GEHC DXA Bone Densitometers with enCORE version 18

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Ms. Martha Kamrow Regulatory Affairs Leader 3030 Ohmeda Drive MADISON WI 53718 ## Re: K191112 Trade/Device Name: GEHC DXA Bone Densitometers with enCORE version 18 Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: August 16, 2019 Received: August 19, 2019 Dear Ms. Kamrow: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. September 19, 2019 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) ### K191112 Device Name ## GEHC DXA Bone Densitometers with enCORE version 18 Indications for Use (Describe) - A) Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, Total Body, and Forearm). These values can then be compared to an adult reference population at the sole discretion of the physician. - B) Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). - C) Provides an assessment of 10-year fracture risk using WHO FRAX model. - D) Provides a standardized bone density report using data from the densitometer and physiciangenerated assessments based on the patient's demographics, which can assist the physician in communicating scan results to the patient's referring physician. Optional Hand BMD software estimates the BMD at the hand. - E) Optional Hand BMD software estimates the BMD at the hand. - F) Optional Dual-Energy Vertebral Assessment software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry). - G) 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) | | |-------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) # K191112 ### Device Name ### GEHC DXA Bone Densitometers with enCORE version 18 Indications for Use (Describe) - H) Optional Complete Pediatric software option measures bone mineral content (BMC), bone mineral 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 absorptiometry 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 physician. The software does not provide a reference population for comparative purposes for patients younger than 5 years of age. - I) Optional Body Composition software measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass, and calculates other derivative values which can be displayed in user-defined statistical formats and trends and compared to reference populations at the sole discretion of the healthcare professional. Some of the diseases/conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. - J) The Mirrorlmage function used on the GE Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the bodv. - K) Optional CoreScan software estimates the Visceral Adipose Tissue (VAT) content and the Subcutaneous Adipose Tissue (SAT) content within the android region in a male or female population between the ages of 18 and 90 with a BMI between 18.5 and 40, excluding pregnant women. The content that is estimated is the VAT Volume, VAT Area, SAT Mass, SAT Volume, and SAT Area. The values can be displayed in user-defined statistical formats and trends. Some of the diseases/conditions for which VAT estimation can be useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, metabolic syndrome, and some cancers that are correlated to adipose tissue inflammation. - L) Optional total body composition software estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. - M) Optional total body composition software estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. - N) Optional Advanced Hip Assessment (AHA) software provides a measurement of hip axis length (HAL) and a mean value of HAL for Caucasian and Asian females on femur images. It also calculates hip geometry values used to evaluate the structural properties of the hip. {4}------------------------------------------------ ## Indications for Use ## K191112 ### Device Name ### GEHC DXA Bone Densitometers with enCORE version 18 Indications for Use (Describe) - O) Optional Atypical Femur Fracture (AFF) software uses femur images to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. This software provides measurements of the lateral and medial cortex width and quantifies focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. - P) Optional sarcopenia software calculates values based on published definitions and thresholds using measured appendicular lean mass in combination with patient demographics and entered values of muscle strength and physical performance. These values may be useful to health care professionals in their management of sarcopenia. - Q) Optional DXAVision software feature provides a complete bone and body composition assessment in one optimized exam including BMD with TBS, Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status. - R) TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease or recommend treatment regimens. Only the health care professional can make these judgments. {5}------------------------------------------------ ### 510(k) Summary K191112 In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | 16-Aug-2019 | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Submitter: | GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.)<br>3030 Ohmeda Drive<br>P.O. Box 7550<br>Madison, WI, USA 53707 | | | Primary Contact<br>Person: | Martha Kamrow<br>Regulatory Affairs Leader<br>GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.)