CORRIDOR4DM

K080575 · Invia · KPS · May 13, 2008 · Radiology

Device Facts

• Record ID: K080575
• Device Name: CORRIDOR4DM
• Applicant: Invia
• Product Code: KPS · Radiology
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

Corridor4DM is a cardiac software application for processing, quantifying, and reviewing SPECT, PET, and CT cardiac images. It accepts reconstructed cardiac emission tomographic data and CT data as input. The device performs quantitative analysis, including calculation of left ventricular chamber volumes, ejection fraction, and transient ischemic dilation (TID) values; it also provides calcium scoring for coronary artery disease risk assessment. It supports coregistration and fusion of ECT and CT volumetric data for spatial correlation. Used in clinical settings by healthcare professionals, the software provides multi-dimensional displays and slice-by-slice visualization. Outputs assist clinicians in diagnostic interpretation, monitoring disease progression, and assessing cardiac function. The device benefits patients by providing non-invasive diagnostic information regarding heart function and coronary artery calcification.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and system performance characteristics relative to predicate devices.

Technological Characteristics

Software-based application for cardiac image processing and quantification. Features include multi-dimensional display, ECT/CT data fusion, and calcium scoring algorithms. Operates on standard computer hardware; supports local, network, or printed file storage. Connectivity includes digital image retrieval. No specific materials or sterilization methods applicable as it is a software-only device.

Indications for Use

Indicated for patients undergoing cardiac emission tomographic studies (SPECT/PET) or cardiac CT. Used for processing, quantification, and review of cardiac images, including calcium scoring to evaluate coronary artery calcified plaques as a risk factor for coronary artery disease and to monitor progression/regression of coronary calcium.

Regulatory Classification

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.

Predicate Devices

• 3D-MSPECT system (K001026)
• Siemens, Calcium Scoring Software Package (K990426)

Submission Summary (Full Text)

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K080575

## 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.

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## 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<br>Scoring Software<br>Package |
|-------------------------------------------------------------------------|--------------|-----------|------------------------------------------------|
| Computer based<br>templating system | Yes | Yes | NA |
| Digital image retrieval<br>of patient radiographs | Yes | Yes | NA |
| Patient Studies Type | ECT, PET, CT | ECT, PET | N/A |
| Measurement Tools | Yes | Yes | NA |
| Overlay of prosthetic<br>templates for proper<br>selection by physician | Yes | Yes | NA |
| Generation of Parts List | Yes | Yes | NA |
| Patient files can be<br>saved locally, on a<br>network, or printed. | Yes | Yes | NA |
| Allows for assessment<br>of wear. | Yes | Yes | NA |
| Identify and quantify<br>CT data via imaging | Yes | No | Yes |

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## 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.

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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.

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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 (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 [phone] or [phone] 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

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# 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