(214 days)
This system is a Magnetic Resonance Medical Electrical System indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent 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, and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. 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 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 are 60 cm bore 1.5 Tesla (1.5T) magnetic resonance diagnostic devices. The systems and control software are substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017). The system includes a new 1.5T magnet, new set of RF receive coils, new patient support, new in-house Gradient system and RF transmit system and adapted RF receive system which is substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Philips Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Magnetic Resonance Diagnostic Devices. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-driven device.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI performance, ground truth, sample sizes for test/training sets, experts, and MRMC studies, cannot be fully extracted as such studies are not described for this type of device submission.
Here's an attempt to answer based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The verification and validation test results... demonstrate that the proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4... Meets the acceptance criteria and is adequate for its Intended Use."
However, the specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, SNR thresholds, geometric distortion limits) are not detailed in this summary document. Instead, the acceptance criteria are implicitly linked to compliance with various international and FDA-recognized consensus standards for medical electrical equipment and MR devices.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with international and FDA-recognized consensus standards (e.g., IEC 60601-2-33, AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, IEC 62304, ISO14971, NEMA MS 1-2008, NEMA MS 2-2008 (R2014), NEMA MS 3-2008 (R2014), NEMA MS 4-2010, NEMA MS 5-2009, NEMA MS 6-2008 (R2014), NEMA MS 8-2008, NEMA MS 9-2008 (R2014), NEMA MS 12-2016, NEMA PS 3.1-PS 3.20 - [DICOM]) and device-specific guidance documents related to safety and essential performance of MR equipment, signal-to-noise ratio, geometric distortion, image uniformity, acoustic noise, slice thickness, SAR, phased array coils, and the content of premarket submissions for software, cybersecurity, and human factors. | "The verification and validation test results, combined with sample clinical images demonstrate that the proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4: Complies with the aforementioned international and FDA recognized consensus standards and device-specific guidance document... Meets the acceptance criteria and is adequate for its Intended Use." The device is intended to produce diagnostic quality images. |
| Ability to generate diagnostic quality images (implicitly, demonstrated via sample clinical images). | Clinical sample images were provided to support the ability of proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 to generate diagnostic quality images. |
2. Sample size used for the test set and the data provenance
The document states: "The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
"Clinical sample images were provided to support the ability of proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 to generate diagnostic quality images."
- Test Set Sample Size: Not specified. This submission relies on "sample clinical images" rather than a formal test set with a specified sample size.
- Data Provenance: Not specified. It only mentions "sample clinical images" without details on their origin (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as a formal "test set" with expert-established ground truth as typically understood for AI performance evaluation is not described. The document indicates that images, spectra, and measurements are to be "interpreted by a trained physician" for diagnosis and therapy planning, but this refers to the intended use of the device, not a specific ground truth establishment for a performance study within this 510(k) submission.
4. Adjudication method for the test set
- Not applicable, as a formal test set and expert review process for ground truth establishment are not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a submission for a Magnetic Resonance Diagnostic Device (hardware and software system), not an AI-assisted diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or referenced. The document states its indications for use involve images "when interpreted by a trained physician," implying human interpretation of the device's output, not AI assistance for that interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is an MR system, not an algorithm being evaluated in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as a formal establishment of ground truth for a performance study is not described. The submission focuses on demonstrating that the MR system meets performance standards related to image quality and safety, and its output is intended for interpretation by trained physicians.
8. The sample size for the training set
- Not applicable. This is a 510(k) for an MR system, not an AI/ML algorithm that requires a training set. The "verification/validation testing" relies on compliance with established engineering and medical device standards.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML algorithm requiring a training set, no ground truth needed to be established in this context.
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June 15, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Philips Healthcare (Suzhou) Co., Ltd. % Jacky Shi Senior Regulatory Engineer No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K173507
Trade/Device Name: Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, and MOS Dated: May 30, 2018 Received: June 6, 2018
Dear Jacky Shi:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173507
Device Name
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical System indicated for use as a diagnostic device.
The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent 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. The image acquisition process can be synchronized 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 the 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.
