(30 days)
Not Found
No
The summary describes image processing and reconstruction techniques but does not mention AI, ML, or related terms, nor does it describe any training or testing of algorithms on data.
No.
The device is described as an ultrasonic imaging system for diagnostic purposes, providing images of a patient's breast, and is not intended for therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (Breast) - Reflection, Transmission (Speed of Sound)." Additionally, the device output aids in "diagnostic evaluation of the breast" as stated in the "Device Description."
No
The device description clearly outlines hardware components such as a Patient Scanning System, Operator Console, Viewer Console, patient support table, scan tank, water management system, and ultrasound transducer arrays. While software controls the system and processes images, it is an integral part of a larger hardware system.
Based on the provided information, this device 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. They are used to examine these samples outside of the body ("in vitro").
- Device Function: The QT Ultrasound Breast Scanner - 1 is an imaging system that uses ultrasound to create images of the breast within the patient's body. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for providing "reflection-mode and transmission-mode images of a patient's breast" and for "ultrasonic breast exams." This is consistent with an in-vivo imaging device, not an in-vitro diagnostic test.
Therefore, the QT Ultrasound Breast Scanner - 1 is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (Breast) - Reflection, Transmission (Speed of Sound). QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams.
Product codes
IYO, ITX
Device Description
The QT Ultrasound Breast Scanner - 1 is an automated software-controlled ultrasonic imaging system that performs a standardized scan of the whole breast. The OT Ultrasound Breast Scanner - 1 is comprised of a Patient Scanning System, Operator Console and Viewer Console.
The Patient Scanning System consists of a patient support table, scan tank, water management system, ultrasound transducer arrays and all associated image processing electronics. 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 Ultrasound Breast Scanner – 1 outputs the images to the QTviewer™ which allows the images to be stored until they are reviewed on a Viewer Console. Coronal, axial and sagittal images are generated for review by the radiologist. Speed of sound images may be queried by the Probe and Region of Interest (ROI) tools provided in the Viewer Console. These tools provide speed of sound values in meters/sec. to aid in diagnostic evaluation of the breast.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The function and performance of the modified OT Ultrasound Breast Scanner - 1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed QT Ultrasound Breast Scanner - 1 to support a determination of substantial equivalence to the unmodified predicate device. Specifically, the impacts of the design changes presented with the subject device were evaluated through Design Control, and a number of required testing accordingly determined and subsequently performed. Testing included system performance and simulated use tests. All necessary validation testing, including comprehensive software verification and validation, was performed, the results of which demonstrate that the modified QT Ultrasound Brast Scanner - 1 successfully meets design specification. As a part of design validation, a small usability investigation was conducted, which demonstrated the new user interface presented with Reseach Mode meets user requirements.
This testing confirms that the design changes presented with the subject device do not raise new questions of safety and effectivess, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent. The modified QT Ultrasound Breast Scanner – 1 is only different due to an updated version of the QTviewer Software Module.
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
§ 892.1560 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
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 14, 2018
QT Ultrasound LLC Mark W. Lenox Chief Technology Officer 3 Hamilton Landing. Suite 160 NOVATO, CA 94949
Re: K182213
Trade/Device Name: OT Ultrasound Breast Scanner - 1 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: August 14, 2018 Received: August 15, 2018
Dear Mark Lenox:
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/cfpmn/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
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Jeffre
-S
DN: c=US, o=U.S. Govern
ou=HHS, ou=FDA, ou=Pe
0.9.2342.19200300.100.1
9725, cn=Jeffrey J. Ballym
Date: 2018.09.14 13:52:5
c=US, o=U.S. Government,
=HHS, ou=FDA, ou=People,
2342.19200300.100.1.1=200056
5, cn=Jeffrey J. Ballyns -S
e: 2018.09.14 13:52:52 -04'00'
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182213
Device Name QT Ultrasound Breast Scanner - 1
Indications for Use (Describe)
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 soreening mammography.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| For Evaluation Use (Per 21 CFR 201.66, Subpart D) |
|---|
| For Compassionate Use (21 CFR 312.300) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Diagnostic Ultrasound Indications for Use
System: QT Ultrasound Breast Scanner-1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||
| Doppler | Combined | Other | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Breast) | N1 | N2 | ||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N=New Indication; P = previously cleared by FDA; E = added under this appendix
1 – Reflection
2 – Transmission (Speed of Sound)
Additional Comments: QT Ultrasound Breast Scanner-1 is intended for ultrasonic breast exams
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Image /page/4/Picture/0 description: The image shows the logo for QT Ultrasound. The logo features the letters "QT" in a light green color, with the word "ultrasound" in a light gray color next to it. The font is sans-serif and modern.
