(144 days)
No
The document describes software applications for viewing and analyzing spectral CT images to extract quantitative information (length, width, volume, effective atomic number, attenuation, HU). It focuses on providing tools for trained personnel to perform analysis and does not mention any AI/ML techniques for image processing, analysis, or decision support. The validation process described involves human evaluation of the software's ability to meet intended uses, not performance metrics typically associated with AI/ML models.
No
The device is described as a diagnostic tool for visualization and analysis, providing quantitative and graphical information. It is intended to assist clinicians in viewing and evaluating images for inspection and diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that "This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures." Furthermore, the individual applications (sCCA, sAVA, sTT) are described as assisting clinicians in viewing, evaluating, analyzing, and even in the case of sCCA and sAVA, "diagnostic" of specific conditions like Cardiac Cases and CT Angiography cases.
Yes
The device is explicitly described as a "set of three SW clinical applications" and the description focuses solely on the software's functionality for viewing and analyzing images. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The description clearly states that the device supports "viewing and analysis of images" from a CT scanner. It processes and analyzes image data, not biological samples.
- The intended use is image-based diagnosis: The intended use describes the device as a "diagnostic tool for the visualization and analysis of anatomical and pathological structures" based on CT images.
Therefore, while it is a diagnostic tool, it falls under the category of medical imaging software or a medical image analysis device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
The Spectral enhanced Advanced Vessel Analysis (SAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.
The Spectral enhanced Comprehensive Cardiac Analysis (SCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images.
The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
The Spectral CT Applications package introduces a set of three SW clinical applications: spectral enhanced Comprehensive Cardiac Analysis (sCCA), spectral enhanced Advanced Vessel Analysis (sAVA), and spectral enhanced Tumor Tracking (sTT). Each application provides tools that assist a trained personal in visualization and analysis of anatomical and pathological structures.
The sCCA application is targeted to assist the user in analysis and diagnostic of Cardiac Cases, as contrast enhanced and ECG triggered scans. The application input is a cardiac case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the coronary tree and chambers. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the coronary vessel & findings along it.
The sAVA application is targeted to assist the user in analysis and diagnostic of CT Angiography cases, as contrast enhanced and whole body CT-angiography scans. The application input is a CT Angiography case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the vessel of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the vessels & findings along it.
The sTT application is targeted to assist the user in analysis of tumors, as contrast enhanced, soft tissue oriented, and whole body scans. The application input is a tumor suspected contrast enhanced case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the tumor of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the tumor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Body materials, anatomical and pathological structures, contrast-enhanced vessels, cardiovascular, tumors, coronary tree and chambers, vessels, soft tissue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professional, clinicians
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
Non-Spectral CT applications have been verified through SW verification Clinical Testing: process. In which covered Functionality, risk mitigations, and IFU. The Verification was using datasets that were generated by the Philips IQon Spectral CT system (K133674) and Verification testing specs to methodically cover functionality as described in the requirement specification documents. The verification indicated that SW requirements were met and IFU contains appropriate clarification on functionality and warnings. The conclusions are summarized in the Verification report. Summary of Clinical Spectral CT applications have been validated to show that intended uses Testing: of the spectral CT applications are met. Validation stage was using clinical datasets derived from Philips IQon Spectral CT system (K133674) and the SW version that successfully passed verification process. The intended uses of each application were evaluated by Philips Internal certified radiologists that represented a typical user. The evaluators were questioned against each of the intended uses and provided score to describe their level of satisfaction.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The validation indicated that intended uses and defined user needs were met, hence: sCCA and sAVA applications allow visualization, manipulation and analysis of spectral data and that sTT application assist clinicians in viewing and evaluating CT images for the inspection of tumors. Conclusion: Philips Medical Systems believes that the Spectral CT Applications are similar to the applications that are incorporated in the predicate devices. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests have been performed to demonstrate that the Spectral CT Applications are as safe and effective as the applications that are incorporated in the predicate devices, without raising any new safety and/or effectiveness concerns.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Philips Medical Systems Nederland B.V. % Ms. Susan Ouick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44143
Re: K150665
Trade/Device Name: Philips Spectral CT Applications Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: July 28, 2015 Received: July 29, 2015
Dear Ms. Quick:
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. Acting 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) K150665
Device Name
Philips Spectral CT Applications
Indications for Use (Describe)
The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
The Spectral enhanced Advanced Vessel Analysis (SAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.
The Spectral enhanced Comprehensive Cardiac Analysis (SCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images.
