GE LUNAR BODY COMPOSITION SOFTWARE

K071570 · Ge Medical Systems Lunar · KGI · Jun 27, 2007 · Radiology

Device Facts

• Record ID: K071570
• Device Name: GE LUNAR BODY COMPOSITION SOFTWARE
• Applicant: Ge Medical Systems Lunar
• Product Code: KGI · Radiology
• Decision Date: Jun 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional. These body composition values are 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 patient fat and lean tissue. The GE Lunar 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 body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV and cystic fibrosis. DEXA body composition is a useful alternative to hydrostatic weighing and skin fold measurements.

Device Story

Software option for GE Lunar DEXA bone densitometers; processes existing DEXA scan data to calculate body composition metrics. Inputs: DEXA scan data (BMD, BMC, area). Outputs: regional/whole body lean mass, fat mass, % fat, A/G ratio, BMI. Used in clinical settings by healthcare professionals to monitor patient body composition changes related to disease or treatment. Does not require additional radiation exposure or hardware changes. Results displayed as statistical trends or color-mapped images. Assists clinicians in managing conditions like obesity, wasting syndromes, and metabolic disorders. Not for diagnostic use or treatment recommendation.

Clinical Evidence

No clinical tests were required. Safety and effectiveness established via bench testing, including electrical/mechanical safety verification and in vitro precision/accuracy testing using phantoms.

Technological Characteristics

Software-based analysis for DEXA bone densitometers. Operates on existing scan data. Provides quantitative body composition metrics (fat/lean mass, ratios). Conforms to 21 CFR 820 and ISO 13485 quality standards. Electrical and mechanical safety verified per applicable standards.

Indications for Use

Indicated for patients with conditions affecting fat and lean tissue distribution, including nutritional disorders, obesity, eating disorders (e.g., anorexia nervosa), wasting syndromes, gastrointestinal disorders (e.g., Crohn's, celiac), renal failure, organ transplantation, endocrinological disorders (e.g., Cushing's, growth hormone deficiency), bone disorders (e.g., osteoporosis), pulmonary diseases (e.g., COPD, cystic fibrosis), cardiovascular disease, HIV/AIDS, and muscular dystrophies.

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

• Body Composition Software Option for Norland DEXA Bone Densitometers (K973459)
• GE Lunar Prodigy Total Body Software option

Submission Summary (Full Text)

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K071570

510{k} Premarket Notification E Medical Systems Lunar - GE Lunar Body Composition Software March 12th, 2007

JUN 2 7 2007

Attachment B 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

GE Healthcare

Section a):

| 1. Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division of<br>General Electric Company<br>GE Medical Systems Lunar (business name)<br>726 Heartland Trail<br>Madison, WI 53717 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James P. Raskob<br>Safety and Regulatory Engineering Manager<br>Telephone: [phone]; Fax: [phone] |

March 12th, 2007 Date Prepared: 2. Device Name: GE Lunar Body Composition Software Option

- Bone Densitometer, 21 CFR 892,1170. 90-KGI
- 3. Marketed Device: Body Composition Software Option for Norland DEXA Bone Densitometers K973459 currently in commercial distribution.
- 4. Device Description: The Body Composition Software Option for GE Lunar DEXA Bone Densitometers measures the bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping and compared to reference populations at the sole discretion of the health care professional. The software does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans.

5. Indications for Use:

## Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers

The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer scans measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

These body composition values are 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 patient fat and lean tissue. The GE Lunar 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 body composition values are

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510(k) Premarket Notification GE Medical Systems Lunar - GE Lunar Body Composition Software March 12th, 2007

useful include nutritional disorders, overweight, obesity, weight management, eating disorders, anorexia nervosa, wasting syndrome, sarcopenia , gastrointestinal disorders, Crohn's disease, celiac disease, gastrectomy, hepatobiliary disorders, cirrhosis, gallstones, renal disorders, chronic renal failure, hemodialysis, organ transplantation, endocrinological disorders, hypopituitarism, acromegaly, Cushing's syndrome, growth hormone deficiency, bone disorders, osteoporosis, Paget's disease, osteopetrosis, pulmonary diseases, cystic fibrosis, chronic pulmonary obstructive disease (COPD), cardiovascular disease, corticosteroids therapy, hormone therapy, total parenteral nutrition (TPN), diabetes, AIDS(HIV. sympathetic dystrophy syndrome, amiotrophic lateral sclerosis, tetraplegy, Duchenne's muscular dystrophy, spinal cord injury complication. DEXA body composition is a useful alternative to hydrostatic weighing, skin fold measurements and bio-impedance estimates.

- 6. Comparison with Predicate Device: The Body Composition Software Option for GE Lunar DEXA Bone Densitometers is of a comparable type and substantially equivalent to the Body Composition Software Option for Norland DEXA Bone Densitometers and the GE Lunar Prodigy Total Body Software option. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and mas similar intended uses as the predicate devices.
#### Section b):

- 1. Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
2. Clinical Tests: No clinical tests were required to establish safety or effectiveness.

3. Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer body composition software. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through independent evaluation with ongoing factory surveillance. The Body Composition Software Option for GE Lunar DEXA Bone Densitometers is substantially equivalent to currently marketed devices with respect to safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 27 2007

GE Medical Systems Lunar % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K071570

Trade/Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: June 7, 2007 Received: June 8, 2007

## Dear Mr. Kogoma:

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.

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Prototing and Promoting Public Hadth

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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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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

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K071570

#### Attachment E

### 510 (k) Indications for Use

510(k) Number (if known):

## Device Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers

The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.

These body composition values are 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 patient fat and lean tissue. The GE Lunar 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 body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV and cystic fibrosis. DEXA body composition is a useful alternative to hydrostatic weighing and skin fold measurements.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801)

Over The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

Helenteeur

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