(146 days)
Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief.
The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are single use, sterile, non-pyrogenic and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet (mandrin). This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e. within minutes) by the professional anesthetist. Alternatively or additionally, an evidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.
This document is a 510(k) summary for Pajunk Anesthesia Conduction Needles (Tuohy, Quincke, Chiba, and Crawford). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information cannot be extracted directly from the provided text.
Here's an attempt to answer the questions based on the available information:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance in terms of quantifiable measures are provided. The submission relies on demonstrating substantial equivalence to existing predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for substantial equivalence based on material and design comparison, not a study involving a test set of data.
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" was established in the context of a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a medical needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Substantial equivalence relies on comparing design, materials, and intended use to existing legally marketed devices, not on a ground truth derived from expert consensus or patient outcomes for this specific device. The closest concept to "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned as this device is a physical medical instrument.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study / Basis for Acceptance (based on available text):
The "study" in this context is a demonstration of substantial equivalence to legally marketed predicate devices.
- Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that the new device has the same technological characteristics (design, physical dimensions, materials) and intended use as the predicate.
- Proof: The submission states:
- "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."
- "The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - have the same technological characteristics as the predicate devices identified above."
- "The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are equivalent in design, physical dimensions, luer hub, metal and plastics materials, and packaging to Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003."
- Biocompatibility testing was also conducted and referenced in Section 7 (though not provided in this excerpt).
In essence, the device meets its "acceptance criteria" by being a direct technological and material equivalent to previously cleared devices.
§ 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).