(104 days)
The Malleable Suction™ Instrument is indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software.
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.
The Malleable Suction™ Instrument is indicated for use in the following procedures:
- . Pituitary tumor removal only ENT procedures
- CSF leak repair only related or from an ENT procedure . ●
- Skull base procedures for ENT access .
- Transsphenoidal procedures .
- · Intranasal procedures
- Optic nerve decompression procedures .
- . Orbital decompression procedures
- . Polyposis procedures
- Endoscopic dacryocystorhinostomy .
- Encephalocele procedures .
- Sinus procedures, such as maxillary antrostomies .
- Ethmoidectomies .
- Sphenoidotomies/sphenoid explorations .
- Turbinate resections and frontal sinusotomies .
The Malleable Suction instruments are sterile, single use instruments intended for use with the ENT software applications on a Medtronic computer assisted surgery systems, StealthStation® systems (S7, i7 and Fusion®). The Malleable Suction instruments are electromagnetically navigated devices that are designed to be bendable by hand into a shape by the user in order to customize the instrument to the needs of the surgeon for each individual patient's anatomy and disease.
Each Malleable Suction instrument incorporates a tracking system within the instrument tip. The mobile emitter of the navigation system generates a low-energy magnetic field to locating the tracker mounted within the tip of the instrument. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
The instrument attaches to, and functions with, standard surgical vacuum suction systems and comes with a cleaning stylet to assist in dislodging blockages.
Here's a breakdown of the acceptance criteria and the study information for the Medtronic Malleable Suction™ Instruments based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy Requirement | Bench-top and simulated environment: 95% confidence / 99.5% reliability, as dictated by risk analysis, of ≤ 3.00 mm. |
| Suction Capabilities | Capable of removing fluids, semi-fluid substances, tissue, and bone dust. |
| Shaft Flex/Configurations | Bendable, configuration surgeon defined |
| Tip Configurations | Standard (straight), Angle, Ball |
| Materials | Aluminum shaft, Pebax Liner, LCP Tip, Polyester Shrink tubing |
| Sterile/Reusable | Sterile, Single Use |
Note on "Reported Device Performance": The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the types of tests performed. For some criteria, such as "Shaft Flex/Configurations," "Tip Configurations," "Materials," and "Sterile/Reusable," the "reported device performance" is essentially a description of the device's characteristics that meet the intended design and comparison with predicate devices. The accuracy criterion is the most quantitative.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for a "test set" in the context of an algorithm or AI performance evaluation. The "Accuracy" testing was conducted in "2D and 3D space" and "Accelerated Life Functionality" tests involved "accelerated life exposures and user conditions" in a "bench-top and simulated environment." The data provenance is described as "bench-top and simulated environment," implying laboratory testing rather than human patient data, and therefore, no specific country of origin or retrospective/prospective designation applies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and is not provided in the document. The device is a physical surgical instrument and not an AI or diagnostic algorithm that requires expert ground truth for its performance evaluation for this 510(k) submission.
4. Adjudication Method
This information is not applicable. The device is a surgical instrument, and its performance testing as described does not involve expert adjudication of results in the way an AI diagnostic tool would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission for a surgical instrument, not an AI or software device that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study
No. This document describes a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance, specifically its accuracy, would be established by metrology standards and measurements in a controlled laboratory environment. For functionality tests like suction capabilities and malleability, the ground truth is simply whether the device performs its intended mechanical function as designed and specified.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning algorithm, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).