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

The International Medical Industries, Inc. Tamper Evident Cap consists of a polystyrene outer sleeve and bottom cover and a polypropylene tip cap held in place by a breakaway ring integrated into the sleeve. Evidence of access to the Luer lock cap is achieved by physically breaking the connection and removing the polystyrene outer sleeve exposing the Luer lock cap. Removal of the Luer Lock Cap is restricted by the presence of the sleeve. The restrictive sleeve and cap are available in multiple colors (cosmetic purposes only) in individual blister packs and trays of 10. The Luer Lock Caps are provided sterile to the end user. The sterilization method used is Ethylene Oxide.

The provided text is a 510(k) summary for a medical device called "Tamper Evident Cap." It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

**However, the document does not describe:

• An AI-powered device.
• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• A study that proves an AI device meets acceptance criteria.**

Instead, the document focuses on the physical and material properties of a non-AI medical device (Tamper Evident Cap) and its compliance with ISO 80369-7:2016 ("Small-bore connectors for liquids and gases in healthcare applications – Part 7 Connectors for intravascular or hypodermic applications") and ISO 80369-20:2015 ("Common test methods"), as well as biocompatibility testing standards.

Therefore, I cannot extract the information required by your prompt regarding AI device acceptance criteria and study details from the