IQQA-CHEST SOFTWARE PACKAGE

K042408 · Edda Technology, Inc. · OMJ · Oct 8, 2004 · Radiology

Device Facts

• Record ID: K042408
• Device Name: IQQA-CHEST SOFTWARE PACKAGE
• Applicant: Edda Technology, Inc.
• Product Code: OMJ · Radiology
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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

Device Story

IQQA-Chest is a PC-based software package for digital chest radiographic image analysis. It ingests DICOM images; provides viewing tools (window level, pan, zoom); and utilizes automated segmentation to identify potential lung lesions. The software assists physicians by highlighting regions meeting intensity and shape constraints correlating with nodules. It enables regional analysis (size, shape, position) of physician-identified lesions to aid characterization and documentation. Used in clinical settings by physicians, the output supports clinical decision-making regarding lesion evaluation and patient management. It benefits patients by providing quantitative support for lesion identification and follow-up.

Clinical Evidence

Bench testing only. Software testing and validation were performed according to internal company procedures and written test protocols. Results were reviewed by technical professionals to confirm performance satisfies design intent.

Technological Characteristics

PC-based software package; runs on standard PC hardware with Windows OS. Features graphical user interface for image viewing, automated segmentation, and quantitative measurement tools. Inputs via DICOM. No specific hardware materials or energy sources listed; software-only device.

Indications for Use

Indicated for use by physicians to support identification, confirmation, evaluation, and documentation of lung lesions (e.g., nodules) in digital chest radiographic images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Siemens LungCARE CT Software Package with extended functionality (K033374)
• R2 ImageChecker CT Software Package with Filling Defect Indicator (K041380)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Contact: Xiaolan Zeng, Vice President, Clinical Affairs Date: August 30, 2004

- 1. 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
- 2. Equivalent legally marketed devices:

| Manufacturer | Name of the Predicate<br>Device | FDA 510(k)<br>Number | FDA Clearance<br>Date |
|----------------------------|----------------------------------------------------------------------|----------------------|-----------------------|
| Siemens Medical<br>Systems | LungCARE CT Software<br>Package with extended<br>functionality | K033374 | 11/06/2003 |
| R2 Technology | ImageChecker CT<br>software package with<br>Filling Defect Indicator | K041380 | 06/08/2004 |

- 3. 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
- 4. 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)<br>submission: |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Siemens LungCARE CT<br>software package with<br>extended functionality<br>(K033374) | R2 ImageChecker CT<br>Software Package with<br>Filling Defect Indicator<br>(K041380) | IQQA-Chest Software<br>Package |
| | Siemens Medical Solutions | R2 Technology, Inc | EDDA Technology, Inc. |
| Indications for<br>Use | LungCARE CT is a self-<br>contained image analysis<br>software package for evaluating<br>CT volume data sets. Combining<br>enhanced commercially available<br>digital image processing tools<br>with an optimized workflow and<br>reporting tools, the software is<br>designed to support the physician<br>in confirming the presence or<br>absence of physician identified<br>lung lesions (e.g. nodules) in<br>addition to evaluation,<br>documentation and follow-up of<br>any such lesions using standard<br>or low-dose spiral CT scanning.<br>The LungCARE CT Software<br>Package with extended<br>functionality contains<br>modifications which support the<br>user with a special workflow<br>based on automated<br>segmentation for the visual<br>identification of possible lesions<br>(Nodule Enhanced Viewing).<br>This visualization tool allows for<br>volumetric analysis of<br>pulmonary nodule or lesion size<br>over time, helping the Physician<br>to assess the changes in their<br>growth. It is also designed to | The ImageChecker CT<br>Software Package with<br>Filling Defect Indicator<br>(FDI) is used during the<br>review of contrast-enhanced<br>CT images of the chest. This<br>software tool enables the<br>radiologist to view and<br>analyze regions of the image<br>containing low density<br>within vascular structures<br>that may be indicative of<br>filling defects or other<br>intravascular abnormalities.<br>The software is designed to<br>assist the radiologist in<br>characterization and<br>classification of these<br>suspicious candidate<br>thoracic abnormalities in<br>terms of density, size,<br>dimension, shape and<br>position, thus aiding in the<br>patient management care<br>decision process. | The IQQA-Chest is a PC-<br>Based, self-contained, non-<br>invasive image analysis<br>package used during the<br>review of digital chest<br>radiographic images.<br>Combining image viewing,<br>evaluation and reporting<br>tools, the software is<br>designed to support the<br>physician in the<br>identification of lung lesions<br>(e.g. nodules), as well as the<br>confirmation, evaluation and<br>documentation of such<br>physician-identified lesions.<br>The IQQA-Chest software<br>package supports a<br>workflow based on<br>automated segmentation for<br>the visual identification of<br>possible lesions. The tools<br>also allow for regional<br>analysis of possible lesions<br>in terms of size, shape and<br>position, thus aiding the<br>physician in the<br>characterization of<br>physician-identified<br>suspicious lesions.<br>Image source: DICOM |

- 5. Safety and Effectiveness, comparison to predicate device:

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| | Predicate Device:<br>Siemens LungCARE CT<br>software package with<br>extended functionality<br>(K033374) | Predicate Device:<br>R2 ImageChecker CT<br>Software Package with<br>Filling Defect Indicator<br>(K041380) | Device of 510(k)<br>submission:<br>IQQA-Chest Software<br>Package |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | help the physician classify<br>conspicuous regions of tissue<br>unambiguously having<br>determined their size,<br>dimensions, shape and position. | | |
| Hardware /<br>Operating<br>systems | Standard PC / Windows | Standard PC / Windows | SAME |
| User interface | A graphical user interface for<br>users to interact with the<br>software, select tools and<br>drive workflow | A graphical user interface<br>for users to interact with<br>the software, select tools<br>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.

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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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

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