(87 days)
Not Found
No
The document describes modifications to existing MR hardware and workflow, with no mention of AI or ML capabilities.
No.
Explanation: The Intended Use section explicitly states that "Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device." While it mentions that images "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."
No
The device description clearly states it is a 1.5 Tesla Magnetic Resonance Diagnostic Device, which is a hardware system. It also describes physical components like a bore, patient table, and dS Interface. While it includes software (SW R5.8), it is an integral part of a larger hardware system.
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 "diagnostic device" used to obtain "cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremites". This describes an in vivo diagnostic process (examining the living body), not an in vitro diagnostic process (examining samples outside the body).
- Device Description: The description details a "Magnetic Resonance Diagnostic Device" which is a type of medical imaging equipment used on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside the body, which are hallmarks of IVD devices.
The device is a Magnetic Resonance (MR) system, which is a type of medical imaging equipment used for in vivo diagnosis.
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 extremites, 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.
Product codes
LNH, LNI
Device Description
The proposed MR 5300 R5.8 with Breeze Workflow Solution is a 70 cm bore 1.5 Tesla (1.5T) Magnetic Resonance Diagnostic Device, hereafter to be known as MR 5300. Philips Medical Systems Nederland B.V. believes that the proposed MR 5300 is a modification of our legally marketed devices Achieva, Intera, Ingenia, Inqenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following modifications to the proposed MR 5300 when compared to the legally marketed predicate Ingenia Ambition S: 1. Introduction of new product model: MR 5300 2. Introduction of Breeze Workflow Solution: a. dS Interface: newly developed 16 channel dS interface to connect coils to the MR 5300 system. The dS Interface allows to connect two coils at the same time to one dS Interface. dS Interface is available in two variants: dS interface S 1.5T with a short cable o dS interface L 1.5T with a longer cable O b. Rearrangement of connector layout of the patient table to fit to the dS Interface. Connectors are not changed. Comfort Mattress Partner to improve patient setup, C. patient comfort and cable management. Besides enable the new product model MR 5300 and the coils mentioned above. There is no new software features introduced in SW R5.8. The proposed MR 5300 is intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA: 1. mDIXON (K102344) 2. SWlp (K131241) 3. mDIXON-Quant (K133526) 4. mDIXON XD (K143128) 5. O-MAR (K143253) 6. MultiBand SENSE software application (K162940), to support MutiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or extremites
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)
The proposed MR 5300 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)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems Nederland B.V. % Jan van de Kerkhof Sr. Manager Regulatory Affairs Veenpluis 4-6 5684 PC Best THE NETHERLANDS
Re: K212673
Trade/Device Name: MR 5300 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: August 23, 2021 Received: August 24, 2021
Dear Jan van de Kerkhof:
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 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.
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
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Indications for Use
510(k) Number (if known)
K212673
Device Name MR 5300
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 extremites, 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.
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.
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k)
MR 5300
510(k) Summary
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510(k) Summary of Safety and Effectiveness
This 510(k) summary is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | Aug 23, 2021 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Veenpluis 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 | AN Ce |
| Regulatory Affairs Specialist | |
| Telephone: +31 638161043 | |
| E-mail: ce.an@philips.com | |
| Device Name: | MR 5300 |
| 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, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K193215 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class II | |
| Product Code: 90LNH | |
| 90L NI |
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The proposed MR 5300 R5.8 with Breeze Workflow Solution is a 70 Device Description: cm bore 1.5 Tesla (1.5T) Magnetic Resonance Diagnostic Device, hereafter to be known as MR 5300. Philips Medical Systems Nederland B.V. believes that the proposed MR 5300 is a modification of our legally marketed devices Achieva, Intera, Ingenia, Inqenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following modifications to the proposed MR 5300 when compared to the legally marketed predicate Ingenia Ambition S: 1. Introduction of new product model: MR 5300 2. Introduction of Breeze Workflow Solution: a. dS Interface: newly developed 16 channel dS interface to connect coils to the MR 5300 system. The dS Interface allows to connect two coils at the same time to one dS Interface. dS Interface is available in two variants: dS interface S 1.5T with a short cable o dS interface L 1.5T with a longer cable O b. Rearrangement of connector layout of the patient table to fit to the dS Interface. Connectors are not changed. Comfort Mattress Partner to improve patient setup, C. patient comfort and cable management. Besides enable the new product model MR 5300 and the coils mentioned above. There is no new software features introduced in SW R5.8. The proposed MR 5300 is intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA: 1. mDIXON (K102344) 2. SWlp (K131241) 3. mDIXON-Quant (K133526) 4. mDIXON XD (K143128) 5. O-MAR (K143253) 6. MultiBand SENSE software application (K162940), to support MutiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.
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| Indications for Use: | The indications for use, provided below, of the proposed MR 5300 is the same as the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S.
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 |
| ---------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| Design Features/
Fundamental
Scientific
Technology: | The proposed MR 5300 is 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 is identical to those used in the legally marketed
predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia
Elition and Ingenia Ambition MR systems (K193215, 04/10/2020),
among which MR 5300 is specifically predicated to Ingenia Ambition
S. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-
Clinical
Performance Data: | The proposed MR 5300 complies 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
337) 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: |
| | Comply with the aforementioned international and FDA
recognized consensus standards and Device specific guidance
document, entitled "Guidance for the Submission Of Premarket
Notifications for Magnetic Resonance Diagnostic Devices –
November 18, 2016" Meet the acceptance criteria and is adequate for its intended
use. |
| | Therefore, the proposed MR 5300 is substantially equivalent to the
legally marketed predicate device Achieva, Intera, Ingenia, Ingenia
CX, Ingenia Elition and Ingenia Ambition MR systems (K193215,
04/10/2020), among which MR 5300 is specifically predicated to
Ingenia Ambition S in terms of safety and effectiveness. |
| Summary of Clinical
Data: | The proposed MR 5300 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 the legally marketed predicate device
Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR systems (K193215, 04/10/2020), among which MR
5300 is specifically predicated to Ingenia Ambition S 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 is substantially equivalent to the legally
marketed predicate device Achieva, Intera, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR systems (K193215,
04/10/2020), among which MR 5300 is specifically predicated to
Ingenia Ambition S, 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 MR 5300
meets the acceptance criteria and is adequate for its intended use. | |
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