LIFEJET VIDEO LINK

K013395 · Ferrania S.P.A. · LMA · Oct 30, 2001 · Radiology

Device Facts

• Record ID: K013395
• Device Name: LIFEJET VIDEO LINK
• Applicant: Ferrania S.P.A.
• Product Code: LMA · Radiology
• Decision Date: Oct 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal. The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.

Device Story

LifeJet™ Video Link is a compact video image digitizer; integrates Pentium-based PC hardware into a small enclosure. Device accepts analogue video signal inputs from medical equipment (e.g., ultrasound systems). It converts these signals into digital format for output to LifeJet™ Printers. Operated via a front-panel LCD and functional keys; eliminates need for external keyboard/monitor. Designed for clinical environments to facilitate referral printing of medical images. Benefits patient by enabling hard-copy documentation of diagnostic images from modalities lacking native digital export functions.

Clinical Evidence

No clinical data. Bench testing only; performance data not required for this device type and level of concern.

Technological Characteristics

Pentium-based architecture; 32 MB RAM; RTOS; Brooktree frame grabber board; front-panel LCD and functional key interface; standalone unit; converts analogue video to digital.

Indications for Use

Indicated for the acquisition and conversion of analogue video signals from medical equipment, such as ultrasound systems, into digital format for the production of referral prints.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• CHILI® Video (K000411)

Submission Summary (Full Text)

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510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeJet™ Video Link

K013395
Page 1 of 2

# Section 10 - 510(k) Summary of Safey and Effectiveness as required by 21 CFR 807.92(c)

| 10.1 Submitted by | Ferrania S.p.A. Viale della Libertà 57 17014 Ferrania Savona (Italy) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 10.2 Contact person | Ing. Mannella Paolo Regulatory Manager [phone] (phone) [phone] (fax). E-mail: [e-mail] |
| 10.3 Date Summary Prepared: | July 06, 2001 |
| 10.4 Device name: | Common Name: Video image digitizer Trade name: LifeJet™ Video Link Classification Name: Medical image digitizer (per 21 CFR 892.2030) |
| 10.5 Predicate device: | CHILI® Video (510(k) number: K000411), Steinbeis-Transferzentrum Medizinische Informatik, Im Neuenheimer Feld 517, D-69120 Heidelberg, Germany. |

#### 10.6 Description of device

OCT 3 0 2001

The LifeJet™ Video Link is a small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture, for the purpose of acquisition and conversion into digital format of medical images codified as analogue video signal.

#### 10.7 Statement of intended use

The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.

The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.

### Comparison with predicate device 10.8

The purpose and functionality of the Ferrania LifeJet™ Video Link are substantially equivalent to the CHILI® Video system (510(k) number: K000411). The basis for the equivalence is that both of them are video capture systems based on standard

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### 510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeJet™ Video Link

# Section 10 - 510(k) Summary of Safey and Effectiveness as required by 21 CFR 807.92(c)

K013395
page 2 of 2

hardware components and software operating systems which perform the same functions relating to image acquisition.

The only difference is that the LifeJet™ Video Link integrates the functions and the hardware of a standard personal computer based on a Pentium architecture in a small box. So, no external keyboard and monitor are necessary to use the Video Link; a dedicated user interface, composed of a LCD and a few functional keys, is mounted on the front panel of the device for its control.

The technological equivalence of the two devices and the equivalence in terms of their features are summarized in the table below.

| Feature/<br>Specification | LifeJet™<br>Video Link | CHILI® Video |
|-----------------------------------------------------------------------------------|------------------------|------------------------|
| Operating System | RTOS | Windows NT / Linux |
| RAM | 32 MB | Various (PC dependent) |
| Used to grab images from modalities<br>which have not digital export<br>functions | Yes | Yes |
| Can grab single images | Yes | Yes |
| Can grab sequences of images | No | Yes |
| Patient demographic data can be<br>added to images | No | Yes |
| Input operating device | Front panel | PC Keyboard |
| Image grabbing triggered by an<br>external device | Yes | No |
| Single channel color acquisition | Yes | Yes |
| Frame grabber board | Brook tree | Various |
| Grabbed image can be manipulated | No | No |
| Can be used with any device that has<br>a video data stream output | Yes | Yes |
| User selectable video sources | Yes | Yes |

### Table of comparison of features of Predicate Device

#### 10.9 Performance data

Not required for this type of device and its level of concern.

### 10.10 Conclusion

Based on the analysis of the comparisons made between the LifeJet™ Video Link and the predicate device, Ferrania S.p.A. concluded that the LifeJet™ Video Link is safe, effective and performs as well as the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2001

Ferrania S.P.A. % Ms. Chantel Carson Engineering Team Leader Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K013395

Trade/Device Name: LifeJet Video Link Video Image Digitizer Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: October 11, 2001 Received: October 15, 2001

Dear Ms. Carson:

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.

Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized lines or bars, arranged in a way that suggests movement or flow.

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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

and the comments of

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# Statement of Indications for Use

510(k) Number (if known)_ K 01 33 95

Device Name: LifeJet™ Video Link

Indications for Use:

The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.

The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
|--------------------------------------------------------|----|------------------------|--|--|
| Prescription Use _ V | OR | Over the Counter Use _ | | |

Nancyc broadon

(Division Sign-Off)
Division of Reproductive, Abdominel,
and Radiological Devices
510(k) Number K013395

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