing: Providing cross-sectional images based on the magnetic resonancephenomenon Interpretation of the images is the responsibility of trained physicians Images can be used for interventional and treatment planning purposes |
| Conclusion: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 withDistributed Multi Nuclei R5.9 are substantially equivalent to the legally marketedpredicate Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and IngeniaAmbition MR Systems R5.7 (K193215, 04/10/2020) in terms of design features,fundamental scientific technology, indications for use, and safety andeffectiveness.Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognized consensus |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Bundled Abbreviated 510(k)
The results of these tests demonstrate that the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 meet the acceptance criteria and are adequate for their intended use.
§ 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.