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The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter.

The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum.

The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

The Arisure® Closed Male Luer with Spike Adapter (YM060) is an extravascular administration set.
The device's performance was evaluated through a series of non-clinical tests.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., leakage, flow rate). It generally indicates that "Aged, packaged parts underwent the appropriate testing" for shelf-life, and "The following tests were completed with passing results."
   • The data provenance is not specified (e.g., country of origin). The studies appear to be non-clinical performance and laboratory tests conducted by the manufacturer, Yukon Medical, LLC. These are retrospective data in the sense that they were collected and analyzed to support the 510(k) submission.

2. Number of Experts and Qualifications for Ground Truth:

   • This information is not applicable. The device is a medical accessory, and its performance criteria are objective, based on engineering, material, and biological standards (e.g., ISO, ASTM). The "ground truth" for these tests is established by the specifications of these standards, not expert consensus in diagnostic interpretation.

3. Adjudication Method for Test Set:

   • This information is not applicable as the evaluation involves objective performance metrics against established standards, not interpretation by human experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human interpretation is involved. The Arisure® Closed Male Luer with Spike Adapter is a medical accessory with objective performance characteristics.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against engineering, material, and biological standards. This involved testing various mechanical, chemical, and biological attributes of the device without human-in-the-loop performance measurement related to its primary function as a connector.

6. Type of Ground Truth Used:

   • The ground truth used for performance evaluation was based on established international and national standards for medical devices, infusion equipment, and material biocompatibility. These include, but are not limited to, ISO 8536-4, ISO 80369-7, IEC 62366-1, ISO 22413, ISO 15747, ISO 10993 series, ASTM standards (e.g., D4169, F1980), and EN/SS-EN standards for sterilization. The "ground truth" is defined by the measurable parameters and acceptance limits specified within these standards.

7. Sample Size for Training Set:

   • The document describes performance testing for a medical device accessory and does not involve AI or machine learning algorithms that would typically require a "training set." Therefore, this information is not applicable.

8. How Ground Truth for Training Set Was Established:

   • As there is no AI/machine learning component described for this device, a training set and its associated ground truth establishment are not relevant to this submission.

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The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous drugs when paired with the SmartSite™ NFC.

The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous drugs for adults, pediatrics and neonates.

The BD Texium™ CML is an airtight, leak-free and drip-free closed system drug transfer device (CSTD). When paired with devices containing a SmartSite™ NFC, the BD Texium™ CML mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ CML/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks and spills. The BD Texium™ CML is a sterile single-use CSTD intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.

This document describes the premarket notification (510(k)) for the BD Texium™ Closed Male Luer (CML). It is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer, and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-Free Connector (NFC).

Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a dedicated section. However, the "Technological Characteristics and Substantial Equivalence" table outlines differences and similarities between the subject device (BD Texium™ CML) and the predicate device (Alaris® Safety Male Luer, K053049) and indicates where testing was conducted to verify new claims or differences. The "Substantial Equivalence Discussion" and "Discussion of Non-Clinical Tests" sections detail the types of tests performed and state that "All test results met their acceptance criteria".

Below is a reconstructed table based on the provided text, indicating acceptance criteria implicitly by reference to the predicate or standards, and the reported performance as meeting those criteria.

Study Details

The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not specify the exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, biocompatibility, flow rate).
   • The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's a premarket submission for a new device design and material changes, the testing is prospective and conducted by the manufacturer, CareFusion/BD.

2. 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 is a non-clinical device test for physical and chemical properties, not a clinical study involving diagnosis or interpretation by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to AI/clinical diagnostic studies is not relevant here. Ground truth is established by standardized test methods and measurement equipment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as this is not a study involving human interpretation or clinical adjudication. Test results are objective measurements against predefined criteria from standards.

4. 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:

   • No MRMC study was done. This is a non-clinical device submission, not an AI/software as a medical device (SaMD) product.

