ACCUIMAGE SMARTGATE UPGRADE

K012106 · Accuimage Diagnostics Corp. · JAK · Sep 25, 2001 · Radiology

Device Facts

• Record ID: K012106
• Device Name: ACCUIMAGE SMARTGATE UPGRADE
• Applicant: Accuimage Diagnostics Corp.
• Product Code: JAK · Radiology
• Decision Date: Sep 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Heart calcium scoring for gated CT images to minimize effects of heart movements.

Device Story

AccuImage SmartGate Upgrade is a software enhancement for the AccuScore 1.0 workstation. It processes CT images by matching them with EKG signals or image-derived cardiac motion signals. This gating process allows physicians to select images acquired when the heart was relatively still, reducing motion artifacts during calcium scoring. The device is intended for use in clinical settings on standard PC/Windows workstations. By enabling the selection of motion-corrected images, it assists clinicians in performing more accurate cardiac calcium scoring, potentially improving diagnostic assessment of heart disease.

Clinical Evidence

Bench testing only. The manufacturer performed software verification and validation according to internal procedures. Hazard analysis was conducted throughout the design, coding, and testing phases. No clinical study data was provided.

Technological Characteristics

Software-based gating enhancement for CT imaging workstations. Operates on Pentium/Windows PC hardware. Compatible with EBCT and standard CT scanners. Utilizes EKG signals or image-derived cardiac motion signals for gating. Software development follows standard procedures for verification and validation. Regulatory software level of concern is 'Minor'.

Indications for Use

Indicated for heart calcium scoring using gated CT images to minimize the adverse effects of heart movement.

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

• GE Medical Systems HiSpeed Lxi with SmartScore (K980169)
• Vital Images Vscore with AutoGate option (K003230)

Submission Summary (Full Text)

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SEP 2 5 2001

# 510(k) Summary

K 012/06

#### Company Identification 1.

Acculmage Diagnostics Corporation 400 Grandview Drive South San Francisco, CA 94080 Phone [phone] Fax [phone] Contact Person: Oscar Gils Carbó Email [e-mail] Establishment Registration No. 2953774

#### 2. Official Correspondent

Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Phone [phone] Fax [phone] Email: [e-mail]

#### 3. Date of Submission July 3, 2001

- 4. Device Name

| Proprietary Name: | Acculmage SmartGate Upgrade: Acculmage<br>EKG Gating Tool Enhancement for AccuScore<br>1.0. |
|----------------------|---------------------------------------------------------------------------------------------|
| Classification Name: | 90JAK – CT, Image Processing |
| Device/Usual Name: | Gated Calcification Scoring of CT images. |

#### 5. Substantial Equivalence

The Acculmage Smartgate Upgrade Option is Substantially Equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options.

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KO12106
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#### Device Description and Intended Use 6.

### Device Description

The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.

## Intended Use

Heart calcium scoring for gated CT images to minimize effects of heart movements.

#### Software Development: 7.

The software was designed, developed, verified and validated according The soltware was assigned procedures specify individuals within the to which procedule for developing and approving product organizations, software colling and testing, validation testing and field maintenance.

### Performance Testing:

All software testing specified in the Software Product Development Plan will be successfully completed prior to market release.

#### 8. Hazard Analysis

Hazard analysis on this product has been performed throughout the l definition, design, coding and testing phases of product development and implementation. This process has emphasized:

- identification of potential hazards, their causes, and their effects; .
- development of methodologies to control the occurrence of hazards . and to constrain their effects; and
- Determine any effect on patient safety and system effectiveness. .

The potential hazards associated with this software product are no different The potomian nazar PACS components . These are primarily related to than those of computer system components, and may be variously obviated by

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Koi2106
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decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.

It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".

#### Safety Concerns 9.

The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.

#### Substantial Equivalence Comparison Chart 10.

The following product(s) provides functions, which are substantially equivalent to this product:

| Manufacturer | GE Medical<br>Systems | Vital Images | Acculmage |
|---------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Name | HiSpeed LX/i<br>with SmartScore | Vscore with<br>AutoGate option | Acculmage<br>Smartgate Upgrade |
| 510(k)<br>Number | K980169 | K003230 | |
| Computer<br>Platform | Not Known | PC / Windows<br>workstation | Pentium / Windows<br>workstation |
| Gating Option<br>for Calcium<br>Scoring | HiSpeed LX/i<br>with SmartScore<br>option | Match cardiac CT<br>images with the<br>corresponding EKG<br>signal. This allows<br>the physician to<br>select images<br>acquired when the<br>heart was still. | Match cardiac CT<br>images with the<br>corresponding EKG<br>signal. This allows<br>the physician to<br>select images<br>acquired when the<br>heart was still. |
| Type of CT<br>scanners for<br>which it is<br>applicable | LightSpeed and<br>HiSpeed GE CT<br>scanners | EBCT and<br>standard CT | EBCT and<br>standard CT |
| Types of<br>Gating | Prospective and<br>Retrospective<br>Gating | Images with either<br>associated EKG<br>signal or image-<br>derived cardiac<br>motion signal | Images with either<br>associated EKG<br>signal or image-<br>derived cardiac<br>motion signal |

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 5 2001

AccuImage Diagnostics Corporation % Mr. Gary Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116

Re: K012106

Trade/Device Name: AccuImage SmartGate Upgrade Gated Calcification Scoring for CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: July 3, 2001 Received: July 6, 2001

Dear Mr. Allsebrook:

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 either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

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This letter will allow you to begin marketing your device as described in 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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#### 510(k) Number (if known): KO12106

## Device Name:

AccuImage SmartGate Upgrade: AccuImage EKG Gating Tool Enhancement for Accuscore 1.0

## Indications For Use:

Heart calcium scoring for gated CT images to minimize effects of heart movements.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 901.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012106