ADVANCED HIP ASSESSMENT SOFTWARE

K011917 · Ge Lunar Corp. · KGI · Aug 3, 2001 · Radiology

Device Facts

• Record ID: K011917
• Device Name: ADVANCED HIP ASSESSMENT SOFTWARE
• Applicant: Ge Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females. The use of the Prodigy bone densitometer is restricted to prescription use only. The operator's manual for these products contains the following statement: "United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

Device Story

Advanced Hip Assessment Software analyzes previously acquired dual-energy x-ray absorptiometry (DEXA) images of proximal femur; inputs are DEXA images from Prodigy bone densitometer. Software performs automated measurement of hip axis length (HAL); provides mean HAL value for Caucasian females for physician comparison. Used in clinical settings by trained operators under physician supervision. Output assists clinicians in assessing hip morphology; supports clinical decision-making regarding bone health. Benefits include standardized, objective measurement of HAL to aid in hip assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based analysis of DEXA images. Operates on Prodigy bone densitometer platform. Measures hip axis length (HAL) via image processing algorithms. Standalone software option.

Indications for Use

Indicated for use on DEXA images of the proximal femur acquired via Prodigy bone densitometer to measure hip axis length (HAL). Intended for prescription use by physicians.

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 EXPERT Morphometry Software (K950611)
• LUNAR EXPERT Spine Morphometry Reference Values (K961007)

Submission Summary (Full Text)

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K011917

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Contact Person:

James P. Raskob GE Lunar Corporation 726 Heartland Trail Madison, WI 53717 [phone] [phone]

Fax: Date:

Phone:

June 19th , 2001

Device/Trade Name:

Advanced Hip Assessment Software Option

Bone Densitometer

Bone Densitometer

21CFR 892.1170

Common Name:

Classification Name:

Predicate Devices:

LUNAR EXPERT Morphometry Software 510(k) K950611

LUNAR EXPERT Spine Morphometry Reference Values 510(k) Number K961007

### DESCRIPTION OF THE DEVICE: 10.1

The Hip Morphometry Software, to be marketed as Advanced Hip Assessment Software, analyzes previously acquired dual-energy x-ray absorptiometry (DEXA) images of the proximal femur from the Prodigy bone densitometer for measurement of the hip axis length (HAL). The patient is scanned for bone density of the proximal femur with the currently distributed product, and puterit is bounded for official ware measures the HAL. A mean value of HAL for Caucasian females is included for comparison at the sole discretion of a physician.

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K011917

### CONCLUSION 10.2

The Hip Morphometry Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Hip Morphometry Software application.

James P. Rasbol

---

Signed

James P. Raskob Printed Name

Regulatory Affairs/Quality Assurance Manager

Title

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "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

AUG - 3 2001

Mr. James P. Raskob Regulatory Affairs & Quality Assurance Manager GE Lunar Corporation 726 Heartland Trail MADISON WI 53717

Re: K011917

Advanced Hip Assessment Software Dated: June 19, 2001 Received: June 20, 2001 Regulatory Class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Raskob:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have been include devines We have reviewed your Section > IQK ) notications of mind of the enclosure) to tegally markets predicate devices of to Aer device is substantially equivalent (or the mactions to the enactment date of the Arabical Device Amendments, or to devices of to devices of to devices of to devices of to dev marketed in interstate commerce proc of the provisions of the Federal, Drug, and Cometic Act (Act.). You may,
the Are been reclassified in accordance with the provisions of that have been reclassified in accordance will the provisions of the general controls provisions of the Act
therefore, market the device, subject to the general controls prov therefore, market the device, subject to the general controls provided on the 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 (Prematet Approval), it nay Categorial Penlations If your device is classified (see above) into effecting your device can be found in the Code of Feesa Regulations, to such additional controls. Existing major regulations areceinter with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent determination Title 21, Parts 800 to 895. A substantaly equival accimation (QS) for Medical Devices: Central regulation (21 CFR Part Practice requirements, as set forth in the Quality System Noglianon (40) will be infort its such assumptions. Failure
820) and that, through periodic QS inspections, the Food 820) and that, through periodic (S mspeciolis, the Franchisan. DA may publish further announcements
to comply with the GMP regulation may result in regulatory action who resu to comply with the GMP regulation may testion in the more this response to your premaces notification submission doss not concerning your device in the Federal Register. Trease noter in provices under the Electronic Product 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 for your device and This letter will allow you to begally marketed predicated in your by proposed 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 additionally for anymotions on the promotions on the promotions on the promotions on If you desre specific advice for your device of Compliance at (301) . Additionally, for questions on the promotion diagnosic devices), please comtact the Office of Complance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entified, "Misbranding by reference to preharker (21 col Man) for an assistance at its toll-free number (800)
responsibilities under the Act may be obtained from the Division responsibilities under the Acc may be obtained tront and 21:44 pm //www.fda.gov/cdrh/dsmadsmamain.html".
638-2041 or [phone] or at its internet address "http://www.fda

Sincerely yours,

Nancy C. Hogdon

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

Enclosure (s)

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K01/9/7

#### INDICATION FOR USE FORM 3.0

Page 1 of 1

- 8011917 510(k) Number (if known) __
Device Name: Hip Morphometry Software .

Market Name: Advanced Hip Assessment �

- Indications for use: .
.

Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females.

The use of the Prodigy bone densitometer is restricted to prescription use only. The operator's manual for these products contains the following statement:

> "United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

# PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Vernil C. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number. 01141