(545 days)
Not Found
No
The summary describes a software package using established quantitative computed tomography (QCT) methods for bone density estimation. There is no mention of AI, ML, training data, or any other indicators of AI/ML technology.
No
The device is intended to estimate bone mineral content and density for diagnostic purposes, specifically to aid in determining fracture risk, not to treat or alleviate a medical condition.
Yes
Explanation: The device is intended to estimate bone mineral content and density, and the calculated T-scores can be used by a physician as an aid in "determining fracture risk," which is a diagnostic purpose.
Yes
The device description explicitly states it is a "software package" and its function is to process existing CT image data. It does not include or require any specific hardware components beyond compatible CT scanners and phantoms, which are external to the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that the CTXA Hip Bone Mineral Densitometer uses quantitative computed tomography (QCT) methods to analyze 3D CT image data sets of the proximal femur. This is an analysis of images of the body, not a sample taken from the body (like blood, urine, or tissue).
- The intended use is to estimate bone mineral content and density in the proximal femur. This is a measurement taken directly from the patient's body using imaging.
Therefore, the CTXA Hip Bone Mineral Densitometer falls under the category of medical imaging devices or diagnostic imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CTXA Hip Bone Mineral Densitometer is intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur. The BMD estimates can be compared with CTXA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores can be used by the physician as an aid in determining fracture risk.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in glem', of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets. The CTXA Hip is intended to be used with compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Quantitative Computed Tomography (QCT)
Anatomical Site
Proximal Femur
Femoral neck
Trochanter
Intertrochanter
Ward's Triangle
Total hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
In vitro phantom studies with the CTXA Hip indicate a device precision of approximately 0.007 g/cm2 across a variety of CT scanners. These tests also indicate that in vitro CTXA Hip BMD estimates are unbiased when expressed as equivalent K2HPO4 mineral density.
CTXA Hip clinical studies indicate a long term in vivo device precision of 0.011 g/cm2 for total hip and 0.012 g/cm2 for femoral neck regions of interest. Clinical studies were done comparing BMD results from CTXA Hip with results from Hologic QDR 1000 and QDR4500 bone densitometers. BMD correlations (Pearson's R) were 0.90-0.97 for the Total Hip region of interest and 0.88-0.95 for the Femoral Neck region of interest. A clinical study was done to collect a set of young normal female reference data for calculation of T-scores for CTXA Hip results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Device precision: approximately 0.007 g/cm2 (in vitro)
Long term in vivo device precision: 0.011 g/cm2 for total hip, 0.012 g/cm2 for femoral neck
BMD correlations (Pearson's R): 0.90-0.97 for Total Hip, 0.88-0.95 for Femoral Neck
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Information: | Christopher E. Cann, Ph.D.
CEO and Director of Research and Development
Mindways Software, Inc
282 Second St., 4th Floor
San Francisco, CA 94105
Phone: 415-247-9930
Fax: 415-247-9931
Email: chris@qct.com |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 28, 2001 |
| Device/Trade Name: | CTXA Hip |
| Common/Usual Name: | Bone Mineral Densitometer |
| Classification Name: | Bone Densitometer, 21 CFR 892.1170, Class II |
| Predicate Devices: | K894854: QCT Bone Mineral Density Analysis Software
Intended Use: Estimate bone mineral density within the spine. |
| | K883280: Hologic QDR 1000 X-Ray Bone Densitometer
Intended Use: Estimate bone mineral density and bone mineral
content at various anatomical sites, including the proximal
femur. |
| | K943505: Hologic QDR 3000 X-Ray Bone Densitometer
Intended Use: Estimate bone mineral density and bone mineral
content at various anatomical sites, including the proximal
femur. |
| | Preamendment: Norland Model 178 Bone Densitometer
Intended Use: An aid to the physician in determining fracture
risk. |
Device Description
The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in glem', of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets. The CTXA Hip is
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intended to be used with compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density.
Intended Use
The CTXA Hip Bone Mineral Densitometer is intended to estimate bone mineral content (BMC) and bone mineral density (BMD) in the proximal femur. The BMD estimates can be compared with CTXA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores can be used by the physician as an aid in determining fracture risk.
Summary of Technological Characteristics and Comparison with Predicate Devices
The CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values smilar to those obtained from the predicate DXA devices (K883280: Hologic QDR 1000 X-Ray Bone Densitometer, K943505: Hologic ODR 3000 X-Ray Bone Densitometer) for regions of interest in the proximal femur. CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are used as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk, as is done with the predicate preamendment device Norland Model 178 Bone Densitometer.
BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions-of-interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward's Triangle, and (5) total hip (i.e., superposition of ROIs 1-3).
Summary of Non-Clinical Performance Data
In vitro phantom studies with the CTXA Hip indicate a device precision of approximately 0.007 g/cm2 across a variety of CT scanners. These tests also indicate that in vitro CTXA Hip BMD estimates are unbiased when expressed as equivalent K2HPO4 mineral density.
Summary of Clinical Performance Data
CTXA Hip clinical studies indicate a long term in vivo device precision of 0.011 g/cm2 for total hip and 0.012 g/cm2 for femoral neck regions of interest. Clinical studies were done comparing BMD results from CTXA Hip with results from Hologic QDR 1000 and QDR4500 bone densitometers. BMD correlations (Pearson's R) were 0.90-0.97 for the Total Hip region of interest and 0.88-0.95 for the Femoral Neck region of interest. A clinical study was done to collect a set of young normal female reference data for calculation of T-scores for CTXA Hip results.
Conclusions
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The CTXA Hip Bone Mineral Densitometer is substantially equivalent to the listed predicate devices. The CTXA Hip in vitro and in vivo performance is comparable to that associated with the predicate devices. The radiation dose associated with the CT study that provides the data set to be analyzed by the CTXA Hip is well within accepted patient dose guidelines.
lyzed by the CTAA trip is well wi
Signature
Christopher Cann Printed Name
CEO and Director of Research and Development Title
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2001
Christopher E. Cann. Ph.D. CEO and Director of Research Mindways Software, Inc. 282 Second St., 4th Floor SAN FRANCISCO CA 94105 Re: K002113
Trade/Device Name: CTXA HIP, CTXA; QCT PRO CTXA HIP Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: September 28, 2001 Received: October 2, 2001
Dear Dr. Cann:
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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Brogdin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known): K002113/S002
Device Name: CTXA Hip Bone ellineral Densitometer
Indications For Use:
Intended Use
The CTXA Hip Bone Mineral Densitometer is intended to estimate bone mineral content (BMC) The CTAA Hip Bone Mineral Dalishour. The BMD estimates can be compared with CTXA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores can be used by the physician as an aid in determining fracture risk.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | Nancy C Brogdon |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K02113 |