(35 days)
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
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.
The provided text describes the IQQA-Chest Software Package's 510(k) summary. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement of equivalency.
Therefore, I cannot populate the requested tables and information adequately. The document states:
- "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."
This indicates that internal testing was conducted, but the specifics such as criteria, methods, and results are not provided in this 510(k) summary.
Here's what I can provide based on the given text, highlighting the missing information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance (Achieved Performance) |
|---|---|
| Not specified in the document. | Not specified in the document beyond a general statement that "actual device performance satisfies the design intent." |
Study Information
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified (e.g., 2+1, 3+1, none).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Was an MRMC study done? Not specified.
- Effect size of improvement with AI vs. without AI assistance: Not applicable, as no MRMC study or effect size is reported. The device is described as "designed to support the physician in the identification of lung lesions," implying assistive capabilities, but no comparative effectiveness data is presented.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Was a standalone study done? Not explicitly stated, though the device's function involves "automated segmentation for the visual identification of possible lesions," which is an algorithm-only function. However, performance metrics for this standalone function are not provided.
7. The type of ground truth used:
- Type of ground truth: Not specified (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set:
- Training set sample size: Not specified.
9. How the ground truth for the training set was established:
- Ground truth establishment method: Not specified.
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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
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- 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
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- Equivalent legally marketed devices:
| Manufacturer | Name of the PredicateDevice | FDA 510(k)Number | FDA ClearanceDate |
|---|---|---|---|
| Siemens MedicalSystems | LungCARE CT SoftwarePackage with extendedfunctionality | K033374 | 11/06/2003 |
| R2 Technology | ImageChecker CTsoftware package withFilling Defect Indicator | K041380 | 06/08/2004 |
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- 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-
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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 CTsoftware package withextended functionality(K033374) | R2 ImageChecker CTSoftware Package withFilling Defect Indicator(K041380) | IQQA-Chest SoftwarePackage | |
| Siemens Medical Solutions | R2 Technology, Inc | EDDA Technology, Inc. | |
| Indications forUse | LungCARE CT is a self-contained image analysissoftware package for evaluatingCT volume data sets. Combiningenhanced commercially availabledigital image processing toolswith an optimized workflow andreporting tools, the software isdesigned to support the physicianin confirming the presence orabsence of physician identifiedlung lesions (e.g. nodules) inaddition to evaluation,documentation and follow-up ofany such lesions using standardor low-dose spiral CT scanning.The LungCARE CT SoftwarePackage with extendedfunctionality containsmodifications which support theuser with a special workflowbased on automatedsegmentation for the visualidentification of possible lesions(Nodule Enhanced Viewing).This visualization tool allows forvolumetric analysis ofpulmonary nodule or lesion sizeover time, helping the Physicianto assess the changes in theirgrowth. It is also designed to | The ImageChecker CTSoftware Package withFilling Defect Indicator(FDI) is used during thereview of contrast-enhancedCT images of the chest. Thissoftware tool enables theradiologist to view andanalyze regions of the imagecontaining low densitywithin vascular structuresthat may be indicative offilling defects or otherintravascular abnormalities.The software is designed toassist the radiologist incharacterization andclassification of thesesuspicious candidatethoracic abnormalities interms of density, size,dimension, shape andposition, thus aiding in thepatient management caredecision process. | The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysispackage used during thereview of digital chestradiographic images.Combining image viewing,evaluation and reportingtools, the software isdesigned to support thephysician in theidentification of lung lesions(e.g. nodules), as well as theconfirmation, evaluation anddocumentation of suchphysician-identified lesions.The IQQA-Chest softwarepackage supports aworkflow based onautomated segmentation forthe visual identification ofpossible lesions. The toolsalso allow for regionalanalysis of possible lesionsin terms of size, shape andposition, thus aiding thephysician in thecharacterization ofphysician-identifiedsuspicious lesions.Image source: DICOM |
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- Safety and Effectiveness, comparison to predicate device:
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| Predicate Device:Siemens LungCARE CTsoftware package withextended functionality(K033374) | Predicate Device:R2 ImageChecker CTSoftware Package withFilling Defect Indicator(K041380) | Device of 510(k)submission:IQQA-Chest SoftwarePackage | |
|---|---|---|---|
| help the physician classifyconspicuous regions of tissueunambiguously havingdetermined their size,dimensions, shape and position. | |||
| Hardware /Operatingsystems | Standard PC / Windows | Standard PC / Windows | SAME |
| User interface | A graphical user interface forusers to interact with thesoftware, select tools anddrive workflow | A graphical user interfacefor users to interact withthe software, select toolsand 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.
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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.
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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
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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
Page I of 1
§ 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).