PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM

K972053 · Lunar Corp. · KGI · Aug 8, 1997 · Radiology

Device Facts

• Record ID: K972053
• Device Name: PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Aug 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value. This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers. The use of the PIXI™ young adult reference population for os calcis and forearm, is restricted to prescription use only. The operator's manual for the PIXI system 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."

Device Story

Device provides reference BMD values for PIXI bone densitometer; enables comparison of patient os calcis and forearm BMD results to average young adult (age 20-45) values. Input: patient BMD measurements. Transformation: calculation of T-scores (standard deviations from young adult mean) and percentage of young adult values. Output: T-score and percentage metrics displayed to clinician. Used in clinical settings by physicians or under physician order. Benefits: assists clinicians in bone density assessment and clinical decision-making regarding bone health.

Clinical Evidence

No clinical data. Evidence consists of a reference database derived from 250 normal white young adults (143 females, 107 males for os calcis; 126 females, 91 males for forearm) aged 20-45 years, providing mean and standard deviation values for BMD.

Technological Characteristics

Software-based reference population database for bone densitometry. Provides normative BMD data for os calcis and forearm sites. Integrates with PIXI bone densitometer system.

Indications for Use

Indicated for use by physicians to compare bone mineral density (BMD) results of the os calcis and forearm in patients against a reference population of normal white men and women aged 20-45 years.

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)

{0}------------------------------------------------

K972053

313 W. BELTLINE HIGHWAY

MADISON, WI 53713

[phone]

AUG - 8 1997

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0

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<br>LUNAR Corporation<br>313 West Beltline Highway<br>Madison, WI 53713 |
|----------------------|-------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Date: | May 29, 1997 |
| Device/Trade Name: | PIXITM young adult reference population for os calcis and<br>forearm. |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer<br>21CFR 892.1170 |
| Predicate Device: | Osteon Osteoanalyzer<br>510 (k) K891582<br><br>Norland pDEXA<br>510 (k) K931996 |

### DESCRIPTION OF DEVICE 10.1

-

The reference BMD values incorporated in this submission, provides the ability to compare the BMD result of the PIXI™, to the value of an average young adult, age 20 - 45 years old, of the the BMD result of the FTAT - , to the vatus of an areased as a percentage of young adult, or as a T-Score, defined as number of standard deviations from the young adult value.

Data were collected on normal white young adult men and women, age 20 to 45 years. This data is summarized as shown in Table A.

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| | Female | | | Male | | |
|-----------|--------|-------|-------|------|-------|-------|
| Site | n | Mean | SD | n | Mean | SD |
| Os Calcis | 143 | 0.556 | 0.089 | 107 | 0.682 | 0.106 |
| Forearm | 126 | 0.523 | 0.062 | 91 | 0.623 | 0.085 |

## Table A

#### 10.2 CONCLUSION

The use of reference values with the PIXI™ bone densitometer is comparable to how reference values are utilized on other commercially available bone densitometers. This feature can be used by the clinician entirely at his/her discretion. No new safety and effectiveness questions are raised with PIXIM young adult reference population for os calcis and forearm.

Signature

Kenneth D. Buroker Printed Name

Director, Regulatory Affairs Title

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 1997

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

Re: K972053

PIXI™ Young Adult Reference Population for OS Calcis and Forearm Dated: May 29, 1997 Received: June 2, 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 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 III (Premarket Aproval), 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 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 yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at (30) 594-4639. 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 your

Lillian Yin, Ph.D.

Lilian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATION FOR USE FORM 4.0

Page 1 of 1

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- 501(k) Number (if known) K972053

- PIXI™ young adult reference population for os calcis . Device name: and forearm... .. . . . .
Indications For Use: .

The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value.

This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers.

The use of the PIXI™ young adult reference population for os calcis and forearm, is restricted to prescription use only. The operator's manual for the PIXI system 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."

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------------------------------------|------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K972053 |
| Prescription Use | X |
| (Per 21 CRF 801.109) | |
| | OR |
| Over-the-Counter Use | __________ |
| (Optional Format 1-2-96) | |