5. 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 or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the non-clinical tests is established by recognized international and national standards (e.g., ISO, USP, ASTM, ANSI/AAMI) and the performance of a legally marketed predicate device. For example:
     • Biocompatibility: Conformance to ISO 10993 series of standards.
     • Sterilization: Conformance to ISO 11137 series and USP chapters.
     • Packaging: Conformance to ISO 11607 series and ASTM standards.
     • Performance (Leakage, Flow Rate, etc.): Conformance to ISO 80369 series and ISO 8536-4, as well as showing performance equivalent to or better than the predicate device.
     • Particulate: Conformance to USP .

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device design and materials are developed and then validated through testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a physical device.

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The Closed Male Luer (CML) is a single use, sterile, swab-able, bi-directional valve intended for use as an accessory to an Intravascular Administration Set. The Closed Male Luer provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter which is inserted into the vein or artery.

Not Found

The provided text is a clearance letter from the FDA for a medical device called "Closed Male Luer" and an "Indications for Use" statement. It does not contain the acceptance criteria or a study describing the device's performance against such criteria. The document explicitly states that the FDA's substantial equivalence determination does not mean the device complies with other requirements of the Act or any Federal statutes and regulations.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on presenting performance data.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a comprehensive market submission that includes performance testing results.

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The Q-Flo™ Closed Male Luer Connector is intended for use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.

The Q-Flo™ Closed Male Luer Connector is a sterile, non-pyrogenic, and single-use luer device. It enables clinical personnel to handle fluids, including hazardous materials such as chemotherapy, radioactive isotopes, and blood products when used in conjunction with a compatible female luer connector. This includes the preparation and administration of fluids to the patient and waste handling. This provides access for the administration of fluids from a container to a patient's vascular system through an administration needle or catheter which is inserted into an artery or vein.

The Q-Flo™ CML connector uses a sequential locking mechanism with a colored visual indicator to provide the user with confirmation of the status of the connection. There are three (3) connection states possible. When the device is not connected to a female luer it is closed and drip-less. When the device is connected to a female luer but the connection is deactivated, the visual indicator is not present and no flow is permitted. Continuing to turn the device and female luer connection together actuates the connection and opens the system to permit flow.

The Q-Flo™ CML connector utilizes the engagement of the luer threads to open the fluid path and, with the silicone sealing member, to provide a leak free state. The action of the thread engagement moves the male luer connector forward and visible to the used thus giving visual confirmation of full connection.

The Q-Flo™ CML connector has been designed with a weight and size to be consistent with IV administration set connections. It weighs less than 2.5 grams and is 12.8 mm in diameter.

The provided document describes the Q-Flo™ Closed Male Luer Connector and its nonclinical testing. This device is a medical apparatus and not an AI/ML device, therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable to the information provided.

However, based on the nonclinical tests conducted, here's a summary of the acceptance criteria and the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided text. The document indicates "Risk analyses were conduct for the Q-Flo™ Closed Male Luer Connector and design verification and validation tests were based on the results of those analyses." This implies multiple units were tested to ensure compliance with the standards, but the exact number is not given.
• Data Provenance: Not specified. It's internal testing conducted by the manufacturer, Infusion Innovations, Inc. The document is for a 510(k) submission to the FDA (USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The ground truth here is adherence to established international standards for medical devices.

4. Adjudication method for the test set:

• Not applicable. The testing involves standardized laboratory methods against established technical criteria, not human adjudication of results.

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 is a physical medical device, not an AI/ML system, so MRMC studies are not relevant.

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 AI/ML system. The device's performance is inherently "standalone" in that its physical properties and functionality are tested directly.

7. The type of ground truth used:

• The ground truth for this device is based on established international standards for medical devices (ISO 10993-1, ISO 594-2, ISO 8536-4, ISO 11137-2). Compliance with these standards indicates the device meets safety and performance requirements.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is a physical medical device, not an AI/ML system.

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