(199 days)
No
The summary describes a calibration method based on phantom measurements acquired on the same CT scanner, not on AI/ML algorithms. There are no mentions of AI, ML, or related concepts.
Yes.
The device measures bone mineral content (BMC) and bone mineral density (BMD), which are used in the diagnosis and monitoring of conditions affecting bone density. This falls under the definition of a therapeutic device as it provides quantitative measurements that inform patient management and treatment decisions related to bone health.
Yes
The device is intended for the assessment of bone density (BMC and BMD) from CT images, which is diagnostic information used in the clinical evaluation of bone health. The "Intended Use/Indications for Use" section explicitly states its purpose involves "assessment of bone density," a diagnostic function.
Yes
The device is described as a "Module" that extends the capabilities of existing software products (QCT Pro bone mineral densitometer products). The description focuses on the software's function of providing an alternative calibration method using existing CT images and phantom measurements, without mentioning any new hardware components being part of this specific submission. The performance studies also focus on software validation and comparison to the predicate software.
Based on the provided information, the QCT Pro Asynchronous Calibration Module 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 QCT Pro Asynchronous Calibration Module is a software module that processes CT scans (medical images) of the spine and proximal femur to measure bone mineral content and density. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for calibrating QCT data sets from CT scans for bone density assessment. This is an imaging-based diagnostic procedure, not an in vitro test.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of imaging software or a bone densitometer, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.
Product codes
KGI
Device Description
The OCT Pro Asynchronous Calibration Module is intended to extend the capabilities of OCT Pro bone mineral densitometer products (K894854. K002113. K030330) currently marketed by Mindways to the measurement of bone mineral content (BMC) and bone mineral density (BMD) from patient-specific CT images acquired without the simultaneous use of a CT calibration phantom. The QCT Pro bone mineral densitometer products distributed with or supplemented with the QCT Pro Asynchronous Calibration Module will be marketed under the name QCT Pro CliniQCT or more simply CliniQCT. Mineral calibration with the asynchronous calibration method is obtained from phantom measurements acquired on the same CT scanner, operated in a substantially similar mode used to acquire a patient CT scan. The phantom measurements used for calibration purposes may be acquired before or after a patient CT scan to which they are to be applied. The asynchronous calibration mode facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. Retrospective bone density analysis provides bone density information without exposing a patient to additional ionizing radiation while combining CT studies results in an overall reduction in patient exposure to ionizing radiation relative to the expected radiation dose associated with performing the studies separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Spine, proximal femur
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)
The design and performance of CliniQCT installed with QCT Pro was evaluated and compared to QCT Pro using retrospective data analysis, phantom testing and prospective patient studies. Software validation was performed using standard techniques.
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.
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Image /page/0/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 image of three human profiles facing to the right, with flowing lines representing hair or a cape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Mindways Software, Inc. % Keenan Brown, Ph. D. President/ Director of Research and Development 3001 S Lamar Blvd. Suite 302 AUSTIN, TX 78704
Re: K140342
Trade/Device Name: OCT Pro Asynchronous Calibration Module, CliniOCT Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Mineral Densitometer Regulatory Class: II Product Code: KGI Dated: July 25, 2014 Received: July 31, 2014
Dear Dr. Brown:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140342
Device Name
QCT Pro Asynchronous Calibration Module, CliniQCT
Indications for Use (Describe)
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Mindways Software, Inc. 3001 S Lamar Blvd, Suite 302 Austin, TX 78704, USA
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: | J. Keenan Brown, Ph.D. |
|---|---|
| President and Director of Research and Development | |
| Mindways Software, Inc | |
| 3001 S Lamar Blvd, Ste 302 | |
| Austin, TX 78704 | |
| Phone:512-912-0871 | |
| Fax: 512-912-0871 | |
| Email: keenan@qct.com | |
| Date: | July 24, 2014 |
| Model Number: | CLINIQCT |
| Device/Trade Name: | QCT Pro Asynchronous Calibration Module, CliniQCT, QCT Pro |
| CliniQCT | |
| Common/Usual Name: | Bone Mineral Densitometer |
| Classification Name: | Bone Densitometer, 21 CFR 892.1170, Class II |
| Predicate Devices: | K894854: Mindways QCT Pro Bone Mineral Density Analysis |
| Software | |
| Intended Use: Estimate bone mineral density within the spine. |
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K002113: Mindways QCT Pro CTXA Hip Bone Mineral Densitometer Intended Use: Estimate bone mineral density at the proximal femur, T-Score calculation, aid in determining fracture risk.
K030330: OCT Pro CTXA Hip Extended Reference Data Intended Use: Reference data for Z-Score calculation between ages 20 and 80.