The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors."
| 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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| Section 5: | 510(k) Summary
[As required by 21 CFR 807.92(c)] | | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|--|
| Applicant's Name:
Address: | Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
The Netherlands | | |
| Contact Person:
Title:
Address: | Susan Quick
Regulatory Affairs Specialist
595 Miner Road
Cleveland, OH 44143
USA | | |
| Telephone
number: | +1 440 483-2291 | | |
| Fax number:
E-mail: | +1 440 483-4918
Susan.quick@philips.com | | |
| 510(k) Summary
Date of
Preparation: | 05-March-2015 | | |
| Device Trade Name: | Spectral CT Applications | | |
| Common or Usual
Name: | Computed Tomography X-ray System (CT System) | | |
| Classification
Name:
Regulation:
Class:
Product Code:
Panel: | Computed Tomography X-ray System
21 CFR 892.1750
ll
JAK, LLZ
Radiology | | |
| Predicate devices | IQon Spectral CT (K133674)
EBW NM 2.0 (K111336)
Brilliance iCT (K060937) | | |
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Device Description: The Spectral CT Applications package introduces a set of three SW clinical applications: spectral enhanced Comprehensive Cardiac Analysis (sCCA), spectral enhanced Advanced Vessel Analysis (sAVA), and spectral enhanced Tumor Tracking (sTT). Each application provides tools that assist a trained personal in visualization and analysis of anatomical and pathological structures.
The sCCA application is targeted to assist the user in analysis and diagnostic of Cardiac Cases, as contrast enhanced and ECG triggered scans. The application input is a cardiac case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the coronary tree and chambers. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the coronary vessel & findings along it.
The sAVA application is targeted to assist the user in analysis and diagnostic of CT Angiography cases, as contrast enhanced and whole body CT-angiography scans. The application input is a CT Angiography case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the vessel of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the vessels & findings along it.
The sTT application is targeted to assist the user in analysis of tumors, as contrast enhanced, soft tissue oriented, and whole body scans. The application input is a tumor suspected contrast enhanced case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the tumor of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the tumor.
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- The Philips Spectral CT Applications support viewing and analysis of Intended Use: images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
The Spectral enhanced Advanced Vessel Analysis (sAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.
The Spectral enhanced Comprehensive Cardiac Analysis (sCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images.
The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.
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Substantial Philips has identified one Primary and two Reference predicate devices Equivalence: for the Spectral CT Applications.
The Primary predicate, Spectral CT viewer (part of Philips IQon Spectral CT), addresses the enhanced visualization and analysis capabilities of spectral images derived by the spectral data.
The Reference predicates address functionality of the baseline applications AVA, CCA, and TT.
Table 5-1 Primary Predicate
| Device trade name | 510(k) number | Product code |
|---|---|---|
| Philips IQon | ||
| Spectral CT | ||
| (Spectral CT Viewer) | K133674 | JAK |
Table 5-2 Reference Predicates
| Spectral CT
Applications | Reference
Predicate | 510(k)
number | Product code |
|-----------------------------|---------------------------------------------------|------------------|--------------|
| sAVA | AVA from Brilliance
iCT (Brilliance
Volume) | K060937 | JAK |
| sCCA | CCA from Brilliance
iCT (Brilliance
Volume) | K060937 | JAK |
| sTT | TT from EBW NM
2.0 | K111336 | LLZ |
Intended Use and Indications for Use Discussion
The proposed intended uses of the Spectral CT Applications are combining indications coming from their primary and reference predicates.
Similar to the reference predicates (CCA, AVA: K133674, K060937; TT: K111336), the Spectral CT Applications assist clinicians in viewing and evaluating CT images of Cardiac, Angiography, and Tumor related cases. The differences between the intended use of the Reference predicates and the proposed Spectral CT applications is that the Spectral CT applications introduce capabilities of viewing and analysis of CT images of Cardiac, Angiography, and Tumor related cases at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number which is not available with the reference predicates.
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Technological Characteristics
The proposed Spectral CT Applications (sAVA, sCCA, and sTT) are based on Spectral CT Viewer (K133674) as the Primary predicate, while incorporating basic tools, like: measurements, Display modes (2D, 3D) and layouts, etc. and enhanced visualization and analysis capabilities that are derived from utilization of spectral data. These enhanced visualization and analysis capabilities include spectral plots, keV slider, and Spectral Magic Glass.
