(140 days)
The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are intended to be connected to a nerve monitoring unit, such as the Neurosign 100 Nerve Monitor, which requires a standard 1.5mm DIN 42802 touch proof connector, in order to provide an electrical path by which electrical impulses may pass from the monitoring unit to the patient, thus effecting nerve stimulation to assist its user in locating and identifying motor nerves.
The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are surface electrodes used to stimulate nerves during various surgical procedures. They may be used on the surface of the skin, or on the surface of surgically exposed tissue, and as such, they are not intended nor designed to be inserted into tissue.
This 510(k) premarket notification for the Kirwan Disposable Nerve Stimulator Probes (Models: 41-3400, 41-3401, 41-302, and 41-3403) describes a device that is substantially equivalent to legally marketed predicate devices. As such, the study focuses on demonstrating this equivalence rather than establishing novel acceptance criteria through a standalone performance study as would be required for a new technology.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a device demonstrating substantial equivalence to existing predicate devices, the "acceptance criteria" are primarily met through compliance with recognized standards and a demonstration that the device's design, materials, and function are virtually identical to the predicates. There aren't specific quantitative performance metrics reported for this device in the same way one might find for a diagnostic algorithm (e.g., sensitivity, specificity).
| Acceptance Criteria Category | Description of Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use | The device's intended use must be the same as or very similar to the predicate devices. | The Kirwan 41-34XX Series probes are intended to connect to a nerve monitoring unit (e.g., Neurosign 100) to provide an electrical path for impulses to stimulate nerves, assisting in locating and identifying motor nerves. This is stated to be substantially equivalent to the predicate devices. |
| Technological Safety | The device must not introduce new technological risks or characteristics. | The device's technological safety is established by the fact that it does not contain any new technological risks or characteristics compared to the predicate devices. Its design, materials, and function are virtually identical to the predicates, with minor exceptions (handle grip, probe insulation) that were selected to enhance design without compromising substantial equivalence. |
| Technological Effectiveness | The device's core function and mechanism of action must be equivalent to predicates. | The device's core function (electrical stimulation for nerve localization) and energy source are identical to the predicates. The effectiveness is implicitly covered by the "virtually identical" design and function claim. |
| Performance | The device's performance must be substantially equivalent to predicates. | The device's performance is supported by adherence to prevailing standards and guidelines. Specifically, testing was conducted to current dielectric strength and biocompatibility requirements to assure no compromise due to minor design changes. Safety and hazard analysis determined hazard conditions to be low-to-moderate, which is acceptable. This demonstrates performance consistent with established safety and efficacy requirements for this type of device. |
| Compliance with Standards | The device must meet relevant national and international medical device standards. | Kirwan 41-34XX Series probes were tested and manufactured in accordance with prevailing standards and guidelines, and found to comply with: |
- ISO 10993-1 (Biological evaluation)
- IEC 60601-1 (Medical electrical equipment)
- IEC 60601-2-10 (Specific requirements for nerve and muscle stimulators)
- ISO 11137 -1/2 (Sterilization - radiation sterilization) |
| Biocompatibility | Materials in contact with the patient must be biocompatible. | Testing for biocompatibility requirements was assured, implying compliance. |
| Dielectric Strength | Electrical insulation properties must meet safety standards. | Testing to current dielectric strength requirements was assured, implying compliance. |
| Sterilization | Sterilization methods must be validated and controlled. | Compliance with ISO 11137 -1/2 (Sterilization of health care products requirements for validation and routine control - radiation sterilization) is stated. |
| Hazard Analysis | Hazards associated with the device must be identified and adequately controlled. | Safety and hazard analysis determined that the hazard conditions for the 41-34XX Series of Disposable Nerve Stimulating Probes range in the low-to-moderate level and for this reason are acceptable. This indicates that identified risks are managed to an acceptable level. |
Study Details
The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is not a clinical study designed to establish quantitative performance metrics of a new AI algorithm. Therefore, many standard AI/MDCAS study components are not applicable or explicitly mentioned.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not specified. This submission relies on engineering and manufacturing verification and validation, as well as comparison to predicate devices, rather than a clinical test set with patient data for performance evaluation in the context of an AI algorithm. The testing described (dielectric strength, biocompatibility) would involve material and electrical samples, not patient data sets.
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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):
- Not applicable / Not specified. Ground truth, in the context of an AI/MDCAS device, typically refers to expert consensus, pathology, or outcomes for clinical data. This type of ground truth is not relevant for this device's 510(k) submission, which focuses on substantial equivalence of physical and functional characteristics.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods are used to resolve discrepancies in expert-derived ground truth for clinical data, which is not part of this device submission.
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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:
- No. An MRMC study is not relevant for this type of device (disposable nerve stimulating probes). This device is a tool used by a clinician, not an AI diagnostic or assistive imaging tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithmic device. It's an electrical probe used to stimulate nerves.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the testing performed (dielectric strength, biocompatibility, sterilization), the "ground truth" would be the established scientific and engineering standards and methodologies defined in the ISO and IEC standards listed. These standards define acceptable limits and procedures.
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The sample size for the training set:
- Not applicable / Not specified. This device does not use machine learning, therefore, there is no training set.
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How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no training set, this question is not relevant.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).