510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
1.0 SUBMITTER INFORMATION
| Submitted By | QT Ultrasound® LLC
3 Hamilton Landing, Suite 160
Novato, CA 94949 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Contact Information | Mark W. Lenox, PhD
Phone: (865) 382-2649
Fax: (415) 234-6511
Email: mark.lenox@qtultrasound.com |
| Date of Submission | September 12, 2018 |
| Type of Submission | Special 510(k)
Modification to QT Ultrasound Breast Scanner – 1(K162372) |
| DEVICE INFORMATION | |
| Trade / Proprietary Name | QT Ultrasound Breast Scanner – 1 |
| Common Name | System, Imaging, Pulsed Echo Ultrasonic
Transducer, Ultrasonic, Diagnostic |
| Classification Name and
Regulation Number | 21CFR §892.1560 Ultrasonic pulsed echo imaging system
21CFR §892.1570 Diagnostic ultrasonic transducer |
Product Codes IYO, ITX
3.0 PREDICATE DEVICE
2.0
The predicate device is the QT Ultrasound Breast Scanner - 1, also manufactured by QT Ultrasound, LLC. QT Ultrasound Breast Scanner - 1 received market clearance under 510(k) number K162372.
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Image /page/5/Picture/0 description: The image shows the logo for QT Ultrasound. The logo consists of the letters "QT" in a light green color, with the word "ultrasound" in a light gray color next to it. The font is sans-serif and the overall design is simple and modern.
4.0 DEVICE DESCRIPTION
The QT Ultrasound Breast Scanner - 1 is an automated software-controlled ultrasonic imaging system that performs a standardized scan of the whole breast. The OT Ultrasound Breast Scanner - 1 is comprised of a Patient Scanning System, Operator Console and Viewer Console.
The Patient Scanning System consists of a patient support table, scan tank, water management system, ultrasound transducer arrays and all associated image processing electronics. 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 Ultrasound Breast Scanner – 1 outputs the images to the QTviewer™ which allows the images to be stored until they are reviewed on a Viewer Console. Coronal, axial and sagittal images are generated for review by the radiologist. Speed of sound images may be queried by the Probe and Region of Interest (ROI) tools provided in the Viewer Console. These tools provide speed of sound values in meters/sec. to aid in diagnostic evaluation of the breast.
INTENDED USE 5.0
The OT 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.
6.0 PREDICATE DEVICE COMPARISON
The modified QT Ultrasound Breast Scanner - 1 is substantially equivalent to the predicate device, the OT Ultrasound Breast Scanner - 1 cleared by the FDA in K162372. QT Ultrasound claims substantial equivalence because the proposed device has an equivalent intended use, operating principles, fundamental scientific technology, technological characteristics, and physical and operational specifications as compared to
6
Image /page/6/Picture/0 description: The image shows the logo for QT ultrasound. The logo consists of the letters "QT" in a light green color, followed by the word "ultrasound" in a light gray color. The logo is simple and modern, and it is likely used to represent a medical imaging company or service.
the predicate device. The modified QT Ultrasound Breast Scanner - 1 and the predicate device utilize B-mode grayscale ultrasound images to achieve their intended use. Both the modified QT Ultrasound Breast Scanner - 1 and the predicate device are table-top systems that have automatic scanning transducers to image breast tissue.
A brief summary of the similarities and differences between the modified QT Ultrasound Breast Scanner – 1 and the QT Ultrasound Breast Scanner – 1 (K162372) is included below:
Similarities
The fundament scientific technology and all Technological Characteristics are the same for both the modified QT Ultrasound Breast Scanner – 1 and the QT Ultrasound Breast Scanner - 1 (K162372); all technological characteristics and are listed below:
- Both systems use an automated transducer to acquire images of a patient's breast. ●
- o Both systems use broadband transducers.
