(174 days)
No
The summary describes image processing techniques like registration, segmentation, and subtraction, but does not mention AI or ML.
No.
The device is a post-processing application intended for viewing, evaluating, manipulating, and comparing neurological images from an MR device to aid in diagnosis and follow-up, but it explicitly states the physician retains ultimate responsibility for diagnosis and treatment decisions and does not directly provide therapy.
No
The device is described as a "post-processing application" that "enables visualization of information," "provides analysis tools to help the user assess, and document changes," and "provides a supportive tool for visualization." It explicitly states, "The physician retains the ultimate responsibility for making the final diagnosis and treatment decision," indicating that the device assists in the diagnostic process rather than performing the diagnosis itself.
Yes
The device is described as a "post processing software application" and its features are entirely software-based functionalities for viewing, manipulating, and analyzing existing MR image data. There is no mention of any accompanying hardware component that is part of the device itself.
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 Longitudinal Brain Imaging (LoBI) application processes and analyzes medical images (MR scans) of the brain. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for "viewing and evaluating neurological images provided by a magnetic resonance diagnostic device." This is image analysis, not in vitro testing.
The device is a post-processing software application for medical imaging, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device.
The LoBI application is intended for viewing, manipulation and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions.
The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.
Product codes
LLZ
Device Description
Philips Medical Systems' Longitudinal Brain Imaging application (LoBI) is a post processing software application intended to assist in the evaluation of serial brain imaging based on MR data.
The LoBI application allows the user to view images, perform segmentation of lesions, along with segmentation editing tool and volumetric quantification of segmented volumes and quantitative comparison between time points. LoBI application provides automatic registration between studies from different time points. for longitudinal comparison.
The LoBI application provides a supportive tool for visualization of subtle differences in the brain of the same individual across time, which can be used by clinicians as the assessment of disease progression.
The physician retains the ultimate responsibility for making the final diagnosis based on image visualization as well as any segmentation and measurement results obtained from the application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance diagnostic device.
MRI
Anatomical Site
neurological images
brain
MR neurological images.
Indicated Patient Age Range
The LoBI application is intended to be used for adult population only
Intended User / Care Setting
Radiologists and Technologists
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
Validation- the validation proves that the LoBI application meets the customer needs and its performance fulfills its intended functionality. The validation activities include real recorded clinical data cases in order to simulate the actual use of the application.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes
- IEC 62366-1 Medical devices Part 1:Application of usability engineering to medical devices
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- DICOM PS 3.1-3.18 standard Digital Imaging and Communications in Medicine (DICOM) Standard
The following verification and validation testing were conducted with the Longitudinal Brain Imaging (LoBI) application:
- Verification- the verification activities proves that the LoBI application includes the CoBI feature, function correctly and meets its specification. The verification testing includes the following testing:
- Full functionality test- a comprehensive list of test cases which covers a specific function/feature in the application. This test covers all of the detailed requirements according to the PRS (Product Requirement Specification).
- A RMF testing- testing which covers of the test that are specifically designed to check in the risk management file
- Validation- the validation proves that the LoBI application meets the customer needs and its performance fulfills its intended functionality. The validation activities include real recorded clinical data cases in order to simulate the actual use of the application.
The test results in this 510(k) premarket notification demonstrate that Longitudinal Brain Imaging (LoBI):
- Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use and specifications.
The subject of this premarket submission. Longitudinal Brain Imaging (LoBI) application did not require clinical studies to support equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K160315, K150665, K023785, K111336
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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May 11, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems Nederland B.V. % Yoram Levy QA/RA Consultant Osite 31 Haavoda Street Binyamina 30500 ISRAEL
Re: K163250
Trade/Device Name: Longitudinal Brain Imaging (LoBI) application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 29, 2017 Received: May 2, 2017
Dear Yoram Levy:
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 device-related 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/Resourcesfor You/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 yours,
Michael D'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
2
Indications for Use
510(k) Number (if known) K163250
Device Name Longitudinal Brain Imaging (LoBI) application
Indications for Use (Describe)
The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device.
The LoBI application is intended for viewing, manipulation and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, follow-up and documentation of any such lesions.
The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY
510(k) Number K163250 Longitudinal Brain Imaging (LoBI) application
Date prepared:
April 24, 2017
I. Submitter's name and address
| Establishment name: | Philips Medical Systems Nederland B.V. |
|---|---|
| Establishment address: | Veenpluis 4-6 |
| 5684 PC Best | |
| The Netherlands | |
| Establishment registration: | 3003768277 |
| Primary Contact person: | Yoram Levy, Qsite |
| QA/RA Consultant | |
| 31 Haavoda Street | |
| Binyamina, Israel 30500 | |
| Tel (972)4-638-8837; | |
| Fax (972)4-638-0510 | |
| Yoram@qsitemed.com | |
| Alternative contact person: | Mr. Yonel Braunstein |
| Head of Regulatory and Clinical Affairs | |
| Philips Medical Systems Nederland B.V | |
| E-mail: Yonel.Braunstein@philips.com | |
| II. Device information | |
| Trade name: | Longitudinal Brain Imaging (LoBI) application |
| Device Classification Name | System, Image processing, Radiological |
| Device Class | Class II |
| Classification Panel | LLZ |
Radiological Image Processing Software 21 CFR 892.2050
III. Device Description:
Regulation Description
Product Code
4
Philips Medical Systems' Longitudinal Brain Imaging application (LoBI) is a post processing software application intended to assist in the evaluation of serial brain imaging based on MR data.
