(93 days)
Not Found
No
The device description focuses on thermal imaging, 3D data acquisition, and software for viewing and calculating temperature differentials based on user-defined thresholds. There is no mention of algorithms that learn from data or perform automated analysis beyond simple comparisons to thresholds. The performance studies also focus on hardware and software functionality, not the performance of any AI/ML model.
No
The device is described as an "adjunctive diagnostic screening" tool, meaning it assists in detecting or screening for conditions, rather than directly treating them. Its function is to view and record heat patterns, which is a diagnostic capability, not a therapeutic one.
Yes
The device is explicitly stated to be for "adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs." This indicates its role in assisting in diagnosis.
No
The device description explicitly states that the system consists of hardware components including a thermal camera, a 3D camera, a tester main body, a computer, monitors, and an air cooling unit. The performance studies also detail verification and validation of these hardware components.
Based on the provided information, the FIRSTSense Breast Exam® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- FIRSTSense Breast Exam® Function: The FIRSTSense Breast Exam® device works by capturing and recording thermal infrared energy (heat) emitting directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as being for "viewing and recording heat patterns generated by the human body" and for "adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs." This is a non-invasive, external assessment of the body.
- Device Description: The description details a system with cameras, a computer, software, and an air cooling unit that interacts with the patient's body externally. There is no mention of collecting or analyzing biological samples.
Therefore, because the device operates by directly assessing the patient's body externally and does not perform tests on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
Product codes
LHQ
Device Description
The FirstSense Breast Exam® system consists of a portable device (FSBE Tester) that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact during a screening test. The device emits no radiation to the patient. The device consists of a thermal camera, a 3D camera, a tester main body consisting of metal and plastic to safely and securely house the electronic and mechanical components and motors (to adjust cameras for various sized patients), a computer, software components and two color monitors, as well as an air cooling unit that blows cool air during part of the screening test cycle. The FSBE system also contains a cloud server for safe storage of test data. During a screening test, the FSBE Tester’s thermal camera acquires thermal images, and the 3D camera acquires depth data and visible light images of the patient breasts. When a test is completed, the acquired data is uploaded to the FSBE system’s cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thermal infrared energy (heat), 3D camera (acquires depth data and visible light images)
Anatomical Site
Breast
Indicated Patient Age Range
Adult patient populations.
Intended User / Care Setting
Qualified healthcare personnel in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided.
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 device performance was validated by conducting the following tests:
- The FSBE Tester was tested for its compatibility with both IEC 60601-1-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance collateral standard: Electromagnetic compatibility.
- The FSBE Tester’s mechanical parts and their expected performance are validated during full device validation. specifically during the verification of the device’s pre-check routine which checks each device hardware component and its expected functionality. Also during execution of software functional verification tests, the performance of individual mechanical components are verified.
The following verification tests were executed for full device validation:
- FSDAQ software pre-check routine test verifies the pre-check routine and integrity O of device hardware components.
- FSDAQ device log test verifies the device log and software ability to record events O related to test sequence and hardware status.
- FSDAQ test sequence and error manaqement verifies the software for manaqing a o test sequence and managing the errors, as well as verifies device hardware performance during the test sequence.
- FSDAQ data storage and data upload verifies software functionality for temporary O test data storage and test data upload to the server.
- FSDAQ patient positioning verifies the software functionality to provide assistance O to the operator to position the device before the test sequence. Also verifies the hardware components such as the 3D camera and its performance during patient positioning.
- The thermal camera performance is validated by executing the following thermal camera performance verification tests to evaluate the respective characteristics of the thermal camera:
- Thermal Camera Uniformity Test; o
- Thermal Camera Drift Test; O
- Thermal Camera Calibration Verification and Bias Test; O
- Thermal Camera Consistency Test; O
- Thermal Camera Sensitivity Test; o
- BBR Accuracy and Uniformity Test.
Key results: This testing demonstrates that the device meets all FIRSTSense Breast Exam® requirements and specifications. In all instances, the FIRSTSense Breast Exam® functioned as intended and the results observed and reported were as expected.