The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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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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: | November 8, 2017 | |||
|---|---|---|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |||
| No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024 | ||||
| Establishment Registration Number: 3009529630 | ||||
| Primary ContactPerson: | Jacky ShiSenior Regulatory EngineerPhone: +86 512-67336881E-mail: Jacky.Shi@philips.com | |||
| Secondary ContactPerson | Gordon ShuSenior Regulatory ManagerPhone: +86-512-67336804E-mail: Gordon.Shu@philips.com | |||
| Device Name:Classification: | Classification name: | Magnetic resonance diagnostic device (MRDD) | ||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification Panel: | Radiology | |||
| Device Class: | Class II | |||
| Primary Product Code: | 90LNH90LNI90MOS | |||
| Primary PredicateDevice: System | Trade name: | Ingenia 1.5T CX R5.3 | ||
| Manufacturer: | Philips Medical SystemsNederland B.V. | |||
| 510(k) Clearance: | K162931 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Magnetic resonance diagnostic device (MRDD) | |||
| Classification Panel: | Radiology | |||
| Device class | Class II | |||
| Product Code: | 90LNH90LNI | |||
| Reference PredicateDevice: Coils | Trade name: | dS Anterior, dS Base, dSHead-neck, dS Head, Flex(S, M L) | ||
| Manufacturer: | PHILIPS MEDICALSYSTEMS3545 s w 47th avenueGainesville, FL 32608 -1099 | |||
| 510(k) Clearance: | K123492 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Coil, Magnetic Resonance,Specialty |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Device class | Class II |
|---|---|
| Product Code: | 90MOS |
| Device Description: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 are 60 cm bore 1.5 Tesla (1.5T) magnetic resonance diagnostic devices. The systems and control software are substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017).The system includes a new 1.5T magnet, new set of RF receive coils, new patient support, new in-house Gradient system and RF transmit system and adapted RF receive system which is substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3. |
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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Indications for Use: | This system is a Magnetic Resonance Medical ElectricalSystem indicated for use as a diagnostic device. |
|---|---|
| The system can produce cross-sectional images,spectroscopic images and/or spectra in any orientation ofthe internal structure of the head, body or extremities. | |
| Magnetic Resonance images represent the spatialdistribution of protons or other nuclei with spin. Imageappearance is determined by many different physicalproperties of the tissue and the anatomy, and the MR scantechnique applied. The image acquisition process can besynchronized with the patient's breathing or cardiac cycle.The systems can use combinations of images to producephysical parameters, and related derived images. | |
| Images, spectra, and measurements of physicalparameters, when interpreted by a trained physician,provide information that may assist the diagnosis andtherapy planning. The accuracy of determined physicalparameters depends on system and scan parameters, andmust be controlled and validated by the clinical user. | |
| The use of contrast agents for diagnostic imagingapplications should be performed consistent with theapproved labeling for the contrast agent. | |
| In addition the Philips MR systems provide imagingcapabilities, such as MR fluoroscopy, to guide and evaluateinterventional and minimally invasive procedures in thehead, body and extremities. MR Interventional procedures,performed inside or adjacent to the Philips MR system, mustbe performed with MR Conditional or MR Safeinstrumentation as selected and evaluated by the clinical | |
| user for use with the specific MR system configuration in thehospital. The appropriateness and use of information from aPhilips MR system for a specific interventional procedureand specific MR system configuration must be validated bythe clinical user. |
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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Fundamental | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
|---|---|
| Scientific | are based on the principle that certain atomic nuclei present |
| Technology: | in the human body will emit a weak relaxation signal whenplaced in a strong magnetic field and excited by a radiosignal at the precession frequency. The emitted relaxationsignals are analyzed by the system and a computed imagereconstruction is displayed on a video screen. |
| The principal technological components (magnet, transmitbody coil, gradient coil, receive coils and patient support) ofthe proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4substantially equivalent to the currently marketed predicatedevice Ingenia 1.5T CX R5.3 (K162931, 01/06/2017). | |
| Based on the information provided above, the proposedProdiva 1.5T CX and Prodiva 1.5T CS R5.4 does not raisedifferent questions of safety and effectiveness compare tothe currently marketed predicate device Ingenia 1.5T CXR5.3 (K162931, 01/06/2017). |
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| Summary of Non-Clinical Performance Data: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 comply with the following international and FDA-recognized consensus standards: |
|---|---|
