(58 days)
Not Found
No
The document describes image fusion and electromagnetic tracking but does not mention AI, ML, or related concepts like deep learning or neural networks. The performance studies focus on safety and compatibility testing, not algorithmic performance metrics typical of AI/ML devices.
No
The device is described as a tool for electromagnetic tracking and image fusion, aiding in navigation and registration during medical imaging procedures. It does not directly treat or diagnose a disease or condition.
No
The device is intended for electromagnetic tracking of instruments and image fusion, serving as a tool for navigation and guidance rather than diagnosing a condition.
No
The device description explicitly details physical components like fluid-filled cavities, adhesive tape, skin marking areas, and a connection point for an electromagnetic sensor accessory. It also mentions biocompatibility testing and MR safety testing for these physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly indicate that this device is used externally on the patient's skin to aid in image fusion and tracking of instruments within the body during procedures. It does not analyze biological samples.
- The device's function is related to image guidance and tracking. Its purpose is to provide registration points and facilitate the fusion of medical images (MRI and ultrasound) and track instruments in relation to those images. This is a function related to medical imaging and navigation, not diagnostic testing of biological samples.
Therefore, this device falls under the category of a medical device used for image guidance and tracking, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO, LNH
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 following model is included in this submission:
Part No. 610-1306, Device Name 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) and ultrasound (US)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / healthcare facility/hospital
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)
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.
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 (
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of an eagle with three stripes extending from its head, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
1
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
2
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.
Section 5 - 510(k) Summary
A. Submitter Information
| Submitter Name & Address: | CIVCO Medical Instruments Co., Inc.
d/b/a CIVCO Medical Solutions
102 First Street South
Kalona, IA 52247 |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amanda Stahle, Regulatory Affairs Specialist
Telephone: 319-248-6628, Fax: 877-218-0324
amanda.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 Tracker
Active Fiducial Marker
System, Imaging, Pulsed Echo, Ultrasonic (892.1560)
System, Nuclear Magnetic Resonance Imaging (892.1000)
Class II
Radiology
IYO, LNH |
B. Predicate Device
The proposed device is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer |
|---|---|
| Active Fiducial Marker in K092619 Electromagnetic Tracking | |
| System | CIVCO Medical |
| Instruments 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
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.
| 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 |
4
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
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.
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 (