IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

K972903 · Imatron, Inc. · JAK · Nov 4, 1997 · Radiology

Device Facts

• Record ID: K972903
• Device Name: IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
• Applicant: Imatron, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data. Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

Device Story

Workstation accessory for Imatron Ultrafast CT scanner; receives CT image data for advanced post-processing. Functions include 2D image review, multiplanar reformatting, 3D surface/volume rendering, maximum intensity projection, and cardiac analysis (calcium scoring, TDA perfusion). Operated by trained physicians in clinical settings. Software enables semi-automated identification of calcified regions, user-override capabilities, and automated computation of calcium scores and perfusion parameters. Outputs include enhanced images, parametric maps, and diagnostic reports. Benefits include improved visualization of spatial relationships in 3D, enhanced perception of perfusion data via color mapping, and streamlined cardiac diagnostic workflows.

Clinical Evidence

Bench testing only. The device successfully passed internal testing at Imatron to verify performance against design specifications and substantial equivalence to predicate devices.

Technological Characteristics

Workstation for medical image processing; supports DICOM 3.0 and ACR/NEMA DICOM 3.0 Digital Interchange Standard for Cardiology (DISC95-96). Features include 2D/3D image rendering, multiplanar reformatting, and automated cardiac analysis algorithms. Connectivity via local and wide area networks. Software-based processing for image enhancement and quantification.

Indications for Use

Indicated for trained physicians to receive, manipulate, transmit, store, view, characterize, compare, and enhance high-quality CT electronic images as an aid in diagnosis, specifically including cardiac analysis.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• C150XP's Physician Workstation (Imatron, Inc.)
• NetraMD Workstation (Scimage, Inc.)
• AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation (Acculmage, Inc.)
• VRSAPP Workstation (ISG Technologies)

Submission Summary (Full Text)

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K97 29 03

**NOV - 4 1997**

# 510(K) SUMMARY

Submitter's Name:

Imatron, Inc.

Address:

Phone(s):

Contact Person:

Date:

Common Names:

Proprietary Names:

Classification Name:

389 Oyster Point Blvd. South San Francisco, CA 94087

(0) 415-583-9964, ext. 206 (F) 415-827-7790

J.A. Coduto

August 8, 1997

Workstation, Image Processing Workstation, and Image Workstation

Imatron Ultra Access® Workstation with Cardiac Software Extensions

No classifications have been specifically issued No classifications have been benefits. For purposes of lor PACS of TROO ecall equivalence workstations determining substantial oquired to medical imaging devices.

The Imatron Ultrafast CT scanner is such an The "Imatron" Onraido. "Onraido. "Such, is Class II (reference: Imaging device and, as section sales Ultra Access Workstation is similarly classified.

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Predicate Device:

Device Description:

Predicate devices include: the C150XP's Physician Workstation as a component of the Imatron scanner (an Imatron, Inc. product); the NetraMD Workstation (a Scimage, Inc. product); the AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation (an Acculmage, Inc. product); and the VRSAPP Workstation (an ISG Technologies product).

### Device Description

### The Imatron Ultrafast CT Scanner --

The Imatron Ultrafast CT scanner is a scanning system (like those generically described in 21 CFR section 892.1750, which deals with "computed tomography X-ray systems") which operates by directing a focused beam of electrons along tungsten target rings to produce X-rays which pass through the body at multiple angles as in conventional CT scanning systems.

The Imatron Ultrafast CT scanner is capable of producing CT slices at rapid speeds since the data is produced by electronic rotation of the electron beam itself rather than the mechanical rotation of an X-ray tube as in conventional CT scanning systems.

the Imatron Ultrafast CT scanner Currently. operating at its highest resolution mode has 864 single or paired, contiguous X-ray detectors subtending an arc of 0.250 degrees each. The resulting 5% amplitude modulation transfer function (MTF) for high contrast objects at the center of the circle of reconstruction is 7 line pairs per centimeter (lp/cm).

Such scanner has the current ability to receive. manipulate, transmit, store, view, characterize, compare and enhance medical images.

#### The ISG Workstation --

The ISG Workstation is a device for picture

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archiving and communications cleared for use in processing and displaying medical images on a monitor, storing medical image data on fast access media, i.e. hard disk, and on slow access media, i.e. archive media, and transmitting data over local and wide area networks.

#### The Significant Modification

The only change Imatron is making to ISG's Workstation is the addition of a software package. This package is in addition to (not an amendment of) the software package currently provided with the ISG Workstation. Such package is described in detail within this 510(k) submission, as is the Workstation's intended use.

