(169 days)
No
The summary mentions "automatically performs the measurements" and "automated tools," but there is no explicit mention of AI, ML, deep learning, or neural networks. The performance study describes logistic regression models, which are statistical methods, not necessarily indicative of AI/ML in the context of modern medical imaging analysis.
No
The device is described as a "diagnostic patient-imaging tool" intended for "review and analysis of thoracic CT images" to provide "quantitative and characterizing information about nodules in the lung." It does not directly treat or alleviate a condition.
Yes
The 'Intended Use / Indications for Use' and 'Device Description' sections both explicitly state that the device is "intended for use as a diagnostic patient-imaging tool" and "supports Low Dose CT Lung Cancer Screening."
Yes
The device description explicitly states it is an "application" and "software" intended for the review and analysis of images. While it processes data from a CT system, the device itself is described as software performing measurements and providing a user interface. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "diagnostic patient-imaging tool" that analyzes "thoracic CT images." It processes and analyzes medical images, not biological samples.
- Intended Use: The intended use is for the "review and analysis of thoracic CT images," providing information about lung nodules based on these images.
- Input: The input is "thoracic CT images," which are medical images, not biological specimens.
Therefore, this device falls under the category of medical imaging software or a medical image analysis tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
The Lung Nodule Assessment and Comparison Option application is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The user interface and automated tools help to determine growth patterns and compose comparative reviews. The Lung Nodule Assessment and Comparison Option application requires the user to identify a nodule and to determine the type of nodule in order to use the appropriate characterization tool. Lung Nodule Assessment and Comparison Option may be utilized in both diagnostic and screening evaluations supporting Low Dose CT Lung Cancer Screening*.
*The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. -Please refer to clinical literature that includes the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Key Features
-
- Automatic Lungs and Lobes segmentation
-
- Single-click lung nodule segmentation
-
- Manual nodule segmentation editing tools
-
- Load up to 8 concurrent studies for temporal measurements
-
- Restore previously segmented nodules from prior studies for comparison
-
- Enhanced comparison feature that allows matching and establishing correspondence between pre identified nodules in two studies
-
- Synchronization between studies from different time-points
-
- 3D or MIP visualization of segmented nodules
-
- Reporting based on Lung-RADS™ guidelines and option to export to Clipboard
-
- Risk Calculator tool based on patient and nodule characteristics for estimation of the probability that lung nodules detected on baseline screening low-dose CT scans are malignant, based on McWilliams, Annette, et al. "Probability of cancer in pulmonary nodules detected on first screening CT." New England Journal of Medicine 369.10 (2013): 910-919.
-
- Automatic software calculation of the following measurements for each segmented nodule:
- Quantification of nodule parameters:
- Long Axis- Longest diameter on an axial slice (mm)
- Short axis- Longest diameter perpendicular to the long axis on the same slice (mm) .
- Average \ Max 3D \ Effective diameter (mm)
- Volume (mm3)
- Mean HU (HU)
- Manual edit of the nodule segmentation contour lines with automatic recalculation of . geometric measurements post-editing
- Specification of the following characteristics for each nodule in configurable pre-sets
- Nodule type (solid, part-solid, ground-glass, calcified)
- Lobe Location
- Nodule shape (Circular/Oval/Triangular)
- Nodule Spiculation
- Comparison and matching feature automatic calculations of the following measurements between each follow-up scan and the previous scan:
- Doubling time in days
- Percent (%) and absolute change of all numerical parameters (growth in nodule long axis, short axis, average diameter, max 3D diameter, effective diameter, volume, mean HU).
Additional Information for Risk Calculator
The Risk Calculator feature in LNA is based on the full model with spiculation developed by Brock University as described in McWilliams, et al (2013). This model allows estimating the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. The model's performance was validated using two large population-based prospective studies: the Pan-Canadian Early Detection of Lung Cancer Study (PanCan) and the chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thoracic CT images
Anatomical Site
lung / Chest
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
For the Lung Nodule Assessment and Comparison Option (LNA), validation and verification activities were conducted to provide objective evidence that the design meets user needs and intended use and application specification. These validation activities assure that the lung and lobe segmentation, the comparison, as well as the nodule matching and propagation functionality, and the Prefill functionality for the Lung RADS score and the risk prediction are adequate from an overall product perspective. The LNA application was validated using real recorded clinical data cases in order to simulate the actual use of the software. Each test case was evaluated for the complete clinical workflow.