<br>Telephone: (262) 548-2673<br>Email: Martha.Kamrow@ge.com | | | Secondary Contact<br>Person: | Nicole Landreville, P.Eng, RAC, FRAPS<br>Regulatory Affairs Manager<br>GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC)<br>Telephone: (289) 208-2365<br>Email: Nicole.Landreville@ge.com | | | Device Trade Name: | GEHC DXA Bone Densitometers with enCORE version 18 | | | Common/Usual<br>Name: | X-Ray Bone Densitometer | | | Classification Names:<br>Product Code: | Bone Densitometer (21CFR 892.1170)<br>KGI | | | Predicate Device(s): | 1. Lunar DXA Bone Densitometers with enCORE software:<br>• GEHC DXA Bone Densitometer with enCORE version 17 (K161682)<br>2. MediMaps Group's TBS Insight<br>• TBS Insight (K152299) | | | Device Description: | The changes proposed in this Premarket Notification will be used with the existing<br>GEHC DXA Bone Densitometers, which utilize the enCORE software. | | | | | | | The GEHC DXA Bone Densitometers are marketed under the following names: | | | | Prodigy originally cleared under K982267.<br>o | | | | o Lunar iDXA originally cleared under K052581. | | | | Device Identification/Characteristics/Description: | | | | GEHC DXA Bone Densitometers are composed of a scanner and a computer. The<br>scanner comprises the x-ray source and detector, the patient scan table, the<br>mechanical drive system, and the lowest level portions of the control system. The<br>scanner is in communication with the computer, which is a standard PC. The<br>computer runs the enCORE software, and thus controls the scanner, acquires scan<br>data from the scanner, stores and analyzes the data, and interacts with the human<br>operator. | | | | GEHC DXA Bone Densitometers are used healthcare facilities and hospitals to<br>measure bone mineral density (BMD) and body composition (%fat, fat mass, lean<br>mass) using a technique called Dual-energy X-ray Absorptiometry or DXA. DXA<br>measures the attenuation of x-rays of two different energy levels after they pass<br>through the body of a subject. As bone, fat tissue, and lean tissue absorb the<br>different energy x-rays at different rates, the relative attenuation of each x-ray<br>energy is measured and used to calculate the composition of each pixel. | | | | Key Performance Specifications/Characteristics of the Device: | | | | The existing GEHC DXA Bone Densitometers with enCORE software features were<br>modified: | | | | a)<br>DXAVision software feature provides a complete bone and body<br>composition assessment in one optimized exam including BMD with TBS,<br>Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status.<br>DXAVision combines multiple measurements (Spine, DualFemur, Total<br>Body) in one exam, simplifying workflow. Options to exclude the head and<br>lower legs from the Total Body measurement are available to improve<br>patient throughput while still capturing the core body composition results.<br>Total results are estimated from the area measured (neck to knees) so<br>existing reference data can continue to be used. Bone and composition<br>results are available in a single, comprehensive, patient-focused report.<br>DXAVision body composition estimates of Total Body %fat is comparable<br>to our previously cleared feature: Spine/Femur Estimated Total Body %fat<br>(K071570). | | | | Integrated TBS iNsight. TBSI iNsight is a software provided for use as a<br>b)<br>complement to both the DXA analysis and clinical examination. It<br>computes a Trabecular Bone Score (TBS) from the antero-posterior spine<br>DXA examination file that is compared to those of the age-matched<br>controls. The TBS is derived from the texture of the DXA image and has<br>been shown to be related to bone microarchitecture. enCORE version 18<br>software integrates the cleared TBS iNsight application (K152299) into the<br>DXA software to provide a more streamlined workflow for the user. | | | {6}------------------------------------------------ {7}------------------------------------------------ | c) | CoreScan software feature adds reporting of Visceral Adipose Tissue (VAT)<br>area and Subcutaneous Adipose Tissue (SAT) volume, mass, and area to<br>the existing VAT volume and mass. Area is calculated by dividing the<br>volume by the height of the region. The size of the subcutaneous fat layer<br>is estimated and subtracted from fat in the abdominal region to estimate<br>visceral fat using geometric modeling. There is no change in the algorithm<br>from that was cleared with enCORE v13.6 software (K103730) however the<br>SAT results are now reported in addition to VAT. Both VAT and SAT data<br>can be trended to see how the fat distribution in a person changes over<br>time. | |----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | d) | Total Body Less Head (TBLH) for Adults feature provides BMD and body<br>composition results for a total body scan excluding the head. An option to<br>exclude scanning the head is available to reduce scan time and allow<br>scanning of taller subjects that might not otherwise fit in the san window.