(120 days)
No
The document describes standard MR system functionality and hardware/software modifications without mentioning AI or ML.
No
The text explicitly states that the Philips MR systems are "indicated for use as a diagnostic device" and provide information that "may assist diagnosis, and therapy planning," but it does not claim the device is intended for direct therapeutic use.
Yes
The document explicitly states in the "Intended Use / Indications for Use" section that "Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device." Additionally, the "Device Description" section refers to them as "Magnetic Resonance Diagnostic Devices."
No
The device description explicitly states that the submission includes both hardware (HW) and software (SW) modifications, and mentions specific hardware components like a modified gradient system and a Universal Mains Distribution Unit (uMDU).
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The text clearly describes a Magnetic Resonance (MR) system. MR systems are imaging devices that use magnetic fields and radio waves to create images of the internal structures of the body. They do not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is to "obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities." This is consistent with an imaging device, not an IVD.
- Lack of IVD Language: The text does not mention any processes related to specimen collection, preparation, or analysis, which are hallmarks of IVDs.
Therefore, the Philips MR systems described are diagnostic imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians; clinical user; hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk 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 the acceptance criteria and are adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated; that new risks that were identified are mitigated to an acceptable level; and that the overall residual risk is acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K102344, K131241, K133526, K143128, K143253, K172920
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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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: | Jan. 20, 2022 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Veenpluis 4-6, 5684 PC, Best, The Netherlands | |
| Establishment Registration Number: 3003768277 | |
| Primary Contact | |
| Person: | Jan van de Kerkhof |
| Sr. Manager Regulatory Affairs | |
| Phone: +31 613300542 | |
| E-mail: jan.van.de.kerkhof@philips.com | |
| Secondary Contact | |
| Person | Ioana Ulea |
| Senior Regulatory Affairs Specialist | |
| Telephone: +31 618345875 | |
| E-mail: ioana.ulea@philips.com | |
| Device Name: | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi |
| Nuclei | |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Regulation: 21CFR 892.1000 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: 90LNH | |
| 90LNI | |
| Primary Predicate | |
| Device: | Trade name: Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, |
| and Ingenia Ambition MR Systems R5.7 | |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K193215 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class II | |
| Product Code: 90LNH | |
| 90LNI | |
| Device | |
| Description: | 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). | |
| Indications for | |
| Use: | There are no changes to the indications for use statement for the proposed |
| Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed | |
| Multi Nuclei R5.9. | |
| 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. | |
| Design Features/ | |
| Fundamental | |
| Scientific | |
| Technology: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with |
| Distributed Multi Nuclei R5.9 are based on the principle that certain atomic | |
| nuclei present in the human body will emit a weak relaxation signal when placed | |
| in a strong magnetic field and excited by a radio signal at the precession | |
| frequency. The emitted relaxation signals are analyzed by the system and a | |
| computed image reconstruction is displayed on a video screen. | |
| The table below lists the main changes between the devices from the proposed | |
| Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed | |
| Multi Nuclei R5.9 and devices from the legally marketed predicate device | |
| Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR | |
| Systems R5.7 (K193215, 04/10/2020). | |
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| Device from
predicate device . | Device from this
submission | Main differences |
|-----------------------------------|---------------------------------|---------------------------------------------------------------------|
| Ingenia Elition S/X | MR 7700 | Modified gradient system
Addition of Distributed Multi
Nuclei |
| Ingenia Elition S/X | Ingenia Elition S/X | Addition of Distributed Multi
Nuclei |
| Ingenia 3.0T
Ingenia 3.0T CX | Ingenia 3.0T
Ingenia 3.0T CX | Change in Multi Nuclei
functionality |
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
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| Summary of Non-Clinical
Performance Data: | The 1H RF Amplifier is a unit that delivers high power RF to the
Transmit/Receive coils (either the system Body coil or local Transmit/Receive
coils. A new 3.0T 1H RF Amplifier has been designed with same specifications
and characteristics as the 3.0T 1H RF Amplifier which is part of the 3.0T devices
of the legally marketed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).
Extended Functionality Options
Minor software enhancements regarding extended functionality options. These
minor software enhancements are related to parameter extensions for advanced
users, and do not pose any risk, nor have impact on safety and efficacy.ased on
the 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 raise
different questions of safety and effectiveness compared to the legally marketed
predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems R5.7 (K193215, 04/10/2020), therefore demonstrating
substantial 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 Nuclei
R5.9 are in compliance with all applicable requirements of the following
international 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 Submission
Of Premarket Notifications for Magnetic Resonance Diagnostic Devices"
(issued November 18, 2016) Guidance for Industry and FDA Staff – Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices
(issued May 11, 2005) Guidance for Industry and FDA Staff – Content of Premarket Submissions
for Management of Cybersecurity in Medical Devices (issued October 02
2014) Guidance for Industry and FDA Staff – Applying Human Factors and
Usability Engineering to Medical Devices (issued February 3, 2016) |
| | 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 September 04, 2020 Guidance for Industry and FDA Staff – Information to Support a Claim of
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical
Devices (issued July 11, 2016) Guidance for Industry and FDA Staff -Design Considerations and
Premarket Submission Recommendations for Interoperable Medical
Devices (issued September 6, 2017) |
| | Non-Clinical verification and or validation tests have been performed with regards
to the intended use, the technical claims, the requirement specifications and the
risk 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 the
acceptance criteria and are adequate for its intended use. Additionally, the risk
management activities show that all risks are sufficiently mitigated; that new risks
that were identified are mitigated to an acceptable level; and that the overall
residual risk is acceptable. |
| | Therefore, 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) in terms of safety
and effectiveness. |
| Summary of
Clinical Data: | 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. |
| Substantial
Equivalence: | The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with
Distributed 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 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 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems R5.7 (K193215, 04/10/2020) in terms of design features,
fundamental scientific technology, indications for use, and safety and
effectiveness.
Additionally, substantial equivalence is demonstrated with non-clinical
performance (verification and validation) tests, which complied with the
requirements specified in the international and FDA-recognized consensus |
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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.
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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.