EFILM VIDEO

K013631 · Efilm Medical, Inc. · LMA · Nov 20, 2001 · Radiology

Device Facts

• Record ID: K013631
• Device Name: EFILM VIDEO
• Applicant: Efilm Medical, Inc.
• Product Code: LMA · Radiology
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images. Typical users of eFilm Video™ are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Device Story

eFilm Video™ is a software application for capturing analogue video streams from medical imaging devices; converts streams into DICOM-compliant cine loops or still images. Used by trained medical professionals (radiologists, clinicians, technologists) in clinical settings. Users input patient demographic data; captured images are sent to DICOM-compliant devices for viewing and manipulation. Device does not contact patients or control life-sustaining equipment; relies on human interpretation of displayed images for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only, conducted according to a Software Test Plan as part of the manufacturer's product development process.

Technological Characteristics

Software application for video capture and DICOM conversion. Operates on standard computing hardware. No patient contact. Hazard analysis classified all potential hazards as minor. Complies with voluntary standards.

Indications for Use

Indicated for trained medical professionals (radiologists, clinicians, technologists) to capture video streams from analogue medical image acquisition devices and convert them into DICOM-compliant cine loops for display and processing.

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/Pro Video (K000411)

Submission Summary (Full Text)

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

K01363/

## NOV 2 0 2001

### 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification for eFilm Video™, in accordance with SMDA 1990.

| Date Prepared: | Oct 26, 2001 |
|----------------------------------|---------------------------------------------------------------------------------------------|
| Submitted By: | eFilm™ Medical Inc.<br>500 University Ave, Suite 300,<br>Toronto, Ontario<br>Canada M5G 1V7 |
| Contact Name: | Joseph A. Thomas |
| Contact Email: | [e-mail] |
| Contact Telephone: | [phone] ext 291 |
| Contact Fax: | [phone] |
| Device Trade Name: | eFilm Video™ |
| Device Common Name: | Video Capture System |
| Regulation Number: | 892.2030 |
| Device Classification: | Class II |
| Name: | Medical Image Digitizer |
| Predicate Device: | CHILI Video/Pro Video |
| Predicate Device Manufacturer: | STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE<br>INFORMATIK |
| Predicate Device 510(k) Number: | K000411 |
| Date Received: | 02/08/2000 |
| Decision Date: | 04/14/2000 |
| Decision: | Substantially Equivalent |
| Panel Code Device Reviewed by: | Radiology |
| Panel Code Device Classified by: | Radiology |
| Product Code: | LMA |
| Regulation Number | 892.2030 |
| Classification: | Class II |

#### Device Description

eFilm Video™ is a software application that is used for capturing video streams from analogue medical image acquisition devices with video outputs and converting these streams to DICOM modiant cine loops. Users may capture single stills or consecutive images and save them as DICOM files that can be viewed and manipulated in a picture archiving and communications viewing application.

#### Indications For Use

eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images.

Typical users of eFilm Video™ are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

RA
II

ن ت

2 ଚନ୍ଦ୍ର រីក

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

#### Technological Characteristics

eFilm Video™ performs the same functions relating to image acquisition as the predicate device. of ilm Video™ operates in the same environment as the predicate device and raises no new er inf 11000 ** operation risk and therefore is substantially equivalent to the predicate device.

eFilm Video™ does not contact the patient, nor does it control any life-sustaining devices. A el inf 'ndoo' video mot opportunity for competent human intervention interprets images and information being displayed and/or printed.

#### Testing

eFilm Video™ is tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process

#### Conclusion

The 510(k) premarket notification for eFilm Video™ contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.

- 1. eFilm Video™ has been and will continue to be manufactured according to the voluntary standards listed in the Voluntary Standards section (4.1) of this submission.
- 2. This submission contains the result of a hazard analysis and all potential hazards have been classified as minor.

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

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol resembling an eagle or bird, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

EFilm Medical Inc.™ % Mr. Ned Devine Program Manager Entela Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548 Re: K013631 Trade/Device Name: eFilm Video™ Video Capture System Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: October 26, 2001 Received: November 5, 2001

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection 310(t) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regars) to regars the Medical Device Amendments, or to conninered prior to May 20, 1978, als casordance with the provisions of the Federal Food, Drug, de necs mat have boon recuire approval of a premarket approval application (PMA). and Cosmetic Trol (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, mercerore, manel and net, include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is elassified (500 a00 70) . 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 r lease be advisou that I Dr viewan that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any i vith 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 (21 CFR Part 607), laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{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 noutication. The I Drivinating sification 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 If you desire spooline active 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 Additionally, for questions on [phone]. Also, please note the regulation entitled, "Misbranding Other of Compinated at (2007 oation" (21 CFR Part 807.97). Other general information on of relection to promation the Act may be obtained from the Division of Small Manufacturers, your responsional 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. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications For Use Statement

**510(k) Number:** K: 13631

NOV 2 0 2001

Device Name: eFilm Video™

#### Indications for Use:

eFilm Video™ is a software application that captures video streams from analogue medical image eFilm Video™ is a software application nat capares these streams to DICOM compliant cine
acquisition devices with video outputs and converts these streams to DCOM c acquisition devices with Video outputs and conveliant to Libertis (1) Users
loops. These images can be sent to DICOM compliant devices (1) List (1) Locked loops. These images can be sent to Broom complain as near and the captured images.

Typical users of eFilm Video™ are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109):


OR

Over the Counter Use (optional Format 1-2-96): _______________________________________________________________________________________________________________________________

Nancy C. Beagdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013631

2