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
Lung Nodule Assessment and Comparison Option 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.
McWilliams, A et al conducted a population-based prospective clinical study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up. The authors indicated that the final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set. McWilliams A et al concluded that Predictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. The investigators analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logistic-regression models were prepared to estimate the probability of lung cancer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Areas under the receiver-operating-characteristic curve of more than 0.90.
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.
K153444, K060937, K160315, K111336
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
§ 892.2050 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Philips Medical Systems Nederland B.V. % Yoram Levy General Manager Osite 31 Haavoda Street Binyamina, 30500 ISRAEL
Re: K162484
Trade/Device Name: Lung Nodule Assessment and Comparison Option (LNA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: January 15, 2017 Received: January 23, 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 O'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) K162484
Device Name
Lung Nodule Assessment and Comparison Option (LNA)
Indications for Use (Describe)
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
| 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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3
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
510(k) Summary
K162484
Lung Nodule Assessment and Comparison Option
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Date prepared: February 16, 2017
I. Submitter's name and address
| 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: | Lung Nodule Assessment and Comparison Option (LNA) |
| Device Classification Name | System, Image processing, Radiological |
| Device Class | Class II |
| Classification Panel | LLZ, JAK |
| Product Code | Radiological Image Processing Software |
| Regulation Description | 21 CFR 892.2050, 21CFR 892.1750 |
4
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
III. Predicate device information
Predicate devices:
| Device trade name | 510(k) number | Date of clearance | Classification name | Product code | Regulation | Class | Classification panel |
|---|---|---|---|---|---|---|---|
| Lung | |||||||
| Analysis | |||||||
| Software | K151283 | October | |||||
| 30, 2015 | System, Image | ||||||
| processing, | |||||||
| Radiological | JAK, | ||||||
| LLZ | 21CFR | ||||||
| 892.1750 | Class | ||||||
| II | Radiology | ||||||
| Lung Nodule | |||||||
| Assessment | |||||||
| and | K023785 | Feb 10 | |||||
| 2003 | System, Image | ||||||
| processing, | |||||||
| Radiological | 90 | ||||||
| JAK | 21CFR | ||||||
| 892.1750 | Class | ||||||
| II | Radiology |
Reference devices:
| Device trade
name | 510(k)
number | Date of
Clearance | Classification
name | Product code | Regulation | Class | Classification
panel |
|----------------------------------------------------------------------------------------|------------------|----------------------|-----------------------------------------------|--------------|--------------------|-------|-------------------------|
| Philips
Multi-slice
CT system
with Low
Dose CT
lung cancer
screening | K153444 | April 8,
2016 | Computed
Tomography
X- ray system | JAK | 21 CFR
892.1750 | II | Radiology |
| Brilliance
iCT
(Brilliance
Volume) | K060937 | June 5,
2006 | System, X-
Ray,
Tomography,
Computed | JAK | 21 CFR
892.1750 | II | Radiology |
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
| I4 (Integrated
Intelligent
Imaging
Informatics)
system | K160315 | February
19, 2016 | Picture
archiving and
communication
system | LLZ,
JAK | 21 CFR
892.2050 | II | Radiology |
|--------------------------------------------------------------------|---------|----------------------|-----------------------------------------------------|-------------|--------------------|----|-----------|
| EBW NM2.0 | K111336 | February
3, 2011 | Picture
archiving and
communication
system | LLZ | 21 CFR
892.2050 | II | Radiology |
IV. Device description
The Lung Nodule Assessment and Comparison Option application is intended for use as a diagnostic patient-imaging tool. It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The user interface and automated tools help to determine growth patterns and compose comparative reviews. The Lung Nodule Assessment and Comparison Option application requires the user to identify a nodule and to determine the type of nodule in order to use the appropriate characterization tool. Lung Nodule Assessment and Comparison Option may be utilized in both diagnostic and screening evaluations supporting Low Dose CT Lung Cancer Screening*.
