MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY

{0}------------------------------------------------ K99 3176 ## 510k Summary JUN 2 0 2000 as required by 807.92(c) for ## Multi-Racial Reference Population For pDEXA™ and Discovery™ Bone Densitometers 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, 920-563-8456 x229 | | Device Trade Name: | Multi-Racial Reference Population for pDEXATM and Discovery™ | | Common Name: | Reference Population for DXA bone densitometer | | Classification: | Bone densitometer, (21 CFR 892.1170). product code 90KGI; Class II | | Predicate Devices: | Norland pDEXA with Reference Population (K931996). and<br>Norland Fracture Risk Assessment (K980569) | | Description of<br>Device: | In general, the Multi-Racial Reference Population capability for the pDEXA<br>and Discovery bone densitometers compares the pDEXA and Discovery scan<br>results to average values for people without bone related disease, who have<br>the same gender and ethnic background as the patient. Its purpose is to aid<br>the physician in determining the presence of bone disease other than age<br>related bone loss. Both age matched and young reference comparisons are<br>made. T-Score, Z-Score, % Young Reference, % Age Matched, and a<br>graphical representation are presented.<br><br>The Norland pDEXA and Discovery bone densitometers scan the forearm<br>using the industry standard DXA pencil beam technology to assess bone<br>density of the distal and proximal radius plus ulna sites. The Discovery is a<br>newer, smaller version of the pDEXA with faster scan speeds and lower<br>dose. The Discovery dose is < 1 mRem and the pDEXA is < 3 mRem.<br>Discovery scan time is about 90 seconds and the pDEXA about 3 minutes.<br><br>This reference population also includes Fracture Risk Assessment based on<br>the World Health Organization (WHO) criteria. In general, this means that<br>patients with T- Scores between 1 to -1 are considered to have a low risk of<br>fracture; with T-Scores from -1 to -2.5 are considered to have a medium risk<br>of fracture; and T-Scores below -2.5 are considered to have a high risk of<br>fracture. | | Safety and<br>Effectiveness: | This pDEXA and Discovery multi-racial reference population is comparable to<br>reference population capabilities in use with other bone densitometers in the<br>industry. No new safety or effectiveness issues are raised with this capability. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a partial view of a logo and the word "DEPART". The logo is a circular emblem with three curved lines inside, possibly representing a stylized human figure. The word "DEPART" is in bold, uppercase letters, suggesting it is the beginning of a longer word or phrase, likely "DEPARTMENT". Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 0 2000 Terry Schwalenberg Director, Regulatory Affairs Norland Medical Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538 Re: K993176 Multi-Racial Reference Population for the pDEXA™ and Discovery™ Bone Densitometers Dated: May 16, 2000 Received: May 22, 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 the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 and prohibitions against misbranding and adulteration. lf 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 notfication 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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) {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(K) Number (if known): K993176 Device Name: Multi-Racial Reference Population for the pDEXATM and Discovery TM Bone Densitometers Indications For Use: The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated 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 bone density estimates from the pDEXA™ and Discovery™ bone densitometers 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 OR Over-The-Counter-Use Per 41 CFR 810.109 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K993176 Page 1-1