(270 days)
Dantec™ DCN Disposable Concentric Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
The Dantec™ DCN Disposable Concentric Needle Electrodes are designed as an electrical bipolar recording device for use in electromyography. The Dantec™ DCN Disposable Concentric Needle Electrode consists of an insulated core wire located inside a stainless steel cannula. The hub has a raised bevel indicator, allowing the user to always know the direction of the recording surface. A coaxial hub allows easy connection between needle and the electrode cable.
Acceptance Criteria and Device Performance Study for Dantec™ DCN Disposable Concentric Needle Electrodes
This document describes the acceptance criteria and the study proving that the Dantec™ DCN Disposable Concentric Needle Electrodes meet these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dantec™ DCN Disposable Concentric Needle Electrodes are primarily demonstrated through equivalence to the predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) and successful completion of various performance tests.
| Acceptance Criterion | Predicate Device Specification (K112034 Teca™ Elite) | Dantec™ DCN Performance | Discussion of Equivalence/Compliance |
|---|---|---|---|
| Material | |||
| Core Material | Tungsten | Tungsten | Same |
| Low Friction Lubricant | Silicone | Silicone | Same |
| Cannula | Stainless Steel | Stainless Steel | Same |
| Internal Insulating Polymer Coating (Core to Lumen) | Polyesterimide | Polyesterimide/Araldite | Dantec™ DCN uses Polyesterimide with Araldite, still considered equivalent. |
| Physical Dimensions | |||
| Length Diameter (mm) | 25mm 0.30 (30g), 25mm 0.46 (26g), 37mm 0.46 (26g), 50mm 0.46 (26g), 75mm 0.64 (23g) | 25mm 0.30 (30g), 25mm 0.46 (26g), 37mm 0.46 (26g), 50mm 0.46 (26g), 75mm 0.64 (23g) | Same |
| Tip geometry | Trocar Point | Trocar Point | Same |
| Recording Area | Fine gauge = 0.03 mm², Medium gauge = 0.07mm² | Fine gauge = 0.02 mm², Medium gauge = 0.07mm² | Fine gauge is slightly smaller but meets functional criteria, demonstrating no significant difference. |
| Mechanical Properties | |||
| Hub/Cover Tensile | Specification: >1.2 kgf, Mean: 3.9 kgf | Specification: >1.2 kgf, Mean: 3.9 kgf | Same |
| Needle/Hub Tensile | Specification: >6 lbf, Mean: 19.7 lbf | Specification: >6 lbf, Mean: 22.7 lbf | Exceeds predicate results, demonstrating no significant difference. |
| Penetration Testing | (Implicit: Demonstrates acceptable sliding force) | (Result not explicitly quantified in table, but stated as performed) | Stated that testing was performed, implying satisfactory results to deem equivalence. |
| Electrical Properties | |||
| Impedance | Specification: ) | for endotoxin, ISO 2859-1 for sampling, and ASTM F 1980 for accelerated aging. Compliance with these standards serves as a form of ground truth for safety and performance. |
- Predicate Device Characteristics: For many aspects (materials, dimensions, sterilization, intended use), the characteristics and established performance of the legally marketed predicate device (K112034 Teca™ Elite Disposable Concentric Needle Electrodes) serve as the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning algorithms. Since the Dantec™ DCN Disposable Concentric Needle Electrodes are a physical medical device and not an AI/ML algorithm, there is no training set in this context. The manufacturing process and device design are optimized through engineering principles, quality control, and adherence to established standards, rather than through iterative training with a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
§ 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).