(56 days)
No
The summary describes image processing, segmentation, measurement, and quantitative analysis, but does not mention AI, ML, or related terms. The performance studies focus on standard software validation and compliance with general medical device standards, not AI/ML specific performance metrics or training/test data.
No.
This device is a post-processing software application for analyzing medical images to aid clinicians in diagnosing and managing cancer, not directly treating a disease condition.
Yes
The "Intended Use / Indications for Use" section states: "The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure." This explicitly indicates a diagnostic purpose. Additionally, the "Device Description" states that it provides "an automatic tool which may be used by clinicians in diagnosis, management and surveillance of solid tumors and lymph node".
Yes
The device is explicitly described as a "post processing software application" and "non-organ specific, multi-modality application which is intended to function as an advanced visualization application." The description focuses solely on the software's functions of displaying, processing, analyzing, quantifying, and manipulating images. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, the Multi-Modality Tumor Tracking (MMTT) application is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
- MMTT's Function: The MMTT application processes and analyzes medical images (CT, MR, PET/CT, SPECT/CT). These images are generated from devices that scan the patient's body in vivo (within the body).
- Intended Use: The intended use clearly states it's a "post processing software application used to display, process, analyze, quantify and manipulate anatomical and functional images." It uses these images as a tool for clinicians in determining diagnosis, management, and surveillance. It does not involve the analysis of biological specimens.
Therefore, the MMTT application falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Multi-Modality Tumor Tracking (MMTT) application is a post processing software application used to display, process, analyze, quantify and manipulate anatomical and functional images, for CT, MR PET/CT and SPECT/CT images and/or multiple time-points. The MMTT application is intended for use on tumors which are known/confirmed to be pathologically diagnosed cancer. The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures.
Product codes
LLZ
Device Description
Philips Medical Systems' Multi-Modality Tumor Tracking (MMTT) application is a post - processing software. It is a non-organ specific, multi-modality application which is intended to function as an advanced visualization application. The MMTT application is intended for displaying, processing, analyzing, quantifying and manipulating anatomical and functional images, from multi-modality of CT ,MR PET/CT and SPECT/CT scans.
The Multi-Modality Tumor Tracking (MMTT) application allows the user to view imaging, perform segmentation and measurements and provides quantitative and characterizing information of oncology lesions, such as solid tumor and lymph node, for a single study or over the time course of several studies (multiple time-points). Based on the measurements, the MMTT application provides an automatic tool which may be used by clinicians in diagnosis, management and surveillance of solid tumors and lymph node, conditions in various organs, tissues, and other anatomical structures, based on different oncology response criteria.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR PET/CT and SPECT/CT
Anatomical Site
All body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists and Technologist
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
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 Multi-Modality Tumor Tracking (MMTT) 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 test results in this 510(k) premarket notification demonstrate that Multi-Modality Tumor Tracking (MMTT):
- . 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, Multi-Modality Tumor Tracking (MMTT) application did not require clinical studies to support equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K151353, K123920, K113620, K160315, K150665, K023785
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Philips Medical Systems Nederland B.V. % Mr. Yoram Levy QA/RA Consultant Osite 31 Haavoda St. Binyamina, 30500 ISRAEL
Re: K162955
Trade/Device Name: Multi-Modality Tumor Tracking (MMTT) application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 19, 2016 Received: October 24, 2016
Dear Mr. 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.
Robert Ochs
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) K162955
Device Name
Multi-Modality Tumor Tracking (MMTT) application
Indications for Use (Describe)
Multi-Modality Tumor Tracking (MMTT) application is a post processing software application used to display, process, analyze , quantify and manipulate anatomical and functional images, for CT, MR PET/CT and SPECT/CT images and/or multiple time-points. The MMTT application is intended for use on tumors which are known/confirmed to be pathologically diagnosed cancer. The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure.
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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510(K) SUMMARY
Multi-Modality Tumor Tracking (MMTT) application
Date prepared:
October 19, 2016
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: | Multi-Modality Tumor Tracking (MMTT) application |
| Device Classification Name | System, Image processing, Radiological |
| Device Class | Class II |
| Classification Panel | LLZ |
| Product Code | Radiological Image Processing Software |
III. Device Description:
Regulation Description
Philips Medical Systems' Multi-Modality Tumor Tracking (MMTT) application is a post - processing software. It is a non-organ specific, multi-modality application which is intended to function as an advanced visualization
21 CFR 892.2050
2-1 Multi-Modality Tumor Tracking (MMTT) application – 510k Submission
4
application. The MMTT application is intended for displaying, processing, analyzing, quantifying and manipulating anatomical and functional images, from multi-modality of CT ,MR PET/CT and SPECT/CT scans.
