(141 days)
Yes
Precise Image is explicitly described as a "deep learning based reconstruction technique".
No
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic device" and provides information that "may assist diagnosis, and therapy planning", but not therapy itself.
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." Additionally, the "Device Description" section refers to them as "Magnetic Resonance Diagnostic Devices."
No
The device description clearly states that the submission is for "Philips Magnetic Resonance (MR) systems" which are physical hardware devices. While the submission focuses on a new software feature ("Precise Image"), the device itself is a complete MR system, not just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The text clearly describes the Philips MR systems as devices that obtain cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Lack of Sample Analysis: There is no mention of analyzing biological samples in the provided text. The device works by using magnetic fields and radio waves to generate images of the body's internal structures.
Therefore, while this is a diagnostic device, it falls under the category of in vivo diagnostic imaging rather than In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 MR scan technique applied, and presence of contrast agents. The use of contrast 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
LNH, LNI
Device Description
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems.
This bundled abbreviated 510(k) submission, is prompted by the introduction of a new optional software feature called Precise Image contained in software R12 for the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, as compared to our legally marketed primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) and the secondary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442).
Precise Image is a deep learning based reconstruction technique designed to increase signal-to-noise ratio (SNR), increase sharpness and decrease ringing artefacts from MR images.
The introduction of Precise Image only required updates to the MR System Software.
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA:
- mDIXON (K102344)
- SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR (K143253)
- 3D APT (K172920)
- Compatible System Coils
The accessories to be used with the proposed device Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems have not changed compared to the primary predicate device and secondary predicate device and can be found in the Instructions for Use accompanying the device:
System coils PPU Sensor for wireless physiology Pediatric PPU Sensor FlexTrak trolleys (FlexTrak / HA FlexTrak II) Acoustic Hood MR Elastography
When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply:
Flextrak OR MR-RT CouchTop RT CouchTop XD
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians, trained clinical user
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)
A reader evaluation by ABR board certified radiologists was performed, where following properties have been analyzed as part of the comparison: signal-to-noise ratio (SNR), artifact level, sharpness, and contrast-to-noise ratio (CNR). Furthermore, the radiologists have assessed the quality of the visualization of abnormalities and pathologies in case they were present in the images as well as if the images were of sufficient quality for diagnostic purposes. The review evaluation shows that the proposed device is assessed as equivalent for diagnosis and holds significantly better SNR and sharpness compared to the predicate reconstruction technology, also in the presence of (subtle) abnormalities and pathology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
signal-to-noise ratio (SNR), artifact level, sharpness, and contrast-to-noise ratio (CNR).
Predicate Device(s)
Reference Device(s)
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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April 6, 2023
Philips Medical Systems Nederland B.V. % Ioana Ulea Senior Regulatory Affairs Specialist Veenpluis 6 5684 PC Best NETHERLANDS
Re: K223458
Trade/Device Name: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: March 6, 2023 Received: March 6, 2023
Dear Ioana Ulea:
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.
1
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 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.
D. Ray Kerlick
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 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 MR scan technique applied, and presence of contrast agents. The use of contrast 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 assust 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) | |
|---|---|
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | Apr. 05, 2023 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 6, 5684 PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact Person: | Ioana Ulea | |
| Senior Regulatory Affairs Specialist | ||
| Phone: +31 618345875 | ||
| E-mail: ioana.ulea@philips.com | ||
| Secondary Contact Person | Jan van de Kerkhof | |
| Associate Director Regulatory Affairs | ||
| Phone: +31 613300542 | ||
| E-mail: jan.van.de.kerkhof@philips.com | ||
| Device Name: | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 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: Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (R11) | |
| Manufacturer: Philips Medical Systems Nederland B.V. | ||
| 510(k) Clearance: K213583 | ||
| Classification Regulation: 21CFR 892.1000 | ||
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | ||
| Classification Panel: Radiology | ||
| Device class: Class II | ||
| Product Code: 90LNH | ||
| 90LNI | ||
| Trade name: MR 5300 and MR 7700 R11 MR Systems | ||
| Secondary | ||
| Predicate Device: | Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) Clearance: | K223442 | |
| 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: | SIGNA Premier |
| Manufacturer: | GE Medical Systems, LLC | |
| 510(k) Clearance: | K193282 | |
| Classification | ||
| Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device | |
| (MRDD) | ||
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH | |
| 90LNI |
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| Device | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,
MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5
and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices,
hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, Ingenia
Ambition, MR 5300 and MR 7700 MR Systems. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | This bundled abbreviated 510(k) submission, is prompted by the
introduction of a new optional software feature called Precise Image