- Both systems acquire and process B-mode grayscale images of a patient's breast.
- Both systems acquire and process grayscale speed of sound images of a patient's breast.
- . Both systems position the patient in a prone position lying on their examination table with the patient's breast in a pendulous position within an imaging chamber.
- Both systems position the patient's breast in a fluid environment to eliminate the need for breast compression and to facilitate the transmission of ultrasound waves.
- . Both systems display of speed of sound Information is the same. Both provide grayscale speed of sound images that may be acquired by Probe and/or ROI tools available in the OTviewer. Both systems use this information as an aid/reference information for diagnostic evaluation of the breast.
- . Both systems display 3-D volume image acquisition.
- . Both systems perform image reconstruction in 3-D.
Differences
The differences between the modified QT Ultrasound Breast Scanner - 1 and the QT Ultrasound Breast Scanner – 1 (K162372) are the modifications made to the QTviewer Software Module. The summary of the differences between the modified QT Ultrasound Breast Scanner - 1 and the QT Ultrasound Breast Scanner - 1 (K162372) are listed in Table 2-1.
7
| Table 2-1. Differences Between the Modified QT Ultrasound Breast Scanner – 1 and the
| QT Ultrasound Breast Scanner – 1 (K162372) | |
|---|---|
| Modification | Discussion |
| Modified | |
| QTviewer | |
| Software Module | Various bug fixes, cosmetic changes, addition of annotation features, |
| snapshot feature and research mode, along with enhancements were made | |
| to the QTviewer Software Module that was part of the FDA cleared QT | |
| Ultrasound Breast Scanner – 1 (K162372). |
The differences noted between the modified QT Ultrasound Breast Scanner - 1 and the predicate device, the QT Ultrasound Breast Scanner - 1 (K162372), do not present any new or different questions related to safety and effectiveness.
7.0 SUMMARY OF NON-CLINICAL TESTING
The function and performance of the modified OT Ultrasound Breast Scanner - 1 has been evaluated through non-clinical design verification and validation testing. All necessary testing was conducted on the proposed QT Ultrasound Breast Scanner - 1 to support a determination of substantial equivalence to the unmodified predicate device. Specifically, the impacts of the design changes presented with the subject device were evaluated through Design Control, and a number of required testing accordingly determined and subsequently performed. Testing included system performance and simulated use tests. When applicable, non-clinical testing was conducted per the standards listed in Table 2-2. All necessary validation testing, including comprehensive software verification and validation, was performed, the results of which demonstrate that the modified QT Ultrasound Brast Scanner - 1 successfully meets design specification. As a part of design validation, a small usability investigation was conducted, which demonstrated the new user interface presented with Reseach Mode meets user requirements.
This testing confirms that the design changes presented with the subject device do not raise new questions of safety and effectivess, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent. The modified QT Ultrasound Breast Scanner – 1 is only different due to an updated version of the QTviewer Software Module; therefore, not all testing was applicable since the original submission. A comparsion of all testing between the modified OT Ultrasound Breast Scanner - 1 and the predicate, QT Ultrasound Breast Scanner - 1 (K162372) is shown in Table 2-2.
