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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Corridor4DM v2010 device and does not contain detailed information about specific acceptance criteria, a comprehensive study proving adherence to such criteria, or performance metrics. It focuses on demonstrating substantial equivalence to predicate devices.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be answered from the provided text. The document states that "Corridor4DM v2010 validation testing showed no new issues of safety and effectiveness when compared to predicate devices," but it does not specify what those validation tests were, what acceptance criteria were set, or the quantitative performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be answered from the provided text. The document does not mention any specific test set sample sizes or data provenance for any validation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be answered from the provided text. There is no information about expert involvement in establishing ground truth for any test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be answered from the provided text. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be answered from the provided text. The document describes the device as a "comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies." It also states "The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment." This suggests it's an aid, but no MRMC comparative effectiveness study or improvement effect size for human readers with and without AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be answered from the provided text directly in terms of a standalone performance study. The document implies that the device performs algorithmic determinations (e.g., "algorithmically determines and displays the left ventricular endocardial and epicardial surfaces"). However, it's explicitly stated that the "Clinician retains the ultimate responsibility," indicating it's not a standalone diagnostic device. No specific standalone performance study metrics are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be answered from the provided text. The document does not specify how ground truth was established for any validation or testing performed.

8. The sample size for the training set

Cannot be answered from the provided text. There is no mention of a training set or its size.

9. How the ground truth for the training set was established

Cannot be answered from the provided text. As no training set is mentioned, naturally, how its ground truth was established is also not provided.

Summary of what is present:

Intended Use: To provide processing, quantification, and multidimensional review of biodistribution of radionuclides using planar and tomographic images, perform quantitative measurements of tracer uptake, aid in myocardial perfusion image interpretation, and offer optional cardiac CT interpretation and calcium quantification.
Safety and Effectiveness Assessment: Assessed via a Risk Management Plan in accordance with ISO 14971.
Conclusion: The device is deemed substantially equivalent to predicate devices based on intended usage, technology comparison, and system performance, with validation testing showing "no new issues of safety and effectiveness."
Device Functionality: Algorithmically determines and displays left ventricular endocardial and epicardial surfaces, provides quantitative assessments of cardiac function, and generates various image formats and dynamic files.

To obtain the detailed information requested, one would need to refer to more comprehensive documentation related to the device's validation and verification testing, which is typically part of the full 510(k) submission but not fully included in the public-facing summary.

Summary

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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:

Invia 510(k)

April 26, 2010

Corridor4DM v2010

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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

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The chart below compares the Corridor4DM v2010 device to predicate devices.

Features	Corridor4DMv2010	Corridor4DMK080575	Syngo CirculationDynamicK083327	Syngo CirculationK063762	E. CAMK023190	OdysseyK003437
Product Code	KPS,JAK,LLZ	KPS,JAK,LLZ	LLZ	JAK	LLZ	LLZ
Reconstruction oftomographic datasets	Yes	No	No	No	Yes	Yes
Processing of PlanarImages	Yes	No	No	No	Yes	Yes
Quantification of traceruptake over time	Yes	No	Yes(PET only)	No	Yes(NM only)	Yes(NM only)
Digital image retrievalof radiographs	Yes	Yes	Yes	Yes	Yes	Yes
Quantitative Estimatesof Cardiac Function	Yes	Yes	No	Yes	No	No
Quantitative estimatesof cardiac perfusion	Yes	Yes	Yes	Yes	No	No

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Corridor4DM v.2010

. .

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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

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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

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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

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Indications for Use

510(k) Number (if known): K101279

AUG 0 4 2010

Device Name: Corridor4DM v2010

Indications for Use:

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

Page 1 of 1

Corridor4DM v2010

INVIA 510(k)

005

Regulation Number and Section

§ 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).