(112 days)
The Stingray Epidural Catheter Connector is intended to provide various anesthetic and fluid administration devices with a single, common access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
The Stingray Epidural Catheter Connector consists of two molded plastic body Sections that mate in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.
This document, a 510(k) summary for the Stingray Epidural Catheter Connector, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The purpose of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, not necessarily to present a de novo study with acceptance criteria and performance data in the format requested. While it mentions "The testing performed and comparison to the predicate device demonstrates that the Stingray Epidural Catheter is safe and effective," it does not elaborate on what that testing entailed, its methodology, or its results.
Therefore, I cannot provide the requested information for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document states the device is "safe and effective" and "substantially equivalent" but provides no specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: Not present. No information about specific test sets, their size, or origin (country, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. This type of information is typically for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's 510(k) submission. No expert review for ground truth is mentioned.
- Adjudication method: Not applicable/present.
- 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 physical connector, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "testing performed" likely referred to bench testing or engineering evaluations to ensure physical and functional equivalence to the predicate, rather than ground truth in the context of diagnostic performance.
- The sample size for the training set: Not applicable. This device is not an AI/machine learning model that would require a training set.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: Stingray Epidural Catheter Connector
- Intended Use: A connection device to provide various anesthetic and fluid administration to an access point to an epidural catheter for delivery of anesthetics, used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
- Predicate Device: B. Braun Medical Perifix® Catheter Connector (K032144)
- Conclusion: The device is "safe and effective and is substantially equivalent to the predicate device" based on "testing performed and comparison to the predicate device."
To obtain the detailed information requested, one would typically need to review the full 510(k) submission, which would include detailed test reports, protocols, and results. This summary, by its nature, is an abbreviated version.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).