(60 days)
No
The document describes enhancements to existing MR technology, including workflow improvements, new scan sequences, and reconstruction algorithms, but does not mention AI or ML.
No.
The "Intended Use / Indications for Use" section explicitly states that "This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device." It further clarifies that images, spectra, and measurements "provide information that may assist the diagnosis and therapy planning," but the device itself is for diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device." It also mentions that images, spectra, and measurements "provide information that may assist the diagnosis and therapy planning."
No
The device description explicitly mentions hardware components (70 cm magnet, computing platform and peripherals for MR Spectrometer) and describes changes to both hardware and software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this system is a Magnetic Resonance Medical Electrical System that produces images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities. This is an in vivo imaging technique, meaning it examines the body directly, not through samples taken from the body.
- Intended Use: The intended use is as a diagnostic device that provides information to assist diagnosis and therapy planning based on images, spectra, and measurements of physical parameters. This is consistent with an in vivo imaging device.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features are provided with a 70 cm magnet. The system and its control software are substantially equivalent to the currently marketed and primary predicate device Ingenia R4 (K110151, 03/22/2011), combined with the ScanWise Implant feature and other minor changes as in the currently marketed and reference device Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324, 03/22/2016).
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, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features also consolidate separately-cleared novel functionalities, and minor hardware and software changes since the clearance of the currently marketed and primary predicate device, Ingenia R4 (K110151, 03/22/2011).
Following minor hardware and software changes are covered in this submission:
- Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols.
- New computing platform and peripherals for MR Spectrometer (DDAS).
- Planning on cine images.
- SAR related parameters (SED). Pregnancy status related to Normal Mode.
- SED limit
- Parameter optimization for the reconstruction algorithms.
- Partial NSA algorithm in reconstruction.
- AutoVoice, using pre-recorded spoken instructions.
- VCG, optimized electrode placement and enhanced algorithm.
- ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise.
- Enhanced sequences:
a. LIPO
b. Black Blood Imaging
c. 4D TRAK XD
d. Zoom Diffusion Imaging
e. 3D Vane XD
f. 4D TRANCE
g. 3D NerveVIEW
h. Fast B1 Mapping and B1 Shading filter
i. AutoSpair.
j. TSE flow compensation enhancement
k. Optimized 3D TSE flip angle sweeps per anatomy
l. ENCASE: 3D encoding
m. CardiacQuant: triggered T1 mapping sequence
n. pCASL
o. DTI enhancements
p. QA Tool and fMRI stability
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or extremities (internal structure of)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical verification 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, Ingenia 1.5T S and Ingenia 3.0T 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, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features are substantially equivalent to the currently marketed and primary predicate device Ingenia R4 (K110151, 03/22/2011) in terms of safety and effectiveness.
The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol that resembles three overlapping human profiles or faces, creating a sense of community or interconnectedness.
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 Veenpluis 4-6 Best, 5684PC NL
Re: K163116
Trade/Device Name: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 3, 2016 Received: November 7, 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.
