FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS

K980569 · Norland Corp. · KGI · Jun 12, 1998 · Radiology

Device Facts

• Record ID: K980569
• Device Name: FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
• Applicant: Norland Corp.
• Product Code: KGI · Radiology
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

Device Story

Software capability for Norland X-Ray Bone Densitometers (XR, pDEXA, Apollo, XCT, SXA series); processes bone mineral density (BMD) and T-score values derived from densitometer scans; incorporates patient demographic data (gender, age, ethnic background). Operates by applying World Health Organization (WHO) diagnostic criteria to classify bone density status: T-scores +1 to -1 (normal), -1 to -2.5 (low bone mass/increased fracture risk), below -2.5 (osteoporotic/high fracture risk). Output presented as graphical and textual information on device screens and reports. Used by clinicians in clinical settings to assist in fracture risk assessment and treatment monitoring. Does not alter scanning hardware, patient dose, or radiation exposure.

Clinical Evidence

No clinical data provided. The device relies on established World Health Organization (WHO) criteria for interpreting bone density values (BMD and T-scores) to assess fracture risk.

Technological Characteristics

Software-based assessment module for existing Norland X-Ray Bone Densitometers. Utilizes rule-based logic to map BMD/T-score values and patient demographics to WHO fracture risk categories. No hardware changes, no impact on radiation dose or scan time. Integrated into existing densitometer reporting software.

Indications for Use

Indicated for use as an aid to physicians in determining fracture risk, bone disease risk, or treatment effectiveness in patients undergoing bone density testing with Norland X-Ray Bone Densitometers.

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

• Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104)
• Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer

Submission Summary (Full Text)

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February 1998

Fracture Risk Assessment 510(k) - Supplement 1

JUN 12 1998

## 510k Summary

as required by 807.92(c) for

Fracture Risk Assessment Capability

for Norland X-Ray Bone Densitometers

Prepared February 1998

Norland Medical Systems, Inc. Submitted by: W6340 Hackbarth Road Fort Atkinson, WI 53538 Reg. # 2124648 Contact Person: Mr. Terry Schwalenberg Director Regulatory Affairs 920-563-8456 x229 Fracture Risk Assessment Capability for Norland X-Ray Bone Device Trade Name: Densitometers Common Name: Fracture risk assessment for bone densitometers Classification: Bone densitometer. (21 CFR 892.1170), product code 90KGI: Class II Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104) Predicate Devices: Norland Medical Systems, Inc., Fort Atkinson, WI Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer, which is a pre-amendment device. Description of This fracture risk assessment capability provides information that aids the Device: physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are 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 with T-Scores below -2.5 are considered to be osteoporotic

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and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.

This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.

This Norland Fracture Risk Assessment Capability is comparable to Safety and Effectiveness: fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.

JUN | 7 1998

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

Re:

K980569

Fracture risk capabililty for the Norland Bone Densitometer: Models XR Series, pDEXA Series, Apollo Series, XCT Series and SXA Series Dated: April 16, 1998 Received: April 20, 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 III (Premarket Aporoval), 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsma/dsmamain.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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## INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

Device Name: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers.

Indications For Use:

The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.

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

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

David A. Byrom

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number