(181 days)
The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
The OneRF™ Ablation System components consist of the:
- Radiofrequency (RF) Generator and Accessories
- Generator Interface Cable (GIC), Cart and Foot Pedal (optional)
- sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
- Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box
The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.
To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).
The provided text describes the NeuroOne OneRF Ablation System, a radiofrequency lesion generator and probe indicated for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:
Important Note: The provided text is a summary from an FDA 510(k) premarket notification. It describes the device, its intended use, comparison to predicate devices, and a high-level summary of performance testing. It does not contain detailed pass/fail acceptance criteria values for most tests or granular study design information (e.g., specific sample sizes for particular experiments, expert qualifications, or detailed ground truth methodologies beyond "lesion size was determined"). The information here is inferred from the "Results and Conclusions" section, which consistently states "Pass" or "Met applicable requirements."
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of specific quantitative acceptance criteria in the provided text, the table below will list the tests performed and their reported outcomes, implying that the device met the (unstated) acceptance criteria for each.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Lesion Size: Lesion sizes determined based on time and temperature should be comparable to the predicate. | Pass - Lesion sizes were determined based on time and temperature. Lesion size is comparable to predicate. |
| Dimensional Verification & RFCB Cable Durability: Dimensional characteristics and compatibility between components must be demonstrated; flexural durability of RFCB cables must be met. | Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the dimensional and cable durability requirements. |
| Mechanical Performance: Specifications related to the mechanical interaction between the sEEG-RF Probe and Accessories must be verified. | Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the mechanical performance requirements. |
| Mechanical Integrity: Mechanical durability of the sEEG-RF Probe Accessories must be demonstrated. | Pass - The test results indicate that the sEEG-RF Probe Accessories (Temperature Accessory and Radio Frequency Connector Box) designs meet the mechanical integrity requirements. |
| Ablation System Performance: Specifications related to energy delivery and temperature accuracy, including durability after use, must be met. | Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the system performance requirements. |
| Generator System Performance: Specifications related to the Generator and UI Software must be met. | Pass - The test results indicate that the Generator and UI Software designs meet the system performance requirements. |
| Electrical Safety: Product must meet applicable requirements of Electromagnetic Compatibility and Electrical Safety standards (e.g., IEC 60601-1, -2, -6 and IEC 60601-2-2). | Pass - Met applicable requirements. |
| Temperature Accessory Kit and RFCB Package Integrity: Packaged device and labeling must withstand packaging, shelf life, and distribution testing (e.g., ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980-16, ASTM 2096, ASTM F88) without loss of function, sterility, or legibility. | Pass - The test results indicate that the sEEG-RF Probe Accessories (Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility). |
| Sterilization: Sterilization process must be validated to demonstrate a minimum SAL of 10-6 for the product using Ethylene Oxide per ISO 11135. | Pass - All criteria passed and the sterilization cycle was validated. |
| Usability - Summative Validation: Device must be found safe and effective for intended users, uses, and use environments, in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Pass – The NeuroOne OneRF™ Ablation System has been found to be safe and effective for the intended users, uses, and use environments. |
| Software: Software must address applicable requirements in accordance with FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304. | Software analysis addressed applicable requirements. |
| Cybersecurity: Cybersecurity analysis must address applicable requirements in accordance with FDA guidance documents. | Cybersecurity analysis addressed applicable requirements. |
| Biocompatibility: Components with prolonged (>24 hours to 30 days) contact with tissue/bone and limited ( |
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).