(274 days)
The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery.
The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.
target nerves and to locally stimulate them in order to provide a measurable response. The stimulus will have a very small current spread to reduce the innervation of the surrounding nerves.
The concentric design has two main parts, an inner stainless steel wire and an outer cannula also insulated from reading un-intended signals.
The Inner wire is isolated from the outer stainless steel cannula using a biocompatible heat shrink tubing. This Inner Wire acts as the stimulator and is surrounded by the outer cannula. The Outer Cannula is isolated with a biocompatible heat shrink which isolates the outer cannula allowing contact in a localized area of the intended nerves of interest.
The inner wire, the cathode, is stimulated using EMG/EP electroneurodiagnostic equipment cleared for the stimulation of nerve tissue and recording muscle activity during surgical procedures (not part of this 510(k) submission) The outer cannula acts as the anode or reference.
The Inner wire and outer cannula are isolated from each other using a dielectric heat shrink and are connected to a color coded pair of leadwires which are terminated by two DIN 42 802 touch proof connectors. The concentric stimulators are terminated on the distal end inside of a plastic handle and are independently connected to the leadwires.
This document describes a 510(k) submission for the Rhythmlink Disposable Concentric Stimulation Probe. It outlines the safety and effectiveness testing to demonstrate substantial equivalence to a predicate device, not the performance of an AI model. Therefore, many of the requested fields related to AI model acceptance criteria and study design are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional | Probe diameter and lengths within specified ranges (comparable to predicate) | Conducted (specific ranges not explicitly stated, but implied to be acceptable based on comparison to predicate in "Technological Characteristics" table) |
| Performance - Continuity | 0.5 Ohms | Achieved 0.5 Ohms |
| Performance - Hi Pot | No insulator breakdown | Passed (testing of insulator breakdown conducted and analyzed) |
| Performance - Stimulation Delivery | Effective stimulation delivery (comparable to predicate) | Conducted and analyzed (implied to be effective for intended use) |
| Performance - Pull-off Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Performance - Leadwire Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Sterilization | Current, validated EO Sterilization Cycle 93007 met; acceptable residual EtO and ECH levels | Sterilized under Cycle 93007; residuals at "lowest possible limits" |
| Biocompatibility - ISO BET Get Clot Testing | No interference with lysate reaction; no inhibition or enhancement; no clotting at neat concentration; geometric mean endpoint concentration |
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.