(830 days)
The MAGELLAN™ system, which is comprised of a medical workstation, a magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions:
- process and display pre-operatively radiographic images on a monitor; .
- provide intra-operative image control based on the position and orientation of a . user directed tool;
- . allow for the integration and usage of the Blosense magnetic location system and a range of different tool attachments; and
- store/retrieve image data on computer access media (e.g. hard disks, archive . media)
Circumstances:
The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considered, and also during surgery when:
- . the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy;
- 방 the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery;
- the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotiated; Or
- the target delineation is important and will not move significantly during the . implementation of the approach (e.g. skull-based tumors. sinus diseases, corpus callosotomies).
I Jisease or Conditions:
The MAGELLAN™ system is indicated for patients who have imaged space occupying lesions or malfunctions (both soft tissue and osscous) in the head.
The Magellan system is a subset of the CARTO system. The CARTO system consists of the location system and the viewing station for the EP application combined together in one product. The Magellan system is the same location system used in CARTO, to be sold separately for use with a range of different 510(k) approved locatable accessory devices and viewing stations for applications.
The provided text describes the Magellan system, a location system intended for intrabody mapping and navigation, specifically for image-guided neurosurgery. However, it does not contain information regarding acceptance criteria, device performance, or any specific study detailing such performance.
The document states that "The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness." This statement implies that the device was evaluated against a predicate device (Biosense CARTO system, K954395), and the testing confirmed substantial equivalence. However, no specific data, acceptance criteria, or study details are provided to support this claim.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on standalone performance.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on the 510(k) summary, regulatory compliance (EMC directive, IEC standards), and the intended use and indications for the Magellan system, along with its substantial equivalence to the CARTO system. It does not elaborate on the specific performance studies that would include the requested criteria.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).