REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER

K980125 · Norland Corp. · KGI · May 20, 1998 · Radiology

Device Facts

• Record ID: K980125
• Device Name: REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
• Applicant: Norland Corp.
• Product Code: KGI · Radiology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.

Device Story

Norland Apollo™ Bone Densitometer uses DXA pencil beam technology to scan os calcis (heel) for bone mineral density (BMD) assessment. Device inputs: X-ray attenuation data from heel scan. Processing: Software compares patient BMD results against reference data sets for young normal Caucasian men and women (ages 20-42). Outputs: T-Score (standard deviations from young adult mean), % Young Reference value, and graphical representation. Includes fracture risk assessment based on WHO criteria (normal: T-score +1 to -1; low bone mass: -1 to -2.5; osteoporotic: < -2.5). Used in clinical settings by healthcare professionals to assist in osteoporosis diagnosis and fracture risk management. Benefits include rapid, low-dose assessment (<0.5 mRem) without water bath requirement.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison to predicate devices and established clinical criteria (WHO) for fracture risk assessment.

Technological Characteristics

DXA pencil beam technology; os calcis (heel) scanning; non-water bath system; scan time <30 seconds; patient dose <0.5 mRem; scatter radiation <0.1 mRem/hour at 3 feet.

Indications for Use

Indicated for use as an aid to physicians in diagnosing and managing osteoporosis and determining fracture risk in patients by comparing bone density estimates to young normal Caucasian men and women.

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

• Reference Population for pDEXA™ Bone Densitometer (K931996)
• Fracture Risk Assessment for pDEXA™ Bone Densitometer (K973104)

Submission Summary (Full Text)

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## MAY 2 0 1998

. .

K980125

# 510k Summary as required by 807.92(c) for Reference Population Capability for the Norland Apollo™ Bone Densitometer

### Prepared April 1998

| Submitted by: | Norland Medical Systems<br>W6340 Hackbarth Road<br>Fort Atkinson, WI 53538<br>Reg. # 2124648<br>920-563-8456 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg<br>Director Regulatory Affairs |
| Device Trade Name: | Reference Population for young normal Caucasian men and women for the<br>Norland Apollo™ X-Ray Bone Densitometer |
| Common Name: | Reference Population for dual energy x-ray (DXA) bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Reference Population for pDEXA™ Bone Densitometer (K931996)<br>Norland Corporation, Fort Atkinson, WI |
| | Fracture Risk Assessment for pDEXA™ Bone Densitometer (K973104)<br>Norland Medical Systems, Inc., Fort Atkinson, WI |
| Description of<br>Device: | The Norland Apollo™ Bone Densitometer (Apollo™) scans the os calcis<br>(heel) using the industry standard DXA pencil beam technology to assess<br>bone density. A water bath is not required and the scan takes less than 30<br>seconds. Patient dose is less than 0.5 mRem and scatter radiation is less<br>than 0.1 mRem/hour at 3 feet. |
| | Two reference sets are provided, one for female Caucasians and one for<br>male Caucasians. These reference data sets allow comparison of Apollo™<br>BMD scan results to healthy young adults aged 20 to 42. The results of the<br>comparison is given in terms of T-Score (the number of standard<br>deviations from the healthy young adult value), % Young Reference (the<br>percentage relative to the healthy young adult value), and in graphical<br>form. |
| | The Apollo™ Reference Population capability also includes Fracture Risk<br>assessment based on the World Health Organization (WHO) criteria. In<br>general, this means that patients with T- Scores from +1 to -1 are |

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considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.

Other reference data sets will be available in the future.

Safety and Effectiveness: The Reference Population capability for the Apollo™ is comparable to reference population capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised with this capability.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Terry Schwalenberg Director Regulatory Affairs Norland Medical Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538

Re:

K980125 Norland Apollo™ X-Ray Bone Densitometer Dated: April 15, 1998 Received: April 17, 1998 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 vito 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/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

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

Enclosure

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15 April 98

#### INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K980125

Device Name: Reference Population and Fracture Risk capability for the Norland Apollo TM Bone Densitometer

Indications For Use:

The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \/ OR Over-The-Counter-Use__
(Per 21 CFR 810.109)


(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,

and Radiological Devj

510(k) Number