(81 days)
An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.
The Perifix® Safety Epidural Needle will be available in a 17 Gauge and 18 Gauge size and the usable length of the needle will be 3 ½ inches. The device consists of a safety device mechanism to reduce the risk of needlesticks.
The provided document is a 510(k) summary for the B. Braun Perifix® Safety Epidural Needle. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study with acceptance criteria and a detailed performance evaluation of a novel algorithm or AI system.
Therefore, the requested information points (1-9) which are typical for studies evaluating novel medical devices, especially those incorporating AI or complex algorithms, cannot be fully extracted or are not directly applicable from this 510(k) summary for the following reasons:
- This is not an AI/algorithm-driven device: The Perifix® Safety Epidural Needle is a mechanical device designed to prevent needlesticks. It does not involve any algorithm, AI, or software that would require performance metrics like sensitivity, specificity, or AUC against a ground truth.
- Focus on Substantial Equivalence: The 510(k) pathway "demonstrates that the new device is substantially equivalent to a legally marketed predicate device. This means that the new device has the same intended use as the predicate device and has the same technological characteristics as the predicate device." (FDA website). The "study" here refers to demonstrating this equivalence through functional testing and comparison, not a clinical trial with specific performance metrics against a defined ground truth in the way one would evaluate an AI diagnostic tool.
However, I can provide the available information, interpreting "acceptance criteria" as the basis for claiming substantial equivalence and "reported device performance" as the evidence presented for that claim:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance and Evidence Presented |
|---|---|
| Intended Use: Device must have the same intended use as predicate device(s). | Met: "An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter." This is stated as identical to B. Braun Medical's Perican Epidural Cannula (K813179) and Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter (K813186). |
| Materials: Device must be identical in materials to predicate device(s). | Met: "The Perifix® Safety Epidural Needle is identical in materials [...] to B. Braun Medical's premarket notification, Perican Epidural Cannula, K813179 and B. Braun Medical's premarket notification, Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter, K813186." |
| Technological Characteristics: Device must have similar technological characteristics, or differences must not raise new questions of safety or effectiveness. | Met: The safety mechanism utilized in this device has been previously cleared in B. Braun Medical's Introcan Safety IV Catheter (K982805). "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the Perifix® Safety Epidural Needle." |
| Performance: Must demonstrate that any differences in technological characteristics do not raise new questions of safety or effectiveness. | Met: "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the Perifix® Safety Epidural Needle." (Specifics of this functional testing are not detailed in this summary, but would have been part of the full 510(k) submission). |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context would be the functional tests performed on the device itself. The document does not specify a numerical sample size for these tests (e.g., how many needles were tested or how many times the safety mechanism was activated). It also doesn't involve patient data or data provenance in the sense of country of origin or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. A "ground truth" derived from expert consensus is not relevant for this type of mechanical device. The "ground truth" for functional testing would be whether the device performed according to its engineering specifications and design, as verified by internal testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation), not functional testing of mechanical devices.
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 mechanical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of typical AI/diagnostic studies. For this device, the "ground truth" for the functional testing would relate to engineering specifications, mechanical reliability, and safety mechanism activation under defined test conditions, rather than clinical outcomes or expert labels.
8. The sample size for the training set: Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable. No training set is involved.
In summary, the document states that the Perifix® Safety Epidural Needle achieved acceptance criteria by demonstrating substantial equivalence to existing predicate devices (Perican Epidural Cannula, K813179; Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter, K813186; and Introcan Safety IV Catheter, K982805 for the safety mechanism). This was achieved by confirming identical materials and intended use, and by performing functional testing to ensure the safety mechanism did not raise any new safety or effectiveness concerns compared to the already cleared predicate 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).