The LoBI application allows the user to view images, perform segmentation of lesions, along with segmentation editing tool and volumetric quantification of segmented volumes and quantitative comparison between time points. LoBI application provides automatic registration between studies from different time points. for longitudinal comparison.
The LoBI application provides a supportive tool for visualization of subtle differences in the brain of the same individual across time, which can be used by clinicians as the assessment of disease progression.
The physician retains the ultimate responsibility for making the final diagnosis based on image visualization as well as any segmentation and measurement results obtained from the application.
The LoBI application is intended to be used for adult population only
Key Features
LoBI application has the following key features:
-
- Longitudinal comparison between brain images in multiple studies
-
- Support for multi-slice MR sequences (2D and 3D) and allow user to use basic viewing operations such as: Scroll, pan, zoom, windowing and annotation
-
- Identify pre-defined data types (pre-sets) and user created hanging layouts
-
- Automatic registration between studies (same patient, different time-points)
-
- Single mode: allows reviewing each of the launched studies, showing multiple sequences of the same study, using the whole reading space
-
- Tissue segmentation and editing tools allowing volumetric measurement of different lesion types
-
- Lesion management tool allowing matching between lesions in different studies to facilitate the assessment of differences over time
-
- CoBI feature (Comparative Brain Imaging) a supportive tool for visualization of subtle differences in lesions of the same individual across time for similar sequences. The CoBI feature provides a mathematical subtraction of scans yielding, after bias-field correction and intensity scaling, a colorcoded image of the differences in intensity between two registered scans.
-
- Results are displayed in tabular and graphical formats.
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Longitudinal Brain Imaging (LoBI) application – 510k Submission
5
[V. Intended use:
The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device.
The LoBI application is intended for viewing, manipulation, 3Dvisualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.
V. Predicate Devices:
The Longitudinal Brain Imaging (LoBI) application is substantially equivalent to the following market-cleared devices:
| | Device Name | Manufacturer | 510k No | Date of
Clearance |
|----------------------|------------------------------------------|-----------------------------|---------|----------------------|
| Primary
predicate | syngo.MR Neurology,
syngo.MR Oncology | Siemens Medical
Solution | K151353 | August 07,
2015 |
| Predicate | syngo TrueD | Siemens Medical
Solution | K101749 | August 16,
2010 |
Table 2-1 Predicates table
Further to the predicate devices, Philips has identified the following currently marketed devices as reference predicate devices of proposed Longitudinal Brain Imaging (LoBI) application:
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| Device Name | Manufacturer | 510k No | Date of Clearance |
|---|---|---|---|
| I4 (Integrated Intelligent | |||
| Imaging Informatics) | |||
| system | Philips Medical | ||
| System | K160315 | Feb 19, 2016 | |
| sTT under Spectral CT | |||
| Applications | Philips Medical | ||
| System | K150665 | August 7, 2015 | |
| Lung Nodule Assessment | |||
| and Comparison Option | Philips Medical | ||
| System | K023785 | Feb 10 2003 | |
| EBW NM2.0 | Philips Medical | ||
| System | K111336 | May 24 2011 |
Table 2-2 References table
The proposed Philips Medical Systems Longitudinal Brain Imaging (LoBI) application and its predicate devices, syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749), are substantially equivalent in regards to their intended uses, clinical indications, principle of operation and fundamental technology principles.
I4 (Integrated Intelligent Imaging Informatics) system (K160315), sTT under Spectral CT Applications (K150665), Lung Nodule Assessment and Comparison Option (K023785) and EBW NM2.0 (K111336) are reference devices for their additional technologies and support the additional application functionalities and enhanced capabilities.
