SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

K020929 · GE Medical Systems · JAK · Apr 3, 2002 · Radiology

Device Facts

• Record ID: K020929
• Device Name: SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

Device Story

SmartScore 3.5/4.0/4.5 are software options running on Advantage Windows (AW) workstations; designed to detect and quantify calcifications in CT images. Input consists of CT image data; user selects Regions of Interest (ROI) manually or semi-automatically. Software applies multiple scoring algorithms to calculate calcium scores; generates patient reports; maintains patient database. Used in clinical settings by healthcare professionals to aid in cardiac disease prognosis and monitoring of coronary artery calcium progression. Output assists clinicians in evaluating calcified plaques as a risk factor for coronary artery disease.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by software development, validation, and verification processes, and adherence to industry and international standards.

Technological Characteristics

Software-based accessory for CT systems. Operates on Advantage Windows (AW) workstation. Features manual and semi-automatic ROI selection. Implements multiple scoring algorithms for calcium quantification. Connectivity via workstation integration. Software development follows established validation and verification protocols.

Indications for Use

Indicated for patients requiring evaluation of calcified plaques in coronary arteries to assess risk of coronary artery disease and monitor progression/regression of calcium for cardiac disease prognosis.

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

• CT Coronary Artery Calcification Scoring (CACS) (K982004)

Reference Devices

• Advantage Windows (AW) (K960613)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are in black, creating a strong contrast against the white background.

# APR 0 3 2002

GE Medical Systems General Electric Company P O Box 414 Milwaukee, WI 53201

K020929

(D

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Submitter Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: [phone], FAX: [phone] Date Prepared: February 8, 2002

#### PRODUCT IDENTIFICATION

Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5 Classification Name: Accessory to Computed Tomography System Classification Panel 892 - Radiology Classification Number: 892.1750 Manufacturer : General Electric Medical Systems 283, rue de la Minière 78533 Buc Cedex, FRANCE Distributor: General Electric Medical Systems, Milwaukee, WI Marketed Devices SmartScore 3.5/4.0/4.5 are substantially equivalent to the device listed below: Model: CT Coronary Artery Calcification Scoring (CACS) Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K982004

### Device Description:

SmartScore 3.5/4.0/4.5 are a family of software options that runs on the Advantage Windows (AW) (K960613) workstation and allows the user to detect calcifications in CT images. These Regions of Interest can be selected manually, or semi-automatically. It provides calculation of the calcium score using multiple scoring algorithms. The software also provides the ability to generate patient reports, and maintain a patient database for future reference.

{1}------------------------------------------------

#### Indications for Use:

SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

#### Comparison with Predicate:

SmartScore 3.5/4.0/4.5 are software options that can be used to evaluate calcium scoring in coronary arteries. The functional features of this package are substantially equivalent to that of the following device:

| Device Name | FDA Clearance Number |
|----------------------------------------------------|----------------------|
| CT Coronary Artery Calcification Scoring<br>(CACS) | K 982004 |

#### Adverse Effects on Health :

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
8

- · Adherence to industry and international standards.
#### Conclusions:

SmartScore 3.5/4.0/4.5 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the SmartScore 3.5/4.0/4.5 to be equivalent to those of CT Coronary Artery Calcification Scoring (CACS) (K982004).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and appears to be a title or heading. The words are all capitalized and evenly spaced.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 0 3 2002

Re: K020929

GE Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Trade/Device Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 18, 2002 Received: March 22, 2002

Dear Mr. Gmelin:

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

### STATEMENT OF INTENDED USE

510(k) Number (if known):

Device Name: SmartScore 3.5, SmartScore 4.0, SmartScore 4.5

# Indications For Use:

SmartScore 3.5/4.0/4.5 are non-invasive software options that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. SmartScore 3.5/4.0/4.5 may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.

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

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

Prescription Use (Per 21 CFR 801.109)

-OR-

Over-The-Counter Use

David A. Legerom

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020929