The Tractus TissueMapper Image Recording System is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Device Description

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.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Tractus TissueMapper Image Recording System are primarily related to its accuracy in locating regions of interest and its ability to identify masses in phantoms.

Acceptance Criteria	Reported Device Performance
Absolute location of a region of interest: Within one-half of the width of the ultrasound probe.	The device 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. The absolute location of the probe is accurate within one-half of the width of the ultrasound probe. For the Ultrasonix L141-5W/60 60mm linear transducer, this is within 3 cm.
Image location relative to a previously recorded image: Within 1 mm.	Image location, relative to the previously recorded image is accurate to within 1 mm.
Registration accuracy: Similar to or better than the Civco predicate device.	Registration accuracy tests were performed, and the results demonstrated that the selected target location based on the registration calculation is within the same tolerance range or better than the Civco predicate device.
Mass identification in breast phantoms: All masses successfully identified.	System Validation Testing was performed on 2 breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The test set for the "mass identification in breast phantoms" criterion involved 2 breast phantoms with 11 masses total. The data provenance is internal testing conducted in-house by trained personnel in a simulated work-environment, using phantoms. This suggests it's a prospective test of the device's performance in a controlled setting. The country of origin of the data is not explicitly stated.

For the other accuracy criteria (absolute and relative image location, registration accuracy), the document mentions that "testing was conducted in-house by trained personnel in a simulated work-environment using phantoms." It does not specify a distinct "test set" sample size in terms of number of phantoms or measurements for these individual criteria, but implies these were evaluated as part of the overall performance, verification, and validation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth of the test set (the phantoms). It only mentions that testing was conducted "in-house by trained personnel." Given that phantoms were used, the "ground truth" would likely be the known, engineered positions of the masses or regions within the phantoms, rather than clinical expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described for the test set. The ground truth for the test set (phantoms) would be the precisely known physical properties and locations within the phantoms,
eliminating the need for expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No multi-reader multi-case (MRMC) comparative effectiveness study was reported. This device is an image recording device with spatial tracking capabilities, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to the device described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a form of standalone performance testing was done. The performance data focuses on the intrinsic accuracy and functionality of the device itself (the "algorithm only" in terms of its spatial tracking and image recording). The "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" is an example of standalone performance relative to a known ground truth. The device's ability to accurately locate a region of interest within a specified tolerance also describes its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The type of ground truth used for the performance testing was phantom-based ground truth. The document explicitly states that testing was performed "using phantoms." This implies that the locations of masses and reference points within these phantoms were precisely known and served as the absolute ground truth against which the device's measurements were compared.

8. The sample size for the training set

The document does not mention a training set nor any machine learning or AI components that would require a training set. The device is described as an "electronic image recording and storage system" and an "accessory to standard ultrasound systems" that tracks spatial position coordinates. Its functionality relies on electromagnetic tracking and digital image recording, not on learned parameters from a training dataset.

9. How the ground truth for the training set was established

As no training set is mentioned or implied by the device's described functionality,
there is no information on how its ground truth would have been established.

Summary

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K131489

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.

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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 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.).

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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

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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.

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Tractus corporation tissuemapper image recording system

Substantial Equivalence Chart

	[Tractus TissueMapper ImageRecording System, k TBD]	[Civco ElectromagneticTracking System, K092619]
Intended Use	The Tractus TissueMapper ImageRecording System is intended toprovide physicians with tools forelectromagnetic tracking of instrumentswith respect to image data.	The device is intended toprovide physicians with toolsfor electromagnetic tracking ofinstruments with respect toimage data.
Indications for Use	Same as above	Same as above
User Population	Skilled medical professionals	Skilled medical professionals
Technological Characteristics	Accessory to System, Imaging, PulsedEcho, Ultrasonic; Ultrasonic PulsedEcho Imaging System	Accessory to System,Imaging, Pulsed Echo,Ultrasonic; Ultrasonic PulsedEcho Imaging System
Primary component(s)	Software: Position Sensor Monitoring,Image presentation and recording, userinterface	Software: Position SensorMonitoring, Imagepresentation, user interface
	Hardware: Position Sensor Clip(electromagnetic), Sensor Transmitter,Control Computer	Hardware: Position SensorClip (electromagnetic), SensorTransmitter, 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 scanplane)	External and Internal Marker(one scan plane)
Safety Features	Risk analysis developed in accordancewith 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 testingperformed	EMC testing per IEC 60601-1-2;leakage current testing per IEC 60601-1-1; performance, verification andvalidation testing performed per internalprocedures	Not available in 510(k)

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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.

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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.

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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

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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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Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

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