(35 days)
Not Found
Unknown
The summary mentions "automated segmentation" and "circular shape constraints" for identifying potential lesions, which could potentially be implemented using traditional image processing techniques or AI/ML. However, the summary explicitly states "Mentions AI, DNN, or ML: Not Found" and lacks details about training or test sets, which are typical for AI/ML-based devices. Without further information, it's impossible to definitively confirm or deny the presence of AI/ML.
No
The device is an image analysis package designed to identify, evaluate, and document lung lesions, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is described as "designed to support the physician in the identification of lung lesions" and to aid in "the characterization of physician-identified suspicious lesions," which directly relates to diagnosing conditions.
Yes
The device is described as a "PC-Based, self-contained, non-invasive image analysis package" and a "Software Package" designed to run on "standard PC hardware." The description focuses entirely on the software's functionality for image viewing, analysis, and reporting, without mentioning any proprietary or specific hardware components included as part of the device itself.
Based on the provided information, the IQQA-Chest 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.
- IQQA-Chest Function: The IQQA-Chest is a software package that analyzes digital chest radiographic images. These are images generated from a medical imaging modality (X-ray), not samples taken from the body.
- Intended Use: The intended use clearly states it's for the review and analysis of images, not biological samples.
- Device Description: The description reinforces that it's a software package for analyzing thoracic radiographic images.
Therefore, the IQQA-Chest falls under the category of medical image analysis software, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
Product codes
90 LLZ, OMJ
Device Description
The IQQA-Chest Software Package is a self-contained, non-invasive thoracic radiographic image analysis package that is designed to run on standard PC hardware. Combining image viewing tools (e.g. image window level, pan, zoom, enhancement viewing), evaluation tools (e.g. automatic/interactive segmentation, quantitative measurements derived from marking and segmentation), and reporting tools (e.g. saved lesion, measurement information, physician-input nodule characterization, and etc), the software package is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the the physician in the laonificance or entation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation IQQA-Chost software package bapple lesions (nodule enhanced viewing). Based on physician's request, the tool segments locations in the lung area containing circular prysional o requeed, invites fulfiling intensity signal and circular shape constraints) that would typically correlate with lung nodules. The tools also allow for regional that would typessible lesions with respect to size, shape and position, aiding the anaryold or pobo characterization of physician-identified suspicious lesions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital chest radiographic images, DICOM
Anatomical Site
lung, thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K04-2-408
CC) 3 -- 2004
EXHIBIT 2
510(k) Summary EDDA Technology, Inc Building 2 14 Washington Road Princeton Junction, NJ 08550 Tel: 609-936-8282 Fax: 609-799-1545 Contact: Xiaolan Zeng, Vice President, Clinical Affairs Date: August 30, 2004
-
- Identification of the Device: Proprietary-Trade Name: IQQA-Chest Software Package Classification Name: System, Image Processing, Radiological, Product Code 90 LLZ Common/Usual Name: Radiological Image Processing System
-
- Equivalent legally marketed devices:
| Manufacturer | Name of the Predicate
Device | FDA 510(k)
Number | FDA Clearance
Date |
|----------------------------|----------------------------------------------------------------------|----------------------|-----------------------|
| Siemens Medical
Systems | LungCARE CT Software
Package with extended
functionality | K033374 | 11/06/2003 |
| R2 Technology | ImageChecker CT
software package with
Filling Defect Indicator | K041380 | 06/08/2004 |
-
- Indications for Use (intended use): The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
-
- Description of the device: The IQQA-Chest Software Package is a self-contained, non-invasive thoracic radiographic image analysis package that is designed to run on standard PC hardware. Combining image viewing tools (e.g. image window level, pan, zoom, enhancement viewing), evaluation tools (e.g. automatic/interactive segmentation, quantitative measurements derived from marking and segmentation), and reporting tools (e.g. saved lesion, measurement information, physician-
1
input nodule characterization, and etc), the software package is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the the physician in the laonificance or entation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation IQQA-Chost software package bapple lesions (nodule enhanced viewing). Based on physician's request, the tool segments locations in the lung area containing circular prysional o requeed, invites fulfiling intensity signal and circular shape constraints) that would typically correlate with lung nodules. The tools also allow for regional that would typessible lesions with respect to size, shape and position, aiding the anaryold or pobo characterization of physician-identified suspicious lesions.
