PIXI BONE DENSITOMETER

K970224 · Lunar Corp. · KGI · Apr 16, 1997 · Radiology

Device Facts

• Record ID: K970224
• Device Name: PIXI BONE DENSITOMETER
• 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 PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm²) for the regions of the forearm and heel (os calcis).

Device Story

PIXI Bone Densitometer; estimates bone mineral density (BMD) in g/cm² for forearm and heel (os calcis). Device utilizes 5-second radiation exposure (20 mrem) to scan anatomical sites. System processes attenuation data to calculate BMD values. Used in clinical settings by trained operators. Output provides quantitative BMD measurements to healthcare providers for assessment of bone health. High correlation (r=0.998) with calcium hydroxyapatite standards; precision metrics (in vivo %CV 1.5% forearm, 1.97% os calcis) support clinical utility for bone density monitoring.

Clinical Evidence

Bench testing only. BMD estimations correlated with calcium hydroxyapatite pellets (r=0.998). In vitro short-term precision (%CV) was 0.68%. In vivo short-term precision (%CV) was 1.5% for forearm BMD and 1.97% for Os Calcis BMD. Results demonstrate comparability to predicate devices.

Technological Characteristics

Bone densitometer; utilizes ionizing radiation (20 mrem dose per 5-second exposure). Measures BMD in g/cm² via attenuation of radiation through bone tissue. Form factor designed for forearm and heel scanning. No specific materials, software architecture, or connectivity standards disclosed.

Indications for Use

Indicated for the estimation of bone mineral density (BMD) in the forearm and heel (os calcis) for patients requiring bone density assessment.

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

• Osteon Osteoanalyzer (K891582)
• Norland pDEXA (K931996)

Submission Summary (Full Text)

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LUNAR
APR 16 1997
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
[phone]
K970224

## 10.0 510(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: | January 17, 1997 |
| Device/Trade Name: | PIXI Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | Osteon Osteoanalyzer
510 (k) K891582

Norland pDEXA
510 (k) K931996 |

## 10.1 DESCRIPTION OF THE DEVICE:

The PIXI Bone provides an estimation of Bone Mineral Density (BMD in g/cm²) for the regions of the forearm and heel (os calcis).

## 10.2 SUMMARY OF TECHNICAL CHARACTERISTICS

The PIXI® Bone Densitometer requires a 5 second exposure, with a total exposure dose of 20 mrem. The radiation exposure of 20 mrem is higher than that for the predicate devices but remains low compared to the maximum permissible dose for extremities. The BMD estimations correlate highly (r= 0.998 ) with the actual density of calcium hydroxyapatite pellets. The average short term precision (%CV) in vitro was 0.68 %. The average short term precision (%CV) in vivo is 1.5% for forearm BMD, and 1.97 % for Os Calcis BMD. These values are comparable to those shown on previously cleared devices.

CONFIDENTIAL

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# 10.3 CONCLUSION

The results from the PIXI bone densitometer are comparable to previously registered devices which demonstrate similar precision. No new safety and effectiveness questions are raised with the PIXI Bone Densitometer.


Kenneth D. Buroker
Printed Name

Director, Regulatory Affairs
Title

Summary of Safety, Effectiveness Page 2 of 2

CONFIDENTIAL