OSTEOGRAM BONE DENSITOMETER

{0}------------------------------------------------ K984285 # 510(k) Summary # OsteoGram® 2000 Common/Classification Name: Bone Densitometer, 21 CFR 892.1170 CompuMed, Inc. 1230 Rosecrans Avenue Manhattan Beach, CA 90266 Contact: David Edelstein, Prepared: December 1, 1998 ### LEGALLY MARKETED PREDICATE DEVICES A. The modified OsteoGram® 2000 device is substantially equivalent to the currently marketed OsteoGram device. The UsteoGram is a pre-Amendments device. ### DEVICE DESCRIPTION B. The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability. #### C. INDICATIONS FOR USE The OsteoGram 2000 is indicated for use in estimating me ostimoral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in escore may be association and for monitoring changes in bone mass over time. ### SUBSTANTIAL EQUIVALENCE SUMMARY D. The OsteoGram 2000 has the same indications for use as the currently marketed device. The OsteoGram 2000 has the same technological characteristics as the predicate device. However, the {1}------------------------------------------------ characteristics may not be sufficiently procise to assure equivalence. The sufficiently because and welidation, and, nerformance characteristics may not be sumolonely providation and performance Therefore, CompuMed has carried out valistrate, that the modified , Compulvied nas carred out vanstrate that the modified testing. testing. The results of this testing domently marketed device. OsteoGram 2000 performs as well as the currently marketed device. # TECHNOLOGICAL CHARACTERISTICS E. The technological characteristics of the modified device are very similar The technological charactenstics of the modified only difference is that to those of the currently marketed device. The oil / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / the analysis software has been mounted is a lows the OsteoGram ximproved patient revorus managers managers they are made. ## TESTING F. CompuMed carried out performance testing that compared the results of Compulvied carned out performance transmission and assays by both naïve the scanning and analysis of several patient and annuracy of the the scanning and analysis of several pation and accuracy of the operators and central lab operators. The precision and accuracy of the operators and central lab operators were almost identical. ### CONCLUSIONS G. The validation studies have demonstrated that the modified OsteoCram The validation studies nave demonstrator than currently marketed OsteoGram device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white. # Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 9 1999 Compumed, Inc. C/O T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 RE: K984285 OsteoGram 2000 Bone Densitometer Dated: March 17, 1999 Received: March 17, 1999 Regulatory Class: II 21 CFR 892.1170/Procode: 90 KGI Dear Dr. Athey: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We nower reviewed your ooking with a windications for uses 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 redassified in accordance with the provisions of the Medical Dood, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls r cocial Programs Controls provisions of the Act include requirements for annual registration, listing of provices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may if your device to such additional control ajor regulations affecting your device can be found in the Code of be Subjict to odor additional Sontrolly equivalent determination assumes compliance with r Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Outlett Ooo manandelaning Praxion CEFR Part 820) and that, through periodic QS inspections, the Food and Mcalour Devilled (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in Drog Nammatication. In addition, FDA may publish further announcements concerning your device in the Federal register. In addition, PDF may pour 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 oquivalone of your dovice 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 il you desire specific devices), please control conficience at (301) 554-4613. Additionally for quostions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-9639. Allso, the promotion and dreitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other please not regulation entilibed with 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/dsma/dsmamain.html". Sincerety yours. APT Daniel G. Schultz, M.D Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate The OsteoGram 2000 is indicated for use in estimating bone innized collably (2007). of BMD and t-score may be used as an and to the physician in determining fracture risk, an of BMD and t seers may ------------------------------------------------------------------------------------------------------------------------------------------------------- (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ David A. Segura (Division Sign-Off) Division of Reproductiv Abdominal, EN and Radiological D 510(k) Number