HOLOGIC VISCERAL FAT SOFTWARE

K113356 · Hologic, Inc. · KGI · Mar 6, 2012 · Radiology

Device Facts

• Record ID: K113356
• Device Name: HOLOGIC VISCERAL FAT SOFTWARE
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends. The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.

Device Story

Software extension for Hologic Discovery bone densitometers; processes total body DXA scan data to estimate visceral adipose tissue in the android region. Outputs include Visceral Fat Area, Mass, and Volume. Used by healthcare professionals in clinical settings to monitor visceral fat trends in patients with metabolic conditions. Does not diagnose, recommend treatment, or quantify treatment efficacy; serves as an adjunct tool for clinical management. Results integrated into Adipose Indices section of body composition reports.

Clinical Evidence

Bench testing only. Testing demonstrated that the software meets all functional requirements and performance specifications.

Technological Characteristics

Software-based estimation of visceral fat from DXA total body scans. Operates on Hologic Discovery bone densitometer hardware. Provides quantitative outputs (area, mass, volume) for the android region.

Indications for Use

Indicated for adult males and females, excluding pregnant women, to estimate visceral adipose tissue (area, mass, volume) in the android region for management of conditions like hypertension, diabetes, dyslipidemia, and metabolic syndrome.

Regulatory Classification

Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE Lunar Visceral Fat Software (K103730)
• Hologic NHANES Whole Body DXA Reference Database (K103265)

Submission Summary (Full Text)

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

Hologic Visceral Fat Software 510(k) Premarket Notification

## KII 3.356 1 of 3

# Section 5 -510(k) Summary

## 1 Manufacturing Establishment and Contact Information

MAR - 6 2012

## Manufacturer Name and Address: 1.1

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

## 1.2 Establishment Registration Number:

1221300

### 1.3 Name, Title, and Telephone Number of Contact:

Name: Eileen M. Boyle Regulatory Affairs Specialist II Title: [phone] Phone: [phone] Fax : [e-mail]

## Device Identification 2

### 2.1 Device Trade Name:

Hologic Visceral Fat Software

## 2.2 Common / Usual Name:

Software for Bone Densitometers

## 2.3 Proposed Intended Use:

The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.

The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.

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

Hologic, Inc .: November 10, 2011

## Hologic Visceral Fat Software 510(k) Premarket Notification

## KII 3356 2 of

## Device Classification 3

#### 3.1 Classification:

Class II

#### 3.2 Classification Name and Rule

Bone Densitometer: 21 CFR 892.1170

#### Classification Panel 3.3

Radiology

#### 3.4 Product Code

વે જણાવાદ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત

#### 3.5 Predicate Devices

- . 510(k) No.: K103730 Trade Name: GE Lunar Visceral Fat Software SE Date: 5/6/2011 Manufacturer: GE Medical Systems Lunar
- . 510(k) No.: K103265 Hologic NHANES Whole Body DXA Reference Database Trade Name: SE Date: · 3/16/2011 Manufacturer: Hologic, Inc.

## Device Description 4

The proposed Hologic® Visceral Fat Software provides an estimate of a patient's visceral fat in the abdominal region of a whole body scan. The results are included in the Adipose Indices section of the Hologic Discovery bone densitometer's body composition report.

### 5 Performance Testing

Testing was successfully conducted and demonstrates that the Hologic Visceral Fat Software meets all of its functional requirements and performance specifications.

#### 5 Substantial Equivalence

The Hologic® Visceral Fat Software is substantially equivalent to commercially available devices used for the estimation of a patient's visceral fat. The predicate devices selected for comparison are the GE Lunar Visceral Fat Software Option (K103730) and the Hologic NHANES Whole Body DXA Reference Database (K103265). The predicate devices provide substantially equivalent or the same intended use, features and functions as the proposed device.

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

Hologic, Inc.: November 10, 2011

Hologic Visceral Fat Software 510(k) Premarket Notification

## Conclusion: 6

KI13356 R 3 of 3

. The Hologic Visceral Fat Software is an extension of the cleared Discovery NHANES Whole Body DXA Reference Database (K103265). The features and functions are substantially equivalent to those of the indicated commercially distributed device (GE Lunar Visceral Fat Software K103730) with regard to intended use, performance, safety and effectiveness

Hologic Proprietary and Confidential

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wings.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAR - 6 2012

Ms. Eileen M. Boyle Regulatory Affairs Specialist II Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K113356

Trade/Device Name: Hologic Visceral Fat Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: February 29, 2012 Received: March 1, 2012

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your 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). and Cosmetic roll (1 ret) that as novice, subject to the general controls provisions of the Act. The I ou may, merelore, market 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 class II (Special Controls), it may be subject to such 11 your device is classified (200 acorregulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I lease of advisod that I Dr o retime that your device complies with other requirements of the Act that I DA has made a actorized administered by other Federal agencies. You must or any I catales and regarments, including, but not limited to: registration and listing (21 Compy with an the Fee of requirements 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket whil anow you to organ maing of substantial equivalence of your device to a legally marketed nothicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Hologic, Inc .: November 10, 2011

Hologic Visceral Fat Software 510(k) Premarket Notification

## SECTION 4 - INDICATIONS FOR USE

K113356

510(k) Number (if known): Device Name:

The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.

The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

ffice of Device Evaluation (ODE)

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

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

Concurrence of CDRH, C
(Division Sign-Off)
Division of Radiological Devices

Office of in Vitro

510K K1133

Hologic Proprietary and Confidential

Page 1 of 1

Section 4