EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE

K974437 · Lunar Corp. · KGI · Feb 13, 1998 · Radiology

Device Facts

• Record ID: K974437
• Device Name: EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician. United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.

Device Story

EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory for the EXPERT-XL bone densitometer. It acquires lateral view images of lumbar spine vertebrae; 16-second acquisition time. Software processes image data to estimate BMD (g/cm²). Results are compared against a female reference population (age 20-49 stable; decline after age 50). Used in clinical settings by trained operators; output reviewed by physicians to inform clinical decision-making regarding bone health. Higher radiation exposure (120 mrem) compared to AP view due to lateral thickness; remains within permissible limits.

Clinical Evidence

Bench testing only. In vitro correlation with known phantoms showed high correlation (r=0.99). In vivo precision (CV) reported as 3.0% to 3.5%. No clinical trials or patient outcome studies provided.

Technological Characteristics

Accessory software for EXPERT-XL bone densitometer. Sensing principle: X-ray densitometry. Acquisition time: 16 seconds. Radiation exposure: 120 mrem (skin entrance). Connectivity: Integrated with EXPERT-XL system. Software: Proprietary acquisition and analysis algorithms for lateral spine ROI.

Indications for Use

Indicated for estimation of lumbar spine bone mineral density (BMD) in patients requiring bone densitometry assessment. Use is restricted to prescription by a physician.

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-XL Bone Mineral Densitometer, standard AP spine site (K945526)

Submission Summary (Full Text)

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FEB 13 1998
K974437
LUNAR
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
[phone]

## 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: | November 21, 1997 |
| Device/Trade Name: | EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | EXPERT-XL Bone Mineral Densitometer,
standard AP spine site, 510(k) K945526 |

## 10.1 DESCRIPTION OF THE DEVICE:

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD), in g/cm², of the lumbar spine vertebrae in the lateral view provided for the EXPERT-XL Bone Densitometer with a reference population for comparative purposes.

## 10.2 SUMMARY OF TECHNICAL CHARACTERISTICS

The EXPERT-XL Lateral Spine BMD software acquires images of the lumbar spine in the lateral view; the acquisition takes 16 seconds. The results in vitro correlate highly (r = 0.99) with BMD on known phantoms, and the precision in vitro is equivalent to the AP spine when

CONFIDENTIAL

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analyzed with a region-of-interest (ROI) of the same dimension. The average short term precision (CV) in vivo is 3.0 to 3.5%; this is higher than that of the AP spine BMD due to smaller ROI's and lower bone density. The female reference population has relatively constant BMD for age 20-49, but BMD decreases after age 50 at a rate of $0.008\mathrm{g/cm}^2$ per year ($\sim 1\%$ per year).

The radiation exposure (skin entrance) of 120 mrem is higher than that for the AP view but is necessary due to the increased thickness in the lateral view. The exposure remains low compared to the maximum permissible dose.

## 10.3 CONCLUSION

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software option is substantially equivalent to the EXPERT-XL standard anterior/posterior (AP) spine projection. The BMD results in vitro show excellent precision and a high correlation to the AP spine. The precision results in vivo are acceptable for the small ROI. The female reference population is relatively constant at the younger age groups with a decline starting after age 50.

No new safety and effectiveness questions are raised with the EXPERT-XL Lateral Spine BMD Acquisition and Analysis software accessory.


Kenneth D. Buroker
Printed Name

Director, Regulatory Affairs
Title

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 13 1998

Kenneth D. Buroker
Director, Regulatory Affairs
Lunar Corporation
313 West Beltline Highway
Madison, WI 53713

Re: K974437
Expert-XL Lateral Spine BMD Acquisition
and Analysis Software
Dated: November 21, 1997
Received: November 24, 1997
Regulatory class: II
21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Buroker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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CONFIDENTIAL
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# 3.0 INDICATION FOR USE FORM

- 501(k) Number (if known) _______________
- Device name: EXPERT-XL Lateral Spine BMD Acquisition and Analysis Software
- Indications For Use:

The EXPERT-XL Lateral Spine BMD Acquisition and Analysis software is used with the EXPERT-XL bone densitometer system. This software feature estimates bone mineral density (BMD) of the lumbar spine vertebrae in the lateral view. This BMD value can then be compared to a reference population at the sole discretion of the physician.

The EXPERT-XL User’s Guide and Technical Manual contains the following statement:

> “United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician.”

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PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CRF 801.109)
OR
Over-the-Counter Use ☐ (Optional Format 1-2-96)

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