(79 days)
This system is a Magnetic Resonance Medical Electrical Systems 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.
The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features are provided with a 60 cm magnet. The system and its control software are substantially equivalent to the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007), enhanced by the digital receive coil architecture as in the currently marketed and reference device Ingenia R4 (K110151, 03/22/2011).
ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants. The feature consists of an extension to the Patient Registration User Interface where the information relevant to MR Conditional device labeling can be assessed, controlled and reviewed. The ScanWise Implant feature allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system.
3D ASL functionality enables MR technologists to assess perfusion in the brain without the usage of contrast agents. The feature consists of an extension to the available scan sequences and image reconstruction algorithms. The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features also consolidate separatelycleared novel functionalities, and minor changes since the clearance of the currently marketed and predicate device, Achieva R2.5 (K063559, 01/04/2007). Following minor changes are covered in this submission: Enhanced Patient Communication User Interface Module, 1. IEC/ISO compliant symbols. 2. New computing platform and peripherals for MR Spectrometer (DDAS). 3. MultiTransmit 4. dStream architecture implementation and commercialize system name as Ingenia CX 5. Planning on cine images. 6. SAR related parameters (SED). Pregnancy status related to Normal Mode. 7. SED limit 8. Parameter optimization for the reconstruction algorithms. 9. Partial NSA algorithm in reconstruction. 10. AutoVoice, using pre-recorded spoken instructions. 11. VCG, optimized electrode placement and enhanced algorithm. 12. ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. 13. Enhanced sequences: a. LIPO b. Black Blood Imaging c. 4D TRAK XD d. Zoom Diffusion Imaging e. 3D Vane XD 4D TRANCE f. g. 3D NerveVIEW h. Fast B1 Mapping and B1 Shading filter i. AutoSpair. TSE flow compensation enhancement 1. k. Optimized 3D TSE flip angle sweeps per anatomy ENCASE: 3D encoding 1. m. CardiacQuant: triggered T1 mapping sequence n. pCASL o. DTI enhancements QA Tool and fMRI stability p.
The provided text describes the Philips Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MR systems and their features, including "ScanWise Implant" and "3D ASL". However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and a specific study proving those criteria were met.
Specifically, the document states: "The verification and or validation test results, combined with sample clinical images demonstrate that the proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features: Complies 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 14, 1998” Meets the acceptance criteria and is adequate for its intended use."
This indicates that acceptance criteria exist and were met, but the document does not explicitly list the quantitative acceptance criteria themselves, nor does it describe a detailed study that would allow for a precise breakdown of the device's performance against these criteria.
Therefore, much of the requested information cannot be extracted from this document.
Here's what can be answered based on the provided text, and what remains unknown:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated broadly) | Reported Device Performance |
|---|---|
| Compliance with international and FDA-recognized consensus standards: IEC60601-1 Ed 3 Amd 1, IEC60601-1-2 Ed 3, IEC60601-1-6 Ed 3 / IEC62366, IEC60601-1-8 Ed 2, IEC60601-2-33 Ed 3 Amd 1, IEC 62304, NEMA MS-1 2008, NEMA MS-4 2008, NEMA MS-8 2008, NEMA PS 3.1-PS 3.20 - [DICOM], ISO 14971 (2007). | The device "complies with the aforementioned international and FDA-recognized consensus standards." |
| Compliance with Device specific guidance document: “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998”. | The device "complied with...Device specific guidance document." |
| Adequacy for intended use (producing cross-sectional images, spectroscopic images/spectra; assisting diagnosis and therapy planning; guiding interventional procedures). | The device "meets the acceptance criteria and is adequate for its intended use." The "ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants" and "allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system." The "3D ASL functionality enables MR technologists to assess perfusion in the brain without the usage of contrast agents." Non-clinical verification/validation tests and sample clinical images demonstrate performance. |
| Human Factors Engineering in line with FDA guidance document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design - June 22, 2011" (specifically for ScanWise Implant). | "Human Factors Engineering testing was performed in line with FDA's guidance document." |
| Safety mechanisms for excessive RF exposures, including Whole Body and Head SAR, local SAR, B1+rms controls, and Gradient Slew Rate (ScanWise Implant uses existing safety mechanisms). | "No modifications relative to the implementation of safety mechanisms relative to the predicate device was required." |
| Prevention of peripheral nerve stimulation; dB/dt controlled not to exceed user-specified value (ScanWise Implant extends existing software safety provisions). | "dB/dt is controlled not to exceed a user-specified value." (Previously, it was evaluated and displayed for informational purposes). |
| 3D ASL functionality for perfusion studies using 3D acquisition according to international recommendation (as an extension to previously cleared pCASL). | "3D ASL allows the user to perform ASL perfusion studies according to international recommendation which includes 3D acquisition." (This is an extension to the previously cleared pCASL functionality (K153324)). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Unknown. The document states that "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," and mention "sample clinical images" were used. However, it does not specify the sample size of any test set (e.g., number of patients, number of images), nor its provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Unknown. The document mentions the "interpretation by a trained physician" for general use but does not detail how ground truth was established for any specific test set, nor the number or qualifications of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Unknown. The document does not describe any adjudication method.
