(230 days)
The intended use of the Lutz Needle is for the administration of single-shot epidural anesthesia.
To introduce single-shot anesthetic agents into the epidural space.
The needle presented in this application is equivalent to other anesthesia conduction needles on the market that have been approved for marketing through the Premarket notification process. This is a "me too" device. The subject device has the same technological characteristics as legally marketed predicate devices. The features, specifications, and mode of action are substantially equivalent.
The provided document describes a 510(k) premarket notification for the "Lutz Needle," an anesthetic conduction needle. The submission details the device's equivalence to predicate devices based on non-clinical data and adherence to international standards.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (In vitro testing) |
|---|---|
| Stainless steel components: ISO 9626 | First article inspection for dimensional criteria and conformance to standards. |
| Hub: ISO 594 | |
| Hub-to-needle bond strength: ISO 7864 | |
| Dimensional criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "First article inspection for dimensional criteria and conformance to standards." This implies an initial testing phase for newly manufactured samples. However, the specific sample size used for this "first article inspection" is not explicitly stated.
Regarding data provenance, the testing was conducted "in vitro," which implies a laboratory setting. There is no information about the country of origin of the data or whether it was retrospective or prospective in the context of clinical studies (as it was a non-clinical evaluation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The evaluation was based on conforming to international standards and dimensional criteria, which would typically involve engineering and quality control personnel, not clinical experts for "ground truth" establishment in the sense of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods are relevant for clinical studies where multiple reviewers assess outcomes, typically in diagnostic or prognostic contexts. The provided document describes non-clinical, in vitro testing against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided and is not applicable. The device is an anesthetic conduction needle, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies evaluating human readers with or without AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided and is not applicable. As mentioned above, the device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on international engineering standards (ISO 9626, ISO 594, ISO 7864) and dimensional criteria. This is a form of objective, measurable truth derived from established specifications.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reasons as point 8.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).