*The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. -Please refer to clinical literature that includes the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Key Features
-
- Automatic Lungs and Lobes segmentation
6
-
- Single-click lung nodule segmentation
-
- Manual nodule segmentation editing tools
-
- Load up to 8 concurrent studies for temporal measurements
-
- Restore previously segmented nodules from prior studies for comparison
-
- Enhanced comparison feature that allows matching and establishing correspondence between pre identified nodules in two studies
-
- Synchronization between studies from different time-points
-
- 3D or MIP visualization of segmented nodules
-
- Reporting based on Lung-RADS™ guidelines and option to export to Clipboard
-
- Risk Calculator tool based on patient and nodule characteristics for estimation of the probability that lung nodules detected on baseline screening low-dose CT scans are malignant, based on McWilliams, Annette, et al. "Probability of cancer in pulmonary nodules detected on first screening CT." New England Journal of Medicine 369.10 (2013): 910-919.
-
- Automatic software calculation of the following measurements for each segmented nodule:
- Quantification of nodule parameters: A
- Long Axis- Longest diameter on an axial slice (mm)
- · Short axis- Longest diameter perpendicular to the long axis on the same
- slice (mm) .
- Average \ Max 3D \ Effective diameter (mm)
- Volume (mm3)
- Mean HU (HU)
- Manual edit of the nodule segmentation contour lines with automatic recalculation of . geometric measurements post-editing
-
Specification of the following characteristics for each nodule in configurable pre-sets
- Nodule type (solid, part-solid, ground-glass, calcified)
- Lobe Location
- Nodule shape (Circular/Oval/Triangular)
- Nodule Spiculation
-
Comparison and matching feature automatic calculations of the following measurements between each follow-up scan and the previous scan:
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered.
- I Doubling time in days
- I Percent (%) and absolute change of all numerical parameters (growth in nodule long axis, short axis, average diameter, max 3D diameter, effective diameter, volume, mean HU).
Additional Information for Risk Calculator
The Risk Calculator feature in LNA is based on the full model with spiculation developed by Brock University as described in McWilliams, et al (2013). This model allows estimating the probability that lung nodules detected on baseline screening low-dose CT scans are malignant. The model's performance was validated using two large population-based prospective studies: the Pan-Canadian Early Detection of Lung Cancer Study (PanCan) and the chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute.
Further details can be found in McWilliams, A., Tammemagi, M.C., Mayo, J.R., Roberts, H., Liu, G., Soghrati, K., Yasufuku, K., Martel, S., Laberge, F., Gingras, M. and Atkar-Khattra, S., (2013). Probability of cancer in pulmonary nodules detected on first screening CT. New England Journal of Medicine, 369(10), pp.910-919
V. Intended use
The Philips Medical Systems Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool.
It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
VI. Substantial Equivalence Comparison
Philips believes that Lung Nodule Assessment and Comparison Option product is substantially equivalent to the identified predicate devices , primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785), with additional/enhanced functionality deriving from the reference devices: Philips Multi-slice CT system with Low Dose CT lung cancer screening (K153444), Brilliance iCT (Brilliance Volume) (K060937), 14 (Integrated Intelligent Imaging Informatics) system (K160315) and EBW NM2.0 (K111336)
Below is the comparison table to summarize the similarities and differences of the subject, predicates, and reference devices:
| Feature | The proposed
device:
Lung Nodule
Assessment and
Comparison
Option (LNA
application) | Primary Predicate:
Toshiba's Lung
Analysis Software
(K151283) | Predicate:
Philips' Lung
Nodule
Assessment
and
Comparison
option
(K023785) | Reference
device |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | System, Image
processing,
Radiological | System, Image
processing,
Radiological | System,
Image
processing,
Radiological | Not relevant
for this
subject |
| Device Class | Class II | Class II | Class II | Not relevant for
this subject |
| Classification
Panel | Radiology | Radiology | Radiology | Not relevant for
this subject |
| Product Code | LLZ, JAK | JAK, LLZ | 90 JAK | Not relevant for
this subject |
| Regulation
Description | Radiological
Image Processing
Software | Radiological Image
Processing Software | Radiological
Image
Processing
Software | Not relevant for
this subject |
| Regulation
Number | 21 CFR 892.2050
21CFR 892.1750 | 21CFR 892.1750 | 21CFR
892.1750 | Not relevant for
this subject |
| Indication For
Use | The Lung Nodule
Assessment and
Comparison
Option is intended
for use as a
diagnostic patient-
imaging tool.
