(400 days)
DPX Tissue Quantitation Output, Lunar Corporation, CT 9800
Not Found
No
The description focuses on the DXA technique and a software algorithm for calculating soft tissue characteristics based on x-ray attenuation, with no mention of AI or ML terms or methodologies.
No.
The software estimates lean body mass and fat mass, which is a diagnostic function for body composition, not a therapeutic intervention.
Yes.
The device estimates lean body mass and fat mass, which is a form of diagnostic information used in medically necessary situations.
No
The device is described as a "Software Option for QDR® X-Ray Bone Densitometers," indicating it is a software component that works in conjunction with a hardware device (the bone densitometer) to perform its function. It is not a standalone software application.
Based on the provided information, the Hologic® Body Composition Software Option for QDR® X-Ray Bone Densitometers is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states that this software analyzes data obtained from an X-ray scan of the subject's body (in vivo), not from a sample taken from the body (in vitro).
- The intended use is to estimate body composition directly from the subject. This is a direct measurement on the living person, not an analysis of a biological sample.
Therefore, this device falls under the category of in vivo diagnostic devices, specifically related to medical imaging and analysis of the human body.
N/A
Intended Use / Indications for Use
The intended use of the Hologic® Body Composition Software Option for QDR® X-Ray Bone Densitometers is to estimate the lean body mass and fat mass of non-osseous tissues in situations where medically necessary.
Product codes
90 KGI
Device Description
The Hologic® Body Composition Software Option for QDR® X-Ray Bone Densitometers is a software algorithm that permits an operator to display soft tissue characteristics. Soft tissue estimates are obtained using the Dual X-Ray Photon Absorptiometry (DXA) technique in which the x-ray tube emits alternating pulses of "high" and "low" energy x-rays which pass through the subject and are received by the detector array. The attenuation of the x-ray beam due to the subject is estimated by the detectors. By comparing the attenuation of the high and low energy pulses, the contributions of bone in the subject can be eliminated, leaving only the contributions due to non-osseous tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual X-Ray Photon Absorptiometry (DXA)
Anatomical Site
total body scans (implied by "soft tissue components of body composition")
Indicated Patient Age Range
adult age-range (as well as in children and adolescents)
Intended User / Care Setting
Not Found
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
Study type: Comparative experiments; Generation of normative data; Study to determine strength of agreement among ODR models with body composition software.
Sample size: Not specified for all studies, but measurements were recorded for fat mass, lean mass, total soft tissue mass and percentage fat for each subject in the agreement study.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: Published reports using in vitro and in vivo models have established the utility and validity of determining the soft tissue components of body composition with the QDR® devices. Studies included comparative experiments to evaluate DXA and other modalities commonly used for estimating body composition; normative data generated among healthy individuals spanning the adult age-range (as well as in children and adolescents); and the value of DXA among patients with syndromes known to affect body composition (e.g., AIDS and cystic fibrosis). All correlation coefficients were strongly positive; approximately 0.99 for each comparison. The incremental percentage difference among the models was small, ranging from approximately 0.5% for percentage fat to 2.5% for fat mass. These data support the conclusion that, in selected cases, such as monitoring of patients where marked changes in body composition are expected, the ODR® models may be used interchangeably, especially if attention is given to obtaining cross-calibration data.
Key Metrics
Correlation coefficients were strongly positive (approximately 0.99 for each comparison of fat mass, lean mass, total soft tissue mass and percentage fat).
Incremental percentage difference among models: 0.5% for percentage fat to 2.5% for fat mass.
Predicate Device(s)
DPX Tissue Quantitation Output; Lunar Corporation, CT 9800; General Electric Corporation
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
510(k) SUMMARY
JUN 1 3 1997
గ్ర
Hologic® Body Composition Software Option for QDR® X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 590 Lincoln Street |
| Waltham, Massachusetts 02154 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (617) 890-2300 |
| Fax Number: | (617) 890-8031 |
| Date Prepared: | May 8, 1996 |
| Device Trade Name: | Hologic® Body Composition Software Option |
| for QDR® X-Ray Bone Densitometers | |
| Device Common Name: | X-Ray Bone Densitometer |
| Proposed | |
| Classification Name: | Body Composition Software Option |
| for Bone Densitometer | |
| Predicate Devices: | DPX Tissue Quantitation Output; Lunar Corporation |
| CT 9800; General Electric Corporation | |
| Device Description: | The Hologic® Body Composition Software Option for |
| QDR® X-Ray Bone Densitometers is a software algorithm | |
| that permits an operator to display soft tissue characteristics. | |
| Soft tissue estimates are obtained using the Dual X-Ray | |
| Photon Absorptiometry (DXA) technique in which the x-ray | |
| tube emits alternating pulses of "high" and "low" energy x- | |
| rays which pass through the subject and are received by the | |
| detector array. The attenuation of the x-ray beam due to the | |
| subject is estimated by the detectors. By comparing the | |
| attenuation of the high and low energy pulses, the | |
| contributions of bone in the subject can be eliminated, | |
| leaving only the contributions due to non-osseous tissues. | |
| Intended Use: | The intended use of the Hologic® Body Composition Software |
| Option for QDR® X-Ray Bone Densitometers is to estimate the | |
| lean body mass and fat mass of non-osseous tissues in situations | |
| where medically necessary. |
Page 1 of 2
1
Device Technological There is no significant change from existing QDR® software for total body scans. However, as an optional Characteristics and feature, operators are now able to display soft-tissue Comparison to characteristics, specifically estimation of lean body mass and Predicate Devices: fat mass of non-osseous tissues in situations where medically necessary. Published reports using in vitro and in vivo models have Performance Data: established the utility and validity of determining the soft tissue components of body composition with the QDR® devices. Studies included comparative experiments to evaluate DXA and other modalities commonly used for estimating body composition; normative data generated among healthy individuals spanning the adult age-range (as well as in children and adolescents); and the value of DXA among patients with syndromes known to affect body composition (e.g., AIDS and cystic fibrosis). A study was also conducted to determine the strength of agreement among the ODR® models with the body composition software. Measurements were recorded for fat mass, lean mass, total soft tissue mass and percentage fat for each subject. All correlation coefficients were strongly positive; approximately 0.99 for each comparison. The incremental percentage difference among the models was small, ranging from approximately 0.5% for percentage fat to 2.5% for fat mass. These data support the conclusion that, in selected cases, such as monitoring of patients where marked changes in body composition are expected, the ODR® models may be used interchangeably, especially if attention is given to obtaining cross-calibration data. Conclusion: The Hologic® Body Composition Software Option for ODR® X-Ray Bone Densitometers is substantially equivalent to predicate devices for the intended use of estimation of lean body mass and fat mass of non-osseous tissues in situations where medically necessary.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nandini Murthy Regulatory Scientist Hologic, Inc. 590 Lincoln Street Waltham, Massachusetts .02154 ..................
JUN 1 3 1997
Dear Ms. Murthy: 参
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.
Re: K961787
Dated: May 1, 1997
Received: May 5, 1997 Regulatory class: II
Hologic Body Composition Software Option for
QDR® X-Ray Bone Densitometers
21 CFR 892.1170/Procode: 90 KGI
If your device is classified (see above) into either class III (Prematce Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . پ "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Xia, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
Hologic® Body Composition Software Option for QDR® X-Ray-Bone- -----Densitometers
Indications For Use: ત્ત્વ
The intended use of the Hologic® Body Composition Software for QDR® X-Ray Bone Densitometers is to estimate the lean body mass and fat mass of non-osseous tissues in situations where medically necessary.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR... Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K961787 |
|---|---|
| --------------- | --------- |