(15 days)
No
The description focuses on digitizing analog video signals and does not mention any AI/ML capabilities or image processing beyond simple conversion.
No
The device is a video image digitizer for the acquisition and conversion of medical images, intended to be used with printers to produce referral prints. It does not perform any therapeutic function.
No
This device digitizes analog video signals from medical equipment, primarily for printing referral images, and does not perform any diagnostic interpretation or analysis of the images. Its function is image conversion, not diagnosis.
No
The device description explicitly states it is a "small box that integrates the functions and the hardware of a standard personal computer based on a Pentium architecture," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire and convert analogue video signals of medical images into digital format for printing. This is a function related to image handling and output, not the analysis of biological samples or the diagnosis of disease based on in vitro testing.
- Device Description: The description focuses on the hardware and function of digitizing video signals.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro tests.
The device is a video image digitizer used in conjunction with printers for producing referral prints of medical images. This falls under the category of medical imaging accessories or components, not IVD devices.
N/A
Intended Use / 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.
Product codes
90 LMA
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound systems or other medical equipment through the video signal output.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 required for this type of device and its level of concern.
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
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
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.
0
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 +39 0195224055 (phone) +39 0195224546 (fax). E-mail: pmannella@ferraniait.com |
| 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
1
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/
Specification | LifeJet™
Video Link | CHILI® Video |
|-----------------------------------------------------------------------------------|------------------------|------------------------|
| Operating System | RTOS | Windows NT / Linux |
| RAM | 32 MB | Various (PC dependent) |
| Used to grab images from modalities
which have not digital export
functions | Yes | Yes |
| Can grab single images | Yes | Yes |
| Can grab sequences of images | No | Yes |
| Patient demographic data can be
added to images | No | Yes |
| Input operating device | Front panel | PC Keyboard |
| Image grabbing triggered by an
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
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.
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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 (800) 638-2041 or (301) 443-6597 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
4
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
.