R2 DIGITALNOW HD(DIGITALNOW HD)

K091368 · Hologic, Inc. · LLZ · Jun 4, 2009 · Radiology

Device Facts

• Record ID: K091368
• Device Name: R2 DIGITALNOW HD(DIGITALNOW HD)
• Applicant: Hologic, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

R2 DigitalNow HD is a software application intended to process digitized screen-film mammograms for comparison purposes only. The software processes digitized prior film images to produce lossycompressed DICOM images that more closely resemble digital mammography images. R2 DigitalNow HD images are intended for comparison purposes only and cannot be used for primary diagnosis. DigitalNow HD is a software application which runs on the Hologic Cenova server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).

Device Story

Software application processes digitized prior screen-film mammograms; transforms film images into lossy-compressed DICOM images resembling digital mammography; runs on Hologic Cenova server. Used in clinical settings by radiologists for comparison purposes; output assists in visual alignment of prior film studies with current digital mammography. Benefits include improved visual consistency between historical film and current digital images to aid comparative review. Cannot be used for primary diagnosis.

Clinical Evidence

No clinical data. Performance demonstrated via bench testing, hazard analysis, and software verification/validation in accordance with ISO 13485, ISO 14971, and ANSI/AAMI SW68:2001.

Technological Characteristics

Software application; runs on Hologic Cenova server. No patient contact. Complies with ISO 13485, ISO 14971, ANSI/AAMI SW68:2001. Moderate level of concern for software hazards.

Indications for Use

Indicated for processing digitized screen-film mammograms to create images for comparison purposes only. Not for primary diagnosis. Patient population not specified.

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

• DexTop Mammography Workstation (K080351)

Submission Summary (Full Text)

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Hologic, Inc.

5091368

DigitalNow™ HD 510(k) Submission

#### B.1 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR § 807.92c)

#### Date Prepared: April 14, 2009

JUN - 4 2009

Submitted by:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730, USA

#### Name, Title and Phone Number of Contact:

Michaela Mahl Senior Regulatory Affairs Specialist Phone: [phone] FAX: [phone] Email: michaela.mahl(@hologic.com

#### Trade Name and Common Name:

| Trade Name: | R2 DigitalNow™ HD (DigitalNow™ HD) |
|-------------------|---------------------------------------------|
| Software Version: | 1.0 |
| Common Name: | Picture Archiving and Communications System |

#### Classification:

| Regulatory Class: | II |
|-----------------------|-----------|
| Classification Panel: | Radiology |

Image Processing System 21 CFR § 892.2050 Product Code 90-LLZ

#### Predicate Devices:

The predicate device for DigitalNow HD software is certain software functions contained in the following device:

K080351, Apr 22, 2008

DexTop Mammography Workstation [Dexela Limited]

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### Device Description:

R2 DigitalNow HD is a software application intended to process digitized screen-film mammograms.

DigitalNow HD has been designed and will be manufactured in accordance with the following standards:

| · ISO 13485 | Medical Devices - Quality Management Systems |
|--------------------------|-----------------------------------------------------------------------------------|
| · ISO 14971 | Medical Devices – Application of Risk Management to Medical Devices |
| · ANSI/AAMI<br>SW68:2001 | Medical Device Software – Software Life Cycle Processes |
| · 21 CFR § 820 | US Food and Drug Administration, Quality System Regulation |
| · N/A | General Principles of Software Validation; Final Guidance for Industry and<br>FDA |

The performance of the software is also tested in accordance with Hologic's SOPs and testing procedures to demonstrate adequate performance.

#### Intended Use:

R2 DigitalNow HD is a software application intended to process digitized screen-film mammograms for comparison purposes only. The software processes digitized prior film images to produce lossycompressed DICOM images that more closely resemble digital mammography images. R2 DigitalNow HD images are intended for comparison purposes only and cannot be used for primary diagnosis.

DigitalNow HD is a software application which runs on the Hologic Cenova server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).

#### Technological Characteristics:

DigitalNow HD is a software application intended to process digitized screen-film mammograms. The device does not contact the patient, nor does it control any life-sustaining devices.

#### General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

#### Conclusion:

The 510(k) Pre-Market Notification for DigitalNow HD contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Moderate".

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2009

Hologic, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K091368

Trade/Device Name: R2 DigitalNowTM HD (DigitalNow™ HD) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: May 23, 2009 Received: May 26, 2009

#### Dear Mr. Job:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# B.2 Indication(s) for Use Statement

510(k) Number (if known):

K09/368

Device Name:

R2 DigitalNow™ HD (DigitalNow™ HD)

Indications for Use:

R2 DigitalNow HD is a software application intended to process digitized screen-film mammograms for comparison purposes only. The software processes digitized prior film images to produce lossy-compressed DICOM images that more closely resemble digital mammography images. R2 DigitalNow HD images are intended for comparison purposes only and cannot be used for primary diagnosis.

DigitalNow HD is a software application which runs on the Hologic Cenova server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020). 1

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hele Lesan

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