DIAGNOSTICPRO EDGE

K130406 · Vidar Systems Corp. · LMA · Apr 29, 2013 · Radiology

Device Facts

• Record ID: K130406
• Device Name: DIAGNOSTICPRO EDGE
• Applicant: Vidar Systems Corp.
• Product Code: LMA · Radiology
• Decision Date: Apr 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation. The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

Device Story

DiagnosticPRO Edge is a film digitizer for converting medical X-ray film into digital data. Device utilizes rollers driven by a stepper motor to feed film past scan optics, which include a white LED illuminator, lens, mirrors, and a CCD linear array detector. Connected to a PC via USB 2.0, the device uses Windows driver software to import digital data into DICOM-compliant applications. Operated by medical professionals or trained staff in clinical settings, the device produces digital images for consultation, review, and final interpretation. It does not provide diagnostic results or have patient contact. By digitizing film, it enables integration into digital workflows, facilitating remote review and electronic storage of radiographic images.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Film digitizer with multi-film feeder. Optical resolution: 600 dpi; 16-bit grayscale; DMAX 5.5 OD; medical OD range 0.1 - 4.0. Components: stepper motor, white LED illuminator, lens, mirrors, CCD linear array detector. Connectivity: USB 2.0 to PC. Software: Windows driver for DICOM-compliant applications.

Indications for Use

Indicated for medical professionals or trained staff to digitize medical x-ray film (including mammography) for secondary capture, consultation, review, and final interpretation. Not for use as the sole basis for screening or diagnosis.

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

• DiagnosticPRO M (K993598)
• Mammography PRO (K993598)

Submission Summary (Full Text)

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

KT30406
Page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for VIDAR systems corporation, which is an A.3D Systems Company. The logo is black and white and features the word "VIDAR" in large, bold letters. Below the word "VIDAR" is the text "systems corporation" and "A.3D Systems Company" in smaller fonts. The logo is simple and modern.

APR 2 9 2013

#### 510(k) Summary

Submitter: VIDAR Systems Corporation 365 Herndon Parkway Herndon, VA 20170 U.S.A. 703-471-7070 (phone) 703-471-1165 (fax)

Official Correspondent: Carrie L. Brancart

Date of Submittal: 2/12/13

Trade Name: DiagnosticPRO Edge

Common Name: X-Ray Film Digitizer

Classification Name: Medical Image Digitizer (21CFR892.2030)

Product Code: LMA Predicate Device: Trade Name: DiagnosticPRO M, Mammography PRO 510(k): K993598

Manufacturer: VIDAR Systems Corporation

## Device Description:

The device consists of a film digitizer with multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.

The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.

This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.

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

Image /page/1/Picture/0 description: The image shows the logo for VIDAR Systems Corporation, which is a 3D Systems Company. The logo features a stylized "V" with a horizontal line extending from the left. Below the "V" is the text "systems corporation" in a smaller font, and below that is the text "A 3D Systems Company."

# Intended Use:

The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

# Technological Characteristics:

The VIDAR DiagnosticPRO Edge film digitizer offers a high optical resolution of 600 dpi; 16-bit grayscale, optical density sensitivity (DMAX) of 5.5 OD, and a medical OD range of 0.1 - 4.0 (incorporates noise and linearity measurements).

## Performance Testing:

VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use. Please see Section 19 Bench Testing.

## Substantial Equivalence to Predicate Device:

The DiagnosticPRO Edge is substantially equivalent to the VIDAR DiagnosticPRO M. and Mammography PRO film digitizers. The comparison table of the principal characteristics of the two devices is shown in Section 13 and specification data for the DiagnosticPRO Edge is included in Section 12.

### Conclusion:

In terms of intended use, function, safety, operating environmental conditions and effectiveness of the DiagnosticPRO Edge it is determined to be substantially equivalent to the predicate device used for this application.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

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

April 29, 2013

VIDAR Systems Corporation % Ms. Carrie L. Brancart Director, Quality Assurance and Regulatory Affairs 365 Herndon Parkway ----------------------------------------------------------------------------------------------------------------------------------------------------------HERNDON VA 20170

Re: K130406

Trade/Device Name: DiagnosticPRO Edge Regulation Number: 21 CFR 892.2030 Regulation Name: Medical Image Digitizer Regulatory Class: II Product Code: LMA Dated: February 19, 2013 Received: February 22, 2013

Dear Ms. Brancart:

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. 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 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); 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.

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

## Page 2 - Ms. Brancart

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/ResourcesforYou/Industry/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/default.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

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

# Indications for Use

5 10(k) Number (if known): K130406

Device Name: DiagnosticPRO Edge

Indications for Use:

The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, .including .printed and .radiographic .film. The .target users of these devices are .medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

Prescription Use (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)

Sm.h.P).

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

510(k) K130406

Page 1 of 1