(428 days)
K0011917, K061561
K0011917, K061561
No
The description focuses on calculations based on geometric measurements and patient parameters, without mentioning AI/ML algorithms or training/test data.
No.
The GE Lunar Femur Strength analysis software provides information (like Femur Strength Index, hip geometry values) to aid in the assessment of fracture risk and diagnosis of osteoporosis, but it does not directly treat or alleviate a disease, injury, or condition.
Yes
The software calculates values that are used 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 explicitly states its role in diagnosis and risk assessment, which are diagnostic functions.
No
The device is described as a "Software Option for GE Lunar DEXA Bone Densitometers," indicating it is an accessory to existing hardware (DEXA bone densitometers) and not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device analyzes images (DEXA scans) of the femur and hip. It does not perform tests on biological samples taken from the patient.
- Intended Use: The intended use clearly states it's an accessory to bone densitometer devices and analyzes previously acquired scans to provide information about bone density and structural properties. This is an in vivo measurement and analysis, not an in vitro test.
Therefore, while it's a medical device used in diagnosis and risk assessment, it falls under the category of imaging analysis software rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The GE Lunar Femur Strength Analysis Software option used on GE Lunar DEXA bone densitometer scans of the hip measures the hip axis length (HAL) and provides a female mean reference value of HAL. The software calculates a HAL fracture risk indicator for Caucasian females based on HAL compared to the mean reference value.
The software calculates hip geometry values used to estimate the structural properties of the hip such as sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI) based on inputs of CSMI, CSA, bone mineral density (BMD), patient age, height and weight. FSI represents the biomechanical properties of the hip and provides an estimate of the risk of fracture resulting from a fall on the hip.
The structural properties of the hip, HAL and FSI can assist the health care professional in assessment of fracture risk.
Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments.
Product codes
KGI
Device Description
The Femur Strength Software Option for GE Lunar DEXA Bone Densitometers analyzes femur BMD scans to measure hip axis length (HAL) and provides a mean reference value of HAL and HAL fracture risk indication. The software calculates hip geometry values used to estimate the structural properties of the hip such as buckling ratio, section modulus (Z), cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI) based on inputs of CSMI, CSA, bone mineral density (BMD), patient age, height and weight. FSI represents the biomechanical properties of the hip and provides an estimate of the risk of fracture resulting from a fall on the hip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DEXA
Anatomical Site
Femur / Hip
Indicated Patient Age Range
Adult
Intended User / Care Setting
Health care professional / Physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
Clinical Tests: No clinical tests were required to establish safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
K0011917, K061561
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
1072664
NOV 21 2008
510(k) Premarket Notification GE Medical Systems Lunar - GE Lunar Femur Strength Software September 19th, 2007
Attachment B 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
Image /page/0/Picture/5 description: The image shows the text "Section a):" in a bold, sans-serif font. The text is positioned on the left side of the image. The colon is directly after the letter 'a' and is followed by a parenthesis.
- Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division of General Electric Company GE Medical Systems Lunar (business name) 726 Heartland Trail Madison, WI 53717
Contact Person: James P. Raskob Safety and Regulatory Engineering Manager Telephone: 608-826-7425; Fax: 608-299-2132
September 19th, 2007 Date Prepared:
-
- Device Name: GE Lunar Femur Strength Software Option Bone Densitometer, 21 CFR 892.1170, 90-KGI
-
- Marketed Device: Advanced Hip Assessment Software Option K0011917, Hologic Hip Structural Analysis software K061561 currently in commercial distribution.
-
- Device Description: The Femur Strength Software Option for GE Lunar DEXA Bone Densitometers analyzes femur BMD scans to measure hip axis length (HAL) and provides a mean reference value of HAL and HAL fracture risk indication. The software calculates hip geometry values used to estimate the structural properties of the hip such as buckling ratio, section modulus (Z), cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI) based on inputs of CSMI, CSA, bone mineral density (BMD), patient age, height and weight. FSI represents the biomechanical properties of the hip and provides an estimate of the risk of fracture resulting from a fall on the hip.
5. Indications for Use:
The GE Lunar Femur Strength Analysis Software option used on GE Lunar DEXA bone densitometer scans of the hip measures the hip axis length (HAL) and provides a female mean reference value of HAL. The software calculates a HAL fracture risk indicator for Caucasian females based on HAL compared to the mean reference value.
The software calculates hip geometry values used to estimate the structural properties of the hip such as sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI) based on inputs of CSMI, CSA, bone mineral density (BMD), patient age, height and weight. FSI represents the biomechanical properties of the hip and provides an estimate of the risk of fracture resulting from a fall on the hip.
The structural properties of the hip, HAL and FSI can assist the health care professional in assessment of fracture risk.
Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software option does not diagnose
1
510(k) Premarket Notification
GE Medical Systems Lunar - GE Lunar Femur Strength Software September 19th, 2007
disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments.
-
- Comparison with Predicate Device: The Femur Strength Software Option for GE Lynar DEXA Bone Densitometers is of a comparable type and substantially equivalent to the Hologic Hip Structural Software Option and the GE Lunar Prodigy Advanced hip assessment Software option. 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):
-
- Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
-
- Clinical Tests: No clinical tests were required to establish safety or effectiveness.
-
- Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer Advanced Hip Analysis Software. 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 independent evaluation with ongoing factory surveillance. The Femur Strength Software Option for GE Lunar DEXA Bone Densitometers is substantially equivalent to currently marketed devices with respect to 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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James P. Raskob Safety and Regulatory Engineering Manager GE Medical Systems Lunar 726 Heartland Trail MADISON Wİ 53717
NOV 2 1 2008
Re: K072664
Trade/Device Name: Femur Strength Software Option for GE Lunar DEXA Bone Densitometers
Regulation Number: 21 CFR 892.1170
Regulation Name: Bone densitometer
Regulatory Class: II
Product Code: KGI
Dated: October 21, 2008
Received: October 22, 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.
3
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 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of 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.
Vogue Mr. 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) Indications for Use
510(k) Number (if known): K072664
Device Name: Femur Strength Software Option for GE Lunar DEXA Bone Densitometers
The GE Lunar Femur Strength analysis software option is an accessory to currently marketed GE Lunar DEXA 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. The Femur Strength software is intended to measure the hip axis length (HAL) and provides female adult Caucasian and Asian mean reference values of HAL from previously acquired GE Lunar femur scans.
The software calculates hip geometry values used to evaluate the structural properties of the hip, such as sub-region lengths, angles, ratios, buckling ratio, section modulus (Z), cortical thickness, cross-sectional area (CSA) and cross-sectional moment of inertia (CSMI). The software calculates a Femur Strength Index (FSI), a strength/stress ratio incorporating geometric properties of the hip such as CSMI, CSA, bone mineral density (BMD), patient age, height and weight. A ScanCheck feature is included to provide online messages to assist the operator or physician in checking that the scan was correctly taken. Color mapping of the variable density of bone images is also provided.
The values measured or computed provide additional information about the structure of the hip. They should be used in conjunction with the BMD T-score and 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)
Angu In Whang
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number