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The Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female Luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing Dual Luer Lock Cap and will be sold as a cap to cover an open Luer port after the Luer port has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male Luer lock connection on one end and a female Luer lock connection on the other end.

Below is the requested information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Acceptance Criteria and Device Performance Study

This device, the Dual Luer Lock Cap, is an IV Administration Set component. The performance testing focused on meeting recognized international standards for Luer fittings.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All test results meet the acceptance criteria," indicating successful performance without providing specific quantitative results for each test.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the performance tests (e.g., how many Dual Luer Lock Caps were tested for each criterion). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective, beyond stating that "Baxter Healthcare Corporation conducts risk analyses and design verification tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable. The device is a physical medical component, not an AI/diagnostic software. Ground truth for its performance is established by objective engineering tests against international standards (ISO 594-1 and ISO 594-2), not expert consensus on interpretations.

4. Adjudication Method

This section is not applicable, as there is no expert interpretation or consensus-based ground truth for this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. The device is a physical medical component, not an AI system intended to assist human readers in interpreting cases. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone Performance Study

This section is applicable in the sense that the device's performance was evaluated in a standalone manner (i.e., the physical device itself was subjected to engineering tests without human intervention in the performance of the device's function). The "Performance Data" section directly addresses the results of these standalone tests against ISO standards.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on objective engineering standards ("Bench performance testing requirement according to ISO 594-1:1986" and "ISO 594-2:1986") and biocompatibility standards ("ISO 10993-1").

8. Sample Size for the Training Set

This section is not applicable. The device is a physical medical component and does not utilize a training set in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this type of device.

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Baxter's Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.

The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing port cap on a number of currently marketed Baxter devices such as sets, stopcocks and manifolds. It will also be sold individually as a replacement cap to cover an open luer port after it has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male luer lock connection on one end and a female luer lock connection on the other end.

Here's an analysis of the provided text regarding the "Dual Luer Lock Cap" and its acceptance criteria and supporting study, formatted as requested.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size used for the test set. It mentions "functional testing" was performed, and "data have been generated," but no numbers are provided for the quantity of devices tested.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, it is almost certainly a prospective test conducted by the manufacturer for regulatory approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not detailed in the provided text. For a device like a luer lock cap, "ground truth" would likely be established by engineering specifications and objective measurements against those specs, rather than expert interpretation (e.g., radiologist consensus).

4. Adjudication Method for the Test Set

This information is not detailed in the provided text. Since the acceptance criteria are functional, adjudication would likely involve comparing test results directly to predefined objective standards, rather than a consensus method among human adjudicators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret medical images. The "Dual Luer Lock Cap" is a mechanical medical device, not a diagnostic tool that involves human interpretation of data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was effectively performed, although the term "algorithm" is not applicable here. The device's functional performance was evaluated independently without human intervention influencing the functional outcome itself. The tests would assess properties like seal integrity, connection strength, and material properties.

7. Type of Ground Truth Used

The ground truth used for this device would be based on engineering specifications and objective functional requirements. This includes standards for luer connectivity, sealing capability, material compatibility, and sterilization. The specific details of these functional requirements are not itemized in the summary, but it's implied that the device was tested against such standards.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are used for machine learning algorithms. The "Dual Luer Lock Cap" is a physical medical device, not an AI or software product.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for this physical device, this question is not applicable.

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