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| Table 2-2. Testing Performed | |||
|---|---|---|---|
| Type of Testing | Tests Performed | QT Ultrasound | |
| Breast Scanner – 1 | |||
| (K162372) | Modified QT | ||
| Ultrasound Breast | |||
| Scanner – 1 | |||
| (This submission) | |||
| Electrical Safety | |||
| AAMI ES60601- | |||
| 1:2005/(R)2012 And | |||
| A1:2012 Medical | |||
| electrical equipment - | |||
| Part 1: General | |||
| requirements for basic | |||
| safety and essential | |||
| performance | All applicable electrical, | ||
| basic safety and | |||
| essential performance | |||
| tests. | |||
| Testing was conducted | |||
| by Intertek, an | |||
| independent testing | |||
| laboratory, located in | |||
| Menlo Park, CA. | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. | |||
| Electromagnetic | |||
| Compatibility | |||
| IEC 60601-1-2 Edition | |||
| 3: 2007-03 Medical | |||
| electrical equipment - | |||
| Part 1-2: General | |||
| requirements for basic | |||
| safety and essential | |||
| performance - Collateral | |||
| Standard: | |||
| Electromagnetic | |||
| disturbances - | |||
| Requirements and tests | All applicable testing | ||
| pertaining to | |||
| electromagnetic | |||
| compatibility. | |||
| Testing was conducted | |||
| by Intertek, an | |||
| independent testing | |||
| laboratory, located in | |||
| Menlo Park, CA. | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. | |||
| Usability | |||
| IEC 62366 Edition 1.1 | |||
| 2014-01 - Medical | |||
| devices- Application of | |||
| usability engineering to | |||
| medical devices | |||
| IEC 60601-1-6 Edition | |||
| 3.1 2013-10 - Medical | |||
| electrical equipment Part | |||
| 1-6 General | |||
| requirements for safety - | |||
| Collateral Standard: | |||
| Usability | All applicable testing | ||
| pertaining to usability. | |||
| Testing was conducted | |||
| by Intertek, an | |||
| independent testing | |||
| laboratory, located in | |||
| Menlo Park, CA. | Performed | Performed | |
| Table 2-2. Testing Performed | |||
| Type of Testing | Tests Performed | QT Ultrasound | |
| Breast Scanner – 1 | |||
| (K162372) | Modified QT | ||
| Ultrasound Breast | |||
| Scanner – 1 | |||
| (This submission) | |||
| Acoustic Output | |||
| IEC 60601-2-37 Edition | |||
| 2.0 2007 Medical | |||
| electrical equipment – | |||
| Part 2-37: Particular | |||
| requirements for the | |||
| basic safety and | |||
| essential performance of | |||
| ultrasonic medical | |||
| diagnostic and | |||
| monitoring equipment. | |||
| NEMA UD 2-2004 | |||
| (R2009) Acoustic | |||
| Output Measurement | |||
| Standard for Diagnostic | |||
| Ultrasound Equipment – | |||
| Revision 3 | All applicable testing | ||
| pertaining to the | |||
| requirements for the | |||
| safety of ultrasonic | |||
| medical diagnostic and | |||
| monitoring equipment | |||
| and to demonstrate | |||
| compliance with the | |||
| "Acoustic Output | |||
| Measurement Standard | |||
| for Diagnostic | |||
| Ultrasound Equipment". | |||
| Testing was conducted | |||
| by QT Ultrasound and | |||
| witnessed by Intertek, | |||
| an independent testing | |||
| laboratory, located in | |||
| Menlo Park, CA. The | |||
| QT Ultrasound Breast | |||
| Scanner – 1 meets all | |||
| Track 1 acoustic output | |||
| requirements. The | |||
| results of acoustic | |||
| output testing are listed | |||
| in Table 2-3 below. | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. | |||
| Software Development | |||
| IEC 62304:2006 (First | |||
| Edition) – Medical | |||
| device software – | |||
| Software life cycle | |||
| processes | Internal procedures for | ||
| software life cycle | |||
| management were used | |||
| for software | |||
| development, | |||
| verification / validation | |||
| and configuration | |||
| control | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated viewer | |||
| Software Module. | |||
| Table 2-2. Testing Performed | |||
| Type of Testing | Tests Performed | QT Ultrasound | |
| Breast Scanner – 1 | |||
| (K162372) | Modified QT | ||
| Ultrasound Breast | |||
| Scanner – 1 | |||
| (This submission) | |||
| Software Verification | |||
| and Validation | Software was tested at | ||
| the module and system | |||
| levels to ensure that it | |||
| met the software's | |||
| design and intended use | |||
| requirements. All | |||
| requirements were met, | |||
| and no new issues of | |||
| safety or effectiveness | |||
| compared to the | |||
| predicate device were | |||
| raised. | Performed | Performed | |
| System Verification and | |||
| Performance | System verification | ||
| testing was conducted to | |||
| ensure that the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 met design | |||
| requirements. In | |||
