GE LUNAR VISCERAL FAT SOFTWARE

K103730 · Ge Medical Systems Ultrasound and Primary Care Dia · KGI · May 6, 2011 · Radiology

Device Facts

• Record ID: K103730
• Device Name: GE LUNAR VISCERAL FAT SOFTWARE
• Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
• Product Code: KGI · Radiology
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The GE Lunar Visceral Fat Software option used on GE Lunar DEXA bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the Visceral Fat Mass and Visceral Fat Volume. The 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 GE Lunar Visceral Fat Body Composition Software option 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 option for GE Lunar DXA bone densitometers; utilizes total body DXA scan data to estimate visceral adipose tissue (VAT) mass and volume in the android region. Operates by measuring attenuation of dual-energy x-ray beams; combines direct fat/lean tissue measurements with modeling of fat distribution. Used in clinical settings by healthcare professionals to monitor VAT changes related to disease management (e.g., diabetes, metabolic syndrome). Output displayed as statistical formats/trends; assists clinicians in assessing patient status; does not diagnose, recommend treatment, or quantify treatment efficacy.

Clinical Evidence

Clinical trial performed comparing DXA-estimated visceral adipose tissue (VAT) against CT imaging (Advantage Windows Tissue Volume option, K963345) as the research standard. Bench testing also conducted to verify electrical, mechanical, and radiation safety per 21 CFR 820 and CDRH requirements.

Technological Characteristics

Software module for DXA bone densitometer; utilizes dual-energy x-ray attenuation principle. Operates on existing GE Lunar DXA hardware. Complies with 21 CFR 820 (Quality System Regulations) and CDRH 21 CFR subchapter J radiation safety standards.

Indications for Use

Indicated for male or female patients aged 18-90 with BMI 18.5-40 to estimate visceral adipose tissue (mass and volume) in the android region. Useful for managing conditions like hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome. Contraindicated for pregnant women.

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 Body Composition Software option (K071570)

Reference Devices

• Advantage Windows Tissue Volume option (K963345)

Submission Summary (Full Text)

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K103730 Page 1 of 3

GE Medical Systems Lunar 510(k) Premarket Notification GE Lunar Visceral Fat Software

## 510(K) Summary of Safety and Effectiveness

MAY - 6 2011

Prepared in accordance with 21 CFR Part 807.92.

| Date Prepared: | December 20, 2010 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, (GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC doing business as GE Medical Systems Lunar)<br>3030 Ohmeda Drive<br>Madison, WI 53718 |
| Primary Contact: | Chris Paulik<br>Regulatory Affairs Leader, GE Medical Systems Lunar<br>Telephone: [phone]; Fax: [phone]<br>e-mail: [e-mail] |
| Secondary Contact: | David Blonski<br>Regulatory Affairs Director, X-Ray<br>GE Healthcare, (GE Medical Systems, LLC)<br>Telephone: [phone]; Fax: [phone]<br>e-mail: [e-mail] |

### DEVICE INDENTIFICATION

| Trade Name: | GE Lunar Visceral Fat Software |
|----------------------|--------------------------------|
| Common/Usual Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer |
| | Class II, KGI, 21CFR 892.1170 |

### DEVICE DESCRIPTION:

The Visceral Fat Software option is part of a GE Lunar DXA bone densitometer. It uses data from a DXA total body scan to estimate the visceral adipose tissue (visceral fat), mass and volume within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40.

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white, with the letters and border appearing in black against a white background. The design is simple and iconic, representing the well-known multinational conglomerate.

GE Medical Systems Lunar 510(k) Premarket Notification GE Lunar Visceral Fat Software

#### INDICATIONS FOR USE:

The GE Lunar Visceral Fat Software option used on GE Lunar DEXA bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in a male or female population between the age of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the Visceral Fat Mass and Visceral Fat Volume. The 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 GE Lunar Visceral Fat Body Composition Software option 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.

#### TECHNOLOGY

GE Lunar Bone Densitometers use a technique called Dual-energy X-ray Absorptionetry or DXA. DXA measures the attenuation of an x-ray beam comprised of two energy levels after passing the beam through the body of a subject. When the dual-energy x-ray beam passes through soft tissue, without any bone mineral, the tissue composition for the pixel can be measured by calculating the relative attenuation by the fat and lean issue of the two energy levels in the x-ray beam.

The Visceral Fat software algorithm combines direct measurements of fat and lean tissue with modeling information about the distribution of fat in the android region.

A clinical trial was performed to compare dual-energy x-ray absorptiometry (DXA) estimated visceral fat adipose tissue (VAT) with the accepted research standard for VAT imaging, computed tomography (CT), using the Advantage Windows Tissue Volume option (K963345).

### COMPARISON WITH PREDICATE DEVICES:

The GE Lunar Visceral Fat Software option for GE Lunar DEXA Bone Densitometers is of comparable type and substantially equivalent to the GE Lunar Body Composition Software option (K071570). It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction and materials, and has similar intended uses as the GE Lunar Body Composition Software option.

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The logo is in black and white, with the letters and the outline of the circle in black and the background in white.

GE Medical Systems Lunar 510(k) Premarket Notification GE Lunar Visceral Fat Software

### ADVERSE EFFECTS ON HEALTH:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety standards, as confirmed by a Nationally Recognized Test Laboratory,

The potential hazards of electrical and mechanical are identified in a risk management summary (hazard analysis) and controlled by:

- System verification and validation to ensure performance to specifications, ● Federal Regulations, and user requirements.
- Adherence and certification to industry and international standards. .
- Compliance to applicable CDRH 21 CFR subchapter J requirements. .

The device is designed and manufactured under the Quality System Regulations of 21 CFR 820.

#### CONCLUSION:

The GE Lunar Visceral Fat Software is an extension of the currently cleared GE Lunar Body Composition Software (K071570). It does not result in any new potential safety risks, has the same technological characteristics, and performs as well as the devices currently on the market.

After analyzing performance testing on the bench and in a clinical trial it is the conclusion of GE Healthcare that the GE Lunar Visceral Fat Software is substantially equivalent to other marketed devices with similar indications for use and meeting the same standards.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 1 0 2011

Mr. Chris Paulik Regulatory Affairs Leader GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Doing business as GE Medical Systems Lunar 3030 Ohmeda Drive MADISON WI 53718

Re: K103730

Trade/Device Name: GE Lunar Visceral Fat Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: December 20, 2010 Received: December 21, 2010

Dear Mr. Paulik:

This letter corrects our substantially equivalent letter of May 6, 2011.

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 (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 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

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Page 2 - Mr. Paulik

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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucr1115800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Production 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,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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SION -510(k) Premarket Notification GE Lunar Viscoral Fat Software

# Indications for Use

510(k) Number (if Known): Device Name: GE Lunar Visceral Fat Software

Indications for Use:

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Prescription Use_ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CPR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

5/6/11

Division Sign-Off

Office of In Vitro Diagnostic Device Bvaluation and Safety 510(k) K103

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March 29, 2011

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