(110 days)
specialty needles – Spinal Needle, Pencil Point Needle, and Epidural Needle - 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 different styles. All the needles consist of a plastic hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following:
- Spinal Needles (Quincke)
- Pencil Point Spinal Needle (Whitacre)
- Epidural Needles (Tuohy & Hustead)
The differences between the styles of needles are the tip of the needle, which is either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke).
These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.
The provided text describes a 510(k) premarket notification for "Specialty Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting results from a standalone performance study with a test set, expert adjudication, or MRMC studies for AI devices.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to product description, intended use, and a summary of tests performed to establish substantial equivalence based on material properties and functional comparisons.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available for an AI device study:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like these needles, "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device. The performance is reported in terms of matching key characteristics of the predicate.
| Criteria (Implied for Substantial Equivalence) | Reported Device Performance (vs. Predicate Device) |
|---|---|
| Same intended use | Same intended use |
| Same material | Same material |
| Same flow rate | Same flow rate |
| Same bonding strength | Same bonding strength |
| Biocompatibility | Materials met testing requirements and found acceptable (L929 Men Elution, Kligman Maximization, Intracutaneous Injection, Systemic Injection, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay) |
| Technological Characteristics | Same Technological Characteristics |
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 traditional medical device (needles), not an AI device undergoing a performance study with a test set. The document refers to "testing requirements" for materials and functional characteristics for comparison to a predicate, not a clinical test set.
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 test set requiring expert ground truth for an AI device is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication in the context of AI device performance is described.
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 (needles), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Specialty Needles," the "ground truth" for demonstrating substantial equivalence is based on:
- Predicate Device Characteristics: The established and accepted characteristics and performance of the predicate device (Exel Spinal Needle - K895771).
- Standardized Material Testing: The results of the specified biocompatibility tests (L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay).
- Functional Comparisons: Direct measurement and comparison of properties like flow rate and bonding strength to the predicate device.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device.
§ 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).