EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS

K964307 · Lunar Corp. · KGI · Apr 16, 1997 · Radiology

Device Facts

• Record ID: K964307
• Device Name: EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator’s Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials.

Device Story

Device consists of expanded reference database for LUNAR DPX series bone densitometers; provides comparative BMD data for clinicians. Input: patient BMD measurements from AP Spine, Lateral Spine, Proximal Femur, Total Body, or Radius Shaft. Transformation: software compares patient BMD against tabulated reference values for white adults (U.S./Northern Europe). Output: comparative BMD statistics displayed to clinician. Used in clinical settings by physicians/technicians to assist in bone density evaluation. Benefits: provides broader normative data for clinical interpretation of bone density scans.

Clinical Evidence

No clinical data; submission consists of expanded normative reference values derived from published literature for comparative purposes.

Technological Characteristics

Software-based reference database update for existing DPX series bone densitometers. No changes to hardware, sensing principles, or energy sources.

Indications for Use

Indicated for white adult males and females in the U.S. and northern Europe undergoing bone mineral density (BMD) assessment at AP Spine, Lateral Spine, Proximal Femur, Total Body, and Radius Shaft sites.

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

• Modified DPX Bone Densitometer (K89021)

Submission Summary (Full Text)

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APR 16 1997
K964307
LUNAR
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
[phone]

## 9.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: | October 28, 1996 |
| Device/Trade Name: | Expanded Reference Values for DPX Series Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | K89021 Modified DPX Bone Densitometer |

## 9.1 DESCRIPTION OF THE DEVICE:

The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator’s Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials.

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## 9.3 CONCLUSION

The expanded reference BMD values incorporated in this submission merely add to the reference value data already established and provided with the DPX series bone densitometers. These data can be used for comparative purposes by the clinician entirely at his/her discretion. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values.


Kenneth D. Buroker
Printed Name

Director, Regulatory Affairs
Title