FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER

K980289 · Norland Corp. · KGI · Jun 12, 1998 · Radiology

Device Facts

• Record ID: K980289
• Device Name: FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
• 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 the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.

Device Story

The Norland SXA 3000 is a bone densitometer using single energy x-ray (SXA) pencil beam technology to scan the os calcis (heel). The device measures bone mineral content (BMC), area, and bone mineral density (BMD). It calculates T-scores and Z-scores, which are then compared against World Health Organization (WHO) criteria to assess fracture risk. The system categorizes patients into normal, low bone mass (increased risk), or osteoporotic (high risk) groups. The device is intended for use by clinicians in various medical specialties to assist in disease diagnosis and fracture risk assessment. The output provides quantitative data and risk classification to support clinical decision-making regarding bone health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and the application of established WHO diagnostic criteria for bone density and fracture risk.

Technological Characteristics

SXA pencil beam technology; measures BMC, Area, and BMD of the os calcis. Provides T-score and Z-score calculations. Operates as a bone densitometer (21 CFR 892.1170).

Indications for Use

Indicated for use as an aid to physicians in determining fracture risk in patients by comparing bone density estimates to those of healthy individuals of the same gender and ethnic background.

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 pDEXA Bone Densitometer (K973104)

Submission Summary (Full Text)

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FAX [phone]:51 ~02/24/98

NORLAND ADMIN.

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February 1998

Fracture Risk Capability for SXA 3000704 - Supplement 1

JUN 1 2 1998

: 上一篇:

## 510k Summary as required by 807.92(c) for Fracture Risk Assessment Capability for the Norland SXA 3000TM Bone Densitometer

Prepared February 1998

| Submitted by: | Norland Corporation<br>W6340 Hackbarth Road<br>Fort Atkinson, WI 53538<br>Reg. # 2124648<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg<br>Director Regulatory Affairs<br>920-563-8456 x229 |
| Device Trade Name: | Fracture Risk Assessment Capability<br>for the Norland SXA 3000TM Bone Densitometer |
| Common Name: | Fracture Risk Assessment for a single energy x-ray (SXA) bone<br>densitometer |
| Classification: | Bone Densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104)<br>Norland Medical Systems, Inc., Fort Atkinson, WI |
| Description of<br>Device: | The Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone<br>Densitometer (SXA 3000TM) can be used whenever it is desirable to do a<br>bone assessment of the os calcis (heel). Bone assessments are of interest in<br>many medical disciplines such as nephrology, endocrinology,<br>rheumatology, gynecology, etc. The SXA 3000TM scans the heel using the<br>industry standard SXA pencil beam technology and provides BMC, Area,<br>BMD, T-Score, and Z-Score values. A scan takes about three minutes and<br>the patient dose is less than 1.5 mRem. |
| | The SXA 3000TM provides fracture risk assessment based on the World<br>Health Organization (WHO) criteria for relating the bone density test to<br>fracture risk assessment and disease diagnosis. In general, this assessment<br>states that patients with T-Scores from +1 to -1 are considered to be |

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BURL AT THE MONE

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

Safety and Effectiveness: This Fracture Risk Assessment Capability for the SXA 3000™ is comparable to fracture risk assessment capabilities in use with other boms 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

JUN | 2 1998

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

Re:

· Fracture risk capabililty for the Norland SXA 3000 Bone Densitometer 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.

K980289

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 equivalent determination 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 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian 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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Fracture Risk Capability for SXA 3000TM - Supplement 1

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K980289

## Device Name: Fracture Risk Assessment capability for the Norland SXA 3000™ Bone Densitometer

Indications For Use:

The bone density estimates from the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.

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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 Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number