(33 days)
Not Found
No
The description focuses on image recording, storage, and electromagnetic tracking, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as an "electronic image recording and storage system" and an "accessory to standard ultrasound systems" for electromagnetic tracking of instruments with respect to image data. Its primary function is to record and store images and their spatial coordinates, not to directly treat or diagnose a condition.
No
The device is described as an "Image Recording System" that acts as an "accessory to standard ultrasound systems" for recording and storing images along with spatial position coordinates. Its intended use is to provide "tools for electromagnetic tracking of instruments with respect to image data," not to directly diagnose medical conditions.
No
The device description explicitly mentions hardware components like an electronic image recording and storage system, video input ports (VGA/DVI), and magnetic location sensors attached to the ultrasound probe via a clip.
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 tools for electromagnetic tracking of instruments with respect to image data. This is a system for image guidance and navigation during procedures, not for analyzing biological samples in vitro.
- Device Description: The device records and stores images from standard ultrasound systems and tracks the spatial position of the imaging probe. It does not perform any analysis or testing on biological specimens.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly described as an accessory to standard ultrasound systems for image recording and tracking, which falls under the category of medical imaging and navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Product codes
IYO
Device Description
The TissueMapper Image Recording System consists of:
- the Tractus TissueMapper Image Recording System Application software
- the Tractus TissueMapper Image Recording System hardware
The TissueMapper Image Recording System is an electronic image recording and storage system. The device is an accessory to standard ultrasound systems and allows the digital recording images from those standard ultrasound devices, along with the spatial position coordinates of the recorded images. The images are recorded from the video out port of the standard ultrasound device. The images are recorded as output from the video output of the standard ultrasound imaging device. Brightness, contrast, and gamma are not adjusted by the program. Images are recorded using Video Graphics Array (VGA) or Digital Video Interface (DVI) video output formats. Images are displayed and saved as uncompressed, 8-bit grayscale images. No loss of data occurs with this image format. The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip. The accuracy of the absolute location of any image recorded with the TissueMapper Image Recording System is intended to allow identification of a region of interest in a subsequent review and allow accurate placement of an ultrasound probe in another, subsequent, diagnostic ultrasound procedure. As such, the system specifications are that the device will accurately locate that region of interest, thus the absolute location of the probe, within one-half of the width of the ultrasound probe. This accuracy is not sufficient to determine the appropriate placement of a needle (for biopsy) or tissue marker, or to direct other interventional procedures without real-time imaging. Interventional procedures should be guided by standard real-time imaging techniques (such as real-time, handheld, ultrasound guidance) and should not be performed solely with the TissueMapper images. Image location, relative to previously defined anatomic marker (such as the nipple), is accurate to within ½ of a probe width (3cm in the case of the Ultrasonix L141-5W/60 60mm linear transducer). Image location, relative to the previously recorded image is accurate to within 1 mm. The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip. Images are not reviewed on the TissueMapper Image Recording System for diagnostic or screening findings. Clinical review of recorded images is performed at a separate workstation and that workstation is not a component of the Tractus TissueMapper Image Recording System. Images are reviewed for quality only (shadowing, etc.).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Small Parts (Breast)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Skilled medical professionals
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
Performance, Verification and Validation testing for TissueMapper Image Recording System was performed per internal procedures to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional and accuracy test results. Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was similar to that of the Civco predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Civco predicate device. System Validation Testing of the Tractus TissueMapper Image Recording System was performed on 2 breast phantoms with 11 masses total randomly positioned.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
System Validation Testing of the Tractus TissueMapper Image Recording System was performed on 2 breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified. The results of these tests demonstrate that the TissueMapper Image Recording System validation is within specification. In all instances, the TissueMapper Image Recording System functioned as intended and the operation observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Civco Electromagnetic Tracking System (K092619)
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
510(k) SUMMARY
JUN 2 5 2013
Tractus TissueMapper Image Recording System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tractus Corporation
2010 Crow Canyon Place Suite #100, San Ramon, CA 94583
Phone: (925) 359-3280 Facsimile: (866) 397-4732
Contact Person: Eric A. Eggers.
Date Prepared: March 21, 2013
Name of Device and Name/Address of Sponsor
Tractus TissueMapper Image Recording System
Tractus Corporation
2010 Crow Canyon Place Suite #100
San Ramon, CA 94583
Common or Usual Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: 21 CFR 892.1560
Product Code: IYO
Device Class: Class II
Predicate Device: Civco Electromagnetic Tracking System (K092619)
Intended Use / Indications for Use:
The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
1
Technological Characteristics
The TissueMapper Image Recording System consists of:
- . the Tractus TissueMapper Image Recording System Application software
- . the Tractus TissueMapper Image Recording System hardware
The TissueMapper Image Recording System is an electronic image recording and storage system. The device is an accessory to standard ultrasound systems and allows the digital recording images from those standard ultrasound devices, along with the spatial position coordinates of the recorded images.
