QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

K993763 · Medis Medical Imaging Systems BV · IZI · Nov 26, 1999 · Radiology

Device Facts

• Record ID: K993763
• Device Name: QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
• Applicant: Medis Medical Imaging Systems BV
• Product Code: IZI · Radiology
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

QCA-CMS performs quantitative analysis of coronary angiograms; inputs include digitized video from 35mm cinefilm or DICOM-standard files. System enables user selection of arterial segments; performs automated edge detection and dimensional measurements. Used in clinical and research settings by physicians and scientists. Output consists of quantitative measurements, which can be printed or archived for database export. Device functions as modular software package running on Windows NT; facilitates analysis of angiographic images to support clinical decision-making and research assessments. Benefits include improved productivity in digital image environments and provision of reproducible arterial measurements.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical comparison and software verification/validation testing.

Technological Characteristics

Modular software package for Windows NT. Utilizes edge detection and measurement algorithms for angiographic image analysis. Supports DICOM file formats and digitized 35mm cinefilm. Standalone software application.

Indications for Use

Indicated for physicians and scientists to obtain quantitative, reproducible dimensional measurements of arterial segments from angiographic x-ray images. Used in cardiac cath labs for research studies, assessing patient angiographic condition, evaluating device/drug therapy results, and reviewing patient imaging records.

Regulatory Classification

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.

Predicate Devices

• Cardiovascular Measurement System - (CMS) (K940172)

Reference Devices

• CMS-View

Submission Summary (Full Text)

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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<br>Ridgefield, CT 06877,<br>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

4) 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.

6) 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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:

1. Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,

2. 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,<br>and Radiological Devices |
| 510(k) Number | K993763 |

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)