(132 days)
No
The summary describes modifications to an existing MR system, primarily focusing on hardware upgrades (gradient system), software platform updates (Windows 10), and the inclusion of previously cleared pulse sequences and coils. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.
No
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic device". While it mentions that images, spectra, and measurements "may assist the diagnosis and therapy planning," its primary role is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device." It further explains that "Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning."
No
The device description explicitly mentions the introduction of a "new gradient system hardware with new gradient specifications," indicating it includes significant hardware components beyond just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, or tissue) outside of the body. The text describes a Magnetic Resonance system that produces images and spectra of the internal structure of the head, body, or extremities. This is an imaging modality that works directly on the patient.
- The intended use clearly states it's a "Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device." This aligns with in-vivo imaging, not in-vitro analysis.
- The device description details hardware and software for image acquisition and processing. It doesn't mention any components or processes related to handling or analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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
LNH, LNI
Device Description
The proposed Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications
The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
The following modifications are covered compared to legally marketed predicate device:
- Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10);
- PerformanceBridge Protocol Manager Release 1.0;
- Introduction of new gradient system hardware with new gradient specifications;
- Introduction of new product name and covers.
The proposed Ingenia Elition S and Ingenia Elition X R5.4 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
- MRE K140666
- mDIXON XD K143128
- O-MAR K143253
- MultiBand SENSE K143606
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 Elition S and Ingenia Elition X R5.4 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.
The verification and/or validation test results demonstrate that the proposed Ingenia Elition S and Ingenia Elition X R5.4:
- Complies with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices - November 18, 2016"
- Meets the acceptance criteria and is adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K102344, K131241, K133526, K140666, K143128, K143253, K143606
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Philips Medical Systems Nederland B.V. Henrie Daniels Regulatory Affairs Specialist Veenpluis 4-6 Best, 5684PC N1
Re: K173356
Trade/Device Name: Ingenia Elition S and Ingenia Elition X R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: January 30, 2018 Received: February 2, 2018
Dear Henrie Daniels:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
March 6, 2018
1
Page 2 - Henrie Daniels
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173356
Device Name Ingenia Elition S and Ingenia Elition X R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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:
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information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
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Premarket Notification [510(k)] Submission Philips Medical Systems Nederland B.V. Ingenia Elition S and Ingenia Elition X R5.4 ട് 4
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k)
Ingenia Elition S and Ingenia Elition X R5.4
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: | October 20, 2017 | |
|---|---|---|
| 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 | Henrie Daniels | |
| Regulatory Affairs Specialist | ||
| Telephone: +31 643837374 | ||
| E-mail: henrie.daniels@philips.com | ||
| Device Name: | Ingenia Elition S and Ingenia Elition X R5.4 | |
| 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: | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K163116 | |
| 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 Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). |
The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications
The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).
The following modifications are covered compared to legally marketed predicate device:
- Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10);
- PerformanceBridge Protocol Manager Release 1.0;
- Introduction of new gradient system hardware with new gradient specifications;
- Introduction of new product name and covers.
The proposed Ingenia Elition S and Ingenia Elition X R5.4 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
- MRE K140666
- mDIXON XD K143128
- O-MAR K143253
- MultiBand SENSE K143606 | |
| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systems | |
| | indicated for use as a diagnostic device. The system can produce
cross-sectional images, spectroscopic images and/or spectra in
any orientation of the internal structure of the head, body or
extremities. | |
| | Magnetic Resonance images represent 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, and the MR scan technique applied. The image
acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging
applications should be performed consistent with the approved
labeling for the contrast agent. | |
| | 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 Elition S and Ingenia Elition X R5.4 are
based on the principle that certain atomic nuclei present in the
human body will emit a weak relaxation signal when placed in a
strong magnetic field and excited by a radio signal at the
precession frequency. The emitted relaxation signals are analyzed
by the system and a computed image reconstruction is displayed
on a video screen.
The principal technological components (magnet, receive coils
and patient support) of the proposed Ingenia Elition S and
Ingenia Elition X R5.4 are identical to those used in the legally
marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and
Ingenia 3.0T R5.3 (K163116, 01/06/2017), except for the transmit
body coil and the gradient coil, which have been changed to adapt
to the changed voltage levels of the gradient amplifier.
Based on the information provided above, the proposed Ingenia
Elition S and Ingenia Elition X R5.4 does not raise different
questions of safety and effectiveness compared to the legally
marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and
Ingenia 3.0T R5.3 (K163116, 01/06/2017). | |
| Summary of Non-
Clinical Performance
Data: | The proposed Ingenia Elition S and Ingenia Elition X R5.4
comply with the following international and FDA-recognized
consensus standards: | |
| | • IEC60601-1 Edition 3 | |
| | • IEC60601-1-2 Edition 3 | |
| | • IEC60601-1-6 Edition 3 | |
| | • IEC62366 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 – 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 - Applying Human Factors
and Usability Engineering to Medical Devices 9 issued February
3, 2016) | |
| | • Guidance for Industry and FDA Staff - Content of Premarket
Submissions for Management of Cybersecurity in Medical
Devices issued October 2, 2014 | |
| | • 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) | |
| | • Guidance for Industry and FDA Staff – Information to Support a
Claim of Electromagnetic Compatibility (EMC) of Electrically-
Powered Medical Devices (issued July 11, 2016) | |
| | 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. | |
| | The verification and/or validation test results demonstrate that the
proposed Ingenia Elition S and Ingenia Elition X R5.4: | |
| | • Complies with the aforementioned international and FDA
recognized consensus standards and Device specific
guidance document, entitled "Guidance for the Submission Of
Premarket Notifications for Magnetic Resonance Diagnostic
Devices - November 18, 2016"
• Meets the acceptance criteria and is adequate for its intended
use. | |
| | Therefore, the proposed Ingenia Elition S and Ingenia Elition X
R5.4 are substantially equivalent to the legally marketed predicate
device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
(K163116, 01/06/2017) in terms of safety and effectiveness. | |
| Summary of Clinical
Data: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 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 Elition S and Ingenia Elition X R5.4 and
the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T
S and Ingenia 3.0T R5.3 (K163116, 01/06/2017) have the same
indications for use with respect to the following:
• Providing cross-sectional images based on the magnetic
resonance phenomenon
• Interpretation of the images is the responsibility of trained
physicians
• Images can be used for interventional and treatment planning
purposes
The proposed Ingenia Elition S and Ingenia Elition X R5.4 are
substantially equivalent to the legally marketed predicate device
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116,
01/06/2017) in terms of design features, fundamental scientific | |
| | technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated with non-
clinical performance (verification and validation) tests, which
complied with the requirements specified in the international and
FDA-recognized consensus standards and device-specific
guidance. | |
| Conclusion: | The results of these tests demonstrate that the proposed Ingenia
Elition S and Ingenia Elition X R5.4 meet the acceptance criteria
and is adequate for its intended use. | |
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