The Multi-Modality Tumor Tracking (MMTT) application allows the user to view imaging, perform segmentation and measurements and provides quantitative and characterizing information of oncology lesions, such as solid tumor and lymph node, for a single study or over the time course of several studies (multiple time-points). Based on the measurements, the MMTT application provides an automatic tool which may be used by clinicians in diagnosis, management and surveillance of solid tumors and lymph node, conditions in various organs, tissues, and other anatomical structures, based on different oncology response criteria.
Key Features
The MMTT application has the following key features:
-
- Longitudinal follow-up for oncology.
-
- Multi-modality support: CT ,MR PET/CT and SPECT/CT scans
-
- Load up multiple concurrent studies for temporal measurements
-
- Automatic and manual registration between studies and between series within study (same patient, different time-point).
-
- Identify pre-defined data types (pre-sets) and user created hanging layouts.
-
- Semi-automatic and manual volumetric tissue segmentation and editing tools.
-
- Findings management of the identified lesions (lesion properties, Join, Match, un-match, delete)
-
- Automatic software calculation of the following measurements for each segmented lesion:
- o Long Axis- Longest diameter on an axial slice, between two points on the lesion contour in 2D dimensions found in the segmented volume (mm)
- o Short axis (mm) Longest diameter found perpendicular to Long Axis in the same axial 2D slice.
- o Long axis x short axis- the multiplication result of the longest diameter in axial slice with the short diameter of the same slice
2-2
Multi-Modality Tumor Tracking (MMTT) application – 510k Submission
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- o Max 3D diameter (mm)- longest diameter that can be drawn in the 3D volume
- o Lesion Volume (cm3)
- o Max Area (cm²)- maximal area of lesion on an axial slice in the volume
- o Mean/Max/Min/SD values of all functional volumes
- o Doubling time (days)- the time it takes for the volume to double
- o Density- the mean density of all target tumor (only for CT data)
- o Enhanced volume/Enhanced Percentage/Enhanced Mean/Enhanced SD (available only for qEASL preset).
-
- Support oncology response criteria such as RECIST 1.0, RECIST 1.1, WHO, CHOI, PERCIST, irRC, mRECIST, qEASL.
-
- Support SUV calculation for PET scans, such as: SUV Body Weight (the default option); SUV Lean Body Mass; SUV Body Surface Area; and SUV Body Mass Index
-
- Results displayed in tabular and graphical formats.
-
- Export results in many formats.
[V.Intended use:
Multi-Modality Tumor Tracking (MMTT) application is a post processing software application used to display, process, analyze, quantify and manipulate anatomical and functional images, for CT, MR PET/CT and SPECT/CT images and/or multiple time-points. The MMTT application is intended for use on tumors which are known/confirmed to be pathologically diagnosed cancer. The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures.
V. Predicate Devices:
The following table shows the predicate devices of the proposed Philips Medical Systems Multi-Modality Tumor Tracking (MMTT):
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| | Device Name | Manufacturer | 510k No | Date of
Clearance |
|----------------------|---------------|-------------------------------|---------|----------------------|
| Primary
predicate | Syngo TrueD | Siemens Medical
Solution | K101749 | August 16,
2010 |
| Predicate | EBW NM 2.0 TT | Philips
Medical
Systems | K111336 | May 24, 2011 |
The proposed Philips Medical Systems Multi-Modality Tumor Tracking (MMTT) and its predicate devices, syngo TrueD (K101749) and EBW NM 2.0 (K111336), are substantially equivalent in regards to its intended use, clinical indications, principle of operation and fundamental technology principles.
