Who is the manufacturer of GE Lunar DXA Bone Densitometers with enCORE version 17?

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC filed the 510(k) submission for GE Lunar DXA Bone Densitometers with enCORE version 17 (K161682).

What is the FDA product code for GE Lunar DXA Bone Densitometers with enCORE version 17?

KGI. It is classified under 21 CFR 892.1170 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for GE Lunar DXA Bone Densitometers with enCORE version 17?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GE Lunar DXA Bone Densitometers with enCORE version 17?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GE Lunar DXA Bone Densitometers with enCORE version 17

K161682 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · KGI · Dec 2, 2016 · Radiology

Device Facts

Record ID	K161682
Device Name	GE Lunar DXA Bone Densitometers with enCORE version 17
Applicant	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Product Code	KGI · Radiology
Decision Date	Dec 2, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1170
Device Class	Class 2

Intended Use

The proposed device: “GE Lunar DXA Bone Densitometers with enCORE version 17 software” is intended for medical purposes to measure bone density, bone mineral content, and fat and lean tissue content by x-ray transmission measurements through the bone and adjacent tissues.

Device Story

GE Lunar DXA Bone Densitometers use dual-energy X-ray absorptiometry (DXA) to measure bone mineral density (BMD), bone mineral content (BMC), and body composition (fat/lean tissue). The system consists of a scanner (X-ray source, detector, mechanical drive) and a standard PC running enCORE version 17 software. The software controls the scanner, acquires/stores/analyzes data, and provides a user interface. New features include: 1) Atypical Femur Fracture (AFF) software, which extends femur scans to the distal shaft to visualize/quantify focal thickening and cortical width; 2) Sarcopenia software, which calculates sarcopenia status using appendicular lean mass (from total body scans) combined with user-inputted muscle strength and physical performance data. Used in clinical settings by healthcare professionals. Output is displayed on the PC for clinical decision-making regarding bone health and sarcopenia management. Benefits include improved visualization of potential stress fractures and standardized assessment of sarcopenia based on clinical working group definitions.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, verification, and validation of software features, and a clinical literature search supporting the sarcopenia calculation definitions.

Technological Characteristics

Dual-energy X-ray absorptiometry (DXA) system. Components: X-ray source, detector, mechanical drive, and PC. Software: enCORE version 17. Connectivity: Networked/standalone PC. Features: AFF software (visual/quantitative cortical width measurement), Sarcopenia software (calculation based on published thresholds). Cybersecurity: Microsoft security patches and enhancements.

Indications for Use

Indicated for patients requiring bone mineral density, bone mineral content, and body composition assessment. Optional Atypical Femur Fracture (AFF) software is indicated for visualizing focal reaction or thickening along the lateral cortex of the femoral shaft in femur images. Optional sarcopenia software is indicated for calculating sarcopenia classification based on appendicular lean mass, patient demographics, muscle strength, and physical performance data.

Regulatory Classification

Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Lunar DXA Bone Densitometers with enCORE software (Total Body Composition) (k071570)
Lunar DXA Bone Densitometers with enCORE software (RSMI - Relative Skeletal Muscle Index) (k113286)
Lunar DXA Bone Densitometers with enCORE software (AHA - Advanced Hip Assessment) (k072664)
Lunar DXA Bone Densitometers with enCORE software (HAL - Hip Axis Length) (k011917)
Hologic Bone Densitometers Single Energy (SE) Femur Exams (k130277)

