(44 days)
Not Found
No
The description explicitly states the software uses the FRAX™ Fracture Risk Assessment Tool, which is a validated algorithm based on statistical analysis of large datasets, not AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as an accessory to bone densitometers, intended to assess 10-year fracture risk and aid in the diagnosis of osteoporosis. It provides an estimate of risk based on various patient factors but does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk." This indicates its role in the diagnostic process.
No
The device is described as a "software option" and an "accessory to currently marketed GE Lunar bone densitometer devices," indicating it is a software component that integrates with existing hardware (the bone densitometer). It is not a standalone software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device uses clinical data and BMD: The FRAX™ software option utilizes patient demographic information (age, sex, country, ethnicity, height, weight), bone mineral density (BMD) measurements obtained from a bone densitometer, and the presence of clinical risk factors. It does not analyze biological samples.
- Its purpose is risk assessment, not direct diagnosis from a sample: The software provides an estimate of 10-year fracture risk based on a calculation using various inputs. While this information is used by a physician as an aid in diagnosis and assessment, the software itself is not performing a diagnostic test on a biological sample.
Therefore, the FRAX™ 10-Year Fracture Risk software option, as described, falls outside the definition of an In Vitro Diagnostic device. It is a software accessory that processes clinical data and BMD measurements to provide a risk assessment tool for physicians.
N/A
Intended Use / Indications for Use
This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.
Product codes
KGI
Device Description
The GE Lunar FRAX 10-year fracture risk software option is an accessory to currently marketed GE Lunar bone densitometer devices. 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, clinical spine, forearm, shoulder (for fracture risk); femur neck (for BMD T-score).
Indicated Patient Age Range
Between 40 and 90 years old.
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
The FRAX™ model is based on a large collection of data. Appropriate clinical risk factors for fracture were determined from eleven large cohort studies. The FRAX™ model was then developed from baseline and follow up data from nine prospective, population-based cohorts, including centers in North America, Europe, Asia, and Australia, consisting of 46,340 people and 189,852 person years of follow-up, during which 850 hip fractures and 3318 other osteoporotic fractures were reported. Data were generally randomly selected and analyzed according to accepted epidemiological practices. All data were published in peer-reviewed journals.
Description of the test set, sample size, data source, and annotation protocol
The performance characteristics determined from the primary cohorts were then validated in eleven independent, population-based cohorts that did not participate in the model synthesis. The validation cohorts consisted of 230,486 subjects representing 1,208,528 patient years of follow-up, during which 3360 hip fractures and 15,183 other osteoporotic fractures occurred.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. Design verification tests of the software option were performed using a series of test cases from published data. These tests confirmed outputs from the GE Lunar FRAX™ 10-year Fracture Risk Software were consistent with the independent outputs published that utilized the WHO 10-year fracture probability algorithm for specific age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several clinical risk factors.
Clinical Tests: No new clinical studies were required to establish safety or effectiveness of the new software option. Published literature describing the development and clinical validation of the FRAX™ WHO Fracture Risk Assessment Tool were provided. The FRAX™ model was developed from nine prospective, population-based cohorts (46,340 people, 189,852 person years of follow-up, 850 hip fractures, 3318 other osteoporotic fractures). The model was validated in eleven independent, population-based cohorts (230,486 subjects, 1,208,528 patient years of follow-up, 3360 hip fractures, 15,183 other osteoporotic fractures).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
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.(b)
Classification. Class II.
0
SEP 2 6 2008
Attachment A 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/3 description: This document contains information about the GE Lunar FRAX 10-year fracture risk software option. It includes the submitter's information, which is GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, located in Madison, WI. The contact person is James P. Raskob, and the date prepared is August 12, 2008. The device is a bone densitometer, and marketed devices include fracture risk assessments for DPX bone densitometers K983271 and Hologic QDR x-ray Bone Densitometers K983028.
This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.
composition (lean and fat tissue mass) of patients when medically indicated by their physicians.
The results can be used by a physician in coniunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.
1
510(k) Premarket Notification GE Medical Systems Lunar - FRAX™ 10-year Fracture Risk software option August 12, 2008
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- Comparison with Predicate Device: The GE Lunar FRAX™ 10-year Fracture Risk Software Option for GE Lunar DXA Bone Densitometers is of a comparable type and substantially equivalent to the Fracture Risk for DPX bone densitometers and Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has similar intended uses as the predicate devices.
Section b):
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- Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. Design verification tests of the software option were performed using a series of test cases from published data. These tests confirmed outputs from the GE Lunar FRAX™ 10-year Fracture Risk Software were consistent with the independent outputs published that utilized the WHO 10-year fracture probability algorithm for specific age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several clinical risk factors.
- Clinical Tests: No new clinical studies were required to establish safety or effectiveness of the new 2. software option. Published literature describing the development and clinical validation of the FRAX™ WHO Fracture Risk Assessment Tool were provided.
The FRAX™ model is based on a large collection of data. Appropriate clinical risk factors for fracture were determined from eleven large cohort studies. The FRAX™ model was then developed from baseline and follow up data from nine prospective, population-based cohorts, including centers in North America, Europe, Asia, and Australia, consisting of 46,340 people and 189,852 person years of follow-up, during which 850 hip fractures and 3318 other osteoporotic fractures were reported. Data were generally randomly selected and analyzed according to accepted epidemiological practices. All data were published in peer-reviewed journals.
The performance characteristics determined from the primary cohorts were then validated in eleven independent, population-based cohorts that did not participate in the model synthesis. The validation cohorts consisted of 230,486 subjects representing 1,208,528 patient years of follow-up, during which 3360 hip fractures and 15,183 other osteoporotic fractures occurred.
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- Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer fracture risk software options. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through ongoing internal and applicable medical do noo ouroly ocandards and the GE Lunar FRAX™ 10-year Fracture Risk Software Option for GE Lunar DXA Bone Densitometers is substantially equivalent to currently marketed devices with respect to intended use and safety and effectiveness.
2
Image /page/2/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" around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
Mr. James P. Raskob Safety and Regulatory Engineering Manager General Electric Co. GE Medical Systems Lunar 726 Heartland Trail MADISON WI 53717
Re: K082317
Trade/Device Name: FRAX™ 10-Year Fracture Risk Software Option for GE Lunar Bone Densitometers Regulation Number: 21 CFR 892.1170
Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: August 12, 2008 Received: August 13, 2008
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 such 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.
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Page 2
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.
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 procced 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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
hoque M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
GE Medical Systems Lunar -- FRAX™ 10-year Fracture Risk software option
Attachment D
510 (k) Indications for Use
510(k) Number (if known): V 08 2,3 17
Device Name: FRAX™ 10-Year Fracture Risk Software Option for GE Lunar Bone Densitometers
The FRAX™ 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians.
This software option is intended to provide an assessment of 10-year fracture risk. The option 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 patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several risk County, chiniony, from 110cm, formal nook BMD T Golfe, and the proofito of Group Horsen by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Halia Perez
(Division Sign Off)
ductive. Andominal 2