(14 days)
No
The description focuses on image processing, visualization, and comparative analysis tools, without mentioning AI or ML algorithms for tasks like detection, segmentation, or characterization. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The primary purpose of the device is to assist radiologists in viewing, analyzing, registering, and comparing thoracic CT images to characterize and classify abnormalities, which is a diagnostic function, not a therapeutic one.
Yes.
The device is designed to assist radiologists in the characterization and classification of suspicious thoracic abnormalities (e.g., pulmonary and pleural nodules and lesions) by calculating volume change and doubling time, as well as analyzing their size, dimension, shape, and position to aid in patient management care decisions. This function directly relates to diagnosing or assisting in the diagnosis of medical conditions.
Yes
The device description explicitly states "The C-CAT software is dedicated to assist the radiologist..." and describes its functions solely in terms of software tools for viewing, analyzing, and comparing images. It is designed to be used with existing CT workstations, implying it is a software add-on or package rather than a standalone hardware device.
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 Comprehensive Chest Analysis Tools (C-CAT) software analyzes medical images (CT scans) of the chest. It processes and presents information derived from these images to assist radiologists in their interpretation and decision-making.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient. Its input is image data, not biological material.
Therefore, while the device is used in the diagnostic process, it does so by analyzing images, not by performing in vitro tests on biological samples. It falls under the category of medical image analysis software, not an IVD.
N/A
Intended Use / Indications for Use
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images.
The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.
Product codes
LLZ
Device Description
The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables:
- a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection;
- b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and
- c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist
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
The Comprehensive Chest Analysis Tools package will undergo design verification tests for conformance with specifications.
Key Metrics
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).
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JAN 2 2 2004
Image /page/0/Picture/1 description: The image shows a stylized logo or symbol that appears to be a combination of the letters 'R' and the number '2'. The 'R' is drawn in a bold, somewhat ornate font, with serifs at the top and bottom. The number '2' is stylized to curve around the 'R', and there is a small circle or dot to the right of the '2', possibly serving as a decorative element or punctuation mark. The overall design is simple and monochromatic.
1195 W. Fremont Avenue Sunnyvale, CA 94087 3832 408.481.5600 p 408,481.5601 /
510(k) Summary of Safety and Effectiveness Prepared October 20th 2003
| Submitted by: | R2 Technology, Inc.
1195 W. Fremont Avenue
Sunnyvale, CA 94087 |
|-----------------|----------------------------------------------------------------------|
| Contact Person: | Kathy O'Shaughnessy
Vice President, Regulatory Affairs |
| Product Name: | CA-1500 |
| Common Name: | Comprehensive Chest Analysis Tools (C-CAT) |
| Classification: | LLZ, Class II; CFR 21 892.2050 |
Predicate Devices:
| Product | Company | 510(k) Number | Product
Classification |
|---------------------------------|-------------------------------------|---------------|---------------------------|
| ImageChecker CT
Workstation | R2 Technology Inc. | K023003 | LLZ, Class II |
| Advanced Lung
Analysis-1 | General Electric
Medical Systems | K013381 | JAK, Class II |
| LungCARE CT
Software Package | Siemens Medical
Solutions | K022013 | JAK, Class II |
Device Description:
The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables:
- a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection;
- b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and
w.r2tech.com
1
- c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.
Summary of Intended Use:
The Comprehensive Chest Analysis Tools (C-CAT) package is intended to provide the radiologist the ability to visualize thoracic CT series with enhanced imaging tools such as MPR and MIP; analyze, automatically/manually align and compare simultaneously presented current and previous thoracic CT images and selected "candidate" regions of interest (ROIs).
Comparison with Predicate Devices:
Hardware Platform Predicate:
R2 Technology's Comprehensive Chest Analysis Tools (C-CAT) package will reside in the ImageChecker CT Workstation hardware or any cleared CT workstation that has the ImageChecker CT Workstation software. The ImageChecker CT Workstation is the predicate for the hardware platform for this product.
Software Component Predicates:
R2 Technology's Comprehensive Chest Analysis Tools (C-CAT) package, GE's Advanced Lung Analysis (ALA-1) software package and Siemens LungCARE CT software package enable radiologists to view, analyze, register and compare current and prior thoracic CT series. These software packages allow the radiologist to examine segmented candidate chest lesions found in the CT case studies. These software packages also enable the radiologist to determine volumetric growth and doubling time of these lesions over time. Thus, their functional features are substantially equivalent.
Studies:
The Comprehensive Chest Analysis Tools package will undergo design verification tests for conformance with specifications.
Conclusion:
The Comprchensive Chest Analysis Tools package has the same intended use as the two software predicate devices identified in this section. Any technological differences in the Comprehensive Chest Analysis Tools package and the predicate devices do not raise any new questions regarding safety or effectiveness. Thus, R2 Technology's Comprehensive Chest Analysis Tools package is substantially equivalent to the predicate devices,
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
R2 Technology, Inc. % Ms. Denise Leung Klinker Reviewer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040028 Trade/Device Name: CA-1500, Comprehensive Chest Analysis tools (C-CAT) Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: January 6, 2003 Received: January 8, 2003
Dear Ms. Klinker:
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.
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.
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 (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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R2 Technology Comprehensive Chest Analysis Tools 510(k) Premarket Notification Oct. 20", 2003
Indications for Use:
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images.
The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: x (Pcr 21 CFR 801.109)
Over-The-Counter: -OR-
David des. Seppanen
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _