SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003

K062107 · Hologic, Inc. · LLZ · Aug 18, 2006 · Radiology

Device Facts

• Record ID: K062107
• Device Name: SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
• Applicant: Hologic, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The SecurView DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Device Story

SecurView DX is a multi-modality review workstation software for digital radiology images, focused on mammography. Software accepts standard or multi-frame DICOM images (US, MR, DR, CR, SC, CT, PET) via network interface. Operates on Windows XP PC with high-resolution gray scale displays (5 MP) or color displays (2 MP). Physician/technician uses mouse, keyboard, and workflow keypad to manipulate and interpret images. Image processing is external to software. Output facilitates clinical decision-making by providing visualization tools for screening and diagnostic interpretation. Benefits include efficient review of multi-modality images and support for mammographic diagnostic workflows.

Clinical Evidence

Bench testing only. No clinical data provided. Device validated under ISO 13485 and 21 CFR Part 820 Quality System. Compliance with ACR/NEMA DICOM standards (PS 3.1-3.18) verified.

Technological Characteristics

Software-based workstation for DICOM image display. Runs on Windows XP; Intel CPU >= 2.0 GHz; 2.0 GB RAM; 140 GB HDD. Supports high-resolution 5 MP gray scale displays and 2 MP color displays. Connectivity via 10/100 Base TX Network Interface. Complies with DICOM standards. ISO 13485 and 21 CFR Part 820 compliant development.

Indications for Use

Indicated for trained physicians to display, manipulate, and interpret lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, and other DICOM multi-modality images. Used by trained professionals including radiologists, nurses, and technicians.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• SecurView DX (K041555)

Submission Summary (Full Text)

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

Hologic, Inc. Special 510(k) for SecurView DX

Kob 2107

# 510(k) Summary SecurView DX

AUG 1 8 2006

Product Name: SecurView DX

Product Classification Name: Picture archiving and communication system

Product Classification Code: LLZ CFR Section: 892.2050

Classification Panel: Radiology Class II

Manufacturer: Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 USA

- Contact Person: Gail Yaeker-Daunis Telephone Number: [phone] Fax Number: [phone]
July 18, 2006 Date Prepared:

K041555 SecurView DX, Hologic Inc. Predicate Device:

Device Description: The Hologic Secur View DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive at least two high-resolution gray scale displays (FDA cleared for Mammography), a PC mouse, a keyboard and an optional dedicated workflow keypad.

The software accepts standard or multi-frame mammography images that have been created according to the "FOR PRESENTATION" specification of the DICOM Standard with no compression or using lossless compression. Image processing is external to the SecurView DX software.

The software accepts multimodality images of US, MR, DR, CR, SC, CT, PET, and other DICOM formats for display and manipulation on the high resolution 5 MP gray scale displays or on a color 2 MP display in 2-D or 3-D view.

The SecurView DX software can be used in a single or in a multi-workstation configuration.

The minimum computer requirements to run the Secur View DX software are: Windows XP® Operating System Intel CPU with a clock rate of 2.0 GHz or greater 2.0 GB RAM or greater 140 GB Hard drive or greater, operating at 160 Mbs or greater

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

## CD-ROM/R 10/100 Base TX Network Interface

## Intended Use:

The Hologic SecurView DX is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images using FDA cleared displays for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The Secur View DX software is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

## Comparison with Predicate Device:

The modified SecurView DX is substantially equivalent to the SecurView DX cleared August 9, 2004 as 510(k) #K041555 and has the same intended use as stated above,

| SecurView DX (K)041555 | SecurView DX Modified |
|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intel CPU with clock rate of 2.0 GHz or<br>greater | Same |
| 2.0 GB RAM or greater | Same |
| 140 GB Hard drive or greater operating at 160<br>Mbs or greater | Same |
| CD ROM/read/write / DVD +/- read/write | CD ROM/R |
| Windows 2000 Operating System | Windows XP Operating System |
| US QWERTY Keyboard | Same |
| 10/100 Base TX Network Interface | 10/100 Base TX Network Interface |
| 3-button Mouse | Pointing Device w/wheel |
| Workstation Keypad | Workstation Keypad |
| (2) High-Resolution Grey Scale Display<br>(FDA cleared for Mammography)<br>21" Portrait Orientation,<br>Resolution 2058/2560 pixels (5MP) | At least two High-Resolution Grey<br>Scale Displays (FDA cleared for<br>Mammography)<br>Optional Color at least 2 MP, High<br>Contrast Display for Multimodality<br>viewer |

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

| SecurView DX (K)041555 | SecurView DX Modified |
|------------------------------------------------------------|-----------------------|
| Bar Code Reader (Code 39 Full ASCII, Code<br>128, Code 39) | Same |

### Software:

The SecurView DX software is specified, validated and tested by Hologic, Inc., under an ISO 13485 and 21 CFR Part 820 Quality System.

## Safety and Effectiveness - Performance Standards:

The SecurView DX software is specified, validated and tested by Hologic, Inc., under a registered ISO 13485 and 21 CFR Part 820 Quality System.

The Secur View DX software complies with ACR/NEMA Digital Imaging Communications in Medicine version PS 3.1-3.18 (DICOM) Set

An Operator's Manual will be provided with each system that is user friendly and comprehensive, thus ensuring safe and effective operation.

### Conclusion:

Similar to the predicate device, the SecurView DX software displays and manipulates DICOM images to be interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. The device and the predicate device share similar performance standards Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or retransmission after correcting the problem(s). Passwords are required for operation and to protect against unauthorized use. Potential hazards have been studied and controlled by a Risk Management Plan. Based on the information supplied in this 510(k), Hologic concludes that the device is substantially equivalent to the predicate device.

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

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## AUG 1 8 2006

Ms. Gail Yeaker-Daunis Senior Regulatory Specialist Hologic, Inc. 36 Apple Ridge Rd. DANBURY CT 06810

Re: K062107

Trade/Device Name: SecurView DX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 20, 2006 Received: July 24, 2006

#### Dear Ms. Yeaker-Daunis:

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 (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1826-1926" at the top, followed by the letters "PA" in a bold, blocky font. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line at the bottom of the logo. The logo has a vintage or commemorative appearance.

Protecting and Promoting Public Health

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

Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.l1tml.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

{5}------------------------------------------------

Hologic, Inc. Special 510(k) for SecurView DX

K06 2167

510(k) No.

Indications For Use

Device Name: SecurView DX

The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The SecurView DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>21 CFR 801.109 | <div> <span> <svg height="15" width="15"> <path d="M4.5 9 L10 3 L11 4 L5 10 Z" fill="none" stroke="black"></path> </svg> </span> </div> |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| OR | |
| Over-the-Counter Use | |

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K062102 |
|---------------|---------|
|---------------|---------|

0131 11 11/2