The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.

Device Description

The proposed device contains multiple fluid-filled cavities that serve as registration points (markers) in MR. Adhesive tape on the bottom of the proposed device is used to secure the device to the patient. Skin marking areas allow for repositioning in both MR and ultrasound environments. The device also provides a connection point for an electromagnetic sensor accessory. The proposed device is provided non-sterile, is intended for single patient use, and is manufactured of non-magnetic materials. The proposed device enables automatic or manual image fusion of real-time ultrasound to previously acquired MR data sets. The proposed device may also be used to aid in image fusion of real-time ultrasound to previously acquired ultrasound data sets.

AI/ML Overview

The provided document (K143396) describes the omniTRAX™ Active Patient Tracker, which is an active fiducial marker. The document focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its safety and compatibility for use in Magnetic Resonance (MR) environments, as well as its intended use in ultrasound (US) environments for electromagnetic (EM) tracking.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on safety and compatibility in MR environments, rather than performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices. The device's performance is reported in terms of passing these safety tests.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
MR Safety & Compatibility	Adherence to specific ASTM standards for MR safety:- RF Heating (ASTM F2182-11a): The device must not pose an unacceptable risk of heating when exposed to Radiofrequency fields in an MRI scanner.- Magnetic Induced Torque (ASTM F2052-06): The device must not experience significant torque (rotational force) when subjected to the magnetic field of an MRI scanner, which could cause movement and potential injury.- Magnetically Induced Displacement Force (ASTM F2213-06): The device must not experience significant translational force (pulling or pushing) when subjected to the magnetic field gradient of an MRI scanner, which could cause it to move or become dislodged.- Magnetic Field Interactions (ASTM F2119-07 - modified): Although specifically for implants, modifications were made for external use, implying assessment of interactions with the magnetic field. The acceptance criterion would be that the device does not show adverse interactions.	- RF Heating: "The devices passed the acceptance criteria for RF heating."- Magnetic Induced Torque: "The devices passed the acceptance criteria for... magnetic induced torque."- Magnetically Induced Displacement Force: "The devices passed the acceptance criteria for... magnetically induced displacement force."- Magnetic Field Interactions (modified F2119-07): "The devices passed the acceptance criteria for... [other aspects related to magnetic field interactions]." (Implied from the general statement, as F2119-07 covers this broader category).- Localized Image Artifact: While not an "acceptance criterion" in the sense of a pass/fail for safety, the document notes that "Localized image artifact was observed" and that "information regarding location and size of the artifacts has been included in the Instructions for Use," indicating this was an expected outcome that needed to be addressed through labeling rather than eliminated.
Biocompatibility	Compliance with ISO 10993 standards for biological evaluation of medical devices (for skin contact):- Cytotoxicity (ISO 10993-5:2009/(R) 2014): Materials should not be toxic to cells.- Sensitization & Irritation (ISO 10993-10:2010): Materials should not cause allergic reactions or skin irritation. The device is intended for "limited contact duration (<24 hours) for surface devices (skin)."	"Biocompatibility testing was also completed for patient-contacting materials according to ISO 10993-5:2009/(R) 2014 and ISO 10993-10:2010." (Implied pass, as non-compliance would prevent substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical study or performance evaluation with human data. The testing described is non-clinical testing of the device itself (materials, physical interactions).

Sample Size for Non-Clinical Testing: Not explicitly stated numerically. The text refers to "the devices" (plural), implying multiple units of the omniTRAX™ Active Patient Tracker were subjected to the tests.
Data Provenance: The data provenance is from laboratory testing (non-clinical) conducted against engineering standards (ASTM, ISO). There is no mention of human subject data, country of origin, or retrospective/prospective nature as would be relevant for clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of testing described in the document. The ground truth for MR safety and biocompatibility testing is defined by the established ASTM and ISO standards themselves, which specify procedures and acceptable limits for physical and biological interactions. Experts are involved in conducting and interpreting these standardized engineering tests, but not in establishing a "ground truth" through consensus in the way clinical diagnostic studies do.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the non-clinical engineering and biological safety testing performed. The results are typically quantitative measurements compared against predefined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not described in this document. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks, which is not the scope of this device (an active fiducial marker).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical medical instrument (an active fiducial marker) for tracking, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's function is to serve as a physical marker for electromagnetic tracking in conjunction with imaging modalities and human intervention.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is defined by adherence to established engineering standards (ASTM for MR safety, ISO for biocompatibility). These standards set the benchmarks and methodologies for determining safety and compatibility. For example, the ground truth for RF heating is that the temperature rise must be within acceptable limits as defined by ASTM F2182-11a.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this device is not an AI algorithm requiring a training set or associated ground truth establishment for training.

