APOLLO MULTI-RACIAL REFERENCE POPULATION

K993337 · Norland Medical Systems, Inc. · KGI · May 16, 2000 · Radiology

Device Facts

• Record ID: K993337
• Device Name: APOLLO MULTI-RACIAL REFERENCE POPULATION
• Applicant: Norland Medical Systems, Inc.
• Product Code: KGI · Radiology
• Decision Date: May 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended 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.

Device Story

Apollo™ Multi-Racial Reference Population is a software feature for the Apollo™ DXA bone densitometer. Device uses DXA pencil beam technology to scan the Os Calcis (heel) to estimate bone density. Input data is processed to compare patient bone density values against gender and ethnic-matched reference populations (Caucasian, Afro-American, Hispanic, Asian). Output includes T-Scores, Z-Scores, % Young Reference, % Age Matched, and fracture risk assessments based on WHO criteria. Used in clinical settings by physicians to identify bone disease beyond age-related loss and to evaluate fracture risk. Benefits include improved diagnostic accuracy through ethnically diverse reference data.

Clinical Evidence

No clinical data provided; bench testing only. The device relies on the established performance of the Apollo™ DXA system and the integration of validated reference population datasets.

Technological Characteristics

DXA pencil beam technology for bone densitometry; Os Calcis measurement site. No water bath or gels required. Radiation dose 0.2 mRem; scatter/leakage <0.1 mRem/hour at 3 feet. Software-based reference population comparison module.

Indications for Use

Indicated for Caucasian, Afro-American, Hispanic, and Asian men and women to aid physicians in assessing bone disease and fracture risk via DXA bone densitometry.

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

• Norland Apollo™ with Reference Population (K980125)
• Norland Fracture Risk Assessment (K980569)

Submission Summary (Full Text)

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93337

510k Summary

as required by 807.92(c) for

## Apollo™ Multi-Racial Reference Population

Prepared September 1999

| Submitted by: | Norland Corporation<br>W6340 Hackbarth Road<br>Fort Atkinson, WI 53538<br>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<br>Norland Fracture Risk Assessment (K980569) |
| Description of<br>Device: | The Apollo™ Multi-Racial Reference Population capability compares<br>patient values to average values for people without bone related disease,<br>who have the same gender and ethnic background as the patient. Its<br>purpose is to aid the physician in determining the presence of bone disease<br>other than age related bone loss. Both age matched and young reference<br>comparisons are made. T-Score, Z-Score, % Young Reference, % Age<br>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-<br>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 <0.1 mRem/hour at 3 feet. |
| Safety and<br>Effectiveness: | This Apollo Multi-Racial Reference Population is comparable to reference<br>population capabilities in use with other bone densitometers in the industry.<br>No new safety or effectiveness issues are raised with this capability. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2000

Terry Schwalenberg Director Regulatory Affairs Norland Corporation W-6340 Hackbarth Rd. Fort Atkinson, WI 53538

Re:

K993337 Apollo™ Multi-Racial Reference Population Dated: February 18, 2000 Received: February 28, 2000 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Schwalenberg:

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 legally marketed predicate devices marketed in interstate commerce pror 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xitco 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

David C. Stoltz, MD

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## INDICATIONS FOR USE STATEMENT

K 99 3337 510(K) Number (if known):

Device Name: Apollo™ Multi-Racial Reference Population

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">✓</div> |
|------------------|---------------------------------------|
| | OR |
| | (Per 21 CFR 810.109) |
| | Over-The-Counter-Use |

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| (Division Sign-Off) | |
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| Division of Reproductiva odominal, ENT, and Radiological Device | |
| 510(k) Number | K993337 |