(118 days)
The Cadwell Disposable Probe Handle is a component of the Cadwell Kilowin System that is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
The Cadwell Disposable Probe Handle is a sterile, disposable, single patient use device.
The Cadwell Disposable Probe Handle is a handheld, single-patient-use, sterile, disposable probe holder intended for use in a surgical setting with a Cadwell Kilowin (K971214) instrument. The Cadwell Disposable Probe Handle allows the user to interact with the surgical monitoring instrument. Cadwell Disposable Monopolar Stimulator Probes (from K 103128) specific to the Cadwell Disposable Probe Handle are inserted and removed from the tip of the handle, and make contact with an electrical connector when inserted. The user can select the probe appropriate to the task at hand, removing, repositioning, or changing probes as needed. Electrical stimulation is applied to the Cadwell Disposable Monopolar Stimulator Probe, and used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
The provided 510(k) summary for the Cadwell Disposable Probe Handle (K123589) does not include a detailed study proving device performance against specific quantitative acceptance criteria in the way a diagnostic AI device summary would. This device is a surgical accessory, and its clearance relies on demonstrating substantial equivalence to predicate devices rather than meeting discrete performance metrics in a clinical study.
Therefore, the following information is based on what is available in the document, and many fields will indicate "Not applicable" or "Not specified" as the document primarily focuses on comparisons to predicate devices and general testing, not quantitative performance metrics of a diagnostic nature.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from predicate comparison or general requirements) | Reported Device Performance (from "Same" in table or testing performed) |
|---|---|---|
| Intended Use | Perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. | The Cadwell Disposable Probe Handle is used for the same purpose as the predicate devices. (Substantially equivalent) |
| Compatibility | Compatible with a specific surgical monitoring instrument (Cadwell Kilowin). | Compatible with Cadwell Kilowin (K971214). |
| Stimulator Probes | Detachable, Disposable, Monopolar Ball or Flush Tip. | "Same" as predicate: Detachable, Disposable, Monopolar Ball or Flush Tip. |
| Electrical Insulation | Electrical insulation on surfaces not intended to provide electrical stimulation. | "Same" as predicate: Electrical insulation on surfaces not intended to provide electrical stimulation. |
| IEC 60601-1 Protected Pin Design | Touch Proof Handle Connector. | "Same" as predicate: Touch Proof Handle Connector. |
| Patient Contact Material | Stainless Steel Stimulator Probe with Insulated Shaft. | "Same" as predicate: Stainless Steel Stimulator Probe with Insulated Shaft. |
| Handle Material | Plastic. | Medical Grade Polycarbonate Plastic (considered equivalent to predicate's plastic). |
| Use and Delivery | Single use and sterile. | "Same" as predicate: Single use and sterile. |
| Lead Wire Insulation | Medical Grade Plastic. | "Same" as predicate: Medical Grade Plastic. |
| Actuators | Presence of actuators. | "Same" as predicate: Yes. |
| Theoretical Maximum Voltage | 400 V (Medtronic predicate), 300 V (NuVasive predicate). | 400 V (matches higher predicate value). |
| Stimulation Current | 0-100 mA (Medtronic predicate), 0-90 mA (NuVasive predicate). | 0-100 mA (matches higher predicate value). |
| Stimulation Waveform | Monophasic and Biphasic (Medtronic predicate), Monophasic (NuVasive predicate). | Matches Medtronic predicate: Monophasic and Biphasic. |
| Maximum Pulse/S | 100 (Medtronic predicate), 5 (NuVasive predicate). | Matches Medtronic predicate: 100. |
| Software Performance | Functional as intended. | Software verification and validation (performed). |
| Sterility | Sterile. | Sterility protocol development and validation (performed). |
| Electromagnetic Compatibility (EMC) | Compliant with relevant EMC standards. | Electromagnetic compatibility testing (performed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is not a diagnostic AI/CAD device, and therefore does not have a "test set" in the context of clinical images or patient data to evaluate performance metrics like sensitivity or specificity. The "testing" referred to (software, sterility, EMC) would involve engineering and laboratory verification, not a clinical test set from patients.
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)
Not applicable. As above, there is no "ground truth" established by clinical experts for a diagnostic test set in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No. This device is a surgical instrument accessory; it does not involve AI assistance or human readers for diagnostic interpretation. Its function is to facilitate direct nerve stimulation for monitoring during surgery.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the clearance of this device is based on demonstrating that its design, materials, and function are substantially equivalent to legally marketed predicate devices and that it meets general safety and performance requirements through engineering and laboratory testing (e.g., software functionality, sterility, electrical safety).
8. The sample size for the training set
Not applicable. There is no machine learning model or "training set" for this device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.