(90 days)
Not Found
No
The summary describes image processing and quantitative analysis algorithms, but there is no mention of AI, ML, or related terms.
No.
The device is described as an application for processing, quantifying, and reviewing medical images and data, primarily to aid in interpretation and diagnosis, not to provide therapy.
Yes
The "Intended Use" section directly states that the calcium scoring package is a "non-invasive diagnostic tool" used to evaluate risk factors for coronary artery disease. Additionally, the "Device Description" mentions the ability to save and export "diagnostic findings".
Yes
The device is described as a "comprehensive application" and "application" throughout the description, focusing on processing, reviewing, and analyzing image data. While it processes data from hardware modalities (nuclear medicine, PET, CT, etc.), the device itself is the software application performing these functions. There is no mention of the device including or being dependent on specific hardware components beyond the input imaging modalities.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The description of Corridor4DM v2010 clearly states it processes and analyzes images of the biodistribution of radionuclides in the body, as well as CT images.
- The intended use and device description focus on image processing, quantification, and review. While it aids in diagnostic interpretation, it does so by analyzing imaging data, not biological samples.
Therefore, Corridor4DM v2010 falls under the category of medical imaging software or a picture archiving and communication system (PACS) component with advanced analysis capabilities, rather than an IVD.
N/A
Intended Use / Indications for Use
INVIA's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT).- The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Product codes
KPS, JAK, LLZ
Device Description
Corridor4DM v2010 is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies. The application provides tools to process, quantify, and display static, dynamic, gated planar,- standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. ECT data is displayed on both a slice-by-slice basis and as 3-dimensional surface- rendered images in many user selectable formats. All of the image formats can be viewed as a single dataset or as a comparison of related datasets. Among several optional display screens are sideby-side displays optimized for the review of uncorrected and attenuation corrected cardiac images. Corridor4DM v2010 algorithmically determines and displays the left ventricular endocardial and epicardial surfaces. These surfaces provide quantitative assessments of cardiac functions. Corridor-4DM v2010 includes the ability to save and export diagnostic findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC) in addition to producing static (JPEG, TIFF) and dynamic (AVI) image files.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear medicine, PET, CT, ECT (including SPECT-CT and PET-CT)
Anatomical Site
Body (general), Myocardium, Coronary arteries, Left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
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
Corridor4DM v2010 validation testing showed no new issues of safety and effectiveness when compared to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K080575, K083327, K063762, K023190, K003437
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
510(k) Summary
A) Submitted by: INVIA, LCC
3025 Boardwalk, Suite 200 Ann Arbor, MI 48108 Registration Number: 3004993756 Operator Number: 9069896
AUG 0 4 2010
1401279
Contact:
- MEDIcept 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 508-231-8861 Fax
B) Device Name: Corridor4DM v2010
Classification Name: System, Imaging Processing, Radiogical
Device Class:
21 CFR 892.1200 (KPS) 21 CFR 892.1750 (JAK 21 CFR 892.2050 (LLZ)
CLASS II
Product Code
KPS, JAK, LLZ
C) Substantially Equivalent (predicate) device(s):
Device Corridor4DM syngoCirculation DynamicPET Syngo® Circulation E.CAM Odyssey LX Model
Manufacturer INVIA, LLC Siemens Siemens Siemens Philips Medical
510(k) Number K080575 K083327 K063762 K023190 K003437 ·
D) Device Description:
Corridor4DM v2010 is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies. The application provides tools to process, quantify, and display static, dynamic, gated planar,- standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. ECT data is displayed on both a slice-by-slice basis and as 3-dimensional surface- rendered images in
Invia 510(k)
April 26, 2010
Corridor4DM v2010
1
many user selectable formats. All of the image formats can be viewed as a single dataset or as a comparison of related datasets. Among several optional display screens are sideby-side displays optimized for the review of uncorrected and attenuation corrected cardiac images. .
Corridor4DM v2010 algorithmically determines and displays the left ventricular endocardial and epicardial surfaces. These surfaces provide quantitative assessments of cardiac functions. Corridor-4DM v2010 includes the ability to save and export diagnostic findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC) in addition to producing static (JPEG, TIFF) and dynamic (AVI) image files.
Corridor4DM v2010 is intended to be used only by trained medical professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment.
F) Intended Use:
INVIA's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT).- The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
G) Comparison to Predicate Device(s):
The Corridor4DM v2010 has the same technology, intended use, target population, and clinical setting as the predicate devices.
April 26, 2010
Corridor4DM v.2010
2
The chart below compares the Corridor4DM v2010 device to predicate devices.
| Features | Corridor4DM
v2010 | Corridor4DM
K080575 | Syngo Circulation
Dynamic
K083327 | Syngo Circulation
K063762 | E. CAM
K023190 | Odyssey
K003437 |
|------------------------------------------------|----------------------|------------------------|-----------------------------------------|------------------------------|-------------------|--------------------|
| Product Code | KPS,
JAK,
LLZ | KPS,
JAK,
LLZ | LLZ | JAK | LLZ | LLZ |
| Reconstruction of
tomographic datasets | Yes | No | No | No | Yes | Yes |
| Processing of Planar
Images | Yes | No | No | No | Yes | Yes |
| Quantification of tracer
uptake over time | Yes | No | Yes
(PET only) | No | Yes
(NM only) | Yes
(NM only) |
| Digital image retrieval
of radiographs | Yes | Yes | Yes | Yes | Yes | Yes |
| Quantitative Estimates
of Cardiac Function | Yes | Yes | No | Yes | No | No |
| Quantitative estimates
of cardiac perfusion | Yes | Yes | Yes | Yes | No | No |
i
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
Corridor4DM v.2010
. .
3
H) Safety and Effectiveness:
The Corridor4DM v2010 application and safety is assessed via the Risk Management Plan in accordance with ISO 14971.
I) Guidance Documents:
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final, FDA December 3, 1998
Guidance for the Submission of Premarket Notifications for Medical Image Management Devices Document issued on: July 27, 2000
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final, FDA May 11, 2005
J) Conclusion:
Invia, LLC believes that the Corridor4DM v2010 is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance. Corridor4DM v2010 validation testing showed no new issues of safety and effectiveness when compared to predicate devices.
April 26, 2010
Corridor4DM v.2010
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
ANS 04 2010
INVIA, LLC % Mr. F. David Rothkopf President MEDIcept, Inc. 200 Homer Ave ASHLAND MA 01721
Re: K101279
Trade/Device Name: Corridor4DM v2010 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, KPS, and JAK Dated: April 26, 2010 Received: May 6, 2010
Dear Mr. Rothkopf:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I frease of acrease 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 or mr) 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
5
Enclosure
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): K101279
AUG 0 4 2010
Device Name: Corridor4DM v2010
Indications for Use:
INVIA's Corridor4DM v2010 application is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the corònary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological D Office of In Vitro
510K K101279
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Corridor4DM v2010
INVIA 510(k)
005