DICOM VIDEO

K132183 · Bar Code Computer, Ltd. · LMA · Oct 3, 2013 · Radiology

Device Facts

• Record ID: K132183
• Device Name: DICOM VIDEO
• Applicant: Bar Code Computer, Ltd.
• Product Code: LMA · Radiology
• Decision Date: Oct 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the nework. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.

Device Story

DICOM Video is a software package installed on an off-the-shelf PC; functions as a medical image digitizer. Inputs include analog video signals (S-Video/Composite) from host acquisition devices or digital files (text, images, video). Device captures, records, and stores data; allows user to input patient demographics; transforms data into standard DICOM files. Transmits files via LAN to hospital PACS; retrieves and displays studies from PACS. Used in clinical settings by authorized personnel. Benefits include enabling digital integration for modalities lacking native digital export functions, facilitating centralized storage and viewing within existing hospital network infrastructure.

Clinical Evidence

No clinical data. Bench testing only. Software verified against predefined test plan and validated in end-user environment. Conformance to NEMA PS 3.1-3.20 (2011) DICOM standards confirmed.

Technological Characteristics

Software package for off-the-shelf PC; utilizes company-specified frame grabber board. Inputs: S-Video and Composite video formats. Connectivity: TCP/IP Ethernet using DICOM 3.0 protocol. Standards: NEMA PS 3.1-3.20 (2011).

Indications for Use

Indicated for authorized personnel to acquire, record, store, edit, and transfer medical imaging studies (text, still images, video) or digitized video signals into DICOM format for transmission to a clinic PACS.

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/VIDEO PRO (K000411)

Submission Summary (Full Text)

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K132183
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## 510(k) Summary of Safety and Effectiveness (in accordance to 21CFR 807.92)

#### Submitter details

Bar-Code Computers Ltd. 2 Hayozma St, Tirat Hacarmel 39120, Israel

Telephone [phone]

6 Sireni St., Haifa, 32972, Israel.

### Details of the submitted Device

Preparation Date: 16th September 2013

Submission Contact: Dan Laor

Proprietary Name: Regulation Description: Regulation Number Product Code: Committee/Panel: Device Class:

DICOM Video Medical image digitizer. 892.2030 LMA Radiology ನ

OCT 03 2013

#### Reason for 510(k) Submission:

New Device

#### Identification of the Legally Marketed Predicate Device K000411 CHILI VIDEO/VIDEO PRO

#### Device Description

The DICOM Video is a software package, which is installed in an Off - The - Shelf Host PC. The device is interfaced and configured to a hospital Local Area Network (LAN).

The DICOM Video receives patients' list from the Hospital Modality Work List (MWL ) server and digital files input data (in text, images or video formats). The device records the received data, stores it, transfers the studies into standard DICOM files, and transmits the DICOM files via the LAN to the Hospital PACS.

The DICOM Video can be interfaced to a Host Acquisition Device in order to receive analog video signals. The data is digitized, stored, optionally edited, transferred into standard DICOM files, and transmitted as DICOM files via the LAN to the Hospital PACS.

The device can also retrieve DICOM studies from the PACS and display them on the user screen.

#### Intended use and indications for Use

The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the nework. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.

### Comparison with the predicate device

Intended Use & Indications For Use: Similar to the predicate device, the DICOM Video is intended for use by authorized personnel to acquire individual or sequences of images. Both devices allow the user to input patient demographics. In addition the DICOM Video transforms

Section 5_510K Summary

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K132183
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,

imaging studies to DICOM format before they are made available to other locations in the network.

Similar to the predicate device, the DICOM Video is indicated to receive studies in various formats. The devices' operations include capturing the data, recording, storing and editing. In addition the DICOM Video is communicating DICOM files with the hospital PACS .

| Category | Predicate Device<br>K000411 CHILI<br>VIDEO/VIDEO PRO | Subject Device<br>DICOM Video |
|-------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------|
| Used to grab images from<br>modalities that do not have<br>digital export functions | Yes | Yes |
| Data Capture: Can grab<br>single images | Yes | Yes |
| Data Capture: Can grab<br>sequence images | Yes | yes |
| Viewing | Yes | Yes |
| Editing | Yes | Yes |
| Storing | Yes | Yes |
| Grabbed image can be<br>manipulated. | No | No |
| Images can be added to a<br>study | Yes | No |
| user enters patient<br>demographic data | Yes | Yes |
| Images can be stored<br>with demographic data | Yes | yes |
| Data Source | Includes: Still images & Video | Includes: Files of Text,<br>Still images & Video |
| Control s | Software package included | Software package<br>included |
| Supporting Hardwar PC | Included | Company specified PC |
| Frame grabber | Various boards available | Company specified board |
| Can be used with any<br>device that has a video<br>data stream output | Yes | S Video & Composite<br>formats, ONLY |
| User selectable video<br>sources | Yes | Pre-selected single video<br>source, only |
| Communication | Not provided | TCP/IP Ethernet using<br>DICOM 3.0 protocol |

### Characteristics Comparison

Section 5_510K Summary

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## Design Verification and Validation

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device was tested in conformance to the requirements of NEMA PS 3.1 - 3.20 (2011) DICOM (Digital Imaging and Communications in Medicine) set and was found conforming.

## Performance data

## Bench data:

The device performance has been verified by testing the software with respect to predefined software test plan.

The device has been validated by testing the performance with respect to predefined test plan in end - user environment.

Methods of testing the device safety & effectiveness adhere to state-of-art standards. The tests results demonstrated that the device output meet the design input and support the indications for use.

Clinical Data: Clinical data is not included.

## Substantial Equivalence

The above presented data demonstrate that:

- The predicate device K000411 CHILI VIDEO/VIDEO PRO is legally marketed. ਕ.
- The submitted device and the predicate device have the same intended use. b.
- The technological characteristics are equivalent and do not raise different questions of C. safety and effectiveness.

Conclusion: Based on the data above, it is Bar Code Computers' opinion that the submitted device and the predicate device are substantial equivalent.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized caduceus or a representation of the human form.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

October 3, 2013

Bar-Code Computers Ltd. % Mr. Dan Laor Q&R Consultant 6 Sireni Haifa 32972 ISRAEL

Re: K132183 Trade/Device Name: DICOM Video Regulation Number: 21 CFR 892.2030 Regulation Name: Medical Image Digitizer Regulatory Class: II Product Code: LMA Dated: July 8, 2013 Received: July 19. 2013

Dear Mr. Laor:

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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (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 fimited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

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Page 2-Mr. Laor

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K132183

Device Name: DICOM Video

Indications for Use:

The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the network. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health

510(k) K132183

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