NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS

K973459 · Norland Corp. · KGI · Feb 13, 1998 · Radiology

Device Facts

• Record ID: K973459
• Device Name: NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
• Applicant: Norland Corp.
• Product Code: KGI · Radiology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

Body composition assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values. These body composition estimates 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 Norland Body Composition 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 lean and fat tissue estimates are useful are chronic renal failure, Anorexia Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is also a convenient alternative to hydrostatic weighing and skin fold measurements.

Device Story

Software option for Norland DEXA bone densitometers; utilizes existing bone density scan data to estimate body composition; no additional radiation or scanning required. Inputs: DEXA scan data. Processing: analysis of non-bone tissue to calculate soft tissue mass, fat mass, lean mass, % fat, and TBMC/LBM; applies Siri and Brozek equations. Outputs: quantitative body composition values. Used in clinical settings by healthcare professionals to monitor conditions like renal failure, obesity, or HIV. Does not diagnose or recommend treatment; provides data for clinical management. Benefits: non-invasive alternative to hydrostatic weighing or skin fold measurements.

Clinical Evidence

Clinical study involving hundreds of subjects compared Norland body composition values to underwater weighing (UWW) using Siri and Brozek equations. Results demonstrated that the device provides Siri and Brozek equivalent values for whole body scans.

Technological Characteristics

Software-based analysis module for DEXA bone densitometers. Operates on existing scan data; no hardware changes. Uses mathematical modeling (Siri and Brozek equations) to derive body composition from non-bone tissue data. Standalone software option for existing Norland DEXA systems.

Indications for Use

Indicated for patients requiring assessment of non-bone tissue (soft tissue mass, fat mass, lean mass, % fat) as part of management for conditions affecting body composition, including chronic renal failure, Anorexia Nervosa, obesity, AIDS/HIV, and Cystic Fibrosis. Used by healthcare professionals; no specific age or gender restrictions.

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

• Lunar Total Body Software Option for the DPX bone densitometer (K935454)

Submission Summary (Full Text)

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FEB 1 3 1998

## K973459

## 510k Summary

## as required by 807.92(c) for Norland Body Composition Option

Prepared January 1998

Norland Corporation Submitted by: W6340 Hackbarth Road Fort Atkinson. WI 53538 Reg. # 2124648 920-563-8456 Mr. Terry Schwalenberg Contact Person: Director Regulatory Affairs Norland Body Composition Option Device Trade Name: Body Composition Option for DEXA bone densitometers Common Name: Classification: Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II Predicate Devices: Lunar Total Body Software Option for the DPX bone densitometer (K935454) The Norland Body Composition Option (body composition) is used with Description of Norland DEXA bone densitometers to estimate the relative amounts of lean Device: and fat tissue in the scan area. Body composition does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans. In most cases, existing scans can be re-analyzed to provide the body composition values. Although body composition is most useful for whole body scans, it is compatible with all scan modes for Norland DEXA bone densitometers. Body composition values for whole body scans were compared to underwater weighing (UWW) values in clinical studies involving hundreds of subjects. The UWW values were determined using both the Siri and Brozek equations. Based on this study, the Norland body composition provides the Siri and Brozek equivalent values for the Whole Body scans. Intended use Body composition assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values.

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These body composition estimates 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 Norland Body Composition 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 lean and fat tissue estimates are useful are chronic renal failure, Anorexia Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is also a convenient alternative to hydrostatic weighing and skin fold measurements.

Safety

Body composition doesn't require additional radiation exposure over what is required for the bone density scan alone. The data which is normally analyzed for the bone values can also be analyzed for the lean and fat values. During the scan, the subject lies quietly on a cushioned table (or sits in a chair); they are not required to be in contact with any electrical part or to ingest any chemical/drug.

The delivered dose for Norland bone densitometers range from 0.07 mrem for a whole body scan, to 3 mrem for a pDEXA forearm scan, to 10 mrem for a hip scan. Stray radiation is very small. At a distance of three feet from the x-ray beam, the radiation field is less than 0.1 mRem per hour. This field is present only during the few minutes of the actual patient scan; and is primarily scatter from the patient. Shielded rooms are not required, and the operators are not required to be out of the room during the scan. These dose levels compare favorably to the background radiation level of 100 mrem per year; to a chest x-ray of 35 mrem; and to the increased dose received during a cross country (round trip) airline flight of 5 mrem.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Terry Schwalenberg Director, Regulatory Affairs Norland Corporation W6340 Hackbarth Rd. Fort Atkinson, WI 53538-8999 Re: K973459

Norland Body Composition Option for Norland Dexa Bone Densitometers Dated: January 5, 1998 Received: January 6, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Schwalenberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitte diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrbdsmamain.html": ---------------------------------------------------------------------------------------------

Sincerely yours,

h. Tiau Yu.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) number (if known):

Device Name: Body Composition Option for Norland DEXA Bone Densitometers

Indications for use:

The Norland Body Composition Option (body composition) assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values.

These body composition estimates 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 Norland Body Composition 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 lean and fat tissue estimates are useful are chronic renal failure, Anorexia Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is also a convenient alternative to hydrostatic weighing and skin fold measurements.

- (Please do not write below this line - continue on another page if needed) -----------Concurrence of CDRH; Office of Bevice Evaluation (ODE)--------------

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

OR

Over-the-counter Use

David le. Sejimm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number K973459