(74 days)
Not Found
No
The document describes image processing, quantitative analysis, and comparison to a reference population, but does not mention AI, ML, or related terms like deep learning or neural networks. There is also no information about training or test sets, which are typically associated with AI/ML development.
No
The device is described as a diagnostic tool for processing, quantification, and review of cardiac tomographic studies, and for evaluating calcified plaques and monitoring their progression, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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."
No
The device is described as an "application" and provides "tools for processing and displaying" images, which are characteristics of software. However, the description also mentions "integrated into Corridor4DM (SPECT-CT and PET-CT)" and "integrated into Corridor4DM" for the optional features. This suggests that the software is integrated into or part of a larger system that includes hardware (SPECT, PET, and CT scanners). The summary does not explicitly state that the device is only the software component and does not include any hardware.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They perform tests outside of the body.
- Device Function: The description clearly states that Corridor4DM processes, quantifies, and reviews reconstructed cardiac emission tomographic studies (SPECT and PET) and Cardiac CT interpretation and calcium quantification. These are all imaging modalities that analyze data acquired from within the patient's body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
The device is a medical imaging software application used for the analysis and interpretation of medical images acquired from patients. While it provides diagnostic information, it does so by processing and analyzing images, not by performing tests on in vitro specimens.
N/A
Intended Use / Indications for Use
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). 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. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. 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 (comma separated list FDA assigned to the subject device)
KPS, JAK, LLZ
Device Description
Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac emission tomographic studies (SPECT and PET), Cardiac CT
Anatomical Site
Cardiac, coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
510k Summary
A) Submitted by: INVIA, LCC 3025 Boardwalk, Suite 200 Ann Arbor, MI 48108 Registration: 9069896
MAY 1 3 2008
Contact: MEDIcept 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 x20 508-231-8861 Fax
Corridor4DM B) Device Name: Common Name: System, Emission Computed Tomography & System, X-Ray Computed Tomography
| Device Class: | 21 CFR 892.1200 |
|---|---|
| 21 CFR 892.1750 CLASS I |
KPS, JAK Product Code
C) Predicate:
Reagents of the University of Michigan 3D-MSPECT system (K001026) Siemens, Calcium Scoring Software Package (K990426)
D) Device Description:
Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.
1
E) Intended Use:
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). 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. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. 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.
F) Comparison to Predicate Device(s):
The Corridor 4DM has the same intended use, target population, and clinical setting as other SPECT software including the predicate devices. It uses the same technology as the predicate devices (3D-MSPECT system (K001026) and Calcium Scoring Software Package (K990426).
| Features | Corridor4DM | 3D-MSPECT | Siemens Calcium
Scoring Software
Package |
|-------------------------------------------------------------------------|--------------|-----------|------------------------------------------------|
| Computer based
templating system | Yes | Yes | NA |
| Digital image retrieval
of patient radiographs | Yes | Yes | NA |
| Patient Studies Type | ECT, PET, CT | ECT, PET | N/A |
| Measurement Tools | Yes | Yes | NA |
| Overlay of prosthetic
templates for proper
selection by physician | Yes | Yes | NA |
| Generation of Parts List | Yes | Yes | NA |
| Patient files can be
saved locally, on a
network, or printed. | Yes | Yes | NA |
| Allows for assessment
of wear. | Yes | Yes | NA |
| Identify and quantify
CT data via imaging | Yes | No | Yes |
2
Corridor4DM 510(k) Premarket-Notification Submission
G) Guidance Document
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
H) Conclusion:
Invia, LLC believes that the Corridor4DM is substantially equivalent to the predicate devices based on intended usage, technology comparison and system performance.
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 eagle with three tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2008
Invia Mr. F. David Rothkopf President MEDIcept, Inc. 200 Homer Ave ASHLAND MA 01721
Re: K080575
Trade/Device Name: Corridor4DM Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK, and LLZ Dated: February 20, 2008 Received: February 29, 2008
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 for assession 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.
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 (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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting 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 Manufacturers, 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K080575
Device Name: Corridor4DM
Indications for Use:
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). 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. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. 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.
Prescription Use X OR Over-the-Counter Use _____21 CFR 801.109
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hory M. Khan
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
February 20, 2008
Corridor4DM