(197 days)
Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.
Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use. These RF-cannulas are single use, sterile, non-pyrogenic and latex free medical devices. The RF-cannulas have bevel tips with an active area of 2 - 10 mm.
The needle puncture depth depends on the path chosen by the surgeon to reach and to eliminate the nerve bundle site. This required needle length is the patient contact part of the thermolesion needle. The nerve causing constant pain will be disrupted by utilizing the thermolesion heat radiating from the needle tip. Heat is generated by radio frequency and radiates only from the non-insulated needle tip. This limited heat radiation is used for focussed heat treatment depending on the surgeon's method of operation.
This document is a Premarket Notification Submission (510k) for the Pajunk Thermolesion Cannula "RFTL Radiofrequency Needle". A 510k submission primarily demonstrates substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and performance reporting as might be expected for a novel device. Therefore, the information provided below will reflect the nature of a 510k submission.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. The performance is then judged on how well it matches or is considered equivalent to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Intended Use: Similar indications for use. | Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures. (Page 2) Also, the Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. (Page 4) |
| Technological Characteristics: Similar design, materials, and operating principles. | The indications for use as well as the basic technological characteristics of Pajunk's RFTL cannulas are identical to Radionics thermo lesion needles K021942 manufactured by TOP. Coating, overall cannula length of deinsulated tip are substantially equivalent and as safe and effective as the predicate device's. (Page 2) Pajunk's RFTL cannulas have the same technological characteristics as the predicate device identified above. (Page 2) The NanoLine coating technique Pajunks cannulas are coated with is cleared for market in Pajunks NanoLine PMN K053283. (Page 2) |
| Safety and Effectiveness: Demonstrate device is as safe and effective as the predicate. | Pajunk's single use anesthesia conduction needles for thermo lesion and neuro-stimulation are substantially equivalent in technique, specification, intended use, safety and effectiveness to the marketed predicate device listed above. (Page 2) The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices. (Page 2) |
| Sterilization: Equivalent sterilization methods. | The contract sterilizer and the sterilizing process... is the same as that used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041. (Page 2) |
| Packaging: Equivalent packaging materials and procedures. | The packaging materials and procedures of Pajunk's RFTL cannulas are the same as those used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041. (Page 2) |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices, not on a clinical study that would involve a "test set" in the traditional sense with patient data. Therefore, details regarding a specific sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to this document as no such study is described. The demonstration of equivalence relies on comparing technical characteristics and intended use, not on new clinical performance data from a dedicated test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As explained above, no separate "test set" with ground truth established by experts is discussed in this 510(k) submission. Therefore, this information is not applicable. The "ground truth", in a broader sense for a 510(k), is the established safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
Again, no "test set" or clinical study requiring an adjudication method is described in this 510(k) submission. This information is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned or implied in this 510(k) submission. This information is not applicable. The submission focuses on device characteristics and equivalence, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device (a radiofrequency needle) is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone algorithm performance" is not applicable. Its use invariably involves a human neurosurgeon/anesthetist.
7. The Type of Ground Truth Used
For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate devices. The new device aims to be substantially equivalent to this established standard. In this case, the predicate devices are "Radionics thermo lesion needles K021942" and "Stryker's RF cannulas K032406". The comparison also references other Pajunk devices previously cleared by FDA for sterilization and packaging equivalence (K000722, K043130, K033018, K042979, K023218, K013041, K053283).
8. The Sample Size for the Training Set
No "training set" in the context of an algorithm or AI development is mentioned in this document. This information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As no "training set" or AI/algorithm development is described, the method for establishing its "ground truth" is not applicable.
§ 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).