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
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
First Sense Medical, LLC % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004
Re: K160573
Trade/Device Name: FirstSense Breast Exam Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: May 11, 2016 Received: May 11, 2016
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
FIRSTSense Breast Exam®
Indications for Use (Describe)
The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) SUMMARY
First Sense Medical, LLC's FIRSTSense Breast Exam®
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341 Phone: 770-617-9416 Facsimile: 248-876-9278
Contact Person: Alan Klevens
Date Prepared: May 11, 2016
Name of Device and Name/Address of Sponsor
FIRSTSense Breast Exam®
First Sense Medical, LLC 2001 Centerpoint Parkway, Suite 110 Pontiac, MI 48341
Common/Classification Name
Telethermographic System (Adjunctive Use) (Product Code: LHQ; 21 C.F.R. 884.2980)
Predicate Device
Infrared Sciences Corp., BreastScan IR (K032350)
Intended Use / Indications for Use
The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
Device Description/Technological Characteristics
The FirstSense Breast Exam® system consists of a portable device (FSBE Tester) that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact during a screening test. The device emits no radiation to the patient. The device consists of a thermal camera, a 3D camera, a tester main body consisting of metal and plastic to safely and securely house the electronic and mechanical components and motors (to adjust cameras for various sized patients), a computer, software components and two color monitors, as well as an air cooling unit that blows cool air during part of the screening test cycle. The FSBE system also contains a cloud server for safe storage of test data. During a screening test, the FSBE Tester's thermal camera acquires thermal images, and the 3D camera acquires depth data and visible light images of the patient breasts. When a test is completed, the acquired
4
data is uploaded to the FSBE system's cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.
Performance Data
The device performance was validated by conducting the following tests:
- -The FSBE Tester was tested for its compatibility with both IEC 60601-1-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance collateral standard: Electromagnetic compatibility.
- -The FSBE Tester's mechanical parts and their expected performance are validated during full device validation. specifically during the verification of the device's pre-check routine which checks each device hardware component and its expected functionality. Also during execution of software functional verification tests, the performance of individual mechanical components are verified.
The following verification tests were executed for full device validation:
- FSDAQ software pre-check routine test verifies the pre-check routine and integrity O of device hardware components.
- FSDAQ device log test verifies the device log and software ability to record events O related to test sequence and hardware status.
- FSDAQ test sequence and error manaqement verifies the software for manaqing a o test sequence and managing the errors, as well as verifies device hardware performance during the test sequence.
- FSDAQ data storage and data upload verifies software functionality for temporary O test data storage and test data upload to the server.
- FSDAQ patient positioning verifies the software functionality to provide assistance O to the operator to position the device before the test sequence. Also verifies the hardware components such as the 3D camera and its performance during patient positioning.
- -The thermal camera performance is validated by executing the following thermal camera performance verification tests to evaluate the respective characteristics of the thermal camera:
- Thermal Camera Uniformity Test; o
- Thermal Camera Drift Test; O
- Thermal Camera Calibration Verification and Bias Test; O
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- Thermal Camera Consistency Test; O
- Thermal Camera Sensitivity Test; o
- o BBR Accuracy and Uniformity Test.
The above listed tests summarize the performance and the validation and verification activities conducted for the thermal camera, FSM Black Body Radiator, system performance, software and the device functionality. This testing demonstrates that the device meets all FIRSTSense Breast Exam® requirements and specifications. In all instances, the FIRSTSense Breast Exam® functioned as intended and the results observed and reported were as expected.
Substantial Equivalence
The FIRSTSense Breast Exam® has the same intended uses and indications, as well as similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the FIRSTSense Breast Exam and its predicate device raise no new issues of safety or effectiveness. Thus, the FIRSTSense Breast Exam® is substantially equivalent.
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A comparison table outlining similarities and differences of the predicate device is provided below:
| # | Feature | BreastScan IR ™ (Predicate Device)
K032350 | FIRSTSense Breast Exam®
(Subject Device) | Comments |
|----|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The Infrared Sciences BreastScan
IR™ System is intended for viewing
and recording heat patterns
generated by the human body in the
hospital, acute care settings,
outpatient surgery, healthcare
practitioner facilities or in an
environment where patient care is
provided by qualified healthcare
personnel. The patient populations
include adult. The device is for
adjunctive diagnostic screening for
detection of breast cancer and
diseases affecting blood perfusion or
reperfusion of tissue or organs. This
device is intended for use by qualified
healthcare personnel trained in its
use. | The FirstSense Breast Exam®
system is intended for viewing and
recording heat patterns generated by
the human body in the hospital, acute
care settings, outpatient surgery,
healthcare practitioner facilities or in
an environment where patient care is
provided by qualified healthcare
personnel. The patient populations
include adult. The device is for
adjunctive diagnostic screening for
detection of breast cancer and
diseases affecting blood perfusion or
reperfusion of tissue or organs. This
device is intended for use by qualified
healthcare personnel trained in its
use. | Same |
| 2 | Method of data
collection | Non-contact passive infrared
emissions | Non-contact passive infrared
emissions | Same |
| 3 | Data processing | CPU with custom algorithms | CPU with custom algorithms | Same |
| # | Feature | BreastScan IR™ (Predicate Device)
K032350 | FIRSTSense Breast Exam®
(Subject Device) | Comments |
| 4 | Collection
instrument | Infrared camera | Infrared camera, 3D camera | Substantially Similar
The FSBE system uses a 3D
camera. The FSBE system
includes a 3D camera for proper
patient positioning and acquiring
depth and visible image data
during the screening test. The 3D
camera helps the operator assure
patient positioning before the test
by providing a live patient image.
