(79 days)
No
The description focuses on electromagnetic tracking and image registration using physical sensors and markers, with no mention of AI or ML algorithms for image analysis, tracking, or other functions.
No.
The device's intended use is to provide tools for electromagnetic tracking of instruments with respect to image data to assist with navigating a tracked instrument, not for treating a disease or condition.
No
The device is used for tracking and navigation of instruments during procedures, not for diagnosing medical conditions. It assists physicians by combining instrument tracking with image data.
No
The device description explicitly mentions hardware components such as "attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor." It also mentions utilizing an "electromagnetic sensor in the tracked instrument" and an "EM field introduced by OEM equipment." These are all physical components, not solely software.
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 state that this device is used for tracking instruments within the body during procedures, in conjunction with imaging data. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The purpose is navigation and tracking, not diagnosis based on specimen analysis. The device assists physicians in navigating instruments relative to image data, which is a procedural aid, not a diagnostic test performed on a specimen.
The device falls under the category of surgical navigation systems or image-guided surgery systems, which are distinct from IVDs. The predicate devices listed also support this classification, as they are primarily ultrasound systems, navigation systems, and needle guides, none of which are IVDs.
N/A
Intended Use / Indications for Use
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Product codes
IYO, JAK
Device Description
Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor
The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument.
The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082185, K080624, K040050, K053610, K970513, K974432, K011418, K002258, K882383, K071204, K030064
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
1092619
NOV 1:3 2009
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
CIVCO Medical 102 First Street South Kalona, IA 52247-9589 USA
Phone: 319-656-4447 Fax: 877-218-0324
| Contact Person: | Jim Leong |
|---|---|
| Date of Summary: | September 22, 2009 |
| Trade/Proprietary Name: | Electromagnetic System |
| Classification Name: | EMT Devices |
| Product Code: | IYO |
| JAK |
Intended Use:
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Device Description:
Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor
The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument.
The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.
EMT Sensor Covers:
The cover allows use of a sensor for body surface, endocavity and intra-operative applications while helping to prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.
1
EMT Slot Guide:
The disposable needle guide is intended to attach to a bracket and provide physicians with a tool to keep an instrument in plane during ultrasound procedures. て
Skin Markers:
The skin markers are intended to provide an image registration point for use in fusion of sequential imaging data and intracorporeal instrument tracking when combined with appropriate software delivered in the OEM equipment.
Predicate Devices:
The following predicate devices were referenced in the submission.
K082185 - GE Medical Systems, GE Logiq E9 Diagnostic Ultrasound System
K080624 - CAS Innovation AG, NavStation / RAD EMT
K040050 - InstaTrack with Multiple Dataset Navigation
K053610 - ABARIS Computer assisted, image-guided surgery system
K970513 - Poly ultrasound probe cover
K974432, K011418, K002258 - UltraGuide
K882383 - Maggi ultrasound needle guide
K071204 - SiteRite 6 Ultrasound System and guide
K030064 - iLook 25 Needle Guide attachment and Bracket Assembly
Substantial Equivalence:
CIVCO Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the listings above. CIVCO Medical Instruments claims this equivalence because the proposed devices have equivalent intended uses, manufacturing materials, operating principals, and physical, operational specifications as compared to the predicate devices.
There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
CIVCO Medical Instruments Co., Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 250 Street NW BUFFALO MN 53313
NOV 1 3 2009
Re: K092619
Trade/Device Name: Electromagnetic Tracking System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: September 29, 2009 Received: September 30, 2009
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.
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
3
Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device relation adverse overse) { if regulation (21 CFR Part 820); and if applicable, the electronic form at the qualing of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you actubers in www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K092619
Device Name: Electromagnetic Tracking System
Indications for Use:
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
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 Device Evaluation (ODE)
Page 1 of 1
Vision Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K092619 |
|---|---|
| --------------- | --------- |