It is intended for
the review and
analysis of
thoracic CT
images, providing
quantitative and
characterizing
information about
nodules in the
lung in a single
study, or over the
time course of
several thoracic
studies.
Characterizations
include diameter,
volume and
volume over time.
The system
automatically
performs the
measurements,
allowing lung
nodules and
measurements to
be displayed. | The separately licensed
Lung Analysis option is
intended for the review
and analysis of thoracic
CT images for the
purposes of
characterizing nodules
in the lung in a single
study, or over the time
course of several
thoracic studies.
Characterizations
include diameter,
volume and volume
over time. The system
automatically
performs the
measurements, allowing
lung nodules and
measurements to be
displayed. | The Lung
Nodule
Assessment
and
Comparison
Option is
intended for
use as a
diagnostic
patient-
imaging tool.
It is intended
to provide
quantitative
information
about
physician-
indicated lung
nodules that
are identified
on high-
resolution
computed
tomography
images of the
lung. | Not relevant
for this subject |
| Intended users | Radiologists and
Technologist | Radiologists,
Technologist and
Oncologists | Radiologists
and
Technologist | Not relevant
for this
subject |
| Intended body
part | Chest | Chest | Chest | Not relevant for
this subject |
| Type of scans | Thoracic CT
images | Thoracic CT images | Thoracic CT
images | Not relevant for
this subject |
| 2D image review | Yes | Yes | Yes | Not relevant for
this subject |
| 3D image review | Yes | Yes | Yes | Not relevant for
this subject |
| 2D and 3D
comparative
review | Yes | Yes | No | Not relevant for
this subject |
| | | | | |
| 2D
measurements | Yes | Yes | Yes | Not relevant for
this subject |
| Segmentation of
lung airway,
lungs and lung
lobes | Yes | Yes | No | Brilliance iCT
(Brilliance
Volume),
(K060937) |
| Single click lung
nodule
segmentation | Yes | Yes | Yes | Not relevant for
this subject |
| Nodule
Characteristics | Yes | Yes | No | Not relevant for
this subject |
| Automatic
calculation of
measurements
for each
segmented
nodule | Yes
■ Short
axis- Longest
diameter
perpendicular to
the long axis on
the slice(mm)
■ Long
Axis- Longest
diameter on an
axial slice (mm)
■ Average
\ Max 3D
Effective diameter
(mm)
■ Volume
(mm3)
■ Mean densities
(HU) | Yes
■ Volume (mm³)
■ Mean diameter
(mm)
■ Maximum
diameter (mm)
■ Short axis
diameter (mm)
■ Average/mini
mum/maximum
densities (HU) | No | Not relevant for
this subject |
| Comparison and
Matching | Yes | Yes | Yes | EBW NM
2.0
(K111336)
■ I4
(Integrated
Intelligent
Imaging
Informatics)
system
■ (K160315) |
| Comparison and
matching
automatic
calculations
between each
follow-up scan
and the previous
scan | Yes
■ Doubling
time in days
■ Percent
(%) and absolute
change of all
numerical
parameters | Yes
■ Elapsed time
in days
■ Doubling time
in days
Percent (%) growth in
nodule volume | Yes | Not relevant for
this subject |
| | long axis, short
axis, average
diameter, max 3D
diameter,
effective
diameter, volume,
mean HU). | | | Not relevant for |
| Workflow | ■ Detect and
Segment
■ Comparison and
Matching
■ Results | ■ Point-and-click
detection
■ Automated contouring
■ Automated
measurements
■ Manual correction | ■ Detect and
Segment
■ Comparison
and Matching
■ Results | this subject |
| Loading multiple
studies | Yes
Up to 8 studies | Yes
Up to 3 studies | Yes
Up to 3 studies | Not relevant for
this subject |
| Supporting Low-
dose CT | Yes | Yes | No | Not relevant for
this subject |
| Reporting results | Yes
The results
includes the
following:
• Patient
related
information
• Dictation
• Table with
Nodule result
table and
additional
findings
• Lung-
RADS
• Risk
Calculator | Yes
The results includes the
following:
• Dictation
• Table with Nodule
result table
• Lung-RADS
• Fleischer
• Criteria | Yes
The results
includes the
following:
• Dictation Table
with Nodule
result table | Not relevant for
this subject |
| Printing Option | Yes | Yes | Yes | Not relevant for
this subject |
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Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
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Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out.
