IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0

K022940 · Intelligent Images Srl · LLZ · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K022940
• Device Name: IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
• Applicant: Intelligent Images Srl
• Product Code: LLZ · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.

Device Story

Software application for desktop PC/notebook; retrieves/processes JOMED-specific DICOM IVUS video loops and still frames. Used by physicians/interventional lab staff for clinical review and export to PowerPoint for training/lectures. Enables viewing and measurement of IVUS data; supports clinical decision-making by facilitating image analysis. Limited to JOMED proprietary DICOM files.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only device; runs on standard desktop/notebook hardware. Supports JOMED proprietary DICOM file format. No specific hardware requirements or materials defined.

Indications for Use

Indicated for qualified medical professionals to retrieve, view, and process medical IVUS images stored on JOMED In-Vision Gold or In-Vision Plus CDR storage drives.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• QCU ANALYTICAL SOFTWARE PACKAGE (K011582)

Submission Summary (Full Text)

{0}------------------------------------------------

# KO2 2940

510(k) Summary In-Vision View with Measurements Module Intelligent Images S.r.l.

## OCT 11 2002

### 510 (k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21 CFR 807.92(a).

807.92(a)(1)

Submitter Information

Intelligent Images S.r.I. 12/3 Corso Galliera 16142 Genova, ITALY

Phone: Fax: Contact Person: Date:

807.92(a)(2)

Device Name

In-Vision View with Measurements Module Trade Name: Common Name: In-Vision View

[phone]

[phone]

August 30, 2002

Maria Rosa Bellisario

System, Image Processing Classification Name(s):

Classification Number: LLZ

807.92(a)(3)

Predicate Device(s)

| Manufacturer: | MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 LEIDEN, NL 2333 AA |
|----------------|--------------------------------------------------------------------------------------------------------------|
| Tradename: | QCU ANALYTICAL SOFTWARE PACKAGE |
| 510(k) Number: | K011582 |

Additional substantial equivalence information is provide in the following substantial equivalence comparison table.

{1}------------------------------------------------

510(k) Summary In-Vision View with Measurements Module Intelligent Images S.r.l.

#### 807.92(a)(4)

## Device Description

In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module provides an effective solution for physicians and interventional labs to review JOMED's In-Vision Gold digital IVUS DICOM video loops on a desktop PC or notebook. In addition, video loops and still frames can be exported to PowerPoint presentations for conferences, in-hospital training and lectures.

{2}------------------------------------------------

510(k) Summary In-Vision View with Measurements Module Intelligent Images S.r.l.

807.92(a)(5)

## Intended Use(s)

In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures.

Food and Drug Administratio 00 Corporate Boulevaro ockville MD 20850

Mr. Maurizio Piaggio President Intelligent Images, S.r.l. 12/3 Corso Galliera Genova, Genova I-16142 ITAL Y

#### Re: K022940

Trade/Device Name: In-Vision View with Measurements Module Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: August 30, 2002 Received: September 4, 2002

Dear Mr. Piaggio:

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 adultcration.

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.

{4}------------------------------------------------

Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] 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

{5}------------------------------------------------

## Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Intelligent Images S.r.l.

510(k) Number (if known): _ Ko 2 2940

Device Name: In-Vision View with Measurements Module

Indications For Use:

In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Prescription Use |
|----------------------|
| (Per 21 CFR 801.109) |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <img alt="Signature" src="signature.jpg"/> |
|---------------------------------------------------------------|--------------------------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| (Per 21 CFR 801.590k) Number | K022940 |

Page 12 of 28