(23 days)
No
The document explicitly states that it is addressing "minor hardware enhancements" and does not mention any software modifications related to AI or ML. The performance studies focus on non-clinical verification and risk management, not AI/ML performance metrics.
No
The "Intended Use / Indications for Use" states that the device is "indicated for use as a diagnostic device" and provides information that "may assist diagnosis and therapy planning," but it does not directly administer therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device." It also mentions that the images and measurements obtained "when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning."
No
The device description explicitly mentions "minor hardware enhancements" and describes modifications to physical components like the SmokeDetector Interlock and gradient coil. This indicates the device includes hardware components and is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Medical Electrical System indicated for use as a diagnostic device" that obtains "cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities." This describes an imaging system used to visualize internal structures of the body.
- 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.
- Device Description: The device description details hardware enhancements and pulse sequences related to Magnetic Resonance (MR) imaging, which is an in vivo (within the living body) imaging modality.
- No mention of samples: There is no mention of analyzing samples taken from the body.
Therefore, the Philips Magnetic Resonance (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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
This Special 510(k) submission will include modifications of the proposed Ingenia Elition and MR 7700 MR Systems as compared to Philips legally marketed devices, primary predicate device MR 7700 R11 MR System of the 510(k) submission MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) as well as the secondary predicate device being the legally marketed Ingenia Elition R11 MR System of the 510(k) submission Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022).
In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor hardware enhancements for the proposed Ingenia Elition and MR 7700 MR Systems since the last 510(k) submission (K223442, 12/23/2022) for each of the systems:
- The SmokeDetector Interlock, a component used in the legally marketed Ingenia Elition and MR 7700 systems, becomes a mandatory risk control measure.
- Minor design change to current gradient coil type WB30S
Identical to the predicate devices, the proposed Ingenia Elition 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 (identical to the predicate devices)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians, clinical user
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)
Non-Clinical verification tests have been performed with regards to the requirement specifications and the risk management results. The verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use. The validation testing performed with the primary and secondary predicate devices remain valid for the changes introduced with the proposed device Ingenia Elition and MR 7700 MR Systems. 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. The proposed Ingenia Elition and MR 7700 MR Systems did not introduce any modification to the indication for use or technological characteristics relative to the predicate devices that would require clinical 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2023
Philips Medical Systems, Nederland B.V. % Ioana Ulea Senior Regulatory Affairs Specialist Veenpluis 4-6 Best. 5684 PC Netherlands
Re: K230972
Trade/Device Name: Ingenia Elition 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: April 5, 2023 Received: April 5, 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.
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
1
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. Kyle Kramer
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230972
Device Name
Ingenia Elition 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)
| ☑ 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: | April. 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 Elition 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: MR 5300 and MR 7700 R11 MR Systems |
| 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 | |
| Secondary 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 |
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Image /page/4/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 in the image.
| Device Description: | This Special 510(k) submission will include modifications of the proposed Ingenia Elition and MR 7700 MR Systems as compared to Philips legally marketed devices, primary predicate device MR 7700 R11 MR System of the 510(k) submission MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) as well as the secondary predicate device being the legally marketed Ingenia Elition R11 MR System of the 510(k) submission Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022).
In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor hardware enhancements for the proposed Ingenia Elition and MR 7700 MR Systems since the last 510(k) submission (K223442, 12/23/2022) for each of the systems:
- The SmokeDetector Interlock, a component used in the legally marketed Ingenia Elition and MR 7700 systems, becomes a mandatory risk control measure.
- Minor design change to current gradient coil type WB30S
Identical to the predicate devices, the proposed Ingenia Elition 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 (identical to the predicate devices) |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | There are no changes to the indications for use statement, provided below, of the proposed Ingenia Elition and MR 7700 MR Systems when compared to the primary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) and secondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022): |
| Design Features/
Fundamental
Scientific
Technology: | "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 spatialdistribution 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". |
| | Same as the predicate devices, the proposed Ingenia Elition 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 Elition and MR 7700 MR Systems are fundamentally
the same as those used in the legally marketed primary predicate device
MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) and
secondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition |
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6
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| and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). The | ||||
|---|---|---|---|---|
| gradient coil has a minor modification which does not affect the | ||||
| technological characteristics of the gradient coil. | ||||
| Summary of | ||||
| Non-Clinical | ||||
| Performance | ||||
| Data: | 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. | |||
| Non-Clinical verification tests have been performed with regards to the requirement specifications and the risk management results. | ||||
| The verification test results demonstrate that the proposed Ingenia Elition and MR 7700 MR Systems meet the acceptance criteria and are adequate for the intended use. |
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| | The validation testing performed with the primary and secondary
predicate devices remain valid for the changes introduced with the
proposed device Ingenia Elition and MR 7700 MR Systems. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additionally, the risk management activities show that all risks are
sufficiently mitigated; that new risks that were identified are mitigated to
an acceptable level; and that the overall residual risk is acceptable. |
| | Therefore, the proposed Ingenia Elition and MR 7700 MR Systems are
substantially equivalent to the legally marketed primary predicate device
MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) and
secondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition
and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022), in terms
of safety and effectiveness. |
| Summary of
Clinical Data: | The proposed Ingenia Elition and MR 7700 MR Systems did not
introduce any modification to the indication for use or technological
characteristics relative to the predicate devices that would require clinical
testing. |
| Substantial
Equivalence: | The proposed Ingenia Elition and MR 7700 MR Systems and the
legally marketed primary predicate device MR 5300 and MR 7700 R11
MR Systems (K223442, 12/23/2022) and secondary predicate device
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR
Systems R11 (K213583, 04/15/2022), 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 Elition and MR 7700 MR Systems are
substantially equivalent to the legally marketed primary predicate device
MR 5300 and MR 7700 R11 MR Systems (K223442, 12/23/2022) and
secondary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition
and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022), in terms
of design features, fundamental scientific technology, indications for use,
and safety and effectiveness. |
| | Additionally, substantial equivalence is demonstrated with non-clinical
performance tests and compliance 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 Elition
and MR 7700 MR Systems meet the acceptance criteria and are
adequate for the intended use. |