The images are recorded from the video out port of the standard ultrasound device. The images are recorded as output from the video output of the standard ultrasound imaging device. Brightness, contrast, and gamma are not adjusted by the program. lmages are recorded using Video Graphics Array (VGA) or Digital Video Interface (DVI) video output formats. Images are displayed and saved as uncompressed, 8-bit grayscale images. No loss of data occurs with this image format.
The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip. The accuracy of the absolute location of any image recorded with the TissueMapper Image Recording System is intended to allow identification of a region of interest in a subsequent review and allow accurate placement of an ultrasound probe in another, subsequent, diagnostic ultrasound procedure. As such, the system specifications are that the device will accurately locate that region of interest, thus the absolute location of the probe, within one-half of the width of the ultrasound probe. This accuracy is not sufficient to determine the appropriate placement of a needle (for biopsy) or tissue marker, or to direct other interventional procedures without real-time imaging. Interventional procedures should be guided by standard real-time imaging techniques (such as real-time, handheld, ultrasound guidance) and should not be performed solely with the TissueMapper images. Image location, relative to previously defined anatomic marker (such as the nipple), is accurate to within ½ of a probe width (3cm in the case of the Ultrasonix L141-5W/60 60mm linear transducer). Image location, relative to the previously recorded image is accurate to within 1 mm.
The Imaging probe location is monitored and location identifiers are stored with each recorded image. Magnetic location sensors are attached to the hand-held ultrasound imaging probe via a clip. Images are not reviewed on the TissueMapper Image Recording System for diagnostic or screening findings. Clinical review of recorded images is performed at a separate workstation and that workstation is not a component of the Tractus TissueMapper Image Recording System. Images are reviewed for quality only (shadowing, etc.).
2
The TissueMapper Image Recording System requires the following:
- · Tractus Image Recording System Application software which will run on a computer with display with the following specifications listed below
- . Off-the-Shelf Tower PC Computer to run TissueMapper Image Recording System application software, which meets the following · requirements
- · Minimum 500 GB Hard Drive
- · Minimum 2.5GHz processor
- · Operating System: Linux
- · Minimum 8GB RAM
- · Minimum Quad-core processor
- · Certified to UL/IEC 60950 ITE standard
- · ≥4 USB Ports of USB 2.0 or better
- Wired Ethernet
- . Computer User Interface
- · Kevboard
- · Display
- Minimum display size 17" ◆
- Minimum display resolution 1280x1024
- · Trackball pointing device
- . Off-the-Shelf Framegrabber
- · PCI Framegrabber card inserted into tower computer card slot of computer noted above
- · Video cable from ultrasound system to Framegrabber
- Off-the-Shelf probe position detection subsystem (Ascension . Technologies)
- · Sensor position interface electronics (Ascension DriveBay) inserted into tower computer card slot of computer noted above
- · Sensor position transmitter (Ascension MRT) and electronics connected to DriveBay by cable
- · Three position sensors (Ascension) and electronics connected to DriveBay by cables
- · Urethane clip for affixing three position sensors to ultrasound transducer
- . Off-the-Shelf 3 pedal foot-switch connected to PC by USB interface
- . Off-the-Shelf cart with wheels for mounting computer system
- . Off-the-Shelf isolation transformer certified to UL2601 connecting computer to power source
- . Mounting structure for position transmitter
- . Off-the-shelf media storage (USB) to move Tractus TissueMapper Image Recording System image files from off-the-shelf computer noted above to another computer (PC) running Tractus TissueMapper Reviewer Application
Pursuant to 809.92(a)(6), basically, both the applicant's device ("Tractus TissueMapper Image Recording System") and the predicate device ("Civco Electromagnetic Tracking System"), allow for spatially mapping with calibrated
3
spatial positioning devices for subsequent review, employ electromagnetic sensors to detect the location of an ultrasound transducer for a registration of transducer location with respect to the region of body scanned with ultrasound, allow for collection of ultrasound images gathered in the course an ultrasound scan and include software products that run on PC computers. The only technological difference between the Tractus TissueMapper Image Recording System and its predicate ("Civco Electromagnetic Tracking System") is the TissueMapper Image Recording System will always be used in a non-sterile procedure setting, thus it does not require the sterile sensor covers that may be used with the Civco Electromagnetic Tracking System if a sterile procedure is performed. Both the applicant's device ("Tractus TissueMapper Image Recording System") and the predicate device ("Civco Electromagnetic Tracking System") are accessories to an Ultrasonic Pulsed Echo Imaging System that have a Moderate Level of Concern.