<br>Total results are estimated so existing reference data can continue to be<br>used. TBLH body composition estimates of Total Body %fat is comparable<br>to our previously cleared feature: Spine/Femur Estimated Total Body %fat<br>(K071570). | | e) | Smaller body composition ROIs feature provides additional regional bone,<br>fat, and lean results for the upper and lower arms and legs. This feature is<br>substantially equivalent to previously cleared GEHC body composition<br>software option for GE Lunar DEXA Bone Densitometers (K071570). | | f) | Advanced Analytics software feature allows the user to create custom<br>equations using existing data already available from their DXA system, set<br>user-defined classification thresholds based on these equations, and<br>establish actionable patient goals based on evaluation of the results. | | g) | Additional security features provide compatibility with the US Department<br>of Defense Risk Management Framework (RMF) including FIPS 140-2<br>encryption, TLS for DICOM, IPv6 protocol, and audit trails. | | | The addition of these new enCORE v18 software features expands the Indications<br>for Use with the following statements: | | a) | Optional DXAVision software feature provides a complete bone and body<br>composition assessment in one optimized exam including BMD with TBS,<br>Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status. | | b) | TBS iNsight is a software provided for use as a complement to both DXA<br>analysis and clinical examination. It computes the antero-posterior spine<br>DXA examination file and calculates a score (Trabecular Bone Score - TBS)<br>that is compared to those of the age-matched controls. The TBS is derived<br>from the texture of the DXA image and has been shown to be related to<br>bone microarchitecture. TBS iNsight provides as an option an assessment<br>of 10-year fracture risk. It provides an estimate of 10-year probability of<br>hip fracture and 10-year probability of a major osteoporotic fracture. | {8}------------------------------------------------ | | (clinical spine, forearm, hip or shoulder fracture). This estimate is based<br>on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for<br>the TBS. The tool has been validated for Caucasian and Asian men and<br>post-menopausal women between 40 and 90 years old. TBS provides | | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | information independent of BMD value; it is used as a complement to the<br>data obtained from the DXA analysis and the clinical examination | | | | (questioning by the clinician about patient history, bioassay of bone<br>resorption markers). The results can be used by a physician in<br>conjunction with other clinical risk factors as an aid in the diagnosis of<br>osteoporosis and other medical conditions leading to altered trabecular<br>bone microarchitecture, and ultimately in the assessment of fracture risk.<br>The TBS score can assist the health care professional in monitoring the<br>effect of treatments on patients across time. Overall fracture risk will<br>depend on many additional factors that should be considered before<br>making diagnostic or therapeutic recommendations. The software does<br>not diagnose disease or recommend treatment regimens. Only the health<br>care professional can make these judgments. | | | | Optional CoreScan software estimates the Visceral Adipose Tissue (VAT)<br>C)<br>content and the Subcutaneous Adipose Tissue (SAT) content within the<br>android region in a male or female population between the ages of 18<br>and 90 with a BMI between 18.5 and 40, excluding pregnant women. The<br>content that is estimated is the VAT Mass, VAT Volume, VAT Area, SAT<br>Mass, SAT Volume, and SAT Area. The values can be displayed in user-<br>defined statistical formats and trends. Some of the diseases/conditions<br>for which VAT estimation can be useful include hypertension, impaired<br>fasting glucose, impaired glucose tolerance, diabetes mellitus,<br>dyslipidemia, metabolic syndrome, and some cancers that are correlated<br>to adipose tissue inflammation. | | | | The enCORE v18 software incorporates latest Microsoft security patches and other<br>security enhancements. | | | | Material Used: | | | | There were no changes made to the material used in the fabrication of<br>●<br>Lunar iDXA and Prodigy X-Ray Bone Densitometers. | | | Intended Use: | The intended use of the GE Lunar DXA Bone Densitometers remains the same.<br>The proposed device: GE Lunar DXA Bone Densitometers with the enCORE version<br>18 software is intended for medical purposes to measure bone density, bone<br>mineral content, and fat and lean tissue content by x-ray transmission<br>measurements through the bone and adjacent tissues. | | | Indications for Use: | Provides an estimate of bone mineral density at various anatomical sites<br>A)<br>(Spine, Femur, Total Body, and Forearm). These values can then be | | {9}------------------------------------------------ | | compared to an adult reference population at the sole discretion of the<br>physician. | |----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | B) | Provides an assessment of relative fracture risk based on the patient's T-<br>score value using the categories of fracture risk defined by the World<br>Health Organization (WHO). | | C) | Provides an assessment of 10-year fracture risk using WHO FRAX model. | | D) | Provides a standardized bone density report using data from the<br>densitometer and physician-generated assessments based on the patient's<br>demographics, which can assist the physician in communicating scan<br>results to the patient and the patient's referring physician. | | E) | Optional Hand BMD software estimates the BMD at the hand. | | F) | Optional Dual-Energy Vertebral Assessment software provides an x-ray<br>image of the spine for qualitative visual assessment in order to identify<br>vertebral deformations and estimate vertebral heights (morphometry). | | G) | Optional Orthopedic software estimates periprosthetic BMD of an<br>orthopedic hip or knee implant (pre- and post-surgery). | | H) | Optional Complete Pediatric software option measures bone mineral<br>content (BMC), bone mineral density (BMD) and body composition (lean<br>body mass and