1
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
2
Indications for Use
510(k) Number (if known) K163116
Device Name Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | November 3, 2016 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6, 5684 PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Ruojuan Zhang | |
| Regulatory Affairs engineer | ||
| Phone: +31 631685825 | ||
| E-mail: ruojuan.zhang@philips.com | ||
| Secondary Contact | ||
| Person | Henrie Daniels | |
| Regulatory Affairs Engineer | ||
| Phone: +31 40 2762192 | ||
| E-mail: henrie.daniels@philips.com | ||
| Device Name: | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | |
| 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 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 | |
| Product Code: | 90LNH | |
| 90LNI | ||
| Device Class: | Class II | |
| 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: | 90LNH | |
| 90LNI | ||
| Device description: | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T | |
| R5.3 with ScanWise Implant and 3D ASL features are provided | ||
| with a 70 cm magnet. The system and its control software are | ||
| substantially equivalent to the currently marketed and primary | ||
| predicate device Ingenia R4 (K110151, 03/22/2011), combined with | ||
| the ScanWise Implant feature and other minor changes as in the | ||
| currently marketed and reference device Ingenia 1.5T and Ingenia | ||
| 1.5T S R5.2 (K153324, 03/22/2016). | ||
| 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, Ingenia 1.5T S and Ingenia 3.0T | ||
| R5.3 with ScanWise Implant and 3D ASL features also consolidate | ||
| separately-cleared novel functionalities, and minor hardware and | ||
| software changes since the clearance of the currently marketed and | ||
| primary predicate device, Ingenia R4 (K110151, 03/22/2011). | ||
| Following minor hardware and software changes are covered in this submission: | ||
| 1. Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols. | ||
| 2. New computing platform and peripherals for MR Spectrometer (DDAS). | ||
| 3. Planning on cine images. | ||
| 4. SAR related parameters (SED). Pregnancy status related to Normal Mode. | ||
| 5. SED limit | ||
| 6. Parameter optimization for the reconstruction algorithms. | ||
| 7. Partial NSA algorithm in reconstruction. | ||
| 8. AutoVoice, using pre-recorded spoken instructions. | ||
| 9. VCG, optimized electrode placement and enhanced algorithm. | ||
| 10. ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. | ||
| 11. Enhanced sequences: | ||
| a. LIPO | ||
| b. Black Blood Imaging | ||
| c. 4D TRAK XD | ||
| d. Zoom Diffusion Imaging | ||
| e. 3D Vane XD | ||
| f. 4D TRANCE | ||
| g. 3D NerveVIEW | ||
| h. Fast B1 Mapping and B1 Shading filter | ||
| i. AutoSpair. | ||
| j. TSE flow compensation enhancement | ||
| k. Optimized 3D TSE flip angle sweeps per anatomy | ||
| l. ENCASE: 3D encoding | ||
| m. CardiacQuant: triggered T1 mapping sequence | ||
| n. pCASL | ||
| o. DTI enhancements | ||
| p. QA Tool and fMRI stability | ||
| Indications for Use: | 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 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. | |
| Fundamental
Scientific Technology: | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
with ScanWise Implant and 3D ASL features are based on the
principle that certain atomic nuclei present in the human body will
emit a weak relaxation signal when placed in a strong magnetic
field and excited by a radio signal at the precession frequency.
The emitted relaxation signals are analyzed by the system and a
computed image reconstruction is displayed on a video screen.
The principal technological components (magnet, transmit body
coil, gradient coil, receive coils and patient support) of the proposed
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with
ScanWise Implant and 3D ASL features are identical to those used
in the currently marketed and primary predicate device Ingenia R4
(K110151, 03/22/2011).
ScanWise Implant uses existing safety mechanisms to protect the
patient against excessive RF exposures. This includes Whole Body
and Head SAR, local SAR and B1+rms controls and Gradient Slew
Rate. No modifications relative to the implementation of safety
mechanisms relative to the predicate device was required. | |
| | ScanWise Implant extends existing software safety provisions to
prevent peripheral nerve stimulation. In previous products, dB/dt
was 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 pCASL
functionality (K153324). 3D ASL allows the user to perform ASL
perfusion studies according to international recommendation which
includes 3D acquisition
Based on the information provided above, the proposed Ingenia
1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features do not raise different questions of safety and effectiveness compare to the currently marketed and primary predicate device Ingenia R4 (K110151, 03/22/20110. | |
| Summary of Non-
Clinical Performance
Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features comply with the following international 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, Ingenia
1.5T S and Ingenia 3.0T 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, Ingenia 1.5T S and Ingenia
3.0T R5.3 with ScanWise Implant and 3D ASL features are substantially equivalent to the currently marketed and primary predicate device Ingenia R4 (K110151, 03/22/2011) in terms of safety and effectiveness. | |
| Summary of Clinical
Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T 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, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features and the currently marketed and primary predicate 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 | |
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| The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 |
|---|
| with ScanWise Implant and 3D ASL features are substantially |
| equivalent to the currently marketed and primary predicate device |
| Ingenia R4 (K110151, 03/22/2011) 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, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise |
| Implant and 3D ASL features meet the acceptance criteria and is |
| adequate for its intended use. |