(141 days)
No
The document describes software modifications to existing MR systems, focusing on features like MultiBand SENSE and Compressed SENSE, which are established MR acceleration techniques. There is no mention of AI, ML, or related terms in the description of the device or its features.
No
The document states that the device is "indicated for use as a diagnostic device" and later refers to them as "Magnetic Resonance Diagnostic Devices." While it can assist in therapy planning, its primary stated purpose is diagnostic imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device."
No
The device is described as software modifications to existing MR systems, which are hardware devices. While the submission focuses on software changes, the device itself is the MR system with the updated software, not the software in isolation.
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 Function: The description clearly states that the Philips MR systems are "Medical Electrical Systems indicated for use as a diagnostic device" that obtain "cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities." This involves imaging the internal structure of the body directly, not analyzing specimens taken from the body.
- Intended Use: The intended use is to assist in diagnosis and therapy planning by providing images and related information interpreted by a trained physician. This is consistent with in vivo diagnostic imaging, not in vitro analysis.
Therefore, the Philips MR systems described are diagnostic imaging devices, not In VitDs.
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 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices.
Hereafter Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature will be referred to as the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in this submission.
This bundled abbreviated 510(k) submission will include software modifications to the following legally marketed MR systems: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S and Ingenia Ambition X (K183063, 02/14/2019) and Achieva 1.5T, Achieva 3.0T, Intera 1.5T (K190461, 06/04/2019).
All of the aforementioned legally marketed systems will be brought up to the new baseline software R5.7. This submission addresses only software modifications, there are no hardware modifications made to any of the above legally marketed systems.
In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing modifications to MultiBand SENSE and one labeling change to the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems:
• Removal of contra-indication statement of Compressed SENSE with Gd contrast agent
This 510(k) submission will also address minor software enhancements contained in software R5.7 for the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems since the clearance of the last submission for each of the systems:
- 4D FreeBreathing
- MR Elastography Extension
- EPIC Brain
- LOVA ADC
- Computed DWI
- SmartShim
- VitalScreen
- Extended Functionality Options
The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems 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)
- Ingenia Coils
The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019).
In addition, the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is substantially equivalent to the following legally marketed reference devices: MultiBand SENSE software application (K162940, 12/30/2016), to support MultiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 K173079, 04/04/2018, to support the removal of the contra-indication of the compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging.
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
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
For Compressed SENSE with contrast, bench test results (Shelley phantom), using both retrospectively and prospectively sub-sampled data, demonstrating adequate capture of time-intensity behavior were provided. Philips provided data from retrospective sub-sampled CE-angio data, on 3 human subjects. This allowed for a direct comparison of SENSE and Compressed SENSE in terms of difference images relative to non-accelerated, fully sampled data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical verification and or validation tests have been performed on all of the software modifications with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The results from each set of tests demonstrate that the software features perform as intended and are therefore substantially equivalent to the predicate devices to which they have been compared.
For Compressed SENSE with contrast, bench test results (Shelley phantom), using both retrospectively and prospectively sub-sampled data, demonstrating adequate capture of time-intensity behavior were provided. Philips provided data from retrospective sub-sampled CE-angio data, on 3 human subjects. This allowed for a direct comparison of SENSE and Compressed SENSE in terms of difference images relative to non-accelerated, fully sampled data. Compressed SENSE was shown to be more robust up to higher acceleration factors. Using a retrospective subsampling approach, clinical data for brain perfusion in tumor classification was provided. Philips believes that the analysis and data from all testing demonstrates equivalence of CS-SENSE with the predicate device (non-accelerated data acquisition) for this dynamic contrast uptake application. Test results demonstrate that the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems meet the acceptance criteria and are adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated and that no new risks are introduced, and that the overall residual risks are acceptable.
The proposed Achieva, Interan, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
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.
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
April 10, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
Philips Medical Systems Nederland BV % Ms. Susan Quick Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143
Re: K193215
Trade/Device Name: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: March 11, 2020 Received: March 12, 2020
Dear Ms. Quick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director 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
Indications for Use
510(k) Number (if known) K193215
Device Name
Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Indications for Use (Describe)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, 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 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 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)
Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Section 5
510(k) Summary
4
Image /page/4/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 the primary focus of the image, taking up most of the space.
