(56 days)
Not Found
Unknown
The summary mentions "automated contour detection" and "quantitative analysis with objective and reproducible assessment," which could potentially be implemented using AI/ML techniques, but it does not explicitly state the use of AI, ML, or related terms like DNN. Without further information, it's impossible to confirm.
No.
The device is described as analytical software that supports clinicians in assessing X-ray images and making clinical decisions, not as a device that provides therapy or treatment.
Yes
Explanation: The device is intended to "support clinicians" in "assessing X-ray images" and the parameters generated "may be useful in supporting a clinical decision process," which aligns with the definition of a diagnostic device aiding in diagnosis or treatment planning.
Yes
The device is described as "analytical software tool designed for Windows operating systems" and its functionality is "independent of the X-ray acquisition equipment vendor." This strongly indicates it is a software-only device that processes images acquired by separate hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: QVA-CMS analyzes X-ray images of peripheral arteries. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
- Intended Use: The intended use clearly states it's for the analysis of vascular morphology in peripheral arteries using X-ray images. It supports clinicians in assessing these images.
Therefore, QVA-CMS falls under the category of medical imaging analysis software, not an IVD.
N/A
Intended Use / Indications for Use
The analytical QVA-CMS software, serves a medical purpose and its intended use is:
- a) To quantify medical images of peripheral arteries in an objective and reproducible way by presenting graphs with calculated data of user's selected regions of interest. Quantification is performed by automated contour detection;
- b) To improve the interpretation of vascular images for decisions by the clinicians in hospitals, facilitated by image quantification;
- c) To improve the analysis of the vascular morphology during research trials by analysts in Core Labs on intervention effects, facilitated by image quantification;
- d) To train users for correct interpretation and analysis of images of peripheral arteries, using the objective and reproducible quantified images;
- e) To reduce the risks, due to user variability associated with conventional visual assessment, facilitated by objective and reproducible quantified images;
- To gain more benefits in post-processing activities, avoiding the very timef) consuming conventional manual tracing of boundaries, using the automated contour detection of the analytical software package.
QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. ie. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.
Product codes
90 IZI
Device Description
QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS analytical software facilitates the import and visualization of X-ray images via CD-ROM and digital network. The QVA-CMS functionality is independent of the X-ray acquisition equipment vendor. QVA-CMS, performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions in selected regions of interest. The analysis results of user's selection can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians in hospitals, analysts in Core Labs, cardiologists, radiologists, and referring physicians, vascular lab
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. 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
JAN 2 4 2003
023970
6
QVA-CMS 510(k) Notification
12. SUMMARY OF SAFETY AND EFFECTIVENESS:
Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| 1) Submitter: | MEDIS medical imaging systems B.V. |
|---|---|
| Address: | Poortgebouw Rijnsburgerweg 10 |
| 2333 AA Leiden | |
| The Netherlands | |
| Telephone: | +31 71 5223244 |
| Fax: | +31 71 5215617 |
| Contact Person: | J.I. Hollander, Quality Coordinator |
| Prepared: | November 25, 2002 |
| 2) Device Name: | QVA-CMS analytical software package |
| Common Name: | QVA-CMS |
| Device Class. Name: | System, X-ray, Angiographic |
| Regulation Number: | 21 CFR 892.1600 (90 IZI; Class II) |
QCA-CMS: 510(k) K993763 3) Predicate Device:
4) Device Description:
QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS analytical software facilitates the import and visualization of X-ray images via CD-ROM and digital network. The QVA-CMS functionality is independent of the X-ray acquisition equipment vendor. QVA-CMS, performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions in selected regions of interest. The analysis results of user's selection can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.
5) Intended use:
The analytical QVA-CMS software, serves a medical purpose and its intended use is:
- a) To quantify medical images of peripheral arteries in an objective and reproducible way by presenting graphs with calculated data of user's selected regions of interest. Quantification is performed by automated contour detection;
- b) To improve the interpretation of vascular images for decisions by the clinicians in hospitals, facilitated by image quantification;
- c) To improve the analysis of the vascular morphology during research trials by analysts in Core Labs on intervention effects, facilitated by image quantification;
- d) To train users for correct interpretation and analysis of images of peripheral arteries, using the objective and reproducible quantified images;
- e) To reduce the risks, due to user variability associated with conventional visual assessment, facilitated by objective and reproducible quantified images;
- To gain more benefits in post-processing activities, avoiding the very timef) consuming conventional manual tracing of boundaries, using the automated contour detection of the analytical software package.
- Substantial equivalence Information:
The QVA-CMS software is substantially equivalent to the predicate device of QCA-CMS, K993763, using the same technological characteristics and intended use.
QVA-CMS 510(k) Notification
1
CONCLUSIONS RESPECTING SAFETY and EFFECTIVENESS:
It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluation by hospitals and literature (see Appendix F) supports this statement.
In MEDIS' opinion the level of concern for the stand-alone software to quantify images is 'minor' and that the use of QVA-CMS analytical software does not influence the use of X-ray image acquisition equipment in practice, nor does the use of software result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. I. Hollander Quality Coordinator MEDIS Medical Imaging Systems, B. V. Poortgebouw, Rijnsburgerweg 10 2333 AA Leiden NETHERLANDS
Re: K023970
Trade/Device Name: Ouantitative Vascular Angiography - CMS Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: November 25, 2002 Received: November 29, 2002
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 (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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
4
510(k) Number (if known): K023970
Device Name: Quantitative Vascular Angiography - CMS
Indications For Use: QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. i.e. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
Nancy C. Brogdon