K Number
K020929
Device Name
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
Manufacturer
Date Cleared
2002-04-03

(12 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

No
The description mentions manual or semi-automatic selection of regions of interest and calculation using multiple scoring algorithms, but does not explicitly mention or imply the use of AI or ML for detection or analysis.

No
The device is described as a non-invasive software option used for evaluation and monitoring of calcified plaques, aiding in prognosis, rather than directly treating a condition.

Yes
The device is described as software that evaluates calcified plaques in coronary arteries to aid in the prognosis of cardiac disease and monitor progression/regression of calcium, which directly relates to diagnosing and managing a medical condition.

Yes

The device is described as "software options" that run on a workstation and perform calculations and data management. There is no mention of accompanying hardware being part of the device itself.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The SmartScore software analyzes CT images of the coronary arteries. It does not process or analyze biological samples taken from the patient.
  • Intended Use: The intended use is to evaluate calcified plaques in coronary arteries based on imaging data, not on the analysis of biological specimens.

Therefore, while it's a medical device used for diagnosis and prognosis, it falls under the category of imaging software rather than an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

90 JAK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT images

Anatomical Site

coronary arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K982004

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K960613

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

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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: (262) 544-3894, FAX: (262) 544-3863 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 NameFDA Clearance Number
CT Coronary Artery Calcification Scoring
(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(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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