(219 days)
Not Found
No
The summary describes image acquisition, processing, and viewing capabilities, but does not mention any AI or ML algorithms being used for image analysis, interpretation, or other functions. The "analytics capabilities" mentioned are standard image processing tools like measurement and segmentation.
No
The device is an imaging system designed for diagnosis and not for therapeutic purposes. It generates images for review by a radiologist, and its intended use does not include treating conditions.
Yes
Explanation: The device is an "ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast," which generates "tomographic, speed of sound and reflection ultrasound images" for review by a radiologist. This process of creating medical images for interpretation directly serves to aid in diagnosis.
No
The device description explicitly states that the QT Scanner 2000 Model A consists of hardware components including a Patient Scanning System, an Operator Console, and potentially an offboard image processor, in addition to the QTviewer software. The Patient Scanning System contains electronics, a support table, a scan tank, and ultrasound transducer arrays. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide ultrasonic images of a patient's breast for diagnostic purposes. This is an in vivo (within the living body) imaging procedure, not an in vitro (outside the living body) test performed on biological samples.
- Device Description: The device is an ultrasonic imaging system that interacts directly with the patient's body to acquire images. It does not analyze biological samples like blood, urine, or tissue.
- Nature of the Output: The output is images (reflection-mode and transmission-mode breast images, tomographic, speed of sound, and reflection ultrasound images), not diagnostic results derived from the analysis of biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient's breast. The device is not intended to be used as a replacement for screening mammography.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
patient's breast
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
Description of the test set:
- 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.
- 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.
Sample size:
- 25 breast with silicone implant images
- 25 challenging-case breast images (13 dense breasts and 12 fatty breasts)
Data source: previously-acquired QT Ultrasound breast images
Annotation protocol:
- For Implant Processing, 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.
- For reprocessing features, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Retrospective clinical studies, Nonclinical, bench testing
Sample size: 25 breast with silicone implant images, 25 challenging-case breast images (13 dense breasts and 12 fatty breasts) for clinical studies
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
- 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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 892.1560 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.
0
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
1
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
2
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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3
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
4
PREDICATE DEVICES [807.92(a)(3)]
QT Ultrasound Breast Scanner-1 (K182213)
DEVICE DESCRIPTION [807.92(a)(4)]
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.
INDICATIONS FOR USE [807.92(a)(5)]
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.
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
5
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 LLC
QT Ultrasound Breast Scanner-1
(K182213) | Subject Device:
QT Ultrasound LLC
QT Scanner 2000 Model A
(K190646) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | §892.1560
Ultrasonic pulsed echo imaging system
Class II | §892.1560
Ultrasonic pulsed echo imaging system
Class II |
| Product Code | IYO, ITX | IYO, ITX |
| Indications for Use | The QT Ultrasound Breast Scanner - 1 is
for use as an ultrasonic imaging system
to provide reflection-mode and
transmission-mode images of a patient's
breast. The device is not intended to be
used as a replacement for screening
mammography. | The QT Scanner 2000 Model A is for
use as an ultrasonic imaging system to
provide reflection-mode and
transmission-mode images of a patient's
breast. The device is not intended to be
used as a replacement for screening
mammography. |
| Ultrasound Diagnostic
Application | Small organ (breast) | Same |
| Ultrasound Track | Track 1 | Same |
| Electrical Safety | AAMI ES60601-1:2005/(R)2012 And
A1:2012 | Same |
| Electromagnetic
Compatibility | 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 Lifecycle
Processes | 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 and
volume data
• No compression - positions breast
in pendulous position within a water
bath | Same |
| Transducer Configuration | 3 Reflection Mode , 1 Transmission
Mode transmitter, and 1 Transmission
Mode Receiver | Same basic configuration with updated
transmission mode transducers and
repositioned reflection mode
transducers. |
| Global Maximum
Acoustic 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's
breast | Same |
| Feature | Primary Predicate:
QT Ultrasound LLC
QT Ultrasound Breast Scanner-1
(K182213) | Subject Device:
QT Ultrasound LLC
QT Scanner 2000 Model A
(K190646) |
| Image Processing
Methods | Single processing method All image processing/reprocessing are
performed on the device | General Processing Implant Processing Reprocessing: remove blur,
artifacts, and dark spots All image processing/reprocessing can
be performed on the device or on an
offboard image processor |
| Image Output | Outputs DICOM images to a QTviewer
workstation. | Same |
| Image Views | Coronal, axial, and sagittal | Same |
| Image Manipulation
Functions | Full Screen
Zoom
Scroll
Window/Level
Window Level Presets
Pan
Gamma
Invert, Flip, and Rotate | Same |
| Image Analysis Functions | Correlate
Probe
Region of Interest (ROI)
Segment
Linear Measurement
Manual Annotation | Correlate
Probe
Region of Interest (ROI)
Segment
Linear Measurement
Manual Annotation |
| Patient Position | Positions patient in the prone position on
flat exam table with patient's breast in
pendulous position within an imaging
chamber | Positions patient in the prone position on
curved exam table with patient's breast
in pendulous position within an imaging
chamber |
| Fluid Environment | Positions patient's breast in fluid
environment to eliminate need for breast
compression and facilitate transmission
of ultrasound waves. | Same |
| Breast Positioning | Positions patient's breast by use of a
patient positioning system comprised of
breast insert ring, retention rod and
device to align a patient's breast in
imaging chamber | Same configuration with updated breast
retention device design. |
6
510(k) SUMMARY
7
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.
8
[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.