The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflectionmode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.

Device Description

The QT Scanner 2000 Model A ("QT Scanner") is an automated, software-controlled ultrasound imaging system which performs a standardized scan of the whole breast without the use of ionizing radiation, compression, or contrast injection; and generates both reflection-mode and transmission-mode breast images. The QT Scanner consists of a Patient Scanning System, an Operator Console, an optional offboard image processor, and the QTviewer software.

The Patient Scanning System contains the necessary electronics which perform acquisition and initial processing of the breast images and further provides a support table which allows the patient to rest comfortably while the scanning takes place. The scan tank is centered below a patient's breast and contains the ultrasound transducer arrays. The transducer arrays include a set of three reflection transducers that transmit pulsed ultrasound plane waves into targeted tissues using the water bath in the scan tank as a coupling medium. An additional transmitter and receiver array pair collect the ultrasound energy to provide speed of sound values.

During scanning, a patient lies prone on the examination table with the breast suspended in a warm water bath maintained near skin temperature. Images are automatically acquired on a pendant breast positioned with the nipple as a point of reference. The transducer arrays rotate about a vertical axis to circle the breast in the coronal plane. The array is then translated vertically, and the scanning process is repeated until the entire breast is scanned, allowing B-scan images to be constructively combined into tomographic, speed of sound and reflection ultrasound images.

The QT Scanner outputs the images to a server which allows the images to be stored until they are reviewed on a Viewer Console running the OTviewer™ software. Alternatively, raw data files can be output to a server and remotely constructively combined into tomographic, speed of sound and reflection ultrasound images. Coronal, axial and sagittal images are generated for review by the radiologist. The QTviewer software also provides a number of analytics capabilities, such as biometric measurement, manual segmentation, and Region of Interest calculations.

AI/ML Overview

The provided text describes two clinical studies that support the substantial equivalence of the QT Scanner 2000 Model A to its predicate device. Both studies evaluate features of the device's software.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state quantitative acceptance criteria in the typical format (e.g., AUC > X, Sensitivity > Y). Instead, it describes performance in comparative terms. The acceptance criteria appear to be based on demonstrating superiority or non-inferiority compared to the default processing method, as interpreted and evaluated by expert radiologists.

Feature Evaluated	Acceptance Criteria (Implicit)	Reported Device Performance
Implant Processing	Superior overall interpretability of breast with silicone implant images, superior visualization of implant-specific anatomical features, and non-inferior visualization of general anatomical features compared to default processing.	Achieved: Superior overall interpretability of breast with silicone implant images, superior visualization of implant center and implant-tissue interface, and non-inferior visualization of general anatomical features (e.g., nipple, skin).
Transmission- and Reflection-mode Reprocessing	Superior overall visualization of both speed-of-sound and reflection images, and at least non-inferior visualization of all relevant anatomical features compared to default processing.	Achieved: Superior overall visualization of both speed-of-sound and reflection images, and at least non-inferior visualization of all relevant anatomical features.

2. Sample Size Used for the Test Set and Data Provenance

Study 1 (Implant Processing): 25 breast with silicone implant images.
Study 2 (Transmission- and Reflection-mode Reprocessing): 25 challenging-case breast images (13 dense breasts and 12 fatty breasts).
Data Provenance: Both studies used "previously-acquired QT Ultrasound breast images," indicating a retrospective data collection. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Three (3) expert radiologists for each study.
Qualifications: Referred to simply as "expert radiologists." No further details on their experience (e.g., years of experience, sub-specialty) are provided in this document.

4. Adjudication Method for the Test Set

The document states that "three (3) expert radiologists independently reviewed" the images. The images were reviewed "in a blinded manner" and "comparatively evaluated." This suggests an independent review process, but it does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies. The reported performance implies a consensus or agreement was reached, or that individual findings were statistically aggregated, but the exact method isn't detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

These studies were multi-reader multi-case (MRMC) studies, as they involved multiple expert readers evaluating multiple cases.

Effect Size: The document describes the effect qualitatively (e.g., "superior overall interpretability," "non-inferior visualization") rather than providing specific quantitative effect sizes (e.g., percentage improvement in detection rate, change in diagnostic accuracy metrics).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, these studies primarily evaluated the effect of the software's processing features on human interpretation. The experts reviewed the images generated by the different processing methods to assess interpretability and visualization. This is not a standalone algorithm performance evaluation where the algorithm makes a diagnosis without human input.

7. The Type of Ground Truth Used

The "ground truth" for assessing the interpretability and visualization of the images was based on expert visual grade analysis by three independent expert radiologists. This is a form of expert consensus or subjective expert evaluation of image quality and feature visualization, rather than an objective "ground truth" like pathology results or outcomes data that define the presence or absence of a disease.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the software algorithms. The clinical studies described are performance evaluations of the software output using retrospective test sets.