Further to the predicate devices, Philips has identified the following currently marketed devices as reference predicate devices of proposed Multi-Modality Tumor Tracking (MMTT):
Table 2-2: Identification of MMTT application Reference Devices
| Device Name | Manufacturer | 510k No | Date of Clearance |
|---|---|---|---|
| syngo.MR | |||
| Neurology | |||
| and | |||
| syngo.MR Oncology | Siemens AG | K151353 | April 8, 2016 |
| syngo. Via | Siemens AG | K123920 | Jan 18 2013 |
| Myrian 1.11 | Myrian | K113620 | July 13, 2012 |
| I4 (Integrated Intelligent Imaging | |||
| Informatics) system | Philips Medical | ||
| System | K160315 | Feb 19, 2016 | |
| sTT under Spectral | |||
| Applications | Philips Medical | ||
| System | K150665 | August 7, 2015 | |
| Lung Nodule Assessment and | |||
| Comparison Option | Philips Medical | ||
| System | K023785 | Feb 10 2003 |
The syngo.MR Neurology and syngo.MR Oncology (K151353), syngo. Via (K081426), Myrian 1.11 (K123920), I4 (Integrated Intelligent Imaging Informatics) system (K160315), sTT under Spectral CT Applications
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(K150665) and Lung Nodule Assessment and Comparison Option (K023785) are reference devices for additional technologies and support the additional application functionalities and enhanced capabilities.
VI. Substantial Equivalence to Predicate Devices
| Feature | The proposed device:
Multi-Modality Tumor
Tracking (MMTT) | Primary Predicate:
syngo TrueD (K101749) | Predicate:
EBW NM 2.0 TT
(K111336) |
|-----------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------|
| Device
Classification
Name | System, Image processing,
Radiological | System, Image processing,
Radiological | System, Image processing,
Radiological |
| Device Class | Class II | Class II | Class II |
| Classification
Panel | Radiology | Radiology | Radiology |
| Product Code | LLZ | LLZ | 90 JAK |
| Regulation
Description | Picture Archiving and
communication system | Picture Archiving and
communication system | Picture Archiving and
communication system |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Intended users | Radiologists and
Technologist | Radiologists, Technologist | Radiologists and
Technologist |
| Type of scans | CT ,MR PET/CT and
SPECT/CT | CT ,MR PET/CT and
SPECT/CT | Nuclear scans |
| Intended Body
part | All body | All body | All body |
| Type of scans | Multi-Modality support:
CT ,MR PET/CT and
SPECT/CT | Multi-Modality support:
CT ,MR PET/CT and
SPECT/CT | Multi-Modality support:
PET/CT and SPECT/CT |
| Loading
multiple studies | Yes. | Yes | Yes |
| 3D image review | Yes | Yes | Yes |
| 3D comparative
review | Yes | Yes | No |
| Automatic
image
registration and
synchronization | Yes | Yes | No |
| Feature | The proposed device:
Multi-Modality Tumor
Tracking (MMTT) | Primary Predicate:
syngo TrueD ( K101749) | Predicate:
EBW NM 2.0 TT
(K111336) |
| Matching and
propagation of
lesions | Yes | NO | Yes |
| Semi-Automatic
and manual
Lesion
segmentation | Yes | Yes | Yes |
| Segmentation
editing tools | Yes | Yes | Yes |
| Printing Option | Yes | Yes | Yes |
| DICOM | Yes | Yes | Yes |
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The proposed Philips Medical Systems Multi-Modality Tumor Tracking (MMTT) and the identified predicate devices, primary- syngo TrueD (K101749) and predicate- and EBW NM 2.0 (K111336) 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 Multi-Modality Tumor Tracking (MMTT) does not introduce any new potential safety and/or effectiveness issues and is substantially equivalent to the identified predicate devices, primary- syngo TrueD (K101749) and predicate- and EBW NM 2.0 (K111336).
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:
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- 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 Multi-Modality Tumor Tracking (MMTT) 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 test results in this 510(k) premarket notification demonstrate that Multi-Modality Tumor Tracking (MMTT):
- . 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, Multi-Modality Tumor Tracking (MMTT) 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 Multi-Modality Tumor Tracking (MMTT) were performed. Testing performed demonstrated the Multi-Modality Tumor Tracking (MMTT) meets all defined functionality requirements and performance claims.
X. Overall conclusion:
The Multi-Modality Tumor Tracking (MMTT) is substantially equivalent to the identified predicate devices, primary- syngo TrueD (K101749) and the predicate device EBW NM 2.0
2-7 Multi-Modality Tumor Tracking (MMTT) application – 510k Submission
10
(K111336) 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, Multi-Modality Tumor Tracking (MMTT) 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.