EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE

K972517 · Lunar Corp. · KGI · Nov 18, 1997 · Radiology

Device Facts

• Record ID: K972517
• Device Name: EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is used with the EXPERT-XL Bone Mineral Densitometry system. This new software feature allows for estimation of periprosthetic BMD of an orthopedic hip implant in sub-regions called Gruen zones. These zones are a typical radiographic labeling technique for orthopedic hip implants. The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software requires a 12 seconds with an entrance radiation exposure to the skin of 53 mrem. This software posses no new safety or efficacy concerns. The use on the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is restricted to prescription only. The User's Guide for the system 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

EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is an accessory for the EXPERT-XL Bone Densitometer. It processes radiographic scan data of the orthopedic hip region to estimate bone mineral density (BMD) in g/cm2 for periprosthetic bone. The software segments the hip region into Gruen zones, a standard radiographic labeling technique. The system performs scans in 12 seconds with a skin entrance radiation exposure of 53 mrem. Operated by clinical staff, the output provides quantitative BMD measurements to physicians to assist in assessing periprosthetic bone status. The device benefits patients by enabling monitoring of bone density around hip implants.

Clinical Evidence

Bench testing only. The software results demonstrate high correlation (r=0.97) with the predicate DPX series densitometers. In vivo short-term precision (CV) is 3% or under for all sites, comparable to the predicate device.

Technological Characteristics

Accessory software for EXPERT-XL Bone Densitometer. Scan time: 12 seconds. Radiation exposure: 53 mrem. Analysis method: BMD estimation in Gruen zones. Precision: CV ≤ 3%.

Indications for Use

Indicated for patients requiring estimation of periprosthetic bone mineral density (BMD) adjacent to orthopedic hip implants, specifically within Gruen zones. Restricted to prescription use by or on the order of a physician.

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

• Orthopedic Software for Lunar DPX Series densitometers (K914404)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "LUNAR" in large, bold, black letters. The letters are slightly distressed, giving them a textured appearance. The background is white, providing a strong contrast that makes the word stand out.

K972517

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

[phone]

NOV 1 8 1997

## 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(c).

| Contact Person: | Kenneth D. Buroker |
|----------------------|-------------------------------------------------------------------|
| | LUNAR Corporation |
| | 313 West Beltline Highway |
| | Madison, WI 53713 |
| Phone: | [phone] |
| Fax: | [phone] |
| Date: | July 3, 1997 |
| Device/Trade Name: | EXPERT-XL Orthopedic Hip Acquisition and Analysis<br>Software |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer<br>21CFR 892.1170 |
| Predicate Device: | K914404 Orthopedic Software for Lunar DPX Series<br>densitometers |

#### DESCRIPTION OF THE DEVICE: 10.1

The Orthopedic Hip Acquisition and Analysis Software is an accessory software option for the EXPERT-XL Bone Densitometer that allows estimation of Bone Mineral Density BMD (in g/cm2) of periprosthetic bone adjacent to an orthopedic hip implant.

### SUMMARY OF TECHNICAL CHARACTERISTICS 10.2

Scans of the orthopedic hip region take 12 seconds. The EXPERT-XL Orthopedic Hip software results correlate highly (r =0.97) with DPX series, which already fras 510(k) clearance. Also, the average short term precision (CV) in vivo is 3% or under for all sites, which is comparable to that shown on DPX series densitometers. The entrance radiation exposure to the skin of 53 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose and to conventional radiographs of the region.

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# CONCLUSION 10.3

The BMD results for the EXPERT-XL Orthopedic Hip Acquisition and Analysis and software option are comparable to the DPX results and have similar precision. No new afety and software option are comparable to the DI X results and have stample provisition and Analysis software accessory.

Humphrey D. Buck
Signed

Kenneth D. Buroker Printed Name

Director, Regulatory Affairs Title

1 3

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

> 18 1997 NOV

Richard B. Mazess, Ph.D. President . Lunar Corporation 313 W. Beltine Highway Madison, WI 53713

Re:

K972517

Expert-XL Orthopedic Hip Acquisition and Analysis Software Dated: October 7, 1997 Received: October 15, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Dr. Mazess:

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 intens 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, subject to the general controls provisions of 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 vitro 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/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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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#### 3.0 INDICATIONS FOR USE FORM

- 501(k) Number (if known): .
- Device name: EXPERT-XL Orthopedic Hip Acquisition and Analysis Software .
- Indications For Use: .

The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is used with the EXPERT-XL Bone Mineral Densitometry system. This new software feature allows for estimation of periprosthetic BMD of an orthopedic hip implant in sub-regions called Gruen zones. These zones are a typical radiographic labeling technique for orthopedic hip implants.

The EXPERT-XL Orthopedic Hip Acquisition and Analysis Software requires a 12 seconds with an entrance radiation exposure to the skin of 53 mrem. This software posses no new safety or efficacy concerns.

The use on the EXPERT-XL Orthopedic Hip Acquisition and Analysis Software is restricted to prescription only. The User's Guide for the system 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

510(k) Number

Over-the-Counter Use

(Optional Format 1-2-96)

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Vimind le. Segum

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev

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