| IEC 60601-2-33 Edition 3.1: 2013Medical Electrical Equipment - Part 2-33: ParticularRequirements For The BasicSafety And Essential Performance Of MagneticResonance Equipment For Medical Diagnosis.FDA/CDRH recognition number 12-271 AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R) 2012 and A2:2010/(R) 2012 (ConsolidatedText) Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD).FDA/CDRH recognition number 19-4 IEC 60601-1-2 Edition 3: 2007-03Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticCompatibility -Requirements And TestsFDA/CDRH recognition number 19-1 IEC 60601-1-6 Edition 3.1: 2013-10Medical Electrical Equipment -- Part 1-6: GeneralRequirements For Basic Safety And EssentialPerformance -- Collateral Standard: UsabilityFDA/CDRH recognition number 5-89 IEC 62366 Edition 1.1: 2014-01Medical devices - Application of usability engineering tomedical devicesFDA/CDRH recognition number 5-87 IEC 62304 Edition 1.1: 2015Medical device software - Software life cycle processes.FDA recognition number 13-79 ISO14971 Edition 2: 2007-03-01Medical devices - Application of risk management tomedical devices.FDA/CDRH recognition number 5-40 NEMA MS 1-2008Determination of Signal-To-Noise Ratio (SNR) inDiagnostic Magnetic Resonance ImagingFDA/CDRH recognition number 12-188 NEMA MS 2-2008 (R2014)Determination of Two-Dimensional Geometric Distortion inDiagnostic Magnetic Resonance ImagesFDA/CDRH recognition number 12-196 | |
| ● | NEMA MS 3-2008 (R2014)Determination of Image Uniformity in Diagnostic MagneticResonance ImagesFDA/CDRH recognition number 12-187 |
| ● | NEMA MS 4-2010Acoustic Noise Measurement Procedure for DiagnosingMagnetic Resonance Imaging Devices.FDA/CDRH recognition number 12-232 |
| ● | NEMA MS 5-2009Determination of Slice Thickness in Diagnostic MagneticResonance ImagingFDA/CDRH recognition number 12-231 |
| ● | NEMA MS 6-2008 (R2014)Determination of Signal-to-Noise Ratio and ImageUniformity for Single-Channel, Non-Volume Coils inDiagnostic Magnetic Resonance Imaging (MRI)FDA/CDRH recognition number 12-195 |
| ● | NEMA MS 8-2008Characterization of the Specific Absorption Rate forMagnetic Resonance Imaging SystemsFDA/CDRH recognition number 12-192 |
| ● | NEMA MS 9-2008 (R2014)Characterization of Phased Array Coils for DiagnosticMagnetic Resonance Images (MRI)FDA/CDRH recognition number 12-288 |
| ● | NEMA MS 12-2016Quantification and Mapping of Geometric Distortion forSpecial ApplicationsFDA/CDRH recognition number 12-306 |
| ● | NEMA PS 3.1-PS 3.20 - [DICOM] Digital Imaging andCommunications in Medicine, Parts 1 - 20FDA recognition number 12-300 |
| ● | Device specific guidance document, entitled Guidance forthe Submission of Premarket Notifications for MagneticResonance Diagnostic Devices (issued November 18,2016) |
| ● | Guidance for Industry and FDA Staff - Guidance for theContent of Premarket Submissions for SoftwareContained in Medical Devices (issued May 11, 2005) |
| ● | Guidance for Industry and FDA Staff - Content ofPremarket Submissions for Management of Cybersecurityin Medical Devices (issued October 2, 2014) |
| Guidance for Industry and FDA Staff— Applying HumanFactors and Usability Engineering to Optimize MedicalDevice Design (issued Feb. 03, 2016) Guidance for Industry and FDA Staff - Use ofInternational Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" (issued June16, 2016) Guidance for Industry and FDA Staff - Information toSupport a Claim of Electromagnetic Compatibility (EMC)of Electrically-Powered Medical Devices (issued July 11,2016) | |
| Non-Clinical verification and validation tests have beenperformed with regards to the intended use, the technicalclaims, the requirement specifications and the riskmanagement results. | |
| The verification and validation test results, combined withsample clinical images demonstrate that the proposedProdiva 1.5T CX and Prodiva 1.5T CS R5.4: | |
| Complies with the aforementioned international andFDA recognized consensus standards and devicespecific guidance document, entitled "Guidance forthe Submission Of Premarket Notifications forMagnetic Resonance Diagnostic Devices -November 18, 2016" Meets the acceptance criteria and is adequate for itsIntended Use. | |
| Therefore, the proposed Prodiva 1.5T CX and Prodiva1.5T CS R5.4 are substantially equivalent to the currentlymarketed predicate device Ingenia 1.5T CX R5.3 (K162931,01/06/2017) in terms of safety and effectiveness. | |
| Summary of Clinical | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
| Data: | did not require clinical study since substantial equivalenceto the legally marketed predicate device was proven with |
| the verification/validation testing. | |
| Clinical sample images were provided to support the abilityof proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 togenerate diagnostic quality images. | |
| SubstantialEquivalenceConclusion: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4and the currently marketed predicate device Ingenia 1.5TCX R5.3 (K162931, 01/06/2017) have the same indicationsfor use with respect to the following: |
| Providing cross-sectional images based on themagnetic resonance phenomenon Interpretation of the images is the responsibility oftrained physicians Images can be used for interventional and treatmentplanning purposes | |
| The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4are substantially equivalent to the currently marketedpredicate device Ingenia 1.5T CX R5.3 (K162931,01/06/2017) in terms of design features, fundamentalscientific technology, indications for use, and safety &effectiveness. Additionally, substantial equivalence wasdemonstrated with non-clinical performance (verification andvalidation) tests, which complied with the requirementsspecified in the international and FDA-recognizedconsensus standards and device-specific guidance. | |
| The results of these tests demonstrate that the proposedProdiva 1.5T CX and Prodiva 1.5T CS R5.4 meet theacceptance 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.