HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

K963363 · Hologic, Inc. · KGI · Nov 22, 1996 · Radiology

Device Facts

• Record ID: K963363
• Device Name: HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The intended use of the NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers is to allow comparisons of a subject’s estimated proximal femur (hip) Bone Mineral Density (BMD, in g/cm²) to reference data for sex and ethnicity matched controls. Published results from the NHANES study (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-409, 1995), including male and female proximal femur reference values for African American, Mexican American, and caucasian American subjects are included in this software option.

Device Story

Software option for Hologic QDR Series X-Ray Bone Densitometers; integrates NHANES III published reference data for proximal femur BMD. Inputs: patient BMD measurements (g/cm²), age, sex, ethnicity. Operation: software compares patient data against stratified reference values (Neck, Trochanteric, Intertrochanteric, Ward’s, Total hip regions). Outputs: graphical plots of age-dependent BMD; quantitative Z-scores (age-matched) and T-scores (young adult); percent-of-mean values. Used by clinicians to interpret bone density status. Enables comparison against multiple reference sets (original Hologic, NHANES, or user-defined local data). Benefits: provides expanded ethnic reference data (African American, Mexican American) and updated Caucasian data; assists physician in assessing bone health relative to population norms.

Clinical Evidence

No clinical data; device relies on published reference data from the NHANES III study (Looker et al., 1995) involving 7,116 subjects. Bench testing confirms software correctly integrates and applies these reference values to patient BMD measurements using the same stratification logic as the predicate device.

Technological Characteristics

Software-based reference data module for existing QDR Series X-Ray Bone Densitometers. Implements lookup tables for proximal femur BMD reference values stratified by age (20-80), sex, and ethnicity. Operates within existing Hologic QDR software environment. No changes to hardware, energy source, or sensing principles.

Indications for Use

Indicated for male and female subjects aged 20 to 80 years requiring proximal femur (hip) bone mineral density (BMD) assessment. Used to compare patient BMD results against sex, ethnicity, and age-matched reference populations (Caucasian American, African American, Mexican American) to assist in clinical interpretation.

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

• Hologic QDR Series X-Ray Bone Densitometers with Reference Data

Submission Summary (Full Text)

{0}

NOV 22 1996
K963363

# 510(k) Summary of Safety and Effectiveness:

## NHANES Reference Data Software Option for QDR Series X-Ray Bone Densitometers

Submitter: Hologic, Inc.
Submitter Address: 590 Lincoln Street
Waltham, MA 02154
Contact Person: Nandini Murthy, Regulatory Scientist
Phone Number: [phone]
Fax Number: [phone]
Date Prepared: August 23, 1996
Device Trade Name: NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers
Device Common Name: Reference Data for Bone Mineral Densitometer
Device Classification Name: Reference Data for Bone Mineral Densitometer
Predicate Devices: Hologic QDR Series X-Ray Bone Densitometers with Reference Data
Device Description: The NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers provides proximal femur (hip) reference data for male and female Caucasian American, African American, and Mexican American subjects. The new reference data is used in conjunction with previously existing software on QDR Series densitometers, which allows comparisons of patient results to sex, ethnicity, and age matched reference values. The NHANES Reference Data Software Option provides 1) reference data for male and female African American and Mexican American subjects which was previously not available, and 2) the newest, most up to date male and female caucasian American reference data, while maintaining previous Hologic hip reference data, and still allowing clinicians to generate and use local reference data.

The reference values contained in this software option were obtained from published results (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-409, 1995) of the National Health and Nutrition Education Survey III (“NHANES III”) study, in which 7116 total subjects have been enrolled. Published reference values are stratified by sex, ethnicity, age (from 20 to 80 years), and analysis region (results are tabulated for the Neck, Trochanteric, Intertrochanteric, Ward’s, and Total regions of the hip). Standard existing QDR densitometer software was designed to stratify reference values in exactly the

{1}

510(k) Summary of Safety and Effectiveness
page 2

same manner, and thus the published results are directly transferable to the Hologic QDR software.

Patient results for each analysis region can be compared to reference values both graphically and quantitatively. Graphical plots of the age dependent reference Bone Mineral Density (BMD) values corresponding to the sex and ethnicity of the patient are generated, with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation “scores” are computed, quantifying (in population standard deviation units) the difference between the patient’s estimated BMD and the mean value for either age matched (Z-score) or young adult (T-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean and in percent of the young adult mean.

The NHANES caucasian American female reference data differs slightly from the original Hologic data, due to differences in study design (inclusion/exclusion criteria, number of subjects, geographic region and methods of subject recruitment, etc.) and the unavoidable variability between different reference data sets obtained even under the EXACT same conditions. Thus both the Hologic reference data and the NHANES data are equally valid, and the physician may determine which data most accurately reflects the local population. Alternatively the software allows the physician to define and use unique local reference values of their choice.

**Intended Use:**

The intended use of the NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers is to allow comparisons of a subject’s estimated proximal femur (hip) Bone Mineral Density (BMD, in g/cm²) to reference data for sex and ethnicity matched controls. Published results from the NHANES study (A.C. Looker, et al., Osteoporosis International Vol. 5, pg 389-409, 1995), including male and female proximal femur reference values for African American, Mexican American, and caucasian American subjects are included in this software option.

**Device Technological Characteristics and Comparison to Predicate Device:**

Except for the new reference data itself, there are no differences between the NHANES Reference Data Software Option and the previous reference data software and capabilities included in the standard Hologic QDR software.

**Conclusion:**

The NHANES Reference Data Software Option provides a means for the user to compare proximal femur BMD results to reference data for male and female African American and Mexican American subjects, which was previously not available, and provides an additional option for male and female caucasian American reference data. For caucasian American subjects, this software option gives the physician the ability to compare results to standard Hologic reference data, the most recent NHANES reference data (acquired under a different study design), or, as for any subject, to unique user defined local reference data. Patient results are compared graphically and quantitatively to reference values in order to assist the physician in interpretation.