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 MRMC comparative effectiveness study was done. The document explicitly states: "The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness."
- Furthermore, the document describes the system as a diagnostic device that produces images for physicians to interpret, and features like ScanWise Implant and 3D ASL are described as enabling specific functionalities or workflows. It does not suggest these features involve AI assistance for human readers in the sense of a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While "Non-Clinical verification and or validation tests" were performed, and software/algorithms are integral to the system's function (e.g., image reconstruction algorithms, ASL processing), the document does not describe a standalone algorithm performance study separate from the overall system performance verification. The device is an MRI system, and its performance would be evaluated as a complete system, not just individual algorithms in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Unknown. The document vaguely mentions "sample clinical images" in the context of verification/validation, but does not specify the method for establishing ground truth for these images.
8. The sample size for the training set
- Not applicable / Unknown related to specific AI training. The document describes a medical device (MRI system) with advanced features (ScanWise Implant, 3D ASL) and various software enhancements. It does not explicitly state that these features were developed using machine learning or AI that required a distinct "training set" in the modern sense of AI/ML development. The document predates the widespread regulatory focus on AI/ML training data. It refers to "image reconstruction algorithms" but does not detail their development process.
9. How the ground truth for the training set was established
- Not applicable. As above, the document does not mention a "training set" in the context of modern AI/ML.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a wing-like shape extending from the top profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Philips Medical Systems Nederland B.v. Ruojuan Zhang Regulatory Affairs Engineer Veenpluis 4-6 Best, 5684 PC NL
Re: K162931
Trade/Device Name: Ingenia 1.5T Cx and Ingenia 3.0T Cx R5.3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: October 17, 2016 Received: October 19, 2016
Dear Ruojuan Zhang:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D'Hara
For
Robert A. 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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Indications for Use
510(k) Number (if known) K162931
Device Name Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical Systems 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)
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out. The image is a clear and simple representation of the Philips logo.
510(k) Summary
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: | October 17, 2016 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 | |
| Primary ContactPerson: | Ruojuan ZhangRegulatory Affairs engineerPhone: +31 631685825E-mail: ruojuan.zhang@philips.com | |
| Secondary ContactPerson | Henrie DanielsRegulatory Affairs EngineerPhone: +31 40 2762192E-mail: henrie.daniels@philips.com | |
| Device Name: | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | |
| Classification: | Classification Name: | Magnetic Resonance DiagnosticDevice (MRDD) |
| Classification Regulation: | 21CFR §892.1000 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product code: | 90LNH90LNI | |
| Primary PredicateDevice: | Trade Name: | ACHIEVA, INTERA ANDPANORAMA 1.0T, RELEASE 2.5 |
| Manufacturer: | Philips Medical Systems NederlandB.V. | |
| 510(k) Clearance: | K063559 (01/04/2007) | |
| Classification Regulation: | 21 CFR, Part 892.1000 | |
| Classification Name: | Magnetic Resonance DiagnosticDevice (MRDD) | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | 90LNH90LNI | |
| Reference Device: | Trade Name: | Ingenia 1.5T and Ingenia 1.5T S R5.2 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K153324 (03/22/2016) | |
| Classification Regulation: | 21 CFR, Part 892.1000 | |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | 90LNH90LNI | |
| Reference Device: | Trade Name: | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T( aka Ingenia) |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K110151 (03/22/2011) | |
| Classification Regulation: | 21 CFR, Part 892.1000 | |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | 90LNH90LNI | |
| Device description: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 withScanWise Implant and 3D ASL features are provided with a 60 cmmagnet. The system and its control software are substantiallyequivalent to the currently marketed and primary predicate deviceAchieva R2.5 (K063559, 01/04/2007), enhanced by the digitalreceive coil architecture as in the currently marketed and referencedevice Ingenia R4 (K110151, 03/22/2011).ScanWise Implant functionality enables MR technologists toimplement an improved and controlled workflow for MRConditional implants. The feature consists of an extension to thePatient Registration User Interface where the information relevantto MR Conditional device labeling can be assessed, controlled andreviewed. The ScanWise Implant feature allows the user at theexamination level to define restrictions on the 'active fields'generated by the MR system.3D ASL functionality enables MR technologists to assess perfusionin the brain without the usage of contrast agents. The feature |
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consists of an extension to the available scan sequences and image reconstruction algorithms. The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features also consolidate separatelycleared novel functionalities, and minor changes since the clearance of the currently marketed and predicate device, Achieva R2.5 (K063559, 01/04/2007). Following minor changes are covered in this submission: Enhanced Patient Communication User Interface Module, 1. IEC/ISO compliant symbols. 2. New computing platform and peripherals for MR Spectrometer (DDAS). 3. MultiTransmit 4. dStream architecture implementation and commercialize system name as Ingenia CX 5. Planning on cine images. 6. SAR related parameters (SED). Pregnancy status related to Normal Mode. 7. SED limit 8. Parameter optimization for the reconstruction algorithms. 9. Partial NSA algorithm in reconstruction. 10. AutoVoice, using pre-recorded spoken instructions. 11. VCG, optimized electrode placement and enhanced algorithm. 12. ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. 13. Enhanced sequences: a. LIPO b. Black Blood Imaging c. 4D TRAK XD d. Zoom Diffusion Imaging e. 3D Vane XD 4D TRANCE f. g. 3D NerveVIEW h. Fast B1 Mapping and B1 Shading filter i. AutoSpair. TSE flow compensation enhancement 1. k. Optimized 3D TSE flip angle sweeps per anatomy ENCASE: 3D encoding 1. m. CardiacQuant: triggered T1 mapping sequence n. pCASL o. DTI enhancements QA Tool and fMRI stability p.
