(14 days)
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The document is a 510(k) summary for CardIQ Analysis II, focusing on substantial equivalence to a predicate device rather than performance metrics against set acceptance criteria.
However, based on the available information, we can infer some aspects related to the "study" context, particularly regarding validation and verification.
Here's an attempt to answer your questions based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to an existing predicate device (CardIQ Option 1.0, K003408) rather than specific quantitative performance metrics against novel acceptance criteria.
2. Sample size used for the test set and the data provenance
Not explicitly stated. The document mentions "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." This implies testing was performed, but details on the sample size of test cases or the origin of the data (e.g., country of origin, retrospective/prospective) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The document indicates the product is "to aid trained physicians." However, there is no mention of experts involved in establishing ground truth for any formal validation study described here.
4. Adjudication method for the test set
Not explicitly stated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not explicitly stated. The document describes a "post processing software option" to aid physicians, but it does not present a comparative effectiveness study with human readers, nor an effect size for improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not explicitly stated. Given the description as a "post processing software option that can be used in the analysis of CT angiography images to display structures... [and] measure the diameter of the vessel, Hounsfield Units, or plaque density," it implies a standalone functional assessment of the software's capabilities to perform these tasks. However, a formal standalone performance study with specific metrics is not detailed in this summary.
7. The type of ground truth used
Not explicitly stated. For a device that measures vessel diameter, Hounsfield Units, and plaque density, the ground truth would likely involve physical phantom measurements, expert manual measurements on images, or potentially correlation with other imaging modalities or pathology reports (if applicable to plaque density assessment). However, the document does not specify.
8. The sample size for the training set
Not applicable/Not stated. The document refers to a "Software Development, Validation and Verification Process." This is not a machine learning model, so there is no "training set" in the sense of AI/ML.
9. How the ground truth for the training set was established
Not applicable/Not stated. As it's not described as an AI/ML device, the concept of a "training set" for ground truth establishment is not relevant in the context presented.
Summary of Inferred Information from the Document:
The document focuses on establishing substantial equivalence to a predicate device, CardIQ Option 1.0 (K003408). The primary "proof" of meeting criteria appears to be:
- Software Development, Validation, and Verification Process: This general statement implies that internal testing was conducted to ensure the software performs to specifications and user requirements, and adheres to federal regulations and industry standards.
- Absence of new safety risks: The conclusion states, "CardIQ Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests a risk analysis was performed.
- Functional Description: The device's capabilities (displaying structures, measuring diameter, Hounsfield Units, plaque density) are described. The implied "acceptance criteria" here would be that the software successfully performs these described functions.
Missing Information:
Crucially, this 510(k) summary does not provide the specific, granular details about acceptance criteria and a dedicated study with quantitative performance metrics that you would typically expect for a device proving its performance against established criteria. It mainly relies on validating that the new version (CardIQ Analysis II) is functionally similar and equally safe to its predicate, CardIQ Option 1.0.
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Image /page/0/Picture/0 description: The image shows a date, "MAR 2 6 2002". The month is March, the day is the 6th, and the year is 2002. The text is in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are depicted in black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.
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GE Medical Sv General Electric Company P O Box 414 Milwaukee, WI 53201
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: | CardIQ Analysis II |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | 892 - Radiology |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems283, rue de la Miniere78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
| Marketed Devices | CardIQ Analysis II is substantially equivalent to the device listed below: |
| Model: | CardIQ Option 1.0 |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K003408 |
Device Description:
CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.
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Indications for Use:
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
Comparison with Predicate:
CardIQ Analysis II is a software option for CT Scanners. Features of this software package are substantially equivalent to the following device:
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Adverse Effects on Health :
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
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· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
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· Adherence to industry and international standards.
Conclusions:
CardIQ Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIO Analysis II to be equivalent to those of CT CardIQ Option 1.0 (K003408).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wings, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K020796
Trade/Device Name: Card IQ Analysis II CT Scanner Post-Processing Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 1, 2002 Received: March 12, 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.
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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 | (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 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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STATEMENT OF INTENDED USE
510(k) Number (if known): _ Ko 2 079 6 _______________________________________________________________________________________________________________________________________
Device Name: CardIQ Analysis II
Indications For Use:
CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | -OR- | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Nancy C. Brogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020796 |
§ 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.