(79 days)
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
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.
The provided text describes a 510(k) summary for an Electromagnetic Tracking System. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or performance data.
The document primarily focuses on:
- Intended Use: Electromagnetic tracking of instruments with respect to image data.
- Device Description: EM sensor within tracked instruments, used with OEM imaging devices, and various accessories (EMT sensor covers, EMT slot guide, skin markers).
- Predicate Devices: A list of previously cleared devices to which the current device claims substantial equivalence.
- Substantial Equivalence Claim: Based on equivalent intended uses, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, with the only noted difference being qualification with the GE Logiq E9 system.
- FDA Clearance Letter: Confirming the 510(k) clearance and regulatory details.
- Indications for Use: Reiterating the intended use.
Therefore, I cannot provide the requested table and study details as they are not present in the input text. The document states that "There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system," which implies that the substantial equivalence argument, rather than a new performance study against specific acceptance criteria, was the primary basis for clearance.
§ 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.