Related Devices

K191112 — GEHC DXA Bone Densitometers with enCORE version 18 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Sep 19, 2019
K965226 — EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE · Lunar Corp. · Oct 3, 1997
K133664 — ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS · Ge Medical Systems Ultrasound & Primary Care Diagn · May 15, 2014
K992125 — XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 · Norland Medical Systems, Inc. · Nov 22, 1999
K071570 — GE LUNAR BODY COMPOSITION SOFTWARE · Ge Medical Systems Lunar · Jun 27, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 2, 2016 GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC) % Ms. Nicole Landreville Regulatory Affairs Program Manager 3030 Ohmeda Drive MADISON WI 53718 Re: K161682 Trade/Device Name: GE Lunar DXA Bone Densitometers with enCORE version 17 Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: October 31, 2016 Received: November 1, 2016 Dear Ms. Landreville: 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 (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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/default.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 Industry and Consumer Education 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. Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161682 Device Name GE Lunar DXA Bone Densitometers with enCORE version 17 #### Indications for Use (Describe) 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 femoral shaft. The beaking index can be displayed and trended across serial scans. 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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.gov "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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized font, enclosed within a circular shape. The circle has a swirling design around the letters, giving it a dynamic and recognizable appearance. The logo is colored in a shade of blue. Section 5: 510(k) Summary GE Lunar DXA Bone Densitometers with enCORE version 17 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a swirling, water-like design. The logo is presented in a blue color. ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | 15-Jun-2016 | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.) 3030 Ohmeda Drive P.O. Box 7550 Madison, WI, USA 53707 | | Primary Contact Person: | Nicole Landreville, Eng, RAC Regulatory Affairs Program Manager GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.) Telephone: (289) 208-2365 Email: Nicole.landreville@ge.com | | Secondary Contact Person: | Diane Uriell Regulatory Affairs Director GE Healthcare (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC) Telephone: (262) 290-8212 Email: Diane.Uriell@ge.com | | Device Trade Name: | GE Lunar DXA Bone Densitometers with enCORE version 17 | | Common/Usual Name: | X-Ray Bone Densitometer | | Classification Names: | Bone Densitometer (21CFR 892.1170) | | Predicate Devices: | 1. Lunar DXA Bone Densitometers with enCORE software: Total Body Composition (k071570 – Product Code: KGI) RSMI - Relative Skeletal Muscle Index (k113286- Product Code: KGI) AHA - Advanced Hip Assessment (k072664 – Product Code: KGI) HAL- Hip Axis Length (k011917 – Product Code: KGI) 2. Hologic Bone Densitometers Single Energy (SE) Femur Exams (k130277 – Product Code: KGI). | | Device Description: | GE Lunar DXA Bone Densitometers with enCORE version 17 are composed of a scanner and a computer. The scanner comprises the x-ray source and detector, the patient scan table, the mechanical drive system, and the lowest level portions of the control system. The scanner is in communication with the computer, which is a standard PC. The computer runs the enCORE software, and thus controls the scanner, acquires scan data from the scanner, stores and analyzes the data, and interacts with the human operator. The enCORE software runs on the following list of GE Lunar DXA Bone Densitometers: Lunar Prodigy Series: (Prodigy, Prodigy Compact, Prodigy Pro, Prodigy Pro Compact, Prodigy Primo, Prodigy Primo Compact, Prodigy Advance, Prodigy Advance Compact) Lunar iDXA Series: (iDXA, iDXA Advance, iDXA Pro, iDXA Forma, Lunar iDXA) DPX Series: DPX-NT & DPX-Bravo. The GE Lunar DXA Bone Densitometers with enCORE version 17 measure the bone mineral density (BMD), lean and fat tissue mass and calculate derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The enCORE software is used on GE Lunar DXA bone densitometers. Release 17 of the enCORE software (enCORE 17 or enCORE 17.xx) includes some feature enhancements. | | Device Description (Cont.): | GE Lunar DXA Bone Densitometers with enCORE software were modified to include 2 new software features as well as additional cybersecurity enhancements: A- The software will now expand upon its previously cleared Hip Axis Length (k011917) & AHA - Advanced Hip Assessment (k072664) by the addition of an optional feature for Atypical Femur Fracture (AFF): AFFs are stress or insufficiency fractures that occur in the subtrochanteric or diaphyseal regions of the femur and may be associated with long term bisphosphonate use. The new AFF feature brings minor changes to the anatomical sites to extend the DXA femur scan to include the distal femur shaft, measure the lateral and medial cortex width and quantify focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. The new AFF indication for use is equivalent to the Hologic Single Energy (SE) Femur Exams (k130277). | | | B- The software will now expand upon its previously