The Tractus TissueMapper Image Recording System software is Safety Class B according to ANSI/AAMI/IEC 62304:2006. Determination of the LOC and Safety Class is the result of risk assessment activities per ISO 14971.
4
Tractus corporation tissuemapper image recording system
Substantial Equivalence Chart
| | [Tractus TissueMapper Image
Recording System, k TBD] | [Civco Electromagnetic
Tracking System, K092619] |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Tractus TissueMapper Image
Recording System is intended to
provide physicians with tools for
electromagnetic tracking of instruments
with respect to image data. | The device is intended to
provide physicians with tools
for electromagnetic tracking of
instruments with respect to
image data. |
| Indications for Use | Same as above | Same as above |
| User Population | Skilled medical professionals | Skilled medical professionals |
| Technological Characteristics | Accessory to System, Imaging, Pulsed
Echo, Ultrasonic; Ultrasonic Pulsed
Echo Imaging System | Accessory to System,
Imaging, Pulsed Echo,
Ultrasonic; Ultrasonic Pulsed
Echo Imaging System |
| Primary component(s) | Software: Position Sensor Monitoring,
Image presentation and recording, user
interface | Software: Position Sensor
Monitoring, Image
presentation, user interface |
| | Hardware: Position Sensor Clip
(electromagnetic), Sensor Transmitter,
Control Computer | Hardware: Position Sensor
Clip (electromagnetic), Sensor
Transmitter, Control Computer |
| Accessories | Media storage (USB) | Sensor covers |
| Virtual Navigator Software | Yes | Yes |
| Primary Application | Abdominal, Small Parts (Breast) | Abdominal, small parts |
| Tracking System | Electromagnetic (Ascension) | Electromagnetic (Ascension) |
| Registration | External and Internal Marker (one scan
plane) | External and Internal Marker
(one scan plane) |
| Safety Features | Risk analysis developed in accordance
with ISO 14971 | Not available in 510(k) |
| Software | Yes | Yes |
| 3-D Rendering | Yes | Yes |
| Supported Imaging Modalities | Ultrasound | Ultrasound |
| Software level of concern | Moderate level of concern | Moderate level of concern |
| Standards used and testing
performed | EMC testing per IEC 60601-1-2;
leakage current testing per IEC 60601-
1-1; performance, verification and
validation testing performed per internal
procedures | Not available in 510(k) |
5
Electrical Testing
EMC testing per IEC 60601-1-2 and leakage current testing per IEC 60601-1-1 were performed for the TissueMapper Image Recording System. All test results were acceptable for the TissueMapper Image Recording System.
Performance Data
Performance, Verification and Validation testing for TissueMapper Image Recording System was performed per internal procedures to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional and accuracy test results. Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was similar to that of the Civco predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Civco predicate device. System Validation Testing of the Tractus TissueMapper Image Recording System was performed on 2 breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified.
The results of these tests demonstrate that the TissueMapper Image Recording System validation is within specification.
As such, TissueMapper Image Recording System is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today. The software performs as well as, or better than legally marketed predicate devices.
Tractus' TissueMapper Image Recording System indications for use are drawn from the indications for use of a leqally marketed predicate device: Civco Electromagnetic Tracking System. Tractus TissueMapper Image Recording System draws from features of this predicate device and does not provide novel functionality. As such, the features provided by Tractus TissueMapper Image Recording System do not in themselves raise new concerns of safety or effectiveness.
In all instances, the TissueMapper Image Recording System functioned as intended and the operation observed was as expected.
Substantial Equivalence
The TissueMapper Image Recording System is as safe and effective as the Civco Electromagnetic Tracking System. The TissueMapper Image Recording System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the TissueMapper Image Recording System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the TissueMapper Image Recording System is as safe and effective as Civco Electromagnetic Tracking System Application Thus, the TissueMapper Image Recording System is substantially equivalent.
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, with three curved lines extending upwards.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2013
Tractus Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K131489
Trade/Device Name: TractusTissueMapper Image Recording System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: May 22, 2013 Received: May 29, 2013
Dear Mr. Job:
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.
7
Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K131489
Device Name: Tractus TissueMapper Image Recording System
Indications for Use:
The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Samung M. Mendo
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K131489
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