(18 days)
No
The summary describes quantitative analysis of angiograms using image processing techniques, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices. The predicate device is also from 1994, predating widespread clinical use of AI/ML in medical devices.
No.
The device provides quantitative measurements of arterial segments from angiographic images for analysis and review, rather than directly treating or diagnosing a medical condition.
Yes
The device provides quantitative and reproducible information regarding the calculated dimensions of arterial segments which is used for review and analysis of patient angiographic imaging records, providing additional information to physicians. This information aids in understanding the patient's condition, which is a diagnostic purpose.
Yes
The device description explicitly states that QCA-CMS performs quantitative analysis of angiograms that are input to the system in various digital formats. It does not mention any accompanying hardware components for image acquisition or processing beyond the software itself. The output is also described as being printed or archived in files, further indicating a software-based function.
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 QCA-CMS analyzes angiographic x-ray images, which are in vivo (within the living body) images, not samples taken from the body.
- Intended Use: The intended use describes analyzing images to assess the condition of arterial segments and the results of therapies. This is based on visual information from the body, not laboratory analysis of biological samples.
Therefore, the QCA-CMS falls under the category of medical imaging analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
QCA-CMS allows the user to work productively in the increasingly digital world of images that are archived in DICOM formats as a result of angiography procedures. The QCA-CMS product is used to select an arterial segment for quantitative analysis, resulting in edge detection and measurements of the selected arterial segment(s). The quantitative information is provided for use by physicians and scientists in both research and clinical settings. Image archiving and administration purposes are supported with the OCA-CMS product as well.
QCA-CMS provides quantitative and reproducible information regarding the calculated dimensions of arterial segments imaged during angiographic x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications:
- Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,
- Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
Product codes
90 IZI
Device Description
QCA-CMS performs quantitative analysis of angiograms that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats. The analysis results of the QCA-CMS operation may be printed or archived in files for export to a general-purpose database.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiograms that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats.
Anatomical Site
arterial segments / coronary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and scientists in both research and clinical settings / cardiac cath labs.
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
§ 892.1600 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
K993763 NOV 26 1999 MEDIS medical imaging systems, inc.
QCA-CMS Special 510(k) Notification "Device Modification" SUMMARY 510(k) Summary of safe and effectiveness information conform 21 CFR 807.87(h).
| 1) Submitter | : MEDIS Medical Imaging Systems, Inc. |
|---|---|
| Address | : 109 Danbury Road |
| Ridgefield, CT 06877, | |
| USA | |
| Telephone | : 203.438.5588 |
| Fax | : 203.438.5393 |
| Contact Person | : Douglas Orr, President |
| Prepared | : July 31, 1999 |
| 2) Device Name | : Quantitative analysis of Coronary Angiograms (QCA) |
| Common Name | : QCA-CMS |
| Device Class. Name | : System, X-ray, Angiographic; |
| Regulation Number | : 21 CFR 892.1600 (90 IZI; Class II) |
| 3) Predicate Device(s) | : Cardiovascular Measurement System - (CMS) |
510(k) Number: K940172
- Description of the device:
QCA-CMS performs quantitative analysis of angiograms that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats. The analysis results of the QCA-CMS operation may be printed or archived in files for export to a general-purpose database.
5) Intended use:
OCA-CMS allows the user to work productively in the increasingly digital world of images that are archived in DICOM formats as a result of angiography procedures. The QCA-CMS product is used to select an arterial segment for quantitative analysis, resulting in edge detection and measurements of the selected arterial segment(s). The quantitative information is provided for use by physicians and scientists in both research and clinical settings. Image archiving and administration purposes are supported with the OCA-CMS product as well.
- Substantial equivalence information:
The QCA-CMS software, as a software package, is substantially equivalent to the predicate device "Cardiovascular Measurement System - CMS" by utilizing the same technical standards and image analysis algorithms for efficient, accurate and reproducible results. The differences in the devices are noted as:
a. QCA-CMS now runs on Windows NT, as compared with the predicate device operation on MS-DOS. and
b. QCA-CMS is a modular software package, as compared with the fully-integrated predicate device. Image handling (review, playback, selection) may now accomplished with other modular software packages, including the CMS-View from MEDIS.
Conclusion respecting safety and effectiveness:
It is the opinion of MEDIS medical imaging systems that QCA-CMS is safe and potential hazards are controlled by a risk management plan for the software development process, including hazard analysis, verification and validation tests and evaluations by hospitals. In our opinion the level of concern for stand-alone software to analyze images is "minor" and that the use of QCA-CMS software does not change the intended use of the angiographic systems in practice.
1
Image /page/1/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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1999
Douglass Orr President MEDIS Medical Imaging Systems, Inc. 109 Danbury Road Ridgefield, CT 06877
Re:
K993763 OCA-CMS Dated: July 31, 1999 Received: November 8, 1999 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Orr:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,,
J.T.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of Page
K993763 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_
Indications For Use:
510(k) Number: Device Name:
K993763 Quantitative Analysis of Coronary Angiograms
Indications for Use:
QCA-CMS provides quantitative and reproducible information regarding the calculated dimensions of arterial segments imaged during angiographic x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications:
-
Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,
-
Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K993763 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)