fat mass) in patients from birth to 20 years of age. The<br>software provides a comparison of measured variables obtained by dual<br>energy x-ray absorptiometry to a database of reference values for patients<br>5-19 years of age. These data can be used for comparative purposes at the<br>sole discretion of the physician. The software does not provide a reference<br>population for comparative purposes for patients younger than 5 years of<br>age. | | I) | Optional Body Composition software measures the regional and whole<br>body bone mineral density (BMD), lean and fat tissue mass, and calculates<br>other derivative values which can be displayed in user-defined statistical<br>formats and trends and compared to reference populations at the sole<br>discretion of the healthcare professional. Some of the diseases/conditions<br>for which body composition values are useful include chronic renal failure,<br>anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. | | J) | The MirrorImage function used on the GE Lunar DXA bone densitometers<br>can be used to estimate the total body composition and bone mineral<br>density (BMD) when regions of the body are outside of the scan window<br>by using scanned data from the corresponding region(s) on the opposite<br>half of the body. | | K) | Optional CoreScan software estimates the Visceral Adipose Tissue (VAT)<br>content and the Subcutaneous Adipose Tissue (SAT) content within the<br>android region in a male or female population between the ages of 18 and<br>90 with a BMI between 18.5 and 40, excluding pregnant women. The<br>content that is estimated is the VAT Mass, VAT Volume, VAT Area, SAT<br>Mass, SAT Volume, and SAT Area. The values can be displayed in user- | {10}------------------------------------------------ | | | defined statistical formats and trends. Some of the diseases/conditions for<br>which VAT estimation can be useful include hypertension, impaired fasting<br>glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia,<br>metabolic syndrome, and some cancers that are correlated to adipose<br>tissue inflammation. | |--|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | L) | Optional total body composition software estimates the Resting Metabolic<br>Rate (RMR) in the male or female population age 18 and older. The data<br>can be displayed in user-defined statistical formats and trends. | | | M) | Optional total body composition software estimates the Relative Skeletal<br>Muscle Index (RSMI) in the male or female population age 18 and older.<br>The data can be displayed in user-defined statistical formats and trends. | | | N) | Optional Advanced Hip Assessment (AHA) software provides a<br>measurement of hip axis length (HAL) and a mean value of HAL for<br>Caucasian and Asian females on femur images. It also calculates hip<br>geometry values used to evaluate the structural properties of the hip. | | | O) | Optional Atypical Femur Fracture (AFF) software uses femur images to<br>visualize focal reaction or thickening along the lateral cortex of the femoral<br>shaft which may be accompanied by a transverse radiolucent line. This<br>software provides measurements of the lateral and medial cortex width<br>and quantifies focal thickening of the lateral cortex along the femoral<br>shaft. The beaking index can be displayed and trended across serial scans. | | | P) | Optional sarcopenia software calculates values based on published<br>definitions and thresholds using measured appendicular lean mass in<br>combination with patient demographics and entered values of muscle<br>strength and physical performance. These values may be useful to health<br>care professionals in their management of sarcopenia. | | | Q) | Optional DXAVision software feature provides a complete bone and body<br>composition assessment in one optimized exam including BMD with TBS,<br>Fracture Risk, Adiposity/Metabolic status, and Sarcopenia status. | | | R) | TBS iNsight is a software provided for use as a complement to both DXA<br>analysis and clinical examination. It computes the antero-posterior spine<br>DXA examination file and calculates a score (Trabecular Bone Score - TBS)<br>that is compared to those of the age-matched controls. The TBS is derived<br>from the texture of the DXA image and has been shown to be related to<br>bone microarchitecture. | | | | TBS iNsight provides as an option an assessment of 10-year fracture risk. It<br>provides an estimate of 10-year probability of hip fracture and 10-year<br>probability of a major osteoporotic fracture (clinical spine, forearm, hip or<br>shoulder fracture). This estimate is based on the WHO's FRAX® Fracture<br>Risk Assessment Tool, after adjustment for the TBS. The tool has been<br>validated for Caucasian and Asian men and post-menopausal women<br>between 40 and 90 years old. | {11}------------------------------------------------ | | TBS provides information independent of BMD value; it is used as a<br>complement to the data obtained from the DXA analysis and the clinical<br>examination (questioning by the clinician about patient history, bioassay of<br>bone resorption markers...). The results can be used by a physician in<br>conjunction with other clinical risk factors as an aid in the diagnosis of<br>osteoporosis and other medical conditions leading to altered trabecular<br>bone microarchitecture, and ultimately in the assessment of fracture risk.