(29 days)
The RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions on nerves and can also create percutaneous nerve blocks by delivering anesthetic to the site. It is a single-use, surgically invasive device. It is inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting. The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port.
This document is a 510(k) premarket notification for the Epimed Rulo™ Radiofrequency Lesion Probe. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel performance claims. As such, many of the requested data points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and device performance are primarily focused on engineering performance and biocompatibility, demonstrating that the device functions as intended and is safe for use, and is comparable to the predicate device. Specific quantitative performance targets typically seen in AI/diagnostic device studies are not present here because this is a physical medical device.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | Conical fittings (Luer taper) according to ISO 594-1 and ISO 594-2 | Device meets the requirements of ISO 594-1 and ISO 594-2. |
| Sterility, integrity of epidural catheters and introducer needles (BS 6196) | Device adheres to applicable sections of BS 6196. | |
| Performance of hypodermic needles (ISO 7864) | Device meets the requirements of ISO 7864. | |
| Electrical Safety | Basic safety and essential performance of medical electrical equipment (ANSI/AAMI/EN 60601-1) | Device complies with applicable sections of ANSI/AAMI/EN 60601-1. |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Passed/Met necessary requirements. |
| Sensitization (ISO 10993-10) | Passed/Met necessary requirements. | |
| Irritation or Intracutaneous Reactivity (ISO 10993-10) | Passed/Met necessary requirements. | |
| Systemic Toxicity (ISO 10993-11) | Passed/Met necessary requirements. | |
| Functional Equivalence | Creation of RF lesions on nerves. | Demonstrated comparable performance to the predicate device in creating RF lesions. |
| Percutaneous nerve blocks by delivering anesthetic. | Demonstrated comparable performance to the predicate device in delivering anesthetic. | |
| Localization of nerve by electrostimulation or contrast medium with radiography. | Device supports these localization methods. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual tests. The nonclinical testing involves laboratory and bench testing of device components and the complete device. This is not a study that uses patient data.
- Data Provenance: Not applicable in the context of patient data. The nonclinical test data is generated in a laboratory setting or through engineering assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the submission reports on physical and chemical performance tests, not a diagnostic or AI algorithm that requires expert-established ground truth from images or patient data.
4. Adjudication Method for the Test Set
- Not applicable for the types of nonclinical performance and biocompatibility tests performed. These tests have defined pass/fail criteria based on 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 is a physical medical device, not an AI or diagnostic imaging device that involves human readers or an AI algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
- For performance tests: The ground truth is defined by the specifications in the referenced international and national standards (e.g., ISO, BS, ANSI/AAMI/EN).
- For biocompatibility: The ground truth is established by the specified tests and evaluation criteria outlined in ISO 10993 series.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this device.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).