(224 days)
Not Found
No
The description focuses on standard bone densitometry measurements, comparisons to pre-defined reference populations, and calculations based on established WHO criteria. There is no mention of adaptive algorithms, learning from data, or other characteristics typically associated with AI/ML.
No.
The device is used to determine the presence of bone disease and aid in determining fracture risk, which are diagnostic purposes, not therapeutic.
Yes
The device is described as an aid in determining the presence of bone disease and fracture risk, which are diagnostic purposes. The output values (T-Score, Z-Score, % Young Reference, % Age Matched) help physicians diagnose conditions like osteoporosis and assess fracture risk.
No
The device description explicitly states that the Apollo™ scans the heel using DXA pencil beam technology, which is a hardware-based imaging modality.
Based on the provided information, the Apollo™ bone densitometer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Apollo™ device uses DXA technology to scan the heel (Os Calcis) directly on the patient. It does not analyze blood, urine, tissue, or any other biological sample.
- The device measures bone density directly. It's a diagnostic imaging device that provides a measurement of bone mineral density.
- The intended use and device description focus on in-vivo measurement and comparison to reference populations. The device's function is to acquire data from the patient's body and then process and compare that data to established reference values.
Therefore, the Apollo™ bone densitometer falls under the category of a diagnostic imaging device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The bone density estimates from the Apollo™ bone densitometer can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related 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 Apollo bone density estimates can be used as an aid to physicians in determining fracture risk.
Product codes (comma separated list FDA assigned to the subject device)
90KGI
Device Description
The Apollo™ Multi-Racial Reference Population capability compares patient values 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. 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 be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is
§ 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.
0
93337
510k Summary
as required by 807.92(c) for
Apollo™ Multi-Racial Reference Population
Prepared September 1999
| Submitted by: | Norland Corporation
W6340 Hackbarth Road
Fort Atkinson, WI 53538
Reg. # 2124648 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg, Director Regulatory Affairs |
| Device Trade Name: | Apollo™ Multi-Racial Reference Population |
| Common Name: | Reference Population for DXA bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Norland Apollo™ with Reference Population (K980125), and
Norland Fracture Risk Assessment (K980569) |
| Description of
Device: | The Apollo™ Multi-Racial Reference Population capability compares
patient values 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. 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 be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T-
Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is ✓ |
|------------------|---------------------------------------|
| | OR |
| | (Per 21 CFR 810.109) |
| | Over-The-Counter-Use |
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| (Division Sign-Off) | |
|---|---|
| Division of Reproductiva odominal, ENT, and Radiological Device | |
| 510(k) Number | K993337 |