The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.

Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as the predicate devices - for receiving, are viewing, manipulating, transmitting, storing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis. by a trained physician.

See attached Substantial Equivalence Comparison and Explanation of Differences

Although there are no performance standards established by FDA for PACS devices, the Ultra Access Workstation has been designed and manufactured to meet: the ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) Standard, version 3.0; and the ACR/NEMA DICOM 3.0 Digital Interchange Standard for Cardiology (DISC95-96). The device and its development

#### Intended Use:

Technological Characteristics:

Performance:

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process also comply with FDA's, August 29, 1991 guidance document titled: "Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

## Testing Conclusions:

The Ultra Access Workstation successfully passed all testing at Imatron. Such testing indicates that the device as described in this submission is substantially equivalent to predicated devices.

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SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

ﺴﻴﺴﻪ:

Following in tabular (Table 2) and explanation form is a comparison of the similarities and differences that exist betweer the subject device and the predicate devices.

| TABLE 2: COMPARISON OF FEATURES AND SPECIFICATIONS | | |
|----------------------------------------------------|--|--|
|----------------------------------------------------|--|--|

| ITEM | FEATURE | ULTRA ACCESS<br>DEVICE | C150 XP<br>DEVICE | NETRA MD<br>DEVICE | AIDP<br>DEVICE | VRSAPP<br>DEVICE |
|------|------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| 1 | 2D image review | Yes | Yes | Yes | Yes | Yes |
| | Multiplanar reformatting | Yes | Yes | Yes | Yes | Yes |
| | 3D surface and volume<br>rendering | Yes | No | Yes | Yes | Yes |

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| ITEM | FEATURE | ULTRA ACCESS<br>DEVICE | C150 XP<br>DEVICE | NETRA MD<br>DEVICE | AIDP<br>DEVICE | VRSAPP<br>DEVICE |
|------|-----------------------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| | Maximum intensity<br>projection | Yes | No | Yes | Yes | Yes |
| | Performance of CTA and<br>MRA | Yes | No | Yes | Yes | Yes |
| | Image archiving | Yes | Yes | Yes | Yes | Yes |
| | Image filming | Yes | Yes | Yes | Yes | Yes |
| | Image transfer or network<br>connectivity | Yes | Yes | Yes | Yes | Yes |
| 2 | Examination of 2D image<br>data from a calcium scan | Yes | Yes | Yes | Yes | Yes |
| 3 | Examination of calcium<br>scan as a 3D volume | Yes | No | Yes | Yes | No |

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| ITEM | FEATURE | ULTRA ACCESS<br>DEVICE | C150 XP<br>DEVICE | NETRA MD<br>DEVICE | AIDP<br>DEVICE | VRSAPP<br>DEVICE |
|------|-------------------------------------------------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| 4 | Semi automated<br>identification of regions<br>that are considered<br>calcium | Yes | No | Yes | Yes | No |
| 5 | User override of<br>automatically identified<br>regions | Yes | No | Yes | No | No |
| 6 | Automatic computation of<br>calcium score | Yes | No | Yes | No | No |
| 7 | Ability to measure CT<br>numbers on a 2D image | Yes | Yes | Yes | Yes | Yes |
| 8 | Identification of<br>mistriggered slices | Yes | Yes | No | No | No |
| 9 | Saving of calcium data with<br>patient exam data | Yes | Yes | Yes | No | No |
| ITEM | FEATURE | ULTRA ACCESS<br>DEVICE | C150 XP<br>DEVICE | NETRA MD<br>DEVICE | AIDP<br>DEVICE | VRSAPP<br>DEVICE |
| 10 | Creation of a paper<br>calcium report | Yes | No | Yes | No | No |
| 11 | Comparison of multiple<br>scans | Yes | No | Yes | No | No |
| 12 | Identification of<br>mistriggered TDA data | Yes | Yes | No | No | No |
| 13 | Deselection of a<br>mistriggered image | Yes | Yes | No | No | No |
| 14 | Identification of regions for<br>which TDA computation<br>should be performed | Yes | Yes | No | No | No |
| 15 | Automatic creation of<br>gamma-variate curve fit for<br>TDA data | Yes | Yes | No | No | No |
| 16 | Computation of curve<br>parameter | Yes | Yes | No | No | No |
| 17 | Computation of perfusion | Yes | Yes | No | No | No |
| ITEM | FEATURE | ULTRA ACCESS<br>DEVICE | C150 XP<br>DEVICE | NETRA MD<br>DEVICE | AIDP<br>DEVICE | VRSAPP<br>DEVICE |
| 18 | Creation of a parametric<br>image | Yes | Yes | No | No | No |
| 19 | Creation of a paper TDA<br>report | Yes | No | Yes | Yes | No |
| 20 | Indications for use-<br>general medical imaging<br>workstation | Yes | Yes | Yes | Yes | Yes |
| 21 | Indication for use --<br>calcium | Yes | Yes | Yes | Yes | No |
| 22 | Indication for use -- TDA | Yes | Yes | No | No | No |