contained in software R12 for the proposed Ingenia, Ingenia CX, Ingenia
Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, as
compared to our legally marketed primary predicate device Achieva,
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
(R11) (K213583) and the secondary predicate device MR 5300 and MR
7700 R11 MR Systems (K223442). |
| | Precise Image is a deep learning based reconstruction technique
designed to increase signal-to-noise ratio (SNR), increase sharpness and
decrease ringing artefacts from MR images. |
| | The introduction of Precise Image only required updates to the MR System
Software. |
| | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,
MR 5300 and MR 7700 MR Systems are intended to be marketed with |
| | the following pulse sequences and coils that are previously cleared by FDA: |
| | 1. mDIXON (K102344)
2. SWIp (K131241)
3. mDIXON-Quant (K133526)
4. MRE (K140666)
5. mDIXON XD (K143128)
6. O-MAR (K143253)
7. 3D APT (K172920)
8. Compatible System Coils |
| | The accessories to be used with the proposed device Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems have not changed compared to the primary predicate device and secondary predicate device and can be found in the Instructions for Use accompanying the device: |
| | System coils PPU Sensor for wireless physiology Pediatric PPU Sensor FlexTrak trolleys (FlexTrak / HA FlexTrak II) Acoustic Hood MR Elastography |
| | When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply: |
| | Flextrak OR MR-RT CouchTop RT CouchTop XD |
| Indications for Use: | The indications for Use statement provided below for the proposed device is identical to the one of the primary and secondary predicate devices. The intended use is also not impacted by the introduction of Precise Image feature. |
| | 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: | Just as the primary and secondary predicate devices, the proposed
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and
MR 7700 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, gradient amplifier, RF amplifier and patient support) of the
proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR
5300 and MR 7700 MR Systems are unchanged compared to primary
predicate (K213583) and the secondary predicate device (K223442). |
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| No. | Recognition Number | Standard Number and Date | Standard Name |
|---|---|---|---|
| 1 | 12-295 | IEC60601-2-33 | |
| Ed. 3.2:2010 + | |||
| Amd 1:2013 + | |||
| Amd 2:2015 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | ||
| 2 | 19-4 | ANSI / AAMI ES60601- | |
| 1:2005/(R)2012 | |||
| and A1:2012 | Medical Electrical Equipment - | ||
| Part 1: General Requirements | |||
| For Basic Safety And Essential | |||
| Performance (IEC 60601-1:2006, MOD). | |||
| 3 | 19-8 | IEC60601-1-2 | |
| Ed. 4.0:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | ||
| 4 | 5-89 | IEC 60601-1-6 | |
| Ed. 3.1:2010 + | |||
| Amd 1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability | ||
| 5 | 5-76 | IEC 60601-1-8 | |
| Ed. 2.1:2006 + | |||
| Amd 1:2012 | |||
| (Ed.2.1) | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | ||
| 6 | 5-125 | ISO 14971 Third | |
| Edition 2019 | Medical devices – Application of risk management to medical devices. | ||
| 7 | 5-114 | IEC 62366-1 Ed. | |
| 1.0:2015 | Medical devices – Part 1: Application of usability engineering to medical devices | ||
| 8 | 13-79 | IEC 62304 Ed. | |
| 1.1:2015 | Medical device software - Software life cycle processes. |
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| review, reproducibility of Precise in comparison to predicate device
reconstruction technique can be considered established. Additionally, a
reader evaluation by ABR board certified radiologists was performed,
where following properties have been analyzed as part of the comparison:
signal-to-noise ratio (SNR), artifact level, sharpness, and contrast-to-noise
ratio (CNR). Furthermore, the radiologists have assessed the quality of the
visualization of abnormalities and pathologies in case they were present
in the images as well as if the images were of sufficient quality for
diagnostic purposes. The review evaluation shows that the proposed
device is assessed as equivalent for diagnosis and holds significantly
better SNR and sharpness compared to the predicate reconstruction
| technology, also in the presence of (subtle) abnormalities and pathology. | |
|---|---|
| The verification and/or validation test results demonstrate that the | |
| proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR | |
| 5300 and MR 7700 MR Systems meet the acceptance criteria and are | |
| adequate for the intended use. | |
| The risk management activities show that all risks are sufficiently | |
| mitigated, that no new risks are introduced, and that the overall residual | |
| risks are acceptable. | |
| Therefore, the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia | |
| Ambition, MR 5300 and MR 7700 MR Systems are substantially | |
| equivalent to the legally marketed primary predicate device Achieva, | |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | |
| (R11) (K213583, 16/05/2022) and the secondary predicate device MR | |
| 5300 and MR 7700 R11 MR Systems (K223442) in terms of safety and | |
| effectiveness. | |
| Summary of | |
| Clinical Data: | With the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia |
| Ambition, MR 5300 and MR 7700 MR Systems the indications for use | |
| remain unchanged and there were no technological characteristics relative | |
| to the primary and secondary predicate device that would require clinical | |
| testing. | |
| Substantial | |
| Equivalence: | The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, |
| MR 5300 and MR 7700 MR Systems and the legally marketed primary | |
| predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, and | |
| Ingenia Ambition MR Systems (R11) (K213583, 16/05/2022) and the | |
| secondary predicate device MR 5300 and MR 7700 R11 MR Systems | |
| (K223442), 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, Ingenia CX, Ingenia Elition, Ingenia Ambition, |
| MR 5300 and MR 7700 MR Systems are substantially equivalent to the | |
| legally marketed primary predicate device Achieva, Ingenia, Ingenia CX, | |
| Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) and | |
| the secondary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442) in terms of safety and effectiveness. | |
| (K223442), 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 Ingenia, Ingenia | |
| CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR | |
| Systems meet the acceptance criteria and are adequate for the intended | |
| use. |
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