DPX SERIES BRAVO DUO BONE DENSITOMETER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are in a bold, sans-serif font and are surrounded by a circular border with decorative swirls. JUL 2 5 2003 GE Medical Systems : (7:14:10) der and des Mems 1507 # 11.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c). | Contact Person: | James P. Raskob<br>GE LUNAR Corporation<br>726 Heartland Trail<br>Madison, WI 53717 | |----------------------|-------------------------------------------------------------------------------------| | Phone: | (608) 826-7425 | | Fax: | (608) 826-7825 | | Date: | March 25, 2003 | | Device/Trade Name: | DPX Series Bravo, Duo Bone Densitometer | | Common Name: | Bone Densitometer | | Classification Name: | Bone Densitometer<br>21CFR 892.1170 | | Predicate Device: | LUNAR PRODIGY<br>510(k) K982267<br>LUNAR DPX-Alpha and DPX-L<br>510(k) K904980 | ### DESCRIPTION OF THE DEVICE: 11.1 The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician. The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table. {1}------------------------------------------------ ## SUMMARY OF TECHNICAL CHARACTERISTICS 11.2 The DPX series Bravo. Duo Bone Densitometer performs a 90 second scan, with a total skin exposure dose of 2.0 mrem per measurement. The radiation exposure of 2.0 mrem is comparable to the predicate Prodigy and DPX-L bone densitometers. The BMD spine estimations in vivo provided by the DPX series Bravo, Duo correlate r>0.983 with the Prodigy. The average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo. The average short-term precision (%CV) in vitro was <0.27%. The short-term %CV in vivo was approximately 1.2% for spine, 0.80% for total proximal femur and 1.7% for forearm sub regions BMD. These values are comparable to those shown on currently marketed devices. #### 11.3 CONCLUSION The DPX series Bravo, Duo Bone densitometer is substantially equivalent to currently marketed devices. No new safety and effectiveness questions are raised with the DPX series Bravo, Duo Bone Densitometer. James P. Rashol ***_***_ and the word "Signed" James P. Raskob Name Safety and Regulatory Engineering Manager Title Summary of Safety, Effectiveness Page 2 of 2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure with three stylized wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 5 2003 Mr. James P. Raskob Safety and Regulatory Engineering Manager GE Lunar Corporation General Electric Company 726 Heartland Trail MADISON WI 53717 Re: K030962 Trade/Device Name: DPX Series Bravo Duo Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: July 2, 2003 Received: July 3, 2003 Dear Mr. Raskob: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 3.0 INDICATION FOR USE FORM - 501(k) Number (if known) . K030962 DPX Series Bravo, Duo Bone Densitometer - . Indications For Use: Device name: . The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table. The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only. The operator's manual for the DPX Series Bravo, Duo system contain the following statement: "United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician." # PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED. OR Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number Over-the-Counter Use (Optional Format 1-2-96) البار با Page 1 of 1 4. 15.