The depth data and the visible
image data is presented to the
user as additional information
(reference). The depth data and
the visible image data does not
provide any quantitative
information. This minor difference
raises no new safety or
effectiveness concerns because of
the above described reasons. |
| 5 | Measurement
parameters | Allows for measurement of thermal
emissions | Allows for measurement of thermal
emissions | Same |
| # | Feature | BreastScan IR TM (Predicate Device)
K032350 | FIRSTSense Breast Exam®
(Subject Device) | Comments |
| 6 | Storage | Hard disk | Hard disk and cloud server | Substantially Similar
The predicate device uses a local
hard drive for its data storage.
The FSBE system uses a cloud
server to assure long-term safe
and secure storage of data. The
data transferred to the cloud does
not contain any personally
identifiable patient information.
The data transferred to the cloud
only contains data acquired during
the screening test. The data
transfer occurs using an industry
and government standard and
digitally signed cryptographic
certificates. This minor difference
raises no new safety or
effectiveness concerns because all
information is encrypted, stored,
backed up and maintained by a
professional service. |
| 7 | Detector type | Focal plane array | Focal plane array | Same |
| 8 | Detector
resolution | 320 × 240 Pixels | 320 × 240 Pixels | Same |
| # | Feature | BreastScan IR™ (Predicate Device) | FIRSTSense Breast Exam® (Subject Device) | Comments |
| | | K032350 | | |
| 9 | Thermal sensitivity | 80 mK | 50 mK | Substantially Similar
The FSBE uses a thermal camera with a manufacturer-specified sensitivity of 50mK; this is slightly more sensitive than the 80mK specified by the BreastScan IR™. This minor difference in sensitivity of the thermal camera raises no new safety or effectiveness concerns as the camera has been validated as part of the subject system and meets all performance requirements. |
| 10 | Cooling device | Air conditioning unit | Air conditioning unit | Same |
| 11 | Camera output | 14 bit digital | 14 bit digital | Same |
| 12 | User Interface | A monitor is provided to view thermal images during the test. A keyboard and mouse is provided to the operator to enter the patient ID and start a test. | Two touchscreen monitors are provided (operator and patient) to view the thermal images during the test. A keyboard and mouse is provided to the operator to enter the patient ID and start a test. | Substantially Similar |
| # | Feature | BreastScan IR™ (Predicate Device)
K032350 | FIRSTSense Breast Exam®
(Subject Device) | Comments |
| 13 | Result Reporting | BreastScan IR software allows the
user to select breast regions (nipple,
areola, whole breast, breast
quadrants) and regions of interest
(ROI). BreastScan IR provides the
thermal views, and temperature
differentials for the selected breast
regions and ROIs. BreastScan IR
provides report printing capability. | FirstSense Data Viewer (FSDV)
software allows the user to select
breast regions (nipple, areola, whole
breast, breast quadrants) and regions
of interest (ROI). FSDV provides the
thermal views, and temperature
differentials for the selected breast
regions and ROIs. FSDV provides
report printing capability. | Same |
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The subject device has the same intended use and characteristics as the predicate device. Documentation supplied in this submission demonstrates that any difference in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the First Sense Breast Exam® system is substantially equivalent to the predicate device.
Conclusions
- FIRSTSense Breast Exam® has the same intended use as the . predicate device, Infrared Sciences BreastScan IR™ System, and therefore it may be found substantially equivalent;
- FIRSTSense Breast Exam® and the predicate device have the same ● indication statements;
- FIRSTSense Breast Exam® has similar technological characteristics . as the predicate device, Infrared Sciences BreastScan IR™ System
- . The subject device's new technological characteristics, such as the usage of a 3D camera to help the operator initially position the thermal camera and acquire visible images and 3D images during the test, do not raise any new questions of safety or effectiveness;
- . Accepted scientific methods, i.e., bench tests, demonstrated that the effects of the new characteristics do not raise any new questions of safety and effectiveness. Thus, the subject device is substantially equivalent.