<br>The TBS score can assist the health care professional in monitoring the<br>effect of treatments on patients across time. Overall fracture risk will<br>depend on many additional factors that should be considered before<br>making diagnostic or therapeutic recommendations. The software does<br>not diagnose disease or recommend treatment regimens. Only the health<br>care professional can make these judgments. | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturing Site: | GE Medical Systems Monterrey Mexico, S.A.DE C.V.<br>Calle Espana #300, Parque Industrial Huinala<br>Apodaca, Nuevo Leon, C.P.66645, Mexico | | Technology: | GE DXA Bone Densitometers (Lunar iDXA and Prodigy) with the enCORE version 18<br>employs the same fundamental scientific technology as its predicate device GE<br>Lunar DXA Bone Densitometers with enCORE software v17. | | Determination of<br>Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The GE Lunar DXA Bone Densitometers with the enCORE version 18 and its<br>applications comply with voluntary standards. The following quality assurance<br>measures were applied to the development of the system:<br>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) There is no change to the system hardware.<br>Although these changes do not impact the intended use of the system, adding TBS<br>iNsight, Optional CoreScan and Optional DXAVision software features added new<br>Indications for Use. These software changes were tested successful: | {12}------------------------------------------------ | • Software verification and validation testing results performed on the | | | | | |-------------------------------------------------------------------------------------|--|--|--|--| | enCORE software version 18 confirmed that the software met the design | | | | | | specification requirements. | | | | | | | | | | | | • Bench Performance testing results performed on the DXAVision, Adult | | | | | | TBLH, Integrated TBS iNsight, CoreScan VAT/SAT, Smaller BC ROIs, and | | | | | | Advanced Analytics software options confirmed that the design outputs | | | | | | met the design input requirements. | | | | | | | | | | | | DXAVision and Adult TBLH – We conclude that the differences in DXA<br>● | | | | | | results for DXAVision for neck-to-knees scans and for Adult TBLH total | | | | | | body measurements of bone and body composition in a heterogenous | | | | | | sample of men and women with a diverse range of age, BMI, BMD, and | | | | | | body fat are slightly larger but similar to the results of precision studies | | | | | | of duplicate scans reported in the literature for both iDXA and Prodigy. | | | | | | | | | | | | Integrated TBS's bench testing using internal engineering DXA data<br>● | | | | | | sets demonstrates that TBS and FRAX adjusted for TBS results are | | | | | | comparable between results calculated with the TBS integrated into | | | | | | enCORE 18 software and previously cleared TBS iNsight application. | | | | | | | | | | | | CoreScan's bench testing used an anthropomorphic phantom to<br>● | | | | | | demonstrate the VAT/SAT results for the updated CoreScan software | | | | | | option are precise and accurate. | | | | | | The new Small Body Composition ROI verification results confirm the<br>● | | | | | | accuracy of bone and body composition of the upper and lower arms | | | | | | and legs. | | | | | | | | | | | | ●<br>The new Advanced Analytics software option incorporates results of | | | | | | previously cleared features into user defined equations and does not | | | | | | affect the safety or effectiveness of the system. | | | | | | | | | | | | Therefore, GE Healthcare concludes that GEHC DXA Bone Densitometers with | | | | | | enCORE version 18 is as safe and as effective as the Predicate devices for its | | | | | | intended use. | | | | | | | | | | | | There is no change to the diseases or conditions expected to be diagnosed, | | | | | | treated, prevented, cured or mitigated. There is also no change to the patient | | | | | | population. | | | | | | | | | | | | Summary of Clinical Tests: | | | | | | Although the subject of this premarket submission, GEHC DXA Bone Densitometers | | | | | | with the enCORE version 18, did not require clinical studies to support substantial | | | | | | equivalence, a clinical literature search was performed and provided to support | | | | | | the additional optional software features calculations and associated indications | | | | | | for use. | | | | | {13}------------------------------------------------ | Conclusion: | The GEHC DXA Bone Densitometers with enCORE version 18 expands its previously<br>cleared features and indications for use but does not result in any new potential<br>safety risks. The GEHC DXA Bone Densitometers have the same technological<br>characteristics and performs as well as the predicate devices currently on the<br>market. | |-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Based on: conformance to standards; development under GE Healthcare's quality<br>management system and design controls; successful verification/validation testing<br>and additional bench performance testing. GE Healthcare believes that the GEHC<br>DXA Bone Densitometers with enCORE version 18 is substantially equivalent to its<br>predicate device GE Lunar DXA Bone Densitometers with enCORE version 17<br>(K161682). The TBS feature is substantially equivalent to its predicate device<br>MediMaps Group's TBS Insight (K152299). | | | Therefore, GE Healthcare concludes that GEHC DXA Bone Densitometers with<br>enCORE version 18 is as safe and as effective as the Predicate devices for its<br>intended use. |