ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS

{0}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission Image /page/0/Picture/3 description: The image shows a document with the text 'K133664' at the top, followed by 'page 1 of 3' written in cursive. A circular logo with the letters 'GE' inside is located on the bottom left of the image. The document appears to be the first page of a three-page document, possibly related to a product or service from General Electric (GE). ## 510(k) Summary In occordance with 21 CFR 807.92 the following summary of information is provided: | Date: | November 27. 2013 | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Healthcare (GE Medical Systems Ultrasound & Primary Care<br>Diagnostics, LLC) | | | 3030 Ohmeda Drive<br>P.O. Box 7550 | | | Madison, WI 53707 | | Primary Contact<br>Person: | Chris Paulik | | | Regulatory Affairs Leader | | | GE Healthcare (GE Medical Systems Ultrasound & Primary Care<br>Diagnostics, LLC) | | | Telephone: (262) 548-2010 | | | Email: Christopher.Paulik@med.ge.com | | Secondary Contact<br>Person: | Steven Kachelmeyer<br>Regulatory Affairs Director<br>GE Healthcare (GE Medical Systems Ultrasound & Primary Care<br>Diagnostics, LLC)<br>Telephone: (262) 548 2432<br>Email: Steven.Kachelmeyer@med.ge.com | | Device Trade Name: | Lunar DPX Series: (DPX-MD+, DPX-MD+ Compact , DPX-NT, DPX-NT<br>Compact, DPX Pro, DPX Bravo, DPX Duo)<br>Lunar Prodigy Series: (Prodigy, Prodigy Compact, Prodigy Pro, Prodigy<br>Pro Compact, Prodigy Primo, Prodigy Primo Compact, Prodigy<br>Advance, Prodigy Advance Compact, Prodigy Forma)<br>Lunar iDXA Series: (iDXA, iDXA Advance, iDXA Pro, iDXA Forma, Lunar<br>iDXA) | | Common/Usual<br>Name: | Bone Densitometer | | Classification<br>Names: | Bone Densitometer (21CFR 892.1170) | | Product Code: | KGI | | Predicate Device(s): | Pediatric Reference Data for Prodigy and DPX Bone Densitometers<br>(K001812) | | | Infant Whole Body Software Option for QDR Densitometers (K042480) | | | Expert-XL Orthopedic Hip Acquisition and Analysis Software<br>(K972517) | | Device Description: | enCORE software is used on GE Lunar DXA bone densitometers.<br>Release 16 of the enCORE software (enCORE 16 or enCORE 16.xx)<br>includes some feature enhancements. The software will now expand<br>upon its previously cleared pediatric indication (K001812) by<br>providing a "Complete Pediatric" software that can measure the bone<br>mineral content (BMC), bone mineral density (BMD) and body<br>composition (lean body mass and fat mass) in patients from birth to<br>20 years of age. The software will also provide a comparison of<br>measured variables obtained by dual energy x-ray absorptiometry to<br>a database of reference values for patients 5-19 years of age. The<br>software will also expand its previously cleared orthopedic hip<br>indication (K972517) to include estimates of the BMD of the knee<br>before and after joint implant. | | | The GE Lunar DXA bone densitometers measure the bone mineral<br>density (BMD), lean and fat tissue mass and calculate derivative<br>values of bone mineral content (BMC), area, soft tissue mass, regional<br>soft tissue mass, total soft tissue mass, fat free mass, regional/total<br>soft tissue mass ratio, % fat, region % fat, total body % fat, Android %<br>fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass<br>Index (BMI). | | Intended Use: | The enCORE version 16 for GE Lunar DXA Bone Densitometers is<br>intended for medical purposes to measure bone density, bone<br>mineral content, and fat and lean tissue content by x-ray<br>transmission measurements through the bone and adjacent tissues. | | Technology: | The enCORE version 16 Software Release for the GE Lunar DXA Bone<br>Densitometers employs the same fundamental scientific technology<br>as its predicate device, which is dual-energy x-ray absorptiometry<br>using a PC based image processing algorithm running on a Microsoft<br>Windows operating system. | | | The enCORE version 16 Software Release for the GE Lunar DXA Bone<br>Densitometers has expanded the anatomical sites from the predicate<br>devices to now also include the knee for orthopedic examinations, pre<br>and post joint implant, with its optional orthopedic software. | | | The enCORE version 16 Software Release for the GE Lunar DXA Bone<br>Densitometers has expanded the patient population from the<br>predicate devices for the complete pediatric software option to<br>accommodate those populations from birth to 20 years of age. | | | The differences discussed in this section do not raise new issues of<br>safety and effectiveness. Verification and Validation testing<br>demonstrated that no adverse effects have been introduced by these<br>differences. | | Determination of<br>Substantial<br>Equivalence: | Summary of Non-Clinical Tests: | | | The enCORE version 16 Software Release for the GE Lunar DXA Bone<br>Densitometers and its applications comply with voluntary standards.