cleared Total Body Composition (k071570) and RSMI - Relative Skeletal Muscle Index (k113286) by the addition of an optional feature for Sarcopenia calculation: Sarcopenia is a gradual loss of muscle mass and strength associated with aging and is a factor in the occurrence of frailty, falls, and fractures. Sarcopenia definitions have been published by four leading clinical working groups: • International Working Group on Sarcopenia1: • European Working Group on Sarcopenia in Older People2 • Asian Working Group for Sarcopenia3 • The Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project4 | | | All definitions include DXA appendicular lean mass (ALM), a value measured from DXA total body scans, in combination with other measurements of muscle strength and physical performance (e.g. grip strength and gait speed). The new sarcopenia software feature allows the user to select one of the four definitions, extend the total body user interface so user can input muscle strength and physical performance data along with DXA ALM, and compare individual values against clinical thresholds for assessing sarcopenia. The Sarcopenia feature provides a calculated sarcopenia classification using one of the four definitions above. | | | C- The enCORE version 17 software incorporates latest Microsoft security patches and other security enhancements. | | Device Description (Cont.): | Sarcopenia references: | | | 1. Fielding RA, Vellas B, Evans WJ, et.al, Sarcopenia: An Undiagnosed Condition in Older Adults. Current Consensus Definition: Prevalence, Etiology, and Consequences. J Am Med Dir Assoc. 2011 May ; 12(4): 249–256. | | | 2. Cruz-Jentoft AJ, Baeyens JP, Bauer JM, et al. Sarcopenia: European consensus on definition and diagnosis: report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010;39:412-423. | | | 3. Chen LK, Liu LK, Woo J,et.al. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101 | | | 4. Studenski SA1, Peters KW, Alley DE,et.al. The FNIH Sarcopenia Project: Rationale, Study Description, Conference Recommendations, and Final Estimates. J Gerontol A Biol Sci Med Sci 2014 May;69(5):547-558 | | Intended Use: | The intended use of the GE Lunar DXA Bone Densitometers remains the same. | | | The proposed device: “GE Lunar DXA Bone Densitometers with enCORE version 17 software” is intended for medical purposes to measure bone density, bone mineral content, and fat and lean tissue content by x-ray transmission measurements through the bone and adjacent tissues. | | Indications for Use: | 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. | | | 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. | | Manufacturing Sites: | Site 1: GE Medical Systems Monterrey Mexico, S.A.DE C.V. Calle Espana #300, Parque Industrial Huinala Apodaca, Nuevo Leon, C.P.66645, Mexico Site 2: GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI, 53223, USA Site 3: GE MEDICAL SYSTEMS CHINA CO., LTD. no. 19 changjiang road national hi-tech dev. Zone Wuxi, CHINA 214028 | | Comparison of the technological characteristics: | GE Lunar DXA Bone Densitometers with enCORE version 17 employ the same fundamental scientific technology as its predicate devices with the addition of 2 new software features as well as additional cybersecurity enhancements: 1. The optional feature for Atypical Femur Fracture (AFF) brings minor changes to the anatomical sites to extend the DXA femur scan to include the distal femur shaft, measure the lateral and medial cortex width and quantify focal thickening of the lateral cortex along the femoral shaft. The beaking index can be displayed and trended across serial scans. See Table A – AFF Feature Comparison Table with Predicates GE Lunar, Hologic and Proposed device. 2. The optional feature for Sarcopenia provides a calculated sarcopenia classification using one of four definitions published by sarcopenia leading clinical working groups. The physician can compare individual values against clinical thresholds for assessing sarcopenia. See Table B – Sarcopenia Feature Comparison Table with Predicate GE Lunar and Proposed device. 3. The enCORE version 17 software incorporates latest Microsoft security patches and other security enhancements. | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The color of the letters and the frame is a bright blue, set against a white background. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' stylized in a cursive font, enclosed within a circular frame. The color of the logo is a light blue. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are three white swirls around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known company. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script font, enclosed within a circular frame. The frame has a wavy or water-like design around the edges. The logo is presented in a blue color scheme. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a decorative, wave-like pattern, also in blue. The logo is simple, recognizable, and represents the General Electric brand. Table A – AFF Feature Comparison Table with Predicates GE Lunar, Hologic and Proposed device | Specification | Predicate Device #1 GE Lunar DXA Bone Densitometers - AHA - Advanced Hip Assessment (k072664) - HAL - Hip Axis Length (k011917) | Predicate Device #2 Hologic Bone Densitometers - Single Energy (SE) Femur Exams (k130277) | Proposed GE Lunar DXA Bone Densitometers with enCORE version 17 - AFF Atypical Femur Fracture | Discussion of Differences | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technology | Dual-energy X-ray Absorptiometry (DXA) | Single-energy image | Dual-energy X-ray Absorptiometry (DXA) | Equivalent. enCORE Version 17 AFF image is extending existing GE Lunar DXA femur scans to image distal shaft. | | Exam Site | Proximal Femur | Proximal Femur and distal shaft | Proximal Femur and distal shaft | Identical to Hologic (k130277) | | Values Displayed | HAL and sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cortical thickness, cross- sectional area (CSA) and cross-sectional moment of inertia (CSMI). | None | Cortical thickness (beaking index) | Equivalent. enCORE Version 17 AFF feature measures cortical width for larger femoral scan area compared to Advanced Hip Assessment (AHA). | | Method of Deformity Assessment | Quantitative | Visual | Visual and Quantitative | Equivalent. enCORE Version 17 combines a visual assessment with quantitative measurements of cortical width. | | Specification | Predicate Device #1a GE Lunar DXA Bone Densitometers - Total Body composition (k071570) | Predicate Device #1b GE Lunar DXA Bone Densitometers - RSMI Relative Skeletal Muscle Index (k113286) | Proposed GE Lunar DXA Bone Densitometers with enCORE version 17 Sarcopenia calculator | Discussion of Differences | | Technology | Dual-energy X-ray Absorptiometry (DXA) | Dual-energy X-ray Absorptiometry (DXA) | Dual-energy X-ray Absorptiometry (DXA) | Identical | | Anatomical Sites | Regional and Whole Body | Regional and Whole Body | Regional and Whole Body | Identical | | Values Displayed | Bone Mineral Density (BMD) ● Lean and Fat Tissue mass ● Bone Mineral Content ● (BMC) ● Area ● Soft Tissue Mass ● Regional Soft Tissue Mass ● Total Soft Tissue Mass ● Fat Free Mass ● Regional/Total Soft Tissue ● Mass Ratios ● %Fat ● Region %fat ● Total Body %fat | Bone Mineral Density (BMD) ● Lean and Fat Tissue mass ● Bone Mineral Content ● (BMC) ● Area ● Soft Tissue Mass ● Regional Soft Tissue Mass ● Total Soft Tissue Mass ● Fat Free Mass ● Regional/Total Soft Tissue ● Mass Ratios ● %Fat ● Region %fat | Bone Mineral Density (BMD) ● Lean and Fat Tissue mass ● Bone Mineral Content (BMC) ● Area ● Soft Tissue Mass ● Regional Soft Tissue Mass ● Total Soft Tissue Mass ● Fat Free Mass ● Regional/Total Soft Tissue Mass Ratios ● %Fat ● Region %fat ● Total Body %fat ● RSMI – Relative Skeletal Muscle Index ● FNIH - Foundation for the National ● Institutes of Health Sarcopenia Project: ● AWGS - Asian Working Group for Sarcopenia ● EWGSOP - European Working Group on Sarcopenia in Older People ● IWGS - International Working Group on Sarcopenia | Equivalent. The Total Body composition measurements for lean mass for arms and legs (k071570) were used to calculate Relative Skeletal Muscle Index (k113286). enCORE Version 17 now calculates four similar values based on newly published definitions. | {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. Three curved lines emanate from the circle, suggesting movement or energy. Table B – Sarcopenia Feature Comparison Table with Predicate GE Lunar and Proposed device {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are some white swirls around the letters. The logo is simple and recognizable. Determination of Summary of Non-Clinical Tests: Substantial The GE Lunar DXA Bone Densitometers with enCORE version 17 Equivalence: and its applications comply with voluntary standards. The following quality assurance measures were applied to the development of the system: 트 Risk Analysis 트 Requirements Reviews I Design Reviews ■ Testing on unit level (Module verification) I Integration testing (System verification) I Performance testing (Verification) I Safety testing (Verification) 트 Simulated use testing (Validation) There is no change to the system hardware. Although these changes do not impact the intended use of the system, adding the AFF and Sarcopenia calculator optional software features added two new Indications for Use. These software changes were tested successfully and as described in supporting evidence: · Summary of the verification and validation testing performed on the enCORE software version 17. Test results confirmed that the design outputs met the design input requirements. · Summary of the non-clinical evaluation of the "AFF" software option and the non-clinical evaluation of the optional sarcopenia calculator software. These bench testing results confirmed the substantial equivalence in terms of safety and effectiveness to the predicate devices. There is no change to the diseases or conditions expected to be diagnosed, treated, prevented, cured or mitigated. There is no change to the patient population. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue. | Determination of Substantial Equivalence: (Cont.) | Summary of Clinical Tests: | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The subject of this premarket submission, GE Lunar DXA Bone Densitometers with enCORE version 17, 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. | | Conclusion: | The GE Lunar DXA Bone Densitometers with enCORE version 17 expands its previously cleared features and indications for use but does not result in any new potential safety risks. The GE Lunar DXA Bone Densitometers with enCORE version 17 have the same technological characteristics, and performs as well as the predicate devices currently on the market. Based on the information supplied in this submission, it is the conclusion of GE Healthcare that the GE Lunar DXA Bone Densitometers with enCORE version 17 is substantially equivalent to other marketed devices with similar indications for use and meeting the same standards. |