(44 days)
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 20 - 24 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 20 - 24 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. The second configuration is cleared in the 510(k) K032144. This 510(k) submission is to expand the indications for use for the first configuration to include the 24 Ga. Perifix catheter.
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.
The provided document is a 510(k) premarket notification for a medical device called the "Perifix® Catheter Connector." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies. Therefore, it does not contain the kind of detailed study information (like sample sizes, expert qualifications, or multi-reader studies) typically found for devices requiring more rigorous validation.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for a study. The primary "criterion" for this 510(k) submission is to demonstrate substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K022019) | The device (Perifix® Catheter Connector) is substantially equivalent to its predicate. The only change is a material change to the compressible catheter channel due to a supplier reformulation. This change does not raise new issues of safety or efficacy, allowing for expanded indications for use. |
| Intended Use: Connection to 20-24 gauge Perifix catheters | The device is used to provide various anesthetic and fluid administration devices with a single, common access point to 20-24 gauge Perifix catheters for continuous administration of anesthetic agents. This expands the original indication to include 24 Ga. Perifix catheters. |
| Safety and Efficacy (no new issues) | The applicant states that the minor material change "does not raise any new issues of safety or efficacy." |
2. Sample size used for the test set and the data provenance
No test set or clinical study data is reported in this 510(k) summary. The submission focuses on a minor design change (material reformulation) and expanded indications, relying on the substantial equivalence to a previously cleared device. Therefore, there's no information about sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no test set or clinical study data is presented, there is no mention of experts or ground truth establishment.
4. Adjudication method for the test set
Not applicable. No test set 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 device is a physical medical connector, not an AI or imaging device, so MRMC studies are irrelevant.
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. The "ground truth" for this submission is the established safety and efficacy of the predicate device and the assessment that the minor change does not alter this.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).