| addition, the following | |||
| system performance | |||
| characteristics are | |||
| reported: | |||
| • Measurement Range / | |||
| Accuracy | |||
| • Spatial Resolution | |||
| • Contrast Resolution / | |||
| Contrast to Noise | |||
| Ratio | |||
| • Speed of Sound | |||
| Uniformity and | |||
| Accuracy | |||
| All requirements were | |||
| met, and no new issues | |||
| of safety or | |||
| effectiveness compared | |||
| to the predicate device | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. | |||
| Table 2-2. Testing Performed | |||
| Type of Testing | Tests Performed | QT Ultrasound | |
| Breast Scanner – 1 | |||
| (K162372) | Modified QT | ||
| Ultrasound Breast | |||
| Scanner – 1 | |||
| (This submission) | |||
| Biocompatibility | |||
| ISO 10993- | |||
| 1:2009/(R)2013 - | |||
| Biological evaluation of | |||
| medical devices - Part 1: | |||
| Evaluation and testing | |||
| within a risk | |||
| management process | Biocompatibility testing | ||
| was conducted to ensure | |||
| that the patient | |||
| contacting materials in | |||
| the QT Ultrasound | |||
| Breast Scanner - 1 met | |||
| design requirements. All | |||
| requirements were met, | |||
| and no new issues of | |||
| safety or effectiveness | |||
| compared to the | |||
| predicate device were | |||
| raised. | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. | |||
| ISO 10993- | |||
| 5:2009/(R)2014 - | |||
| Biological evaluation of | |||
| medical devices - Part 5: | |||
| Tests for in vitro | |||
| cytotoxicity | |||
| ISO 10993- | |||
| 10:2010/(R)2014 - | |||
| Biological evaluation of | |||
| medical devices - Part | |||
| 10: Tests for irritation | |||
| and skin sensitization | |||
| ISO 10993- | |||
| 11:2006/(R)2010 - | |||
| Biological evaluation of | |||
| medical devices - Part | |||
| 11: Tests for systemic | |||
| toxicity | |||
| Cleaning Procedures | |||
| Scan Tank | Microbial analysis and | ||
| particulate testing of the | |||
| water in the scan tank | |||
| was conducted. All | |||
| requirements were met, | |||
| and no new issues of | |||
| safety or effectiveness | |||
| compared to the | |||
| predicate device were | |||
| raised. | Performed | Not Applicable; the | |
| only modification | |||
| made to the QT | |||
| Ultrasound Breast | |||
| Scanner – 1 is an | |||
| updated QTviewer | |||
| Software Module. |
9
Image /page/9/Picture/0 description: The image shows the logo for "QT ultrasound". The letters "QT" are in a light green color, with the "Q" being larger than the "T". The word "ultrasound" is in a light gray color and is placed to the right of the "QT".
10
Image /page/10/Picture/0 description: The image shows the logo for "QT ultrasound". The logo is in a light green color. The letters "QT" are larger than the word "ultrasound".
11
Image /page/11/Picture/0 description: The image contains the text "QT ultrasound". The letters "QT" are larger and in a different color than the word "ultrasound". The text appears to be a logo or branding element.
12
Image /page/12/Picture/0 description: The image shows the logo for QT Ultrasound. The logo consists of the letters "QT" in a light green color, with the word "ultrasound" in a light gray color next to it. The logo is simple and modern, and it is likely used to represent a medical imaging company.
8.0 SUMMARY OF CLINICAL TESTING
The modified QT Ultrasound Breast Scanner - 1 is a class II device, and has the same equivalent intended use, operating principles, fundamental scientific technology, technological characteristics, physical and operational specifications as predicate, QT Ultrasound Breast Scanner - 1 (K162372); clinical data is not required for substantial equivalence.
9.0 CONCLUSION
The submission device is a modification to the QT Ultrasound Breast Scanner - 1. The modified QT Ultrasound Breast Scanner - 1 is substantially equivalent to the QT Ultrasound Breast Scanner - 1 as previously cleared in K162372, with respect to intended use, principle of operation, design, performance, method of display and safety features. Both devices are intended as an adjunct to mammography and are not intended for screening purposes. The primary difference between modified device and the OT Ultrasound Breast Scanner - 1 (K162372) is the newer version of the QTviewer software.
QT Ultrasound has demonstrated through verification and validation testing that the modifications made to the QTviewer software as part of the QT Ultrasound Breast Scanner - 1 (K162372) do not raise new or different questions of safety and effectiveness. Therefore, it is the opinion of QT Ultrasound LLC that the modified QT Ultrasound Breast Scanner - 1 is substantially equivalent to the predicate device identified in this submission that is currently cleared for market in the United States.