9. How the Ground Truth for the Training Set Was Established

Since information on the training set and its size is not provided, how its ground truth was established is also not specified in this document.

Summary

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October 18, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

QT Ultrasound, LLC % Rajni Natesan, M.D., M.B.A. Chief Medical Officer 3 Hamilton Landing, Suite 160 NOVATO CA 94949

Re: K190646

Trade/Device Name: OT Scanner 2000 Model A Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 4, 2019 Received: September 6, 2019

Dear Dr. Natesan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190646

Device Name QT Scanner 2000 Model A

Indications for Use (Describe)

The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and transmissionmode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Notification K190646

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

QT Ultrasound LLC 3 Hamilton Landing Suite 160 Novato, CA 94949 Phone: 1-415-930-4070 Fax: 1-415-234-6511

Contact Person:

Rajni Natesan, M.D., M.B.A. Chief Medical Officer OT Ultrasound LLC 3 Hamilton Landing Suite 160 Novato, CA 94949 USA Phone: 1-415-842-7244 Email: rajni.natesan@qtultrasound.com

Date Prepared: October 16, 2019

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

QT Scanner 2000 Model A

Generic/Common Name:

Ultrasonic pulsed echo imaging system

Classification:

21 CFR§892.1560, Ultrasonic Pulsed Echo Imaging System, Class II

Product Code:

IYO, ITX

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PREDICATE DEVICES [807.92(a)(3)]

QT Ultrasound Breast Scanner-1 (K182213)

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

As the QT Scanner 2000 Model A is the technological successor to the Scanner-1 primary predicate device (K182213), the devices are highly consistent with respect to safety and technological characteristics. Both devices are automated diagnostic ultrasound imaging systems which perform a standardized scan of the whole breast in both reflection mode and transmission mode. Both devices share the same basic system layout and operational principles. There are a

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510(k) SUMMARY

few technological differences including the availability of additional processing methods and other minor technological enhancements which primarily represent routine parts upgrades (e.g., transducer elements, table shape, components, water management parts, electronic parts) and refinements in software parameters. The following table presents a high-level comparison of key technological aspects between the subject and predicate devices.

Feature	Primary Predicate:QT Ultrasound LLCQT Ultrasound Breast Scanner-1(K182213)	Subject Device:QT Ultrasound LLCQT Scanner 2000 Model A(K190646)
Classification	§892.1560Ultrasonic pulsed echo imaging systemClass II	§892.1560Ultrasonic pulsed echo imaging systemClass II
Product Code	IYO, ITX	IYO, ITX
Indications for Use	The QT Ultrasound Breast Scanner - 1 isfor use as an ultrasonic imaging systemto provide reflection-mode andtransmission-mode images of a patient'sbreast. The device is not intended to beused as a replacement for screeningmammography.	The QT Scanner 2000 Model A is foruse as an ultrasonic imaging system toprovide reflection-mode andtransmission-mode images of a patient'sbreast. The device is not intended to beused as a replacement for screeningmammography.
Ultrasound DiagnosticApplication	Small organ (breast)	Same
Ultrasound Track	Track 1	Same
Electrical Safety	AAMI ES60601-1:2005/(R)2012 AndA1:2012	Same
ElectromagneticCompatibility	IEC 60601-1-2 Edition 3: 2007-03	IEC 60601-1-2 Edition 4: 2014-02
Acoustic Safety	IEC 60601-2-37 Edition 2.0 2007	IEC 60601-2-37 Edition 2.1 2015
Software LifecycleProcesses	In compliance with IEC 62304:2006	In compliance with IEC 62304:2015
Principles of Operation	Reflection (B-Mode) and• Transmission (Speed of Sound)Ultrasound• Displays 2D slice images andvolume data• No compression - positions breastin pendulous position within a waterbath	Same
Transducer Configuration	3 Reflection Mode , 1 TransmissionMode transmitter, and 1 TransmissionMode Receiver	Same basic configuration with updatedtransmission mode transducers andrepositioned reflection modetransducers.
Global MaximumAcoustic Output Values	Max ISPTA= 1.63 mW/cm²	Max ISPTA= 1.89 mW/cm²
Imaging Modes	Acquires and processes B-mode(reflection) and speed of sound(transmission) images of a patient'sbreast	Same
Feature	Primary Predicate:QT Ultrasound LLCQT Ultrasound Breast Scanner-1(K182213)	Subject Device:QT Ultrasound LLCQT Scanner 2000 Model A(K190646)
Image ProcessingMethods	Single processing method All image processing/reprocessing areperformed on the device	General Processing Implant Processing Reprocessing: remove blur,artifacts, and dark spots All image processing/reprocessing canbe performed on the device or on anoffboard image processor
Image Output	Outputs DICOM images to a QTviewerworkstation.	Same
Image Views	Coronal, axial, and sagittal	Same
Image ManipulationFunctions	Full ScreenZoomScrollWindow/LevelWindow Level PresetsPanGammaInvert, Flip, and Rotate	Same
Image Analysis Functions	CorrelateProbeRegion of Interest (ROI)SegmentLinear MeasurementManual Annotation	CorrelateProbeRegion of Interest (ROI)SegmentLinear MeasurementManual Annotation
Patient Position	Positions patient in the prone position onflat exam table with patient's breast inpendulous position within an imagingchamber	Positions patient in the prone position oncurved exam table with patient's breastin pendulous position within an imagingchamber
Fluid Environment	Positions patient's breast in fluidenvironment to eliminate need for breastcompression and facilitate transmissionof ultrasound waves.	Same
Breast Positioning	Positions patient's breast by use of apatient positioning system comprised ofbreast insert ring, retention rod anddevice to align a patient's breast inimaging chamber	Same configuration with updated breastretention device design.

