K Number

Device Name

QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)

Manufacturer

MEDIS MEDICAL IMAGING SYSTEMS, B.V.

Date Cleared

1999-11-26

(18 days)

Product Code

IZI

Regulation Number

892.1600

Intended Use

QLV-CMS provides quantitative information regarding the calculated dimensions and calculated performance characteristics of the left ventricle of the heart, 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.

Device Description

QLV-CMS performs quantitative analysis of angiograms (specific to the left ventricle) 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 OLV-CMS operation may be printed or archived in files for export to a general-purpose database.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K940172

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes quantitative analysis and image processing but does not mention AI, ML, or related terms like deep learning or neural networks. There is also no information about training or test sets, which are typically associated with ML development.

Therapeutic

No
The device provides diagnostic information (quantitative measurements) but does not directly treat or prevent a disease or condition. It is used for scientific and research studies, and the review and analysis of patient angiographic imaging records.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the device "provides quantitative information regarding the calculated dimensions and calculated performance characteristics of the left ventricle of the heart," which is used by physicians and scientists for "review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators." This information provides additional insights into a patient's condition, which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that it performs quantitative analysis of angiograms that are input to the system in various digital formats. It does not mention any proprietary hardware or physical components included as part of the device itself, only the software's function of processing existing image data.

IVD (In Vitro Diagnostic)

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, or tissue) to provide information about a person's health.
Device Function: The QLV-CMS analyzes images (angiograms) of the left ventricle of the heart. It does not analyze biological specimens taken from the body.
Intended Use: The intended use is to provide quantitative information about the dimensions and performance characteristics of the left ventricle based on these images, for use in research, review, and analysis of patient records. This is image analysis, not in vitro testing.

Therefore, the QLV-CMS falls under the category of a medical device that performs image analysis, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Angiograms (digitized video from 35 mm cinefilm and DICOM-file standard formats)

Anatomical Site

Left ventricle of the heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians and scientists in both research and clinical settings, typically in 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)

K940172

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

OLV-CMS Special 510(k) Notification "Device Modification" SUMMARY 510(k) Summary of safe and effectiveness information conform 21CFR. 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 30, 1999
2) Device Name	: Quantitative Analysis of Left Ventricular Angiograms (QLV)
Common Name	: QLV-CMS
Device Class. Name	: System, X-ray, Angiographic
Regulation Number	: 21 CFR 892.1600 (90 IZI; Class II)

Predicate Device(s) : Cardiovascular Measurement System - (CMS) 510(k) Number: K940172
Description of the device:

5) Intended use:

OLV-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 QLV-CMS product is used to select images of the left ventricle for quantitative analysis, resulting in measurements of the selected images. 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 QLV-CMS product as well.

6) Substantial equivalence information:

The OLV-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. QLV-CMS now runs on Windows NT, as compared with the predicate device operation on MS-DOS, and

b. QLV-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 QLV-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 QLV-CMS software does not change the intended use of the angiographic systems in practice.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

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: K993765

Quantitative Analysis of Left Ventricular Angiograms - Cardiovascular Dated: July 30, 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, 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 regulation 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,

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

Page__________________________________________________________________________________________________________________________________________________________________________ ુર્ભ

510(k) Number (if known): K993765

Device Name: _

Indications For Use:

510(k) Number: Device Name:

K993765 Quantitative Analysis of Left Ventricular Angiograms (QLV-CMS)

Indications for Use:

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	K993765

Prescription Use	✓ (Per 21 CFR 801.109)
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Over-The-Counter Use	(Optional Format 2-16)
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