(42 days)
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 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 anesthesia and/or therapeutic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector is approximately 1.77 inches long and can accept B. Braun Medical Inc. 18 and 20 Ga. Standard Perifix Catheters. The connector consists of a luer device on one end for the attachment of a mating luer device. The rest of the device consists of a threading hole, catheter channel and hinged clamp mechanism.
The provided text is a 510(k) summary for the Perifix® Catheter Connector. It establishes substantial equivalence to a predicate device and includes information about the device's description, intended use, and material changes. However, it does not contain information regarding detailed acceptance criteria, a specific study proving it meets those criteria, or any of the detailed study parameters requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).
The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics as might be seen for novel or higher-risk devices. For simpler medical devices like a catheter connector, acceptance criteria and performance are often demonstrated through:
- Bench testing: Verifying physical properties, connection strength, fluid integrity, and material compatibility.
- Biocompatibility testing: As mentioned in the document, "The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993." This is a key "acceptance criterion" for new materials.
- Comparison to the predicate device: Showing that the new device performs similarly in its intended function.
Therefore, many of the specific questions in your prompt cannot be answered from the provided text.
Here's an analysis based on the information available in the submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance. The primary "performance" reported is its substantial equivalence to existing predicate devices (B. Braun Medical Inc.; Twist Lock Adapter Hub with Luer lock; K840287 and K840179).
The key acceptance criteria implicit in the submission are:
- Similar Indications for Use: The Perifix Catheter Connector has "similar indications for use as the predicate device."
- Biocompatibility: "The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993." This implies that the material met the acceptance criteria for biocompatibility as defined by those standards.
- Functional Equivalence: The design "is different only in that there is a hinged clamp mechanism for the insertion and retention of the catheter, instead of a twisting screwing motion," and these "minor changes do not raise any new safety or efficacy issues." This implies that despite a design change, the function remains equivalent and safe.
Without a detailed test report, specific quantitative performance metrics (e.g., connection force, leak rate) are not provided in this 510(k) summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to "biocompatibility tested" but does not detail the sample sizes or the study design (retrospective/prospective). For bench testing verifying mechanical properties, specific sample sizes would have been used, but they are not reported here.
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)
This information is not applicable and not provided. This device is a mechanical connector, not an imaging or diagnostic device that would typically involve expert ground truth establishment in the way described. Biocompatibility testing is typically performed by certified labs according to established protocols, not by clinical "experts" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical or imaging studies involving human interpretation or subjective assessment.
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
This information is not applicable. This device is a catheter connector, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies or AI improvement metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be established through engineering specifications and recognized standards for medical device connectors, as well as biocompatibility standards (e.g., ISO 10993). Performance is typically verified against these objective criteria rather than expert consensus or clinical outcomes data in a primary submission for this type of device.
8. The sample size for the training set
This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).