(39 days)
No
The summary describes standard MR imaging capabilities and modifications to existing systems, with no mention of AI or ML features.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Philips Magnetic Resonance (MR) systems are "indicated for use as a diagnostic device." While it mentions that images, spectra, and measurements "may assist diagnosis and therapy planning," its primary indication is diagnostic, not therapeutic.
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 explicitly states that the proposed devices are "Magnetic Resonance Diagnostic Devices" with specific bore sizes and Tesla strengths (60 cm and 70 cm bore 1.5 and 3.0 Tesla). This indicates a physical hardware component (the MR system itself) is integral to the device, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Medical Electrical System indicated for use as a diagnostic device" that obtains images and spectra of the internal structure of the body. This describes an imaging system used to visualize internal anatomy and physiology.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions. This device does not perform such tests on biological samples.
- Device Description: The device description confirms it is a Magnetic Resonance Diagnostic Device, which is an imaging modality.
Therefore, the Philips MR systems described are diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user.
In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
The proposed MR 5300 and MR 7700 R11 MR Systems 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 MR 5300 and MR 7700 MR Systems.
This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).
The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).
The proposed MR 5300 and MR 7700 R11 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 MR 5300 and MR 7700 R11 MR Systems are identical to those used in the legally marketed primary predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).
The software R11 used on the proposed MR 5300 and MR 7700 R11 MR Systems is previously cleared on the legally marketed primary predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed Ingenia MR 5300 and MR 7700 R11 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.
K102344, K131241, K133526, K140666, K143128, K143253, K172920
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
December 23, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym 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 the square. The full name reads "U.S. Food & Drug Administration".
Philips Medical Systems Nederlands B.V. % Susan Quick Regulatory Affairs Manager Veenpluis 6 Best. 5684 PC NETHERLANDS
Re: K223442
Trade/Device Name: MR 5300 and MR 7700 R11 MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 14, 2022 Received: November 14, 2022
Dear Susan 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Z. H. Ke
Laurel Burk, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products 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)
K223442
Device Name MR 5300 and MR 7700 R11 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. 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 cvcle.
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 NR 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) |
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Special 510(k)
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: | Nov. 14, 2022 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 6, 5684 PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact Person: | Susan Quick | |
| Regulatory Affairs Manager | ||
| Telephone: (440) 869-4612 | ||
| E-mail: susan.quick@philips.com | ||
| Secondary Contact Person | Jan van de Kerkhof | |
| Associate Director Regulatory Affairs | ||
| Telephone: +31 613300542 | ||
| E-mail: jan.van.de.kerkhof@philips.com | ||
| Device Name: | MR 5300 and MR 7700 R11 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, Ingneia 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 | ||
| Secondary Predicate Device: | Trade name: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei | |
| Manufacturer: Philips Medical Systems Nederland B.V. | ||
| 510(k) Clearance: K213516 | ||
| Classification | ||
| Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic Device | |
| (MRDD) | ||
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | 90LNH | |
| 90LNI | ||
| Secondary | ||
| Predicate Device: | Trade name: | MR 5300 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K212673 | |
| 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 | Description: | The proposed MR 5300 and MR 7700 R11 MR Systems 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 MR 5300 and MR 7700 MR Systems. |
|---|---|---|
| This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021). | ||
| The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021). | ||
| Indications for | ||
| Use: | In this 510(k) submission, Philips Medical Systems Nederland B.V. will | |
| be addressing the following minor software enhancements to the | ||
| proposed MR 5300 and MR 7700 R11 MR Systems when compared | ||
| to the legally marketed primary predicate, Achieva, Ingenia, Ingenia | ||
| CX, Ingenia Elition and Ingenia Ambition MR Systems R11 | ||
| (K213583, 05/16/2022) and the secondary predicate devices Ingenia | ||
| 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with | ||
| distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 | ||
| (K212673, 11/19/2021) : | ||
| 1. SmartSpeed AI |
- SmartSpeed MotionFree