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510(k) SUMMARY

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510(k) SUMMARY

SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the QT Scanner 2000 Model A is substantially equivalent to the indications for use of the predicate devices. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the QT Scanner 2000 Model A is substantially equivalent to the predicate devices.

PERFORMANCE DATA [807.92(b)]

All necessary bench and clinical performance testing was conducted on the QT Scanner 2000 Model A to support a determination of substantial equivalence to the predicate devices.

[807.92(b)(1)] Nonclinical Testing Summary:

The nonclinical, bench testing included:

System Verification and Validation ●
o Software Verification and Validation
o Image Resolution Characterization
Human Factors Testing
Evaluation to the following standards: ●
- ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices Part 1: O Evaluation and Testing Within a Risk Management Process
- IEC 60601-1:2012, Medical Electrical Equipment Part 1: General Requirements O For Basic Safety And Essential Performance
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General o Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- IEC 60601-2-37:2015, Medical electrical equipment Part 2-37: Particular o requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 60601-1-6:2013 Medical electrical equipment Part 1-6 General o requirements for safety - Collateral Standard: Usability
- IEC 62304:2015, Medical device software Software life cycle processes O
- IEC 62366:2014, Medical devices- Application of usability engineering to O medical devices
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for o Diagnostic Ultrasound Equipment - Revision 3

The collective results of the nonclinical testing demonstrate that the OT Scanner 2000 Model A meets its designed specifications to support the acquisition, processing, display, and analysis of transmission- and reflection-mode breast ultrasound images; and support that the subject device does not raise different questions of safety or effectiveness for its intended use when compared to the predicate devices.

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[807.92(b)(2)] Clinical Testing Summary:

The QT Scanner was evaluated clinically within three (3) retrospective clinical studies on previously-acquired QT Ultrasound breast images. Each study specifically evaluated a specific feature of the OT Scanner software which represented a technological difference against the predicate devices, as follows:

The Implant Processing feature was validated through visual grade analysis in which three (3) expert radiologists independently reviewed 25 breast with silicone implant images selected by an image reconstruction expert. Each clinician user reviewed the reprocessed and default processed images in a blinded manner and comparatively evaluated the images with respect to overall interpretability and visualization of both implant-specific and general anatomical features. The study demonstrated that the Implant Processing feature provides superior overall interpretability of breast with silicone implant images, superior visualization of implant-specific anatomical features (i.e., implant center and implant-tissue interface), and non-inferior visualization of general anatomical features (e.g., nipple, skin).
The transmission- and reflection- mode reprocessing features were validated through ● visual grade analysis in which three (3) expert radiologists independently reviewed 25 challenging-case breast images (13 dense breasts and 12 fatty breasts) selected by an image reconstruction expert. Each clinician user reviewed each reprocessed image compared to the default processed image in a blinded manner and comparatively evaluated the images with respect to overall speed-of-sound and reflection image diagnostic quality, as well as visualization of key anatomical features. The study demonstrated that the reprocessing method provides superior overall visualization of both speed-of-sound and reflection images, and provides at least non-inferior visualization of all relevant anatomical features.

The results of these clinical testing further validate the Implant Processing and Reprocessing features for their respective intended functions. As such, the clinical testing in conjunction with the results of nonclinical testing demonstrated that the OT Scanner is validated for its intended use, and that the subject device does not raise different questions of safety or effectiveness for its intended use when compared to the predicate devices.

CONCLUSIONS [807.92(b)(3)]

Performance testing of the OT Scanner supports that the subject device, like the Scanner-1 primary predicate device (K182213), can acquire, process, display, and analyze reflection- and transmission-mode ultrasound images of the breast. The minor differences in technology do not raise different questions of safety or effectiveness, and the QT Scanner is as safe and as effective for its intended use.

Thus, the results of performance testing support that the subject device is substantially equivalent to the predicate devices for its intended use.

SUMMARY

The QT Scanner 2000 Model A is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.