(79 days)
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 18 - 19 gauge Perifix catheter for delivery of anesthetics, The connector is used in conjunction with 18 - 19 gauge Perifix catheters for continuous administration of anesthetic agents.
The Perifix Catheter Connector is a connecting device used to connect an anesthesia conduction catheter (most commonly an epidural or nerve block catheter) to a luer device for the administration of anesthetic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in 510(k) K022019. This new configuration is the same as the previously cleared device except it has a slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters, and the device is made with clear/translucent materials to easily distinguish it from the first configuration which is yellow.
The Perifix Catheter Connector is approximately 1.77 inches long and 0.43 inches in diameter. The connector consists of a luer device on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism.
This looks like a 510(k) summary for a medical device that has been cleared based on substantial equivalence to a predicate device, rather than a device requiring a clinical study with acceptance criteria and performance data.
Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) is not applicable or present in this document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
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Not Applicable. This document describes a medical device (Perifix® Catheter Connector) that received 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (B. Braun Medical Inc.; Perifix Catheter Connector; K022019). Substantial equivalence means the new device is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness. This process generally does not involve establishing specific performance acceptance criteria and conducting a new study to prove those criteria are met in the same way a novel high-risk device or a device making new performance claims might. The changes are described as "minor" and not raising new issues of safety or efficacy.
- Description of Changes:
- Slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters.
- Made with clear/translucent materials (vs. yellow components for the predicate device).
- Description of Changes:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or clinical study data is presented for this substantial equivalence determination.
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 establishment was performed, as no clinical test set data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set adjudication was performed.
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 physical connector, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth data was used as this was a substantial equivalence determination based on device design comparison.
8. The sample size for the training set
- Not Applicable. This is a physical medical device; there is no training set as would be found with an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for one.
Summary of what the document does state:
- Device: Perifix® Catheter Connector
- Predicated On: B. Braun Medical Inc.; Perifix Catheter Connector; K022019
- Key Differences from Predicate:
- Slightly larger inner diameter to accept 18 - 19 gauge Perifix catheters more easily.
- Made with clear/translucent materials (predicate had yellow components).
- Conclusion: These minor changes do not raise any new issues of safety or efficacy, hence the device is substantially equivalent to the predicate.
§ 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).