(153 days)
K001284, Exempt
Not Found
No
The description focuses on a computer-assisted surgery system using magnetic tracking and software to display the location of a surgical instrument within patient images. There is no mention of AI or ML algorithms being used for image analysis, decision support, or any other function. The system appears to be a navigation tool based on established tracking technology.
No
The device is used for incision and removal of tissue/bone and surgical guidance, but it is explicitly stated that it "does not replace the surgeon's knowledge, expertise, or judgment" and is an "aid for precisely locating anatomical structures." It is a surgical tool and guidance system, not a device that directly treats a condition.
No
Explanation: The device is described as a surgical instrument intended for incision and removal of tissue and bone, and a computer-assisted surgery system intended as an aid for precisely locating anatomical structures during surgery. Its purpose is to guide surgical procedures, not to diagnose medical conditions.
No
The device description explicitly mentions hardware components like the Quadcut® surgical instrument, StraightShot M4 handpiece, XPS and IPC Systems (providing power), a tracker mounted on the blade, and a mobile emitter generating a magnetic field. While software is involved for navigation, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this system is a surgical instrument intended for the incision and removal of tissue and bone during surgical procedures. It also includes a navigation system to aid the surgeon in precisely locating anatomical structures during the surgery.
- No Sample Analysis: There is no mention of the device analyzing any samples taken from the patient's body. Its function is entirely focused on surgical intervention and guidance within the body.
Therefore, the XPS/IPC System with the navigated Quadcut® is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.
The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT - or MR-based model, or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The navigated Quadcut® is a sterile, single use surgical instrument intended for the incision and removal of soft and hard tissue or bone in general otothinolaryngology, head and neck and otoneurological surgery. Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems. The XPS and IPC systems provide power to drive the blades during ENT procedures.
Quadcut® is intended for attachment to the M4 hand piece for use in conjunction with Fusion ENT software on a Medtronic computer-assisted surgery system. Each blade has a tracker mounted on it to allow for navigation during the ENT surgical procedure. The system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. Then, the software displays the location of the blade's tip within multiple patient image planes and other anatomical renderings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with Medtronic Navigation systems and Fusion software was conducted to ensure acceptable navigational accuracy. Test samples were subjected to simulated real-life use conditions during functional testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop and simulated environment: 95% confidence / 99.5% reliability, as dictated by risk analysis, of
§ 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).
0