QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT

K140342 · Mindways Software, Inc. · KGI · Aug 29, 2014 · Radiology

Device Facts

• Record ID: K140342
• Device Name: QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
• Applicant: Mindways Software, Inc.
• Product Code: KGI · Radiology
• Decision Date: Aug 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

CliniQCT (QCT Pro Asynchronous Calibration Module) extends existing QCT Pro bone densitometry software; enables BMD/BMC estimation from CT images without requiring a calibration phantom to be scanned simultaneously with the patient. Inputs: patient CT images and separate phantom calibration scans acquired on the same scanner. Operation: phantom scans (acquired before or after patient scan) provide calibration data for QCT analysis. Output: BMD/BMC values for spine and hip. Used in clinical settings by physicians to assess bone density; facilitates retrospective analysis of existing CT scans or combined-purpose imaging. Benefits: reduces patient radiation exposure by eliminating need for dedicated QCT scans; allows opportunistic bone density screening from diagnostic CTs.

Clinical Evidence

Performance evaluated via phantom testing, retrospective data analysis, and prospective patient studies. Results demonstrated non-inferiority in precision and accuracy relative to synchronous calibration predicate devices. Accuracy is reported as unbiased. In vitro precision: 1.4 mg/cm3 (volume) and 0.007 g/cm2 (area). In vivo precision: spine up to 1%, total hip 1.1%, femoral neck 1.2%.

Technological Characteristics

Software-based bone densitometer; utilizes Quantitative Computed Tomography (QCT) principles. Calibrates using aqueous K2HPO4 standard. Operates on standard medical CT scanner images. Asynchronous calibration allows phantom scans to be acquired separately from patient scans. Connectivity: integrates with existing QCT Pro software modules.

Indications for Use

Indicated for patients requiring bone mineral density (BMD) and bone mineral content (BMC) assessment of the spine and proximal femur via Quantitative Computed Tomography (QCT).

Regulatory Classification

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.

Predicate Devices

• Mindways QCT Pro Bone Mineral Density Analysis Software (K894854)
• Mindways QCT Pro CTXA Hip Bone Mineral Densitometer (K002113)
• QCT Pro CTXA Hip Extended Reference Data (K030330)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:[phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date: | July 24, 2014 |
| Model Number: | CLINIQCT |
| Device/Trade Name: | QCT Pro Asynchronous Calibration Module, CliniQCT, QCT Pro<br>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<br>Software<br>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<br>Installed and Used in<br>Conjunction with<br>QCT Pro | QCT Pro<br>(K894854, K002113,<br>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<br>Quantitative Computed Tomography (QCT) | ✓ | ✓ |
| BMC and BMD estimates are provided standardized to an<br>aqueous K2HPO4 bone density standard. | ✓ | ✓ |
| | | |
| BMC and BMD estimates are derived relative to a phantom<br>standard scanned:<br><br>with the patient<br><br>separate from the patient, either before or after patient<br>scan | both scan modes<br>accessible with<br>installation of<br>CliniQCT<br><br><br> | <br> |
| Precision, ( <i>in vitro</i> ) relative to calibration reference standard. | Non-inferior to QCT<br>Pro | Volume Density: 1.4<br>mg/cm3 (0.7% at a<br>nominal volume density<br>of 200 mg/cm3)<br><br>Area Density: 0.007<br>g/cm2 (0.7% at a<br>nominal area density of<br>1.0 g/cm2) |
| Precision, ( <i>in vivo</i> ) patient. | Non-inferior to QCT<br>Pro | Spine: Up to 1%<br>Total Hip ROI:<br>0.011 g/cm2 (1.1% at<br>1.0 g/cm2)<br><br>Femoral Neck:<br>0.012 g/cm2 (1.2% at<br>1.0 g/cm2) |
| Accuracy, relative to calibration reference standard | Unbiased | Unbiased |
| Radiation dose associated with examination is within currently<br>accepted guidelines regarding radiation health risks associated<br>with common radiologic diagnostic procedures.<br>Note, <i>QCT Pro</i> does not directly control the delivery of<br>radiation to a patient, but rather makes use of images acquired<br>from medical CT scanners approved for diagnostic, medical x-<br>ray, CT imaging purposes. | | |
| Device can be used to provide retrospective measurements<br>from CT scans acquired for other purposes without exposing<br>the patient to additional ionizing radiation beyond that required<br>for the other purposes. | | |
| Device can be used to provide BMD and BMC measurements<br>from CT scans acquired for multiple purposes (e.g., dual use of<br>images acquired for CT colonography and bone density<br>screening) without exposing the patient to additional ionizing<br>radiation beyond that required for the other, non-QCT,<br>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.