Search Results

A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation 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 or a radio frequency lesion may be made.

There are four types of needles: SMK, CXE, CX and RCN

SMK is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows an injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then place into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.

CXE is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing, which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion, which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.

CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.

RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.

The provided 510(k) summary for the "RF Injection Needles" does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity, or specific functional benchmarks).

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on:

1. Intended Use: The device shares the same intended use as predicate devices: percutaneous nerve blocks with local anesthetic solution or radiofrequency lesioning, with nerve localization via electrical stimulation or contrast medium injection and radiography.
2. Technological Characteristics: The manufacturer states that "The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices."

Therefore, the requested information elements related to performance criteria, study design, expert involvement, and ground truth are not applicable to this specific 510(k) submission as no performance study was conducted or reported.

Here's a breakdown of why each point is not addressed by the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Applicable: The document does not define specific performance acceptance criteria for the RF Injection Needles nor does it report any associated performance metrics like accuracy, sensitivity, or specificity. The submission aims to show substantial equivalence through intended use and technological characteristics rather than quantitative performance.

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: No test set or performance evaluation study is described.

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: No ground truth establishment is mentioned as there was no performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No test set adjudication is mentioned.

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 not an AI-enabled device; no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical device (needles), not an algorithm or software. Standalone performance is not relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable: No ground truth was established for performance evaluation within this 510(k) submission.

8. The sample size for the training set

• Not Applicable: This device is not an algorithm, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

• Not Applicable: As above, this is not an algorithm, so no training set or ground truth for it.

In summary: The provided 510(k) is a submission for a physical medical device demonstrating substantial equivalence to previously cleared predicate devices based on shared intended use and technological characteristics. It does not contain a performance study with acceptance criteria, test sets, or ground truth as these are typically required for novel performance claims or AI/software devices.

Ask a specific question about this device