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: | November 14, 2019 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Susan Quick | ||||||||||||||||
| Regulatory Affairs Specialist | |||||||||||||||||
| Telephone: 440 869-4612 | |||||||||||||||||
| E-mail: susan.quick@philips.com | |||||||||||||||||
| Device Name: | Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | ||||||||||||||||
| 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, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K183063 Classification Regulation: 21CFR 892.1000 Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology Device class Class II Product Code: 90LNH | ||||||||||||||||
| 90LNI | |||||||||||||||||
| Reference Device: | Trade name: MultiBand SENSE Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K162940 Classification Regulation: 21CFR 892.1000 Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology Device class Class II |
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
| Product Code: | 90LNH | |
|---|---|---|
| 90LNI | ||
| Reference Device: | Trade name: | Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, |
| Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 | ||
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K173079 | |
| 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems R5.7 with MultiBand SENSE software feature
are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
Magnetic Resonance Diagnostic Devices. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Hereafter Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems R5.7 with MultiBand SENSE software feature will be
referred to as the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia
Elition, and Ingenia Ambition MR Systems in this submission. |
| | This bundled abbreviated 510(k) submission will include software modifications
to the following legally marketed MR systems: Ingenia 1.5T, Ingenia 1.5T S,
Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition
X, Ingenia Ambition S and Ingenia Ambition X (K183063, 02/14/2019) and
Achieva 1.5T, Achieva 3.0T, Intera 1.5T (K190461, 06/04/2019). |
| | All of the aforementioned legally marketed systems will be brought up to the new
baseline software R5.7. This submission addresses only software modifications,
there are no hardware modifications made to any of the above legally marketed
systems. |
| | In this 510(k) submission, Philips Medical Systems Nederland B.V. will be
addressing modifications to MultiBand SENSE and one labeling change to the
proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR Systems: |
| | • Removal of contra-indication statement of Compressed SENSE with Gd
contrast agent |
| | This 510(k) submission will also address minor software enhancements
contained in software R5.7 for the proposed Achieva, Intera, Ingenia, Ingenia
CX, Ingenia Elition, and Ingenia Ambition MR Systems since the clearance of
the last submission for each of the systems: |
| | 1. 4D FreeBreathing |
| | |
| | 2. MR Elastography Extension |
| | 3. EPIC Brain |
| | 4. LOVA ADC |
| | 5. Computed DWI |
| | 6. SmartShim |
| | 7. VitalScreen |
| | 8. Extended Functionality Options |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems 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)
- Ingenia Coils |
| | The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019). |
| | In addition, the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is substantially equivalent to the following legally marketed reference devices:
MultiBand SENSE software application (K162940, 12/30/2016), to support MultiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T CX, and Ingenia 3.0T CX R5.4 K173079, 04/04/2018, to support the removal of the contra-indication of the compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-enhanced imaging. |
| Indications for Use: | There are no modifications to the indications for use statement for the proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems.
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast |
| | agents. The use of contrast agents for diagnostic imaging applications should be
performed consistent with the approved labeling for the contrast agent. |
| | The trained clinical user can adjust the MR scan parameters to customize image
appearance, accelerate image acquisition, and synchronize with the patient's
breathing or cardiac cycle. |
| | The systems can use combinations of images to produce physical parameters,
and related derived images. Images, spectra, and measurements of physical
parameters, when interpreted by a trained physician, provide information that may
assist diagnosis and therapy planning. The accuracy of determined physical
parameters depends on system and scan parameters, and must be controlled and
validated by the clinical user. |
| | In addition the Philips MR systems provide imaging capabilities, such as MR
fluoroscopy, to guide and evaluate interventional and minimally invasive
procedures in the head, body and extremities. |
| | MR Interventional procedures, performed inside or adjacent to the Philips MR
system, must be performed with MR Conditional or MR Safe instrumentation as
selected and evaluated by the clinical user for use with the specific MR system
configuration in the hospital. The appropriateness and use of information from a
Philips MR system for a specific interventional procedure and specific MR system
configuration must be validated by the clinical user. |
| Design Features/
Fundamental
Scientific
Technology: | The proposed Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems 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, transmit body coil, gradient coil,
receive coils and patient support) of the proposed Achieva, Intera, Ingenia,
Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are identical
to those used in the legally marketed predicate device Ingenia, Ingenia CX,
Ingenia Elition, and Ingenia Ambition MR Systems (K183063, 02/14/2019. |
| | The following are descriptions of the labeling change or descriptions of the
modified or minor enhanced software features. |
| | Compressed SENSE with Contrast
Faster scanning in the presence of Gadolinium-based contrast agents can be
achieved using Compressed SENSE . The sequence and reconstruction
implementations are identical to those used for previously-cleared Compressed
SENSE for native contrasts, and do not include sparse sampling and signal
combination in the temporal domain. Compressed SENSE provides accurate
temporal and spatial resolution, and contrast appearance. The contra-indication
for compatibility of Compressed SENSE with (dynamic) Gadolinium contrast-
enhanced imaging will be removed from the Instructions for Use. |
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 background is white, which provides a strong contrast to the blue letters, making the word easily readable.