The proposed Spectral CT Applications (sAVA, sCCA, and sTT) are based on the baseline applications mentioned above as the reference predicates while sharing the characteristics of those baseline applications, mainly:
- Both AVA and sAVA support whole body CT Angiography (CTA) scans and assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.
- Both CCA and sCCA support cardiac CT scans and assist clinicians ● in viewing and evaluating cardiovascular CT images.
- Both TT and sTT support whole body CT scans and assist clinicians in viewing and evaluating CT images, for the inspection of tumors.
- The Spectral CT Applications (sAVA, sCCA, and sTT) incorporate in the high level - the same workflow stages and functionalities as the reference predicate baseline CT Applications; and in more details, allow to generate presets and layouts and provide measurement tools, segmentation tools, and summary tables similar to the reference predicate baseline CT Applications.
The difference between the Primary predicate and the Spectral CT applications is the customized workflow and summary tables that are tailored to meet the specific case of interest.
The differences between the Spectral CT applications and the baseline CT Application reference predicates is in the enhanced visualization and analysis capabilities that are derived from utilization of spectral data.
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Table 5-3: Main functionalities and characteristics of Predicates vs. Spectral CT Applications
| Features | Proposed Spectral CT Applications | Primary Predicate (K133674) | Reference Predicate (K060937, and K111336) |
|---|---|---|---|
| SW Clinical application | Yes | Yes | Yes |
| Incorporate workflow stages | Yes | Yes | Yes |
| Supports conventional images | Yes | Yes | Yes |
| Supports spectral images, including: SBI, | |||
| Material Density Pairs, MonoE | Yes | Yes | No |
| DICOM compliant | Yes | Yes | Yes |
| Supports Axial (2D) and volumetric (3D) | |||
| visualization modes | Yes | Yes | Yes |
| Provides presets and layouts for conventional | |||
| images | Yes | Yes | Yes |
| Provides presets and layout for spectral | |||
| images | Yes | Yes | No |
| Provides measurement tools: average, STD, | |||
| length, area, volume, and spectral plots | Yes | Yes | Yes |
| Provides measurement tools: spectral plots | Yes | Yes | No |
| Provides segmentation tools: clipping, inject, | |||
| delete | Yes | Yes | Yes |
| Provides segmentation tools: bone/skull | |||
| removal, couch removal | Yes – in | ||
| Spectral | |||
| Enhanced | |||
| AVA | |||
| application | No | Yes – in | |
| AVA | |||
| application | |||
| Provides segmentation tools: coronary & | |||
| chambers | Yes – in | ||
| Spectral | |||
| Enhanced | |||
| CCA | |||
| application | No | Yes – in | |
| CCA | |||
| application | |||
| Provides summary tables | Yes | No | Yes |
| Generates "on-the fly" datasets | Yes | Yes | No |
| Provides keV slider | Yes | Yes | No |
| Provides spectral magic glass | Yes | Yes | No |
Premarket Notification [510(k)] Submission
Philips Medical Systems
Spectral CT Applications
Philips Medical Systems The Spectral CT Applications are similar to the applications a
Spectral CT Applications The Spectral CT Applications are Similar to the Spectral CT the applications
Spectral CT Applications incorporated in the cleared predicate devices. The Spectra
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Summary of Non-Spectral CT applications have been verified through SW verification Clinical Testing: process. In which covered Functionality, risk mitigations, and IFU. The Verification was using datasets that were generated by the Philips IQon Spectral CT system (K133674) and Verification testing specs to methodically cover functionality as described in the requirement specification documents. The verification indicated that SW requirements were met and IFU contains appropriate clarification on functionality and warnings. The conclusions are summarized in the Verification report. Summary of Clinical Spectral CT applications have been validated to show that intended uses Testing: of the spectral CT applications are met. Validation stage was using clinical datasets derived from Philips IQon Spectral CT system (K133674) and the SW version that successfully passed verification process. The intended uses of each application were evaluated by Philips Internal certified radiologists that represented a typical user. The evaluators were questioned against each of the intended uses and provided score to describe their level of satisfaction. The validation indicated that intended uses and defined user needs were met, hence: sCCA and sAVA applications allow visualization, manipulation and analysis of spectral data and that sTT application assist clinicians in viewing and evaluating CT images for the inspection of tumors. Conclusion: Philips Medical Systems believes that the Spectral CT Applications are similar to the applications that are incorporated in the predicate devices. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests have been performed to demonstrate that the Spectral CT Applications are as safe and effective as the applications that are incorporated in the predicate devices, without raising any new safety and/or effectiveness concerns.