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Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

The Tamper Evident Cap (TEC) is a sterile, single use device which will be used to cover male luer ports on medical devices and provide evidence of access. TEC is offered in multiple colors and all the components used in the device are comprised of polystyrene and polypropylene resin. The TEC device is marketed as a stand-alone device and packaged in bulk.

This document is a 510(k) summary for the Prep-Lock™ Tamper Evident Cap for IV Syringes (K193192). It focuses on demonstrating substantial equivalence to a predicate device (K861276), primarily due to a change in packaging configuration.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document lists various non-clinical bench tests performed to assess the new packaging configuration of the Tamper Evident Cap. It states that "All pre-determined acceptance criteria were met." However, it does not explicitly define the specific acceptance criteria for each test in a quantitative manner, nor does it provide detailed numerical results for the reported device performance. It only states that the device "conforms to the same functional and sterility specifications as 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)

The document does not specify the sample sizes used for any of the described non-clinical bench tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of bench testing for a device modification (packaging), these would typically be conducted prospectively by the manufacturer (International Medical Industries, Inc., Pompano Beach, Florida, USA).

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 is not applicable to the provided document. The study described is a non-clinical bench testing for a physical medical device (tamper evident cap) and its packaging, not an AI/diagnostic device that would require expert-driven ground truth establishment.

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

Not applicable, as this is non-clinical bench testing. Human adjudication methods like 2+1 are typically used for clinical studies involving interpretation of medical images or patient outcomes.

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 not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

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

For the non-clinical bench tests, the "ground truth" is implied by the standards and internal specifications that the device and its packaging must meet (e.g., ANSI/AAMI/ISO 11737-2 for sterility, ASTM F1980-16 for shelf life, ISO 10993-1 for biocompatibility). The tests directly measure whether the physical properties and performance characteristics of the device and its packaging conform to these established benchmarks.

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as no training set was used.

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The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.

The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide the fluid path for transferring large source container ingredients into smaller containers. The product is offered in two configurations; Female Luer lock (57-400) and Female-Male Luer Lock (57-401); both configurations meet the intended use. The Guarded Luer Connector is a connector for connecting two devices with fittings conforming to ISO 80369-7 for intravascular connectors and ISO 8536-10 for fluid line accessories.

The provided text describes a 510(k) summary for a medical device called the "Guarded Luer Connector." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria. Therefore, several of the requested categories of information, particularly those related to clinical studies, human readers, ground truth establishment, and training data, are not applicable or not present in this type of regulatory submission.

However, based on the context of a 510(k) for a connector, the acceptance criteria would primarily revolve around engineering and material performance standards to ensure safe and effective fluid transfer.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated in the document. For engineering bench testing, sample sizes are typically determined by statistical methods or regulatory guidelines for device testing (e.g., AQL – Acceptable Quality Limit).
• Data Provenance: The studies are described as "bench testing requirements" and "design verification," "engineering study," and "biocompatibility tests." This indicates the data was generated in a lab setting, likely by the manufacturer, and is prospective experimentation (though not a clinical trial).
• Countries of Origin: Not specified, but generally assumed to be from the manufacturer's testing facilities or contract labs.

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

This is not applicable as the device is a piece of hardware (a Luer connector), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests are the objective measurements against established technical standards.

4. Adjudication Method for the Test Set:

Not applicable. This concept (adjudication) is typically used in clinical studies or expert review processes, which are not described here. The results of the bench tests are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a fluid transfer connector.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a mechanical connector, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily objective measurements against established performance standards and material specifications. For instance:

• Fluid leak rates (implied by ISO 80369-7)
• Dimensional accuracy (implied by ISO 80369-7)
• Torque strength (Resistance to Override)
• Bacterial endotoxin levels (<2.0 EU/device)
• Sterility (SAL 10-6)
• Biocompatibility (based on specific test results like cytotoxicity, sensitization, etc.)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the collection of bench testing, design verification, and biocompatibility testing as summarized in the document. The document states:

• "Guarded Luer Connector meets the bench testing requirements per ISO 80369-7... and ISO 8536-10..."
• "Compliance with these international standards demonstrates that the proposed cap device is substantially equivalent to the predicate device."
• "All pre-determined acceptance criteria were met."
• "The device Guarded Luer Connector passed all biocompatibility tests."

The primary goal of this FDA 510(k) submission is to demonstrate substantial equivalence to an already legally marketed predicate device (TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP, K900585), rather than proving novel efficacy. The testing (bench tests and biocompatibility) is used to show that despite minor design differences, the new device performs equivalently and safely according to recognized standards.

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