(87 days)
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.
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.
Based on the provided text, the device in question is the Philips MR 5300, a Magnetic Resonance Diagnostic Device. This submission is an abbreviated 510(k) and focuses on modifications to a legally marketed predicate device (Ingenia Ambition S).
It is crucial to understand that this document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm. Instead, it is a 510(k) summary for a hardware magnetic resonance imaging (MRI) system (MR 5300) and its software release R5.8, along with a "Breeze Workflow Solution" that includes interface and patient comfort improvements.
The document explicitly states that the proposed MR 5300 is demonstrated to be substantially equivalent to its predicate device through non-clinical performance (verification and validation) tests that comply with international and FDA-recognized consensus standards. Crucially, it states: "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."
Therefore, I cannot provide the information requested about acceptance criteria and a study proving the device meets an AI/algorithm-specific acceptance criteria, as this information is not present in the provided text. The device described is a medical imaging system, not an AI or algorithm that generates a diagnostic output requiring a performance study in the way requested for AI.
However, I can extract information related to the general acceptance of the device's safety and effectiveness based on the non-clinical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided text for a hardware MRI system):
Since this is a hardware device clearance based on substantial equivalence and compliance with standards, the "acceptance criteria" are compliance with various technical and safety standards, and the "performance" is that it meets these standards and is comparable to the predicate.
| Acceptance Criterion (Inferred) | Reported Device Performance (from text) |
|---|---|
| Compliance with International and FDA-recognized Consensus Standards | "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." |
| Compliance with Device-Specific Guidance Documents | "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)" |
| Safety and Effectiveness Equivalence to Predicate | "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... 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... in terms of safety and effectiveness." |
| Functional Equivalence to Predicate | The document states the MR 5300 allows connection of previously cleared pulse sequences and coils, implying functional equivalence regarding image acquisition capabilities. "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." |
2. Sample size used for the test set and data provenance:
Not applicable as this is not an AI/algorithm performance study. The "tests" are non-clinical verification and validation of the hardware against engineering requirements and safety standards. No patient data "test set" in the context of an AI algorithm is mentioned or implied.
3. Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable. No ground truth for an AI/algorithm test set was established. The "ground truth" for a hardware device is compliance with its engineering specifications and safety standards.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
"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." Therefore, no MRMC study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware MRI system.
7. The type of ground truth used:
For a hardware device, the ground truth is its compliance with validated engineering specifications, safety standards (e.g., electrical, mechanical, RF safety, EMC), and functional performance parameters (e.g., field homogeneity, gradient linearity, signal-to-noise ratio, image quality metrics) established through non-clinical testing. This is not derived from clinical outcomes or expert consensus in the typical sense for AI, but from objective physical measurements and adherence to regulations.
8. The sample size for the training set:
Not applicable. This is a hardware MRI system, not a machine learning model that requires a training set in this context.
9. How the ground truth for the training set was established:
Not applicable.
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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
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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 NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary ContactPerson | AN CeRegulatory Affairs SpecialistTelephone: +31 638161043E-mail: ce.an@philips.com |
| Device Name: | MR 5300 |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI |
| Primary PredicateDevice: | Trade name: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR SystemsManufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K193215Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class Class IIProduct Code: 90LNH90L 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/FundamentalScientificTechnology: | The proposed MR 5300 is based on the principle that certain atomicnuclei present in the human body will emit a weak relaxation signalwhen placed in a strong magnetic field and excited by a radio signal atthe precession frequency. The emitted relaxation signals are analyzedby the system and a computed image reconstruction is displayed on avideo screen.The principal technological components (magnet, transmit body coil,gradient coil, gradient amplifier, RF amplifier and patient support) of theproposed MR 5300 is identical to those used in the legally marketedpredicate device Achieva, Intera, Ingenia, Ingenia CX, IngeniaElition and Ingenia Ambition MR systems (K193215, 04/10/2020),among which MR 5300 is specifically predicated to Ingenia AmbitionS. |
|---|---|
| Summary of Non-ClinicalPerformance Data: | The proposed MR 5300 complies with the following international andFDA-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 theSubmission Of Premarket Notifications for MagneticResonance Diagnostic Devices" (issued November 18, 2016 –document number 340) Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Contained inMedical Devices (issued May 11, 2005 - document number337) Guidance for Industry and FDA Staff – Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices (issued October 2, 2014 – document number 1825) Guidance for Industry and FDA Staff – Applying Human Factorsand Usability Engineering to Medical Devices (issued February3, 2016 - document number 1757) Guidance for Industry and FDA Staff – Use of InternationalStandard ISO 10993-1, “Biological evaluation of medicaldevices – Part 1: Evaluation and testing within a riskmanagement process" (issued June 16, 2016 – documentnumber 1811) Guidance for Industry and FDA Staff – Information to Supporta Claim of Electromagnetic Compatibility (EMC) of Electrically- |
| Powered Medical Devices (issued July 11, 2016 – documentnumber 1400057)Guidance for Industry and FDA Staff – Design Considerationsand Premarket Submission Recommendations forInteroperable Medical Devices (issued September 6, 2017 –document number 1500015)Non-Clinical verification and or validation tests have been performedwith regards to the intended use, the technical claims, the requirementspecifications and the risk management results.The verification and/or validation test results demonstrate that theproposed MR 5300: | |
| Comply with the aforementioned international and FDArecognized consensus standards and Device specific guidancedocument, entitled "Guidance for the Submission Of PremarketNotifications for Magnetic Resonance Diagnostic Devices –November 18, 2016" Meet the acceptance criteria and is adequate for its intendeduse. | |
| Therefore, the proposed MR 5300 is substantially equivalent to thelegally marketed predicate device Achieva, Intera, Ingenia, IngeniaCX, Ingenia Elition and Ingenia Ambition MR systems (K193215,04/10/2020), among which MR 5300 is specifically predicated toIngenia Ambition S in terms of safety and effectiveness. | |
| Summary of ClinicalData: | The proposed MR 5300 did not require a clinical study since substantialequivalence to the legally marketed predicate device was proven withthe verification/validation testing. |
| SubstantialEquivalence: | The proposed MR 5300 and the legally marketed predicate deviceAchieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and IngeniaAmbition MR systems (K193215, 04/10/2020), among which MR5300 is specifically predicated to Ingenia Ambition S have the sameindications for use with respect to the following: Providing cross-sectional images based on the magneticresonance phenomenon Interpretation of the images is the responsibility of trainedphysicians Images can be used for interventional and treatment planningpurposes |
| Conclusion: | The proposed MR 5300 is substantially equivalent to the legallymarketed 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 toIngenia Ambition S, in terms of design features, fundamentalscientific technology, indications for use, and safety and effectiveness. |
| Additionally, substantial equivalence is demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognizedconsensus standards and device-specific guidance. | |
| The results of these tests demonstrate that the proposed MR 5300meets the acceptance criteria and is adequate for its intended use. |
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§ 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.