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ITEM 3: REFORMATTING VS. SHADED SURFACE DISPLAY. Reformatting and shaded surface display are both well accepted methods of examining volumetric data. Gray scale information is lost in a shaded surface display, but because we are looking at high-contrast areas (calcium vs. surrounding tissue), gray scale information is not required. This difference does not affect safety or efficacy.

ITEM 4: FOOTPRINT IDENTIFICATION VS. COLORED SHADED SURFACE. Large contrast difference exist between calcified regions and soft tissue. Therefore, these regions can be identified equally readily on a maximum intensity projection (footprint method) or in a shaded surface display. We have chosen to use a 3D display because the spatial relationships between calcified regions are more clearly observable in a 3D display, and thus calcified regions in arteries and in non-arteries can be more clearly identified. This difference does not affect safety or efficacy.

ITEM 9: SAVING OF 3D DESCRIPTIONS VS. ROIS. The location of calcified regions can be stored as a set of (x, y, z) coordinates or as a set of (x, y, slice position) coordinates. In an axial scanning modality like CT, slice position and the z coordinate are proportional, and thus this difference does not affect safety or efficacy.

ITEM 10: VIEWING OF REPORT DATA IN MICROSOFT WORD OR IN NETSCAPE. Both methods allow a user to view text and image data, and to print these data onto paper. This difference does not affect safety or efficacy.

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ITEM 11: VIEWING OF DUAL-SCANS ON SAME SHEET OR ON TWO-DIFFERENT SHEETS. Both methods allow for side-by-side comparison of two calcium scans. No functional difference is obtained by using two sheets of paper or one. This difference does not affect safety or efficacy.

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ITEM13: USE/NO-USE VS. CLICKING ON AN IMAGE TO INDICATE DESELECTION. Both methods allow the user to tell the software which images to ignore when performing the subsequent gamma-variate curve fit. Ultra Access uses a more graphical approach (clicking on the image) to make it easier for the user to determine which slices were deselected and which were not. This difference does not affect safety or efficacy.

ITEM 17: SUPPORT OF 1 PERFUSION ALGORITHM OR 4. Ultra Access supports the perfusion algorithm used in the predicate device's software. However, as shown by the attached scientific references, other newer algorithms may vield more accurate results at higher flow states. Therefore, these additional algorithms have been provided. This difference does not affect safety or efficacy.

ITEM 18: GRAYSCALE VS. COLOR PARAMETRIC IMAGES. Both systems support grayscale mappings of curve parameter values. However, as the human eye can better perceive subtle changes in color than it can subtle changes in gray values, we have also provided color mappings. This approach is identical to that used in Nuclear Medicine or in PET scanning. We also support the colored display of perfusion. This parameter is being computed by the predicate device, but only being displayed as a number (as opposed to a colored map). Ease of use will be enhanced by displaying this additional parameter in color. This difference does not affect safety or efficacy.

ITEM 20: PAPER PRINTOUT MAP OF TDA REPORT. The predicate device creates paper reports describing the results of a calcium scan. In addition to supporting this type of printout in Ultra Access (see Item #10), Ultra Access will also create paper reports of TDA data. The data being placed on paper is identical to the data being computed by the C150XP predicate device, and therefore placing this information on paper (using a color ink) et printer to preserve color information) does not change its clinical meaning. This difference does not affect safety or efficacy.

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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HU" are arranged in a semi-circle around the left side of the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**NOV - 4 1997**

J. A. Coduto Director, Regulatory Affairs Imatron, Inc. 389 Oyster Point Blvd. South San Francisco, CA 94080 Re: K972903 Imatron Ultra Access Workstation with Cardiac Software Extensions Dated: August 8, 1997 Received: August 6, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Coduto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health -----

Enclosure

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# SECTION 3: PROPOSED INTENDED USE STATEMENT

The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.

Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

David A. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT Division of Reproductive, .
and Radiological Devices
Bro 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)