(196 days)
The Allergan Botox Needle Electrode are for SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
The Allergan Botox Needle Electrode is used in EMG applications to record EMG activity while allowing injection of medication. The Allergan Botox Needle Electrode is a sterile, disposable, monopolar needle electrode with attached lead wire. The needle shaft is insulated so the needle records signals received only from the tip. The needle hub is designed to allow for precise manipulation of the electrode.
The provided text describes a 510(k) premarket notification for the "Allergan Botox Needle Electrode." This document focuses on demonstrating substantial equivalence to a predicate device (K973444 Teca Myoject Disposable Needle Electrode) through non-clinical performance data. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance tests conducted to show the device's functional equivalence and safety/effectiveness compared to its predicate.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional measurement of Needle Electrode – Needle Length | Needle length should be 37.0 ± 1.5mm. | Pass |
| Dimensional measurement of Needle Electrode - Needle Diameter with and without coating | The diameter of the Needle (without PTFE coat) Electrode should be of 27 Gauge (0.40± 0.1mm). The diameter of the Needle with PTFE coating should be between 0.420 to 0.456 mm. | Pass |
| Device Continuity measurement | The resistance between needle tip to the standard 1.5mm connector end should be less than 1.5Ω to allow the biopotential signals. | Pass |
| Biocompatibility Evaluation | Biocompatibility testing per ISO 10993-1, classifying it as an Invasive Electrode, external communicating device in limited (≤ 24 hours) contact with tissue. Tests considered: cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and Blood Compatibility Hemolysis Test (ISO 10993-4). | Pass |
| Tensile testing | Acceptance Criteria: $>/=22N$ (Needle to Wire Crimp Pull Test). | Pass |
| Penetration testing | Comparative data (Verify that the needle consistently produces the comparative sharpness and frictional force). | Pass |
| Leak Testing | The resistance of the needle should be greater than $10MΩ$ (measured across the needle with probe on the PTFE coating). | Pass |
| Tip geometry measurements | The tip geometry of the Product should be compliant with BS EN ISO 7864:2016 standard (Verified by certificate). | Pass |
| Luer Lock Design | The Luer lock and Luer slip fit syringes should be conform to ISO 594-1 & 594-2 standard (Compliance of certificates for Luer lock and Luer slip fit syringes). | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of units tested) for each non-clinical performance test. It only states "Pass" for each test.
The data provenance is from Natus Manufacturing Limited, Ireland, the manufacturer submitting the 510(k). The tests are non-clinical performance tests, typically conducted in laboratory settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical performance study of a physical device (needle electrode). The "ground truth" for these tests is established by engineering and quality control standards (e.g., precise measurements, material specifications, mechanical strength tests, and biocompatibility standards like ISO 10993). Therefore, human expert review in the sense of clinical image interpretation or diagnosis is not applicable. The expertise involved would be in manufacturing, quality assurance, materials science, and biomedical engineering.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or subjective assessment that would require adjudication. The tests are objective measurements and compliance checks against established engineering and safety standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This 510(k) submission is for a medical device (a needle electrode), not an AI-powered diagnostic or assistive tool that would involve human readers. The study performed is a non-clinical performance comparison to a predicate device, focusing on physical and functional characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards) for medical devices. For instance, needle length must fall within a specified range, resistance must be below a certain threshold, and materials must demonstrate biocompatibility through standardized tests. It's objective performance against predefined technical criteria rather than subjective clinical "ground truth."
8. The sample size for the training set
Not applicable. This is a 510(k) submission for a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
§ 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).