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters.
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.
Bundled Abbreviated 510(k)
| MultiBand SENSE |
|---|
| Multiband SENSE allows acceleration factors in single shot EPI sequence in DWI, DTI and fMRI. MultiBand SENSE is allowed on 3.0T and 1.5T DDAS systems. This function is the identical as the legally marketed device MultiBand and is now also implemented with minor changes on the 1.5T systems. The minor change is limiting the allowed MultiBand factor to 2 on 1.5T systems. |
| MultiBand SENSE Extension |
| MultiBand SENSE Extension is an extension of MultiBand SENSE which enables exploring diffusion imaging in the body. |
| VitalScreen |
| The Coil and Accessories Guidance was added to guide the user to correctly position mattresses and connecting coils. |
| 4D FreeBreathing |
| 4D FreeBreating technology uses 3D FFE and TFE radial acquisitions (like in 3D Vane XD) to avoid image artifacts typically seen with Cartesian imaging (Like 4D Thrive) when the patient cannot hold their breath. The MR technique enables dynamic imaging multiple contrast phases of the body without the need for the patient to hold their breath. |
| MR Elastography Specialist |
| Elastography Specialist has been enhanced with the SE-EPI sequence. The SE- EPI sequence is an alternative to the already available FFE sequence to perform elasticity assessment of the liver with MR. |
| Epic Brain |
| EPIC Brain corrects for geometrical distortions in EPI scans. |
| LOVA ADC |
| LOVA ADC corrects for gradient non-linearities so to produce more accurate ADC maps. |
| Computed DWI |
| Computed DWI is used to compute high b-value diffusion images, so to save scan time. |
| SmartShim |
| SmartShim is an automated shimming technology to correct for B0 inhomogenieties. |
| SmartExam Packages |
| The SmartExam Packages for Brain, Spine, Shoulder, Knee and Breast have been enhanced by providing a faster SmartSurvey scan, so to save examination time. The SmartSurvey is accelerated by using Compressed SENSE technology. |
| FFE Extensions |
| Extends the parameter space for m-FFE to allow more than 32 echoes. |
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, which makes the blue letters stand out. The word is horizontally oriented and centered.
| TFE Extensions | Extends the parameter space for product TFE to enable randomized k-space segmentation and CENTRA turbo-direction. |
|---|---|
| SE Extensions | Extends the parameter space to enable LIPO for non-DWI SE. |
| TSE Extensions | Extends the parameter space for TSE to enable DRIVE pre-pulse extensions and to enable user-defined contrasts for 3DView. |
| Diffusion Extensions | Extends the parameter space for DWI/DTI with dynamic imaging. |
| Angio Extensions | Extends the parameter space for eTHRIVE and 4D TRAK with profile order CENTRA. |
| Weighted Gating Navigator Extensions | Extends the parameter space for respiratory gating by allowing k-space weighting. |
| EPI/GraSE Extensions | Extends the parameter space for GraSE to allow more TSE profile orders (low-high or asymmetric). |
| Spiral Extensions | Extends the parameter space for Spiral Brain to allow use without brain coils, and to allow the combination with quantitative flow or diffusion. |
| Respiratory Gating | Extends the parameter space for respiratory gating for cardiac triggered scans. |
| Fast Next Scan Extensions | Extends the parameter space of BolusTrak by allowing a MS or 3D in the BolusTrak scan. |
| Custom Prepulse | Extends the parameter space for Prepulse by allowing the user to specify the pre-pulse or specify a Multi-pulse off-resonance MTC pulse. |
| B0 map & Shim Extensions | Extends the parameter space for BO field mapping, used for breast and brain, to other applications. Extends the parameter space for higher order shimming at 3.0T by allowing user to set shim values. |
| K-t Blast/k-t SENSE Extensions | Extends the parameter space for product k-t BLAST/k-t SENSE by allowing extension of acceleration factor allowing Qflow. |
10
Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out.
