(58 days)
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.
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.
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 (
§ 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.