- SmartSpeed 3D FreeBreathing
- SmartSpeed Implant
- SmartSpeed DWI
- MR Workspace
- ISP MR Packages
- MR Elastography (MR 5300 only) | |
| | This 510(k) submission will also address the following minor hardware
enhancements: | |
| | 1. Introduction of a graphical processing unit in the host recon
computer for image reconstruction - Additional monitor as part of the operating console | |
| | The supporting documentation provided for the proposed MR 5300 and
MR 7700 R11 MR Systems , includes software and hardware
modifications that are addressed in test reports for system level
development project, Voyager R11.1. | |
| | The proposed MR 5300 and MR 7700 R11 MR Systems are intended
to be marketed with the following pulse sequences and coils that are
previously cleared by FDA: | |
| | 1. mDIXON (K102344) - SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR (K143253)
- 3D APT (K172920)
- Compatible System Coils | |
| | There are no changes to the indications for use statement, provided
below, of the proposed MR 5300 and MR 7700 R11 MR Systems
when compared to the primary predicate Achieva, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,
05/16/2022) . | |
| | 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 MR 5300 and MR 7700 R11 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 MR 5300 and MR 7700 R11 MR Systems are identical to
those used in the legally marketed primary predicate, Achieva,
Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR
Systems R11 (K213583, 05/16/2022) and the secondary predicate
devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 | |
| | with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300
(K212673, 11/19/2021). | |
| | The software R11 used on the proposed MR 5300 and MR 7700 R11
MR Systems is previously cleared on the legally marketed primary
predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR Systems R11 (K213583, 05/16/2022). | |
| Summary of Non-
Clinical
Performance Data: | The proposed MR 5300 and MR 7700 R11 MR Systems are in
compliance with the following international and FDA-recognized
consensus standards:
• IEC60601-1 Edition 3
• IEC60601-1-2 Edition 4
• IEC60601-1-6 Edition 3
• IEC62366-1 Edition 1
• IEC60601-1-8 Edition 2
• IEC60601-2-33 Edition 3
• IEC 62304 Edition 1
• NEMA MS-1 2008
• NEMA MS-4 2010
• NEMA MS-8 2008
• NEMA PS 3.1-PS 3.20
• ISO 14971 Edition 2
• Device specific guidance document, entitled "Guidance for the
Submission Of Premarket Notifications for Magnetic Resonance
Diagnostic Devices" (issued November 18, 2016 – document
number 340)
• Guidance for Industry and FDA Staff – Guidance for the
Content of Premarket Submissions for Software Contained in
Medical Devices (issued May 11, 2005 – document number
• Guidance for Industry and FDA Staff – Content of Premarket
Submissions for Management of Cybersecurity in Medical
Devices (issued October 2, 2014 – document number 1825)
• Guidance for Industry and FDA Staff – Applying Human Factors
and Usability Engineering to Medical Devices (issued February
3, 2016 – document number 1757)
• 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 – document
number 1811)
• Guidance for Industry and FDA Staff – Information to Support a
Claim of Electromagnetic Compatibility (EMC) of Electrically-
Powered Medical Devices (issued July 11, 2016 – document
number 1400057)
• Guidance for Industry and FDA Staff – Design Considerations
and Premarket Submission Recommendations for Interoperable
Medical Devices (issued September 6, 2017 – document
number 1500015) | |
| | | |
| | 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 MR 5300 and MR 7700 R11 MR Systems meet the
acceptance criteria and are adequate for the intended use. | |
| | Additionally, the risk management activities show that all risks are
sufficiently mitigated; that new risks that were identified are mitigated to
an acceptable level; and that the overall residual risk is acceptable. | |
| | Therefore, the proposed MR 5300 and MR 7700 R11 MR Systems are
substantially equivalent to the legally marketed primary predicate,
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition
MR Systems R11 (K213583, 05/16/2022) and the secondary predicate
devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700
with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300
(K212673, 11/19/2021), in terms of safety and effectiveness. | |
| Summary of
Clinical Data: | The proposed Ingenia MR 5300 and MR 7700 R11 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 MR 5300 and MR 7700 R11 MR Systems and the
legally marketed primary predicate, Achieva, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,
05/16/2022) and the secondary predicate devices Ingenia 3.0T,
Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed
Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673,
11/19/2021) 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 MR 5300 and MR 7700 R11 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, 05/16/2022) and the
secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia
Elition, and MR 7700 with distributed Multi Nuclei (K213516,
03/03/2022) and MR 5300 (K212673, 11/19/2021), 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 | |
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| requirements specified in the international and FDA-recognized consensus standards and device-specific guidance. |
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| The results of these tests demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the intended use. |