(33 days)
No
The summary describes standard bone densitometry calculations based on QCT data and comparisons to reference data. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is intended to estimate bone mineral content and density for fracture risk determination and therapy effectiveness evaluation, not to provide therapy itself.
Yes
The device estimates bone mineral content and density, and these measurements along with calculated T-Scores and Z-Scores are used by physicians to determine fracture risk and therapy effectiveness, which are diagnostic purposes.
Yes
The device is described as "software Options" to an existing product and performs computations on image sets obtained from a separate imaging modality (CT). There is no mention of accompanying hardware being part of the device itself.
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: The DXAVIEW™ Hip and Spine bone densitometry options analyze imaging data (CT scans) of the proximal femur and spine to estimate bone mineral content and density. This is an in vivo measurement (performed on a living organism), not an in vitro test on a sample.
- Input: The input is CT volumetric image sets, not biological samples.
Therefore, the device falls under the category of medical imaging analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DXAView™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk.
The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.
Product codes
90 KGI
Device Description
The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
proximal femur and spine
Indicated Patient Age Range
Not Found
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, sample size, AUC, MRMC, standalone performance, key results)
Patient validation studies indicate a software precision of 0.012 g/cm² for total femur and 0.017 g/cm² for the femoral neck. Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip showed correlation coefficients R of 0.93-0.94 for the total femur and femoral neck. Correlations between DXAVIEW™ and DXA are on the order of 0.93 and sufficiently high to warrant the use of the NHANES III Reference Data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Software precision of 0.012 g/cm² for total femur and 0.017 g/cm² for the femoral neck.
Correlation coefficients R of 0.93-0.94 for the total femur and femoral neck.
Pearson's R values between DXA and DXAVIEW™ on clinical comparison studies has been shown to be 0.93 to 0.94 for the neck and total femur regions.
Predicate Device(s)
K992246, K941127, K943505, K002113
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.
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Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K03/991". Below this, the text reads "Page 1 of 2". The handwriting is somewhat stylized and appears to be from a document or page numbering system.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Submitted in accordance with the requirements of 21 CFR 807.3)
| Contact information: | Ben Arnold, Ph.D. |
|---|---|
| President | |
| Image Analysis, Inc. | |
| 1380 Burkesville Street | |
| Columbia, KY 42728 | |
| PH: 270-384-6400 | |
| FAX: 270-384-6405 | |
| Email: info@image-analysis.com | |
| Date: | June 4, 2003 |
| Device/Trade Name: | DXAVIEW TM Hip and Spine |
| Common/Usual Name: | QCT Bone Densitometry |
| Classification Name: | Bone Densitometer, 21 CFR 892.1170, Class II |
Predicate Devices:
K992246: OCT Bone Mineral Analysis Software Intended Use: OCT Bone Densitometry to estimate bone density and bone density changes, for monitoring therapy, and to estimate fracture risk.
K941127: OCT Bone Mineral Analysis Software Intended Use: Estimation of bone density in the spine.
K943505: Hologic ODR 3000 X-Ray Bone Densitometer Intended Use: Estimate bone mineral density and bone mineral content at various anatomical sites.
K002113: CTXA Hip Intended Use: Estimate bone density and bone mineral content in the hip. Compare to reference data to determine T-Scores and fracture risk.
Device Description:
The DXAView" Hip and Spine are software Options to the Image Analysis QCT-3D Plus product, which provides 3D projection measurements similar to conventional DXA. The product Options provide estimates of bone mineral content (BMC) and bone density (BMD) of the proximal femur and spine. BMC is expressed in grams and BMD in g/cm2 of calcium hydroxyapatite. DXAView™ uses phantom calibration by Quantitative Computed Tomography (QCT) on all compatible CT scanners. The computations are preformed on 3D CT volumetric image sets obtained with conventional CT protocols and radiation doses.
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KOZIRAL
Rogozloff
Intended Use:
The DXAView™ Hip and Spine bone densitometry options are intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur and spine. The BMD may be compared to DXA reference data. T-Scores and Z-Scores are calculated with respect to young normal and age matched reference data, and can be used by the physician in determining fracture risk.
Summary of Fundamental Scientific Technology and Comparison with Predicate Devices:
The DXAVIEW™ bone densitometry Options provide estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate DXA device (K943505: Hologic ODR 3000 X-Ray Bone Densitometer) for regions of interest in the proximal femur and spine. The predicate device, CTXA Hip K002113 measures bone density in the hip using calibrated CT volumetric images, and is highly similar to DXAVIEW™. DXAVIEW™ uses the same scanning and calibration procedures to acquire and calibrate the CT image as are used for the predicate device K992246: QCT Bone Mineral Analysis Software. NHANES III Standardized Reference Data are used to calculate T-Scores and Z-Scores. Pearson's R values between DXA and DXAVIEW™ on clinical comparison studies has been shown to be 0.93 to 0.94 for the neck and total femur regions. The uncertainty between the two results are about 1/3 of 1 population Standard Deviation (T=1/3), and are quite acceptable. The DXAVIEW™ BMD estimates are compared to reference populations to determine T-Scores, which assists physicians in identifying patients with low bone density and estimating fracture risk.
Summary of Clinical Performance Data:
Patient validation studies indicate a software precision of 0.012 g/cm² for total femur and 0.017 g/cm² for the femoral neck. Clinical studies comparing DXA and DXAVIEW™ for BMD of the hip showed correlation coefficients R of 0.93-0.94 for the total femur and femoral neck.
Conclusions:
The DXAVIEW Hip and Spine Bone Densitometry Options are substantially equivalent to the predicate devices while producing comparable results. Correlations between DXAVIEW™ and DXA are on the order of 0.93 and sufficiently high to warrant the use of the NHANES III Reference Data. The radiation dose resulting from the CT Scans used for analysis by the DXAVIEWTM software is comparable to other CT studies.
Ben Arnold
Signature
Ben Arnold, Ph.D. Printed Name
President Title
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized eagle with its wings spread. The eagle is facing left and has three horizontal lines above it, representing the stripes of the American flag. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Ben Arnold, Ph.D. President Image Analysis, Inc. 1380 Burkesville Street COLUMBIA KY 42728 Re: K031991
Trade/Device Name: DXAVIEW™ Regulation Number: 21 CFR 892.1170 Regulation Name: Radiographic Bone Densitomer Regulatory Class: II Product Code: 90 KGI Dated: June 19, 2003 Received: July 30, 2003
Dear Dr. Arnold:
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 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); 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.
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K 031991 510 (k) Number (if known):
Device Name: QCT DXAVIEW™
The DXAVIEW™ Hip and Spine bone densitometry Options are intended to provide estimates of bone mineral density (BMD) and bone mineral content (BMC) in the proximal femur and spine. Young normal reference data taken from caucasian populations can be used to calculate T-Scores. Age matched normal reference data arc used to calculate Z-Scores. The BMD results, along with the T- and Z-Scores, can be used by physicians in their determination of fracture risk and therapy effectivencss.
NancyC Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K031441
Prescription Use (Per 21 CFR 801.109)