MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY

• K Number: K993176
• Device Name: MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
• Manufacturer: NORLAND MEDICAL SYSTEMS, INC.
• Date Cleared: 2000-06-20 ( 272 days)
• Product Code: KGI
• Regulation Number: 892.1170

Intended Use

The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women. The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.

Device Description

In general, the Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers compares the pDEXA and Discovery scan results to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented. The Norland pDEXA and Discovery bone densitometers scan the forearm using the industry standard DXA pencil beam technology to assess bone density of the distal and proximal radius plus ulna sites. The Discovery is a newer, smaller version of the pDEXA with faster scan speeds and lower dose. The Discovery dose is < 1 mRem and the pDEXA is < 3 mRem. Discovery scan time is about 90 seconds and the pDEXA about 3 minutes. This reference population also includes Fracture Risk Assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores between 1 to -1 are considered to have a low risk of fracture; with T-Scores from -1 to -2.5 are considered to have a medium risk of fracture; and T-Scores below -2.5 are considered to have a high risk of fracture.

Predicate Devices

K931996, K980569

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on comparing scan results to pre-defined reference populations and applying standard WHO criteria for fracture risk assessment. There is no mention of learning algorithms or adaptive capabilities.

Therapeutic

No
This device is for diagnostic purposes, specifically to aid in determining the presence of bone disease and aiding physicians in determining fracture risk, not for treatment.

Diagnostic

Yes
The device provides bone density estimates and compares them to reference populations to aid physicians in determining the presence of bone disease and fracture risk, which are diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that it is a "Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers" and that these densitometers "scan the forearm using the industry standard DXA pencil beam technology." This indicates the device is a feature or software component of a hardware device (the bone densitometers), not a standalone software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze samples taken from the human body. The description clearly states that this device uses DXA technology to scan the forearm and assess bone density in vivo (within the living body). It does not analyze blood, urine, tissue, or any other sample taken from the patient.
• The device's function is based on imaging and comparison to reference populations. It uses a physical measurement (bone density via DXA) and compares it to pre-established data sets. This is characteristic of imaging and diagnostic devices that work directly on the patient, not IVDs.

Therefore, this device falls under the category of an imaging or diagnostic device that performs measurements directly on the patient, rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The bone density estimates from the pDEXATN and DiscoveryTM Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women.

The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.

Product codes (comma separated list FDA assigned to the subject device)

90 KGI

Device Description

In general, the Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers compares the pDEXA and Discovery scan results to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented.

The Norland pDEXA and Discovery bone densitometers scan the forearm using the industry standard DXA pencil beam technology to assess bone density of the distal and proximal radius plus ulna sites. The Discovery is a newer, smaller version of the pDEXA with faster scan speeds and lower dose. The Discovery dose is

Regulation Number and Section

§ 892.1170 Bone densitometer.

(a)
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.(b)
Classification. Class II.

Summary

0

K99 3176

510k Summary

JUN 2 0 2000

as required by 807.92(c) for

Multi-Racial Reference Population For pDEXA™ and Discovery™ Bone Densitometers

Prepared September 1999

| Submitted by: | Norland Corporation
W6340 Hackbarth Road
Fort Atkinson, WI 53538
Reg. # 2124648 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg, Director Regulatory Affairs, 920-563-8456 x229 |
| Device Trade Name: | Multi-Racial Reference Population for pDEXATM and Discovery™ |
| Common Name: | Reference Population for DXA bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170). product code 90KGI; Class II |
| Predicate Devices: | Norland pDEXA with Reference Population (K931996). and
Norland Fracture Risk Assessment (K980569) |
| Description of
Device: | In general, the Multi-Racial Reference Population capability for the pDEXA
and Discovery bone densitometers compares the pDEXA and Discovery scan
results to average values for people without bone related disease, who have
the same gender and ethnic background as the patient. Its purpose is to aid
the physician in determining the presence of bone disease other than age
related bone loss. Both age matched and young reference comparisons are
made. T-Score, Z-Score, % Young Reference, % Age Matched, and a
graphical representation are presented.

The Norland pDEXA and Discovery bone densitometers scan the forearm
using the industry standard DXA pencil beam technology to assess bone
density of the distal and proximal radius plus ulna sites. The Discovery is a
newer, smaller version of the pDEXA with faster scan speeds and lower
dose. The Discovery dose is