<br>The following quality assurance measures were applied to the<br>development of the system: | | | ■ Risk Analysis | | | ■ Requirements Reviews | | | ■ Design Reviews | | | ■ Testing on unit level (Module verification) | | | ■ Integration testing (System verification) | | | ■ Performance testing (Verification) | | | ■ Safety testing (Verification) | | | ■ Simulated use testing (Validation) | | | Summary of Clinical Tests: | | | The subject of this premarket submission, enCORE version 16<br>Software Release for the GE Lunar DXA Bone Densitometers, did not<br>require clinical studies to support substantial equivalence. Bench<br>testing was performed to verify the effectiveness of the expanded<br>population range of the "Complete Pediatric" software application<br>from birth to 20 years as well as add the knee as an additional<br>anatomic site for the orthopedic software application. | | Conclusion: | The enCORE version 16 Software Release for the GE Lunar DXA Bone<br>Densitometers expands upon its previously cleared pediatric<br>indication (K001812) by broadening the patient population from birth<br>to 20 years of age. The software will also expand its previously<br>cleared orthopedic hip indication (K972517) to include estimates of<br>the BMD of the knee before and after joint implant. It does not result<br>in any new potential safety risks, has the same technological<br>characteristics, and performs as well as the devices currently on the<br>market. | | | After analyzing performance testing on the bench it is the conclusion<br>of GE Healthcare that the enCORE version 16 Software Release for the<br>GE Lunar DXA Bone Densitometers e is substantially equivalent to<br>other marketed devices with similar indications for use and meeting<br>the same standards. | A-3 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, while the background is white. # GE Healthcare # 510(k) Premarket Notification Submission . {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "K133664 page 3 of 3" in a handwritten style. The text is arranged in a way that "K133664" is at the top, followed by "page 3 of 3" underneath it. In the bottom left corner of the image, there is a logo of GE, which is a circular emblem with the letters "GE" inside. . . . # GE Healthcare . . . : : ## 510(k) Premarket Notification Submission ・ : : : . {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### May 15, 2014 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC % Mr. Chris Paulik Regulatory Affairs Leader 3030 Ohmeda Drive MADISON WI 53718 Re: K133664 Trade/Device Name: enCORE version 16 software for GE Lunar DXA Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: April 9, 2014 Received: April 10, 2014 Dear Mr. Paulik: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Mr. Chris Paulik If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Smh.7) for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. #### 510(k) Number (if known) K133664 #### Device Name enCORE version 16 for GE Lunar DXA Bone Densitometers #### Indications for Use (Describe) The optional "Complete Pediaric" software option mineral content (BMC), bone nineral density (BMD) and body composition (lean body mass and fat mass) in patients from birth to 20 years of age. The software provides a comparison of measured variables obtained by dual energy x-ray absorpionery to a database of reference values for patients 5-19 years of age. These data can be used for comparative purposes at the sole discretion of the software does not provide a reference population for comparative purposes for patients younger than 5 years of age. Optional Orthopedic software estimates periprosthetic BMD of an orthopedic hip or knee implant (pre- and post-surgery). Type of Use (Select one or both, as applicable) 🇿 Prescription Use {Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) ## Please do not write below this line - continue on a separate page if needed. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Sm) FORM FDA 3881 (9/13) Par Publishing Services . BOI : 441-12 Pr