(146 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 or K-Resin 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: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)
The provided text describes a 510(k) premarket notification for "Specialty Needles" by Busse Hospital Disposables. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based medical device.
Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission strategy is to show the new device is as safe and effective as a device already on the market, not to establish new performance metrics through clinical trials.
Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available or not applicable for this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility: Materials are safe for intended use. | All materials used met testing requirements (Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test) and were found acceptable. |
| Intended Use: Matches predicate device. | Same intended use as the predicate device (transient delivery of anesthetics for regional anesthesia or epidural catheter placement). |
| Material Composition: Similar to predicate device. | Same material with the exception of the needle hub. |
| Flow Rate: Similar to predicate device. | Same flow rate as the predicate device. |
| Bonding Strength: Similar to predicate device. | Same bonding strength as the predicate device. |
| Technological Characteristics: Similar to predicate device. | Has the same Technological Characteristics as a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "biological qualification safety tests" and "tests performed to prove the substantial equivalence," but does not provide numbers of devices or subjects tested.
- Data Provenance: Not specified. This would typically be internal laboratory testing results, not clinical data from a specific country.
- Retrospective or Prospective: Not applicable in this context. These are engineering and biocompatibility tests, not clinical studies.
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)
- Number of Experts: Not applicable. The "ground truth" for these types of tests is typically established by laboratory standards and established test methodologies, not expert consensus on interpretations.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for material or mechanical performance tests.
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
- MRMC study: No, this is not an AI-based device or a diagnostic imaging device. An MRMC study was not performed.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a physical medical device (anesthesia needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the biocompatibility tests (Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test), the "ground truth" is adherence to established biological safety standards and pass/fail criteria for these specific tests. For the functional characteristics (flow rate, bonding strength), the ground truth is likely measured values compared against specifications or the predicate device's performance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
§ 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).