| Summary of Non-Clinical
Performance Data: | Radial Extensions
Extends the parameter space for radial to enable multi slice scans and to enable
ultra-short echo times.
mDIXON TSE Extensions
Extends the parameter interface for mDIXON TSE to enable the combination with
3D, cardiac triggering and respiratory compensation.
Multivane XD Extensions
Extends the parameter interface to MultiVane to combine with cardiac
synchronization and with respiratory navigator compensation.
Automatic Planning Extensions
Extends the parameter interface for SmartExam by allowing user to define the
SmartScout scan.
mDIXON CENTRA Keyhole
Extends the parameter interface for 4D Trak XD by allowing the combination with
mDIXON.
Based on the information provided above, the proposed Achieva, Intera, Ingenia,
Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems do not raise
different questions of safety and effectiveness compared to the legally marketed
predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems (K183063, 02/14/2019), therefore demonstrating substantial
equivalence.
Please note that the Achieva and Intera MR Systems are no longer being
manufactured but at the time of manufacture and release of these systems, the
Achieva and Intera MR Systems were in compliance with the international and
FDA recognized consensus standards. This proposed submission is to release
the updated software features to the install base of the Achieva and Intera MR
Systems.
Philips Medical Systems Nederland B.V. declares that the proposed Ingenia,
Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems 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 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 18
2018) | |
| 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 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) | |
| Guidance for Industry and FDA Staff -(issued September 6, 2017)
● | |
| All software modifications were tested across MR system families (Achieva,
Ingenia, Elition and Ambition). | |
| Non-Clinical verification and or validation tests have been performed on all of the
software modifications with regards to the intended use, the technical claims, the
requirement specifications and the risk management results. | |
| The results from each set of tests demonstrate that the software features
perform as intended and are therefore substantially equivalent to the predicate
devices to which they have been compared. | |
| For Compressed SENSE with contrast, bench test results (Shelley phantom),
using both retrospectively and prospectively sub-sampled data, demonstrating
adequate capture of time-intensity behavior were provided. Philips provided
data from retrospective sub-sampled CE-angio data, on 3 human subjects. This
allowed for a direct comparison of SENSE and Compressed SENSE in terms of
difference images relative to non-accelerated, fully sampled data. Compressed
SENSE was shown to be more robust up to higher acceleration factors. Using a
retrospective subsampling approach, clinical data for brain perfusion in tumor
classification was provided. Philips believes that the analysis and data from all
testing demonstrates equivalence of CS-SENSE with the predicate device (non-
accelerated data acquisition) for this dynamic contrast uptake application. | |
| Test results demonstrate that the proposed Achieva, Intera, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR Systems meet the acceptance criteria
and are adequate for its intended use. Additionally, the risk management activities
show that all risks are sufficiently mitigated and that no new risks are introduced,
and that the overall residual risks are acceptable. | |
11
Image /page/11/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, which makes the blue letters stand out.
.
12
Image /page/12/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out.
| | Therefore, the proposed Achieva, Intera Ingenia, Ingenia CX, Ingenia Elition,
and Ingenia Ambition MR Systems are substantially equivalent to the legally
marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems (K183063, 02/14/2019) in terms of safety and
effectiveness. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Clinical Data: | The proposed Achieva, Interan, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems and the legally marketed predicate device
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063,
02/14/2019) 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 Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems are substantially equivalent to the legally
marketed predicate device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia
Ambition MR Systems (K183063, 02/14/2019) 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
standards and device-specific guidance.
The results of these tests demonstrate that the proposed Achieva, Intera,
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems meet
the acceptance criteria and are adequate for their intended use. |