Summary

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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

CIVCO Medical Instruments Co., Inc. d/b/a CIVCO Medical Solutions % Ms. Amanda Stahle Regulatory Affairs Specialist 102 First Street South KALONA IA 52247

January 23, 2015

Re: K143396

Trade/Device Name: omniTRAX™ Active Patient Tracker Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, LNH Dated: November 21, 2014 Received: November 26, 2014

Dear Ms. Stahle:

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. Iisting 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-Ms. Stahle

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/ResourcesforYou/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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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): K1 4 3 3 9 6

Device Name: Active Fiducial Marker

Indications for Use: The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.

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)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K143396

Page 1 of 1

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Image /page/3/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the company name in a simple, sans-serif font. The words "MEDICAL SOLUTIONS" are written in smaller letters below the company name.

WWW.CIVCO.COM

Section 5 - 510(k) Summary

A. Submitter Information

Submitter Name & Address:	CIVCO Medical Instruments Co., Inc.d/b/a CIVCO Medical Solutions102 First Street SouthKalona, IA 52247
Contact Person:	Amanda Stahle, Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com
Date Summary Prepared:	November 21, 2014
Trade Name:Common Name:Classification Names &Numbers:Device Class:Review Panels:Product Codes:	omniTRAXTM Active Patient TrackerActive Fiducial MarkerSystem, Imaging, Pulsed Echo, Ultrasonic (892.1560)System, Nuclear Magnetic Resonance Imaging (892.1000)Class IIRadiologyIYO, LNH

B. Predicate Device

The proposed device is substantially equivalent to the following predicate device:

Predicate Device	Manufacturer
Active Fiducial Marker in K092619 Electromagnetic TrackingSystem	CIVCO MedicalInstruments Co., Inc.

The purpose of this 510(k) is to expand the indications for use of the proposed device to include use in the MR environment and update the device design. CIVCO has conducted MR safety and compatibility testing to confirm that the proposed device can be safely used in the MR environment.

C. Device Description

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	ⓞ 319.248.6757	Ⓕ 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	ⓞ 319.248.6757	Ⓕ 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	ⓞ +31(0) 182.394495	Ⓕ +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	ⓞ 712.737.8688	Ⓕ 712.737.8654

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The proposed device is provided non-sterile, is intended for single patient use, and is manufactured of non-magnetic materials. The following model is included in this submission:

Part No.	Device Name
610-1306	omniTRAX™ Active Patient Tracker

The proposed device enables automatic or manual image fusion of real-time ultrasound to previously acquired MR data sets. The proposed device may also be used to aid in image fusion of real-time ultrasound to previously acquired ultrasound data sets. The device is used in a healthcare facility/hospital.

D. Indications for Use/Intended Use

E. Comparison of Technological Characteristics

Technological characteristics that have changed between the proposed and predicate device include changes in design and materials. The proposed device consists of four fluid-filled markers positioned at specific locations whereas the predicate device consisted of a single fluid-filled marker. Both devices provide a mount area for attachment of an electromagnetic sensor accessory. The proposed device contains skin marking areas whereas the predicate device does not contain these areas. Different materials were used to manufacture the proposed device and were selected with MR safety and effectiveness considerations.

F. Non-Clinical Testing

Non-clinical testing was completed to confirm that the proposed device is as safe and effective as the predicate device and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness. This included MR safety and compatibility testing in accordance with ASTM Standards F2182-11a, F2052-06. and F2213-06. Testing was also completed using ASTM Standard F2119-07. but modifications were made to accommodate the external use of the device (not implanted). The devices passed the acceptance criteria for RF heating, magnetic induced torque, and magnetically induced displacement force and demonstrate that the device is safe for use in the MR environment. Localized image artifact was observed, and information regarding location and size of the artifacts has been included in the Instructions for Use.

Corporate Headquarters	102 First Street South	Kalona, IA 52247	USA	319.248.6757	319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	319.248.6757	319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	+31(0) 182.394495	+31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	712.737.8688	712.737.8654

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Image /page/5/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in a sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller font.

WWW.CIVCO.COM

Biocompatibility testing was also completed for patient-contacting materials according to ISO 10993-5:2009/(R) 2014 and ISO 10993-10:2010. The device is intended for limited contact duration (<24 hours) for surface devices (skin).

G. Conclusion

This premarket submission for the ornniTRAX™ Active Patient Tracker has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

Corporate Headquarters 102 First Street South		Kalona, IA 52247	TUSA	P 319.248.6757	3 319.248.6660
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	0 319.248.6757	(3 319.248.6660
Europe Office	Pasteurstraat 6	2811 DX Reeuwijk	The Netherlands	0 +31(0) 182.394495	1 +31(0) 182.395014
Orange City Office	1401 8th Street SE	Orange City, IA 51041	USA	0 712.737.8688	G 712.737.8654

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.