Philips Medical Systems Lung Nodule Assessment and Comparison Option (LNA application) and the identified predicate devices, primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785) are substantial equivalent in terms of indication for use and intended
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users, design features, principle of operation and fundamental scientific technology, and safety and/or effectiveness.
The above listed technological differences are considered low risk, providing further support to clinicians in accessing current technologies or features. These functionalities are derived from reference predicate devices and were verified and validated, and do not raise new questions on safety and/or effectiveness.
These features have not changed the intended use and operational principles of the device. Therefore, the Lung Nodule Assessment and Comparison Option is substantially equivalent to the identified predicate devices , primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips' Lung Nodule Assessment and Comparison option (K023785)and the reference devices in terms of technological characteristics.
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
Lung Nodule Assessment and Comparison Option 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.
For the Lung Nodule Assessment and Comparison Option (LNA), validation and verification
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activities were conducted to provide objective evidence that the design meets user needs and intended use and application specification.
These validation activities assure that the lung and lobe segmentation, the comparison, as well as the nodule matching and propagation functionality, and the Prefill functionality for the Lung RADS score and the risk prediction are adequate from an overall product perspective. The LNA application was validated using real recorded clinical data cases in order to simulate the actual use of the software .Each test case was evaluated for the complete clinical workflow.
In addition, a usability study was conducted according to the standards
The test results in this 510(k) premarket notification demonstrate that Lung Nodule Assessment and Comparison Option:
- . 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
McWilliams, A et al ' conducted a population-based prospective clinical study to determine factors predicting the probability that lung nodules detected on the first screening low-dose CT scans are malignant or will be found to be malignant on follow-up.
The authors indicated that the final parsimonious and full models showed excellent discrimination and calibration, with areas under the receiver-operating-characteristic curve of more than 0.90, even for nodules that were 10 mm or smaller in the validation set.
McWilliams A et al concluded that Predictive tools based on patient and nodule characteristics can be used to accurately estimate the probability that lung nodules detected on baseline screening low-dose CT scans are malignant.
The investigators analyzed data from two cohorts of participants undergoing low-dose CT screening. The development data set included participants in the Pan-Canadian Early Detection of
1 McWilliams, A., Tammemagi, M.C., Mayo, J.R., Roberts, H., Liu, G., Soghrati, K., Yasufuku, K., Martel, S., Laberge, F., Gingras, M. and Atkar-Khattra, S.,. Probability of cancer in pulmonary nodules detected on first screening CT. New England Journal of Medicine, 2013: 369(10), 910-919.
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Lung Cancer Study (PanCan). The validation data set included participants involved in chemoprevention trials at the British Columbia Cancer Agency (BCCA), sponsored by the U.S. National Cancer Institute. The final outcomes of all nodules of any size that were detected on baseline low-dose CT scans were tracked. Parsimonious and fuller multivariable logisticregression models were prepared to estimate the probability of lung cancer.
IX. The conclusions drawn from the nonclinical and clinical tests
Verification and Validation (V&V) activities required to establish performance and functionality of Lung Nodule Assessment and Comparison Option were performed. Testing performed demonstrated the Lung Nodule Assessment and Comparison Option meets all defined functionality requirements and performance claims.
- Overall The Lung Nodule Assessment and Comparison Option is X. substantially equivalent to the identified predicate devices , conclusion: primary- Toshiba's Lung Analysis Software (K151283) and predicate- Philips'Lung Nodule Assessment and Comparison option (K023785), 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 specification.
Philips Medical believes that the proposed device, Lung Nodule Assessment and Comparison Option, is substantially equivalence to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.