EXPERT SPINE MORPHOTIETRY REFERENCE

K961007 · Lunar Corp. · KGI · Jul 25, 1996 · Radiology

Device Facts

• Record ID: K961007
• Device Name: EXPERT SPINE MORPHOTIETRY REFERENCE
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The reference value comparison results are used at the discretion of the physician.

Device Story

EXPERT Spine Morphometry Reference Values software add-on; provides normalized reference data for spine morphometry; used by physicians to compare patient morphometry results against established norms; data derived from seven studies involving over 3500 subjects; intended to assist clinical decision-making in bone densitometry; operates as software module within existing EXPERT Spine Morphometry system.

Clinical Evidence

Data from seven studies involving over 3500 subjects used to establish normalized reference values for spine morphometry.

Technological Characteristics

Software-based reference value database; integrated into existing EXPERT Spine Morphometry software platform.

Indications for Use

Indicated for use as an adjunct to spine morphometry analysis to provide normalized reference data for bone densitometry assessments in patients undergoing spine morphometry evaluation.

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

• EXPERT Spine Morphometry (K950611)

Reference Devices

• DPX Bone Densitometer (K890121)

Submission Summary (Full Text)

{0}

LUNAR
K 961007
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
[phone]

JUL 25 1996

## 8.0 510(K) SUMMARY

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

Re: 510(k) Pre-market Notification

Contact Person: Gary Syring
LUNAR Corporation
313 West Beltline Highway
Madison, WI 53713

Phone: [phone]

Fax: [phone]

Date: March 8, 1996

Device Name: EXPERT® Spine Morphometry Reference Values

Common Name: Spine Morphometry Reference Values

Trade Name: EXPERT Spine Morphometry Reference Values

Classification Name: 21 CFR 892.1170, Bone Densitometer

Predicate Device: EXPERT Spine Morphometry, 510(k) K950611

DPX Bone Densitometer, Reference Values
510(k) K890121

## 8.1 DESCRIPTION OF THE DEVICE:

Reference values of spine morphometry have been added to the EXPERT Spine Morphometry Software. The addition of reference values does not change the intended use of the EXPERT Spine Morphometry Software. The reference value comparison results are used at the discretion of the physician.

Summary of Safety and Effectiveness, Page 1 of 2

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Summary of Safety and Effectiveness, Page 2 of 2

## 8.2 DISCUSSION OF PERFORMANCE DATA SUBMITTED IN SUPPORT OF THE SAFETY AND EFFICACY CLAIMS FOR THE DEVICE:

Data from seven studies and over 3500 subjects have been used to provide normalized reference data for spine morphometry.

## 8.3 CONCLUSIONS DRAWN FROM DATA:

The addition of spine morphometry reference values does not raise any new questions of safety or effectiveness. The reference data is used at the discretion of the physician.


Gary Syring
Printed Name

Director, Regulatory Affairs
Title