VI. Substantial Equivalence to Predicate Devices
| Feature | The proposed device:
Longitudinal Brain Imaging
(LoBI) | SIEMENS MEDICAL
syngo.MR Neurology,
syngo.MR Oncology
(K151353) | SIEMENS MEDICAL
syngo TrueD ( K101749) |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | System, Image processing,
Radiological | Same | Same |
| Device Class | Class II | Class II | Class II |
| Classification
Panel | Radiology | Radiology | Radiology |
| Feature | The proposed device: Longitudinal Brain Imaging (LoBI) | SIEMENS MEDICAL syngo.MR Neurology, syngo.MR Oncology (K151353) | SIEMENS MEDICAL syngo TrueD (K101749) |
| Product Code | LLZ | LLZ
Subsequent LNH | LLZ |
| Regulation Description | Picture Archiving and communication system | Same | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indication For Use | The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device. The LoBI application is intended for viewing, manipulation, 3D-visualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision. | The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images. Syngo.MR Oncology is a syngo based post-processing software for viewing, manipulating, and evaluating MR oncological images. | syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of |
| Feature | The proposed device: Longitudinal Brain Imaging (LOBI) | SIEMENS MEDICAL syngo.MR Neurology, syngo.MR Oncology (K151353) | SIEMENS MEDICAL syngo TrueD ( K101749) |
| | | | lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems. syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures. |
| Intended users | Radiologists and Technologists | Same | Same |
| Type of imaging scans | MRI | MRI | CT ,MR PET/CT and SPECT/CT |
| Intended Body part | MR neurological images. | MR neurological images. | All body |
| Loading multiple studies | Yes | Yes | Yes |
| Support 2D anatomical | Yes | Yes | Yes |
| Feature | The proposed device:
Longitudinal Brain Imaging
(LoBI) | SIEMENS MEDICAL
syngo.MR Neurology,
syngo.MR Oncology
(K151353) | SIEMENS MEDICAL
syngo TrueD ( K101749) |
| Support 3D
anatomical
sequences | Yes | Yes | Yes |
| Automatic
image
registration and
synchronization | Yes | Yes | Yes |
| Matching of
lesions | Yes | Yes | No |
| Semi-Automatic
segmentation
tools | Yes. Volumetric segmentation | Same | Same |
| Segmentation
editing tools | Yes | Yes | Yes |
| Matching
between lesions | Yes
A suggestion for matching of
segmented lesions between
studies is provided to the user
based on registration. | Yes
There is an option for
matching of the segmented
lesions | Yes
A suggestion for matching
of segmented lesions
between studies is provided
to the user based on
registration. |
| Automatic
calculation of
the
measurements
of segmented
lesion | Yes
Including Volume,
Min/Max/Mean etc. | Yes | Yes |
| Follow-up
(Tracking)
option | Yes.
Follow-up between studies.
Includes a compare mode
feature of visualization of
subtle differences in the brain
over time between
two
selected images | Yes
Follow-up between studies | Yes.
Track changes in lesion's
parameters and follow-up
between studies |
| Reporting | Results displayed in tabular
and graphical formats. | Same | Same |
| DICOM
Communication | Yes | Yes | Yes |
2 - 4 Longitudinal Brain Imaging (LoBI) application – 510k Submission
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Philips Medical Systems Nederland B.V.
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Longitudinal Brain Imaging (LoBI) application – 510k Submission
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Philips Medical Systems Nederland B.V.
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Philips Medical Systems Nederland B.V.
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2 - 7 Longitudinal Brain Imaging (LoBI) application – 510k Submission
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The Philips Medical Systems Longitudinal Brain Imaging (LoBI) and the identified syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749) are substantially equivalent in terms of indication for use and intended users, design features, principle of operation and fundamental scientific technology, and safety and/or effectiveness.
In conclusion, Philips believes that the proposed Longitudinal Brain Imaging (LoBI) does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate devices, syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749).
VII. Brief discussion of the nonclinical tests submitted, referenced or relied on
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes
- IEC 62366-1 Medical devices Part 1:Application of usability engineering to medical devices
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- DICOM PS 3.1-3.18 standard Digital Imaging and Communications in Medicine (DICOM) Standard
Philips Medical Systems Longitudinal Brain Imaging (LoBI) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The following verification and validation testing were conducted with the Longitudinal Brain Imaging (LoBI) application:
2 - 8 Longitudinal Brain Imaging (LoBI) application – 510k Submission
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- . Verification- the verification activities proves that the LoBI application includes the CoBI feature, function correctly and meets its specification. The verification testing includes the following testing:
-
Full functionality test- a comprehensive list of test cases which covers a specific function/feature in the application. This test covers all of the detailed requirements according to the PRS (Product Requirement Specification).
- A RMF testing- testing which covers of the test that are specifically designed to check in the risk management file
-
- · Validation- the validation proves that the LoBI application meets the customer needs and its performance fulfills its intended functionality. The validation activities include real recorded clinical data cases in order to simulate the actual use of the application.
The test results in this 510(k) premarket notification demonstrate that Longitudinal Brain Imaging (LoBI):
- Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
VIII. Brief discussion of clinical tests submitted, referenced or relied on
The subject of this premarket submission. Longitudinal Brain Imaging (LoBI) application did not require clinical studies to support equivalence.
[X. The conclusions drawn from the nonclinical and clinical tests
Verification and Validation (V&V) activities required to establish performance and functionality of Longitudinal Brain Imaging (LoBI) were performed. Testing performed demonstrated the Longitudinal Brain Imaging (LoBI) meets all defined functionality requirements and performance claims.
X. Overall conclusion:
12
The Longitudinal Brain Imaging (LoBI) is substantially equivalent to the identified predicate devices, primary- syngo.MR Neurology, syngo.MR Oncology (K151353) and syngo TrueD (K101749) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.
Philips Medical believes that the proposed device, Longitudinal Brain Imaging (LoBI) application, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.