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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.

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.

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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

• 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).

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.

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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.

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