QUANTRA

K082483 · Hologic, Inc. · LLZ · Sep 12, 2008 · Radiology

Device Facts

• Record ID: K082483
• Device Name: QUANTRA
• Applicant: Hologic, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 12, 2008
• 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

Quantra™ is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).

Device Story

Quantra is a software application for Hologic digital mammography systems; it processes FFDM images to estimate breast tissue volumes. The device calculates volumetric breast density as a ratio of fibroglandular tissue to total breast volume. It runs on the Hologic Cenova DICOM server. The output consists of numerical values for each breast, provided to radiologists as adjunctive information to assist in the assessment of breast tissue composition. It is not an interpretive or diagnostic aid. The device does not contact the patient.

Clinical Evidence

Bench testing only. Performance demonstrated through Hologic's internal SOPs and testing procedures. Hazard analysis performed; software level of concern classified as Minor.

Technological Characteristics

Software application for digital mammography image processing. Operates on Hologic Cenova DICOM server. Complies with ISO 13485, ISO 14971, NEMA DICOM PS 3 (ISO 12052), and ANSI/AAMI SW68:2001. No patient contact. Non-life-sustaining.

Indications for Use

Indicated for use with Hologic digital mammography systems to calculate volumetric breast density (ratio of fibroglandular tissue to total breast volume) to aid radiologists in assessing breast tissue composition. Not an interpretive or diagnostic aid.

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

• Sectra IDS5 Workstation (K050196)
• WorkstationOne™ Breast Imaging Workstation (K073272)

Submission Summary (Full Text)

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## SEP 1 2 2008

# Quantra™M 510(k) Submission

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

(as required by 21 CFR § 807.92c)

Date Prepared: August 15, 2008

### Submitted by:

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

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

Catherine A. Williams Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: catherine.williams(@hologic.com

### Trade Name and Common Name:

| Trade Name: | Quantra™ |
|-------------------|---------------------------------------------|
| Software Version: | 1.1 |
| 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 devices for Quantra software are certain software functions contained in the following devices:

Sectra IDS5 Workstation [Sectra Imtec AB] K050196. Feb 24, 2005 WorkstationOne™ Breast Imaging Workstation [Three Palm Software, LLC] K073272, Dec 11, 2007

### Device Description:

Quantra is a software application that estimates breast tissue volumes. The estimations are made from mammography images produced by full-field digital mammography (FFDM) systems.

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Quantra 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
- Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) NEMA DICOM PS 3 . (ISO 12052)
- Medical Device Software Software Life Cycle Processes . ANSI/AAMI SW68:2001
- . 21 CFR & 820 US Food and Drug Administration, Quality System Regulation General Principles of Software Validation; Final Guidance for Industry and N/A . FDA

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

### Intended Use:

Quantra™ is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.

Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR & 892.2010 and 21 CFR & 892.2020).

### Technological Characteristics:

Quantra is a software application that processes digital mammography images. 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 Quantra contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices.

The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Minor".

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird image. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

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

Re: K082483

Trade/Device Name: QuantraTM Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 27, 2008 Received: August 28, 2008

### 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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### 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

forque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## B.2 Indication(s) for Use Statement

510(k) Number (if known):

Device Name:

Quantra™M

KO82483

Indications for Use:

Quantra™ is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.

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

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)

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

Section B