Device Description
The OCT Pro Asynchronous Calibration Module is intended to extend the capabilities of OCT Pro bone mineral densitometer products (K894854. K002113. K030330) currently marketed by Mindways to the measurement of bone mineral content (BMC) and bone mineral density (BMD) from patient-specific CT images acquired without the simultaneous use of a CT calibration phantom. The QCT Pro bone mineral densitometer products distributed with or supplemented with the QCT Pro Asynchronous Calibration Module will be marketed under the name QCT Pro CliniQCT or more simply CliniQCT. Mineral calibration with the asynchronous calibration method is obtained from phantom measurements acquired on the same CT scanner, operated in a substantially similar mode used to acquire a patient CT scan. The phantom measurements used for calibration purposes may be acquired before or after a patient CT scan to which they are to be applied. The asynchronous calibration mode facilitates: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans of the anatomical regions where estimating bone density is prescribed, and (3) assessment of bone density without a phantom as an independent measurement procedure. Retrospective bone density analysis provides bone density information without exposing a patient to additional ionizing radiation while combining CT studies results in an overall reduction in patient exposure to ionizing radiation relative to the expected radiation dose associated with performing the studies separately.
Intended Use
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with currently marketed QCT Pro Spine and Hip application modules. Installation of the OCT Pro Asynchronous Calibration Module does not alter the intended use of the QCT Pro Spine and Hip application modules, however, it facilitates an additional means of providing calibration data to QCT Pro that does not require the
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simultaneous scanning of a patient with a CT calibration standard as is required when using the QCT Pro Spine and Hip application modules without the installation of the QCT Pro Asynchronous Calibration Module. Calibration data necessary for use with the QCT Pro Asynchronous Calibration Module is obtained from a standard OCT Pro QA phantom CT scan performed on the same CT scanner used to acquire patient CT images intended for analysis within OCT Pro operating in conjunction with the OCT Pro Asynchronous Calibration Module. The phantom CT scans used to obtain calibration data may be obtained either prior to or subsequent to patient CT scans.
Summary of Technological Characteristics and Comparison with Predicate Devices
QCT Pro when operated with the QCT Pro Asynchronous Calibration Module, collectively marketed as CliniQCT. provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from the predicate OCT Pro bone densitometer devices (K894854. K002113. K030330) for regions of interest in the spine and proximal femur. With the exception of the use of an asynchronous calibration method, the new device has the same technological characteristics as its predicate QCT Pro devices that calibrate bone mineral density with reference to a CT calibration phantom scanned simultaneously with a patient. BMD estimates derived with the asynchronous calibration method are suitable for comparison to the same reference data sets as are used with the QCT Pro predicate devices. Such reference data comparisons provide an aid to the physician in identifying patients with abnormally high or low bone mineral density.
| Device Characteristic | CliniQCT
Installed and Used in
Conjunction with
QCT Pro | QCT Pro
(K894854, K002113,
K030330) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device provides estimates of bone mineral content (BMC). | ✓ | ✓ |
| Device provides estimates of bone mineral density (BMD). | ✓ | ✓ |
| BMC and BMD estimates are provided for the spine and hip. | ✓ | ✓ |
| BMC and BMD estimates are derived using the principals of
Quantitative Computed Tomography (QCT) | ✓ | ✓ |
| BMC and BMD estimates are provided standardized to an
aqueous K2HPO4 bone density standard. | ✓ | ✓ |
| | | |
| BMC and BMD estimates are derived relative to a phantom
standard scanned:
with the patient
separate from the patient, either before or after patient
scan | both scan modes
accessible with
installation of
CliniQCT
|
|
| Precision, ( in vitro ) relative to calibration reference standard. | Non-inferior to QCT
Pro | Volume Density: 1.4
mg/cm3 (0.7% at a
nominal volume density
of 200 mg/cm3)
Area Density: 0.007
g/cm2 (0.7% at a
nominal area density of
1.0 g/cm2) |
| Precision, ( in vivo ) patient. | Non-inferior to QCT
Pro | Spine: Up to 1%
Total Hip ROI:
0.011 g/cm2 (1.1% at
1.0 g/cm2)
Femoral Neck:
0.012 g/cm2 (1.2% at
1.0 g/cm2) |
| Accuracy, relative to calibration reference standard | Unbiased | Unbiased |
| Radiation dose associated with examination is within currently
accepted guidelines regarding radiation health risks associated
with common radiologic diagnostic procedures.
Note, QCT Pro does not directly control the delivery of
radiation to a patient, but rather makes use of images acquired
from medical CT scanners approved for diagnostic, medical x-
ray, CT imaging purposes. | | |
| Device can be used to provide retrospective measurements
from CT scans acquired for other purposes without exposing
the patient to additional ionizing radiation beyond that required
for the other purposes. | | |
| Device can be used to provide BMD and BMC measurements
from CT scans acquired for multiple purposes (e.g., dual use of
images acquired for CT colonography and bone density
screening) without exposing the patient to additional ionizing
radiation beyond that required for the other, non-QCT,
purpose(s). | | |
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Device Testing
The design and performance of CliniQCT installed with QCT Pro was evaluated and compared to QCT Pro using retrospective data analysis, phantom testing and prospective patient studies. Software validation was performed using standard techniques.
Summary
Based on the similarities in analytical methods, calibration standards and performance testing, it is concluded that CliniQCT used in conjunction with QCT Pro is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new safety or effectiveness issues are raised by CliniQCT.
Signature
J. Keenan Brown, PhD Director of Research and Development Mindways Software, Inc.