(51 days)
Not Found.
No
The summary describes automated segmentation and quantitative analysis but does not mention AI, ML, or deep learning. The focus is on objective and reproducible analysis based on automated processes, which can be achieved through traditional image processing algorithms.
No.
The device is described as an "auxiliary tool in assessing CTA studies" and provides quantitative analysis of vessel characteristics, which are then "interpreted by cardiologists and radiologists" or 'used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment'. It processes images and helps in diagnosis and monitoring, but it does not directly treat a disease or condition.
Yes
Explanation: The device is described as an "auxiliary tool in assessing CTA studies" that "enables the quantitative analysis of CT angiograms based on automated segmentation" and "can be used to quantify a number of lesion characteristics." It generates "vessel analysis data, detected stenosis, and quantitative results," which are "used to support the interpretation of CTA data." This clearly indicates its function in providing information for medical diagnosis.
Yes
The device is described as a "software solution" and "analytical software package" that reads and processes DICOM CT images. It is intended for use on workstations or integrated into a PACS environment, which are software-based platforms. There is no mention of accompanying hardware components that are 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: QAngio CT software analyzes images (CTA images) of vessels. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to analyze existing CTA images to quantify lesion characteristics and support the interpretation of these images by medical professionals. This is image analysis, not diagnostic testing of biological samples.
Therefore, QAngio CT falls under the category of medical image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The QAngio CT software solution has been developed for the objective and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics.
QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists or radiologists.
Product codes
90 JAK
Device Description
QAngio CT is able to read DICOM CT images from all major CT scanner vendors. Vessel analysis data, generated by automated (and/or manual) segmentation, detected stenosis, and quantitative results, can be saved in separate files enabling the comparison of results from different users.
Radiologists, cardiologists and technicians use the QAngio CT analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment.
In clinical practice the QAngio CT software is used on workstations in review rooms or integrated in a PACS environment.
Mentions image processing
QAngio CT is a safe medical device. During the development, potential hazards were controlled by a risk management plan, including hazard and risk analyses, verification and validation tests. Evaluations by hospitals and literature information support this statement. The software package QAngio CT itself will not have any adverse effects on health. The operator interprets the objective values of the analysis and chooses to accept or reject the results.
In current thinking, the level of concern for the standalone software in image postprocessing is "Minor' and the use of QAnqio CT does not change the intended use of CT scanners in practice, nor does the use result in any new potential hazard.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
CTA images, CT angiograms
Anatomical Site
vessels
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Radiologists, cardiologists and technicians / clinical practice and in clinical trials, workstations in review rooms or integrated in a PACS environment.
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)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
12. SUMMARY OF SAFETY AND EFFECTIVENESS
Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| • Submitter | : Medis medical imaging systems bv | OCT -5 2006 |
|---|---|---|
| Address | : Schuttersveld 9 | |
| : 2316 XG Leiden, The Netherlands | ||
| Telephone | : +31 71 522 3244 | |
| Fax | : +31 71 521 5617 | |
| Contact Person | : J.I. Hollander, Quality Coordinator | |
| Prepared | : August 10, 2006 | |
| • Device Name | : Automatic quantitative analysis of CTA images | |
| Common Name | : QAngio® CT | |
| Device Class. Name | : Class II; PACS software | |
| Regulation Number | : 21 CFR 892.1750 (90 JAK) |
· Predicate Device(s)
· Device Description and indications for Use
QAngio CT is able to read DICOM CT images from all major CT scanner vendors. Vessel analysis data, generated by automated (and/or manual) segmentation, detected stenosis, and quantitative results, can be saved in separate files enabling the comparison of results from different users.
Radiologists, cardiologists and technicians use the QAngio CT analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment.
In clinical practice the QAngio CT software is used on workstations in review rooms or integrated in a PACS environment ..
· Intended use
062386
The QAngio CT software solution has been developed for the objective and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics.
QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists or radiologists.
· Substantial equivalence Information
QAngio CT is substantially equivalent to the Predicate Device of MRA-CMS, K040746, using the same technique for the same intended use; only CT- instead of MR images.
Conclusion
In Medis' opinion. QAngio CT is a safe medical device. During the development, potential hazards were controlled by a risk management plan, including hazard and risk analyses, verification and validation tests. Evaluations by hospitals and literature information support this statement. The software package QAngio CT itself will not have any adverse effects on health. The operator interprets the objective values of the analysis and chooses to accept or reject the results.
In current thinking, the level of concern for the standalone software in image postprocessing is "Minor' and the use of QAnqio CT does not change the intended use of CT scanners in practice, nor does the use result in any new potential hazard.
Based on the information supplied in this 510(k), Medis concludes that the subject device is safe, effective and substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white and appears to be a scanned or printed image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 5 2006
Mr. J. I. Hollander Quality Coordinator Medis Medical Imaging Systems bv 9 Schuttersveld Leiden The Netherlands 2316XG
Re: K062386
Trade/Device Name: QAngio CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Dated: August 11, 2006 Received: August 16, 2006
Dear Mr. Hollander:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a large, bold font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
2
Page 2 -
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 Or H 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): Ko 6 2 38 4
Device Name: QAngio CT
Indications For Use:
QAngio CT software solution has been developed for the objective and reproducible QAnglo CT sollware Solution has been Geven Groupstitative analysis of CT angiograms
analysis of vessels in CTA images. It enables the quantitative analysis of CT anyonify analysis of vessels in CTA images. It chable the qualing CT can be used to quantify a number of lesion characteristics.
a humber of lesion Characteristics.
QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical QAnglo CT is intended for use as an addidn'y tool in accession of QAngio CT are to be interpreted by cardiologists and radiologists.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use
(Optional Format 3-10-98)
David A. Legron
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devic 510(k) Num