| Manufacturer | Predicate Device: | Predicate Device: | Device of 510(k)
submission: |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Siemens LungCARE CT
software package with
extended functionality
(K033374) | R2 ImageChecker CT
Software Package with
Filling Defect Indicator
(K041380) | IQQA-Chest Software
Package |
| | Siemens Medical Solutions | R2 Technology, Inc | EDDA Technology, Inc. |
| Indications for
Use | LungCARE CT is a self-
contained image analysis
software package for evaluating
CT volume data sets. Combining
enhanced commercially available
digital image processing tools
with an optimized workflow and
reporting tools, the software is
designed to support the physician
in confirming the presence or
absence of physician identified
lung lesions (e.g. nodules) in
addition to evaluation,
documentation and follow-up of
any such lesions using standard
or low-dose spiral CT scanning.
The LungCARE CT Software
Package with extended
functionality contains
modifications which support the
user with a special workflow
based on automated
segmentation for the visual
identification of possible lesions
(Nodule Enhanced Viewing).
This visualization tool allows for
volumetric analysis of
pulmonary nodule or lesion size
over time, helping the Physician
to assess the changes in their
growth. It is also designed to | The ImageChecker CT
Software Package with
Filling Defect Indicator
(FDI) is used during the
review of contrast-enhanced
CT images of the chest. This
software tool enables the
radiologist to view and
analyze regions of the image
containing low density
within vascular structures
that may be indicative of
filling defects or other
intravascular abnormalities.
The software is designed to
assist the radiologist in
characterization and
classification of these
suspicious candidate
thoracic abnormalities in
terms of density, size,
dimension, shape and
position, thus aiding in the
patient management care
decision process. | The IQQA-Chest is a PC-
Based, self-contained, non-
invasive image analysis
package used during the
review of digital chest
radiographic images.
Combining image viewing,
evaluation and reporting
tools, the software is
designed to support the
physician in the
identification of lung lesions
(e.g. nodules), as well as the
confirmation, evaluation and
documentation of such
physician-identified lesions.
The IQQA-Chest software
package supports a
workflow based on
automated segmentation for
the visual identification of
possible lesions. The tools
also allow for regional
analysis of possible lesions
in terms of size, shape and
position, thus aiding the
physician in the
characterization of
physician-identified
suspicious lesions.
Image source: DICOM |
-
- Safety and Effectiveness, comparison to predicate device:
2
| | Predicate Device:
Siemens LungCARE CT
software package with
extended functionality
(K033374) | Predicate Device:
R2 ImageChecker CT
Software Package with
Filling Defect Indicator
(K041380) | Device of 510(k)
submission:
IQQA-Chest Software
Package |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | help the physician classify
conspicuous regions of tissue
unambiguously having
determined their size,
dimensions, shape and position. | | |
| Hardware /
Operating
systems | Standard PC / Windows | Standard PC / Windows | SAME |
| User interface | A graphical user interface for
users to interact with the
software, select tools and
drive workflow | A graphical user interface
for users to interact with
the software, select tools
and drive workflow | SAME |
6. Testing information and Conclusion
In all material respects, the IQQA-Chest Software Package is substantially equivalent to the predicate systems. Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health and human well-being. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
Public Health Service
MAR 1 1 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EDDA Technology, Inc. % Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K042408
Trade/Device Name: IQQA-Chest Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OMJ Dated: August 30, 2004 Received: September 3, 2004
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of October 8, 2004.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely vours.
Harold Leeman
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K.04 2408
Device Name: IQQA-Chest Software Package
The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions.
The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seggern
(Division Sign-Off, Division of Reproduct and Radiological Devi 510(k) Number
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