(377 days)
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro - myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles.
BIONEN Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of stainless steel or platinum. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.
The BIONEN Disposable Monopolar/Subdermal Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography/Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The BIONEN Disposable Monopolar Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The provided text describes BIONEN Needle Electrodes (Disposable Concentric, Disposable Monopolar/Subdermal, and Disposable Monopolar Needle Electrodes) and summarizes the non-clinical tests performed to demonstrate their functionality and safety, asserting substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with quantifiable metrics for device performance (e.g., sensitivity, specificity, accuracy, or precision in signal recording) nor a study that directly proves the device meets such criteria through a clinical validation or comparative effectiveness study.
Instead, the document focuses on compliance with established standards for medical devices and material safety, and performance characteristics related to the physical integrity and electrical properties of the electrodes.
Therefore, many of the requested sections about acceptance criteria and study details cannot be fully extracted as they are not present in the provided text.
Here's a breakdown of what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio, diagnostic accuracy) are not explicitly stated, nor are comparative performance values against the predicate devices for these aspects. The document focuses on performance related to physical attributes and safety.
| Acceptance Criteria Category | Specific Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Penetration and friction force (according to DIN 13097) (Concentric Needle) | "The result of testing indicates that the electrodes are as safe, as effective, and perform at least as safely and effectively as the legally marketed device." (Concentric Needle) |
| Sharpening, Bevel and burrs (visual examination with microscope camera) | "Needs meet criteria" (implied by "Quality control tests" and "Tests performed") | |
| Electrical Performance | Electrical continuity and insulation of poles (automated 100% control for Concentric; audible ohmmeter for Monopolar/Subdermal on 10%) | "Needs meet criteria" (implied by "Quality control tests" and "Tests performed") |
| Biocompatibility | Non-cytotoxicity (ISO 10993-5), Non-irritancy (ISO 10993-10), Non-sensitization (ISO 10993-10) | Cytotoxicity: Test article treated extract cells were 97% viable (NON-CYTOTOXIC) |
| Intracutaneous Reactivity: No erythema (Grade 0) or oedema (Grade 0) effects (NON-IRRITANT) | ||
| Sensitization: No hypersensitivity effects (Grade 0 erythema) (NON-SENSITIZING) | ||
| Sterility | Bioburden |
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).