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PHILIPS
| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systemsindicated for use as a diagnostic device.The system can produce cross-sectional images, spectroscopicimages and/or spectra in any orientation of the internal structure ofthe head, body or extremities.Magnetic Resonance images represent the spatial distribution ofprotons or other nuclei with spin. Image appearance is determinedby many different physical properties of the tissue and the anatomy,and the MR scan technique applied. The image acquisition processcan be synchronized with the patient's breathing or cardiac cycle.The systems can use combinations of images to produce physicalparameters, and related derived images.Images, spectra, and measurements of physical parameters, wheninterpreted by a trained physician, provide information that mayassist the diagnosis and therapy planning. The accuracy ofdetermined physical parameters depends on system and scanparameters, and must be controlled and validated by the clinicaluser. The use of contrast agents for diagnostic imaging applicationsshould be performed consistent with the approved labeling for thecontrast agent.In addition the Philips MR systems provide imaging capabilities,such as MR fluoroscopy, to guide and evaluate interventional andminimally invasive procedures in the head, body and extremities.MR Interventional procedures, performed inside or adjacent to thePhilips MR system, must be performed with MR Conditional or MRSafe instrumentation as selected and evaluated by the clinical userfor use with the specific MR system configuration in the hospital.The appropriateness and use of information from a Philips MRsystem for a specific interventional procedure and specific MRsystem configuration must be validated by the clinical user. |
|---|---|
| FundamentalScientific Technology: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 withScanWise Implant and 3D ASL features are based on the principlethat certain atomic nuclei present in the human body will emit aweak relaxation signal when placed in a strong magnetic field andexcited by a radio signal at the precession frequency.The emitted relaxation signals are analyzed by the system and acomputed image reconstruction is displayed on a video screen.The principal technological components (magnet, transmit bodycoil, gradient coil, receive coils and patient support) of the proposedIngenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWiseImplant and 3D ASL features are identical to those used in the |
| currently marketed and primary predicate device Achieva R2.5(K063559, 01/04/2007) and reference device Ingenia R4(K110151,03/22/2011) | |
| ScanWise Implant uses existing safety mechanisms to protect thepatient against excessive RF exposures. This includes Whole Bodyand Head SAR, local SAR and B1+rms controls and Gradient SlewRate. No modifications relative to the implementation of safetymechanisms relative to the predicate device was required.ScanWise Implant extends existing software safety provisions toprevent peripheral nerve stimulation. In previous products, dB/dtwas evaluated (at the compliance volume defined in IEC60601-2-33) and displayed for informational purposes. In this software,dB/dt is controlled not to exceed a user-specified value. | |
| 3D ASL is an extension to the previously cleared pCASLfunctionality (K153324). 3D ASL allows the user to perform ASLperfusion studies according to international recommendation whichincludes 3D acquisition | |
| Based on the information provided above, the proposed Ingenia1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and3D ASL features are considered substantially equivalent to thecurrently marketed and primary predicate device AchievaR2.5(K063559, 01/04/2007) in terms of fundamental scientifictechnology. | |
| Summary of Non-Clinical PerformanceData: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 withScanWise Implant and 3D ASL features comply with the followinginternational and FDA-recognized consensus standards:• IEC60601-1 Edition 3 Amendment 1• IEC60601-1-2 Edition 3• IEC60601-1-6 Edition 3 / IEC62366• IEC60601-1-8 Edition 2• IEC60601-2-33 Edition 3 Amendment 1• IEC 62304• NEMA MS-1 2008• NEMA MS-4 2008• NEMA MS-8 2008• NEMA PS 3.1-PS 3.20 - [DICOM]• ISO 14971 Application of risk management to medical |
| • devices (2007) | |
| Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998”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.Specifically for ScanWise Implant, Human Factors Engineering testing was performed in line with FDA's guidance document entitled "Applying Human Factors and Usability Engineering to Optimize Medical Device Design - June 22, 2011".The verification and or validation test results, combined with sample clinical images demonstrate that the proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features: Complies 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 14, 1998” Meets the acceptance criteria and is adequate for its intended use. Therefore, the proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features are substantially equivalent to the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007) in terms of safety and effectiveness. | |
| Summary of Clinical Data: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness. |
| Substantial Equivalence Conclusion: | The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features and the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007) enhanced by the digital receive coil architecture from the currently |
| marketed and reference device Ingenia R4 (K110151, 03/22/2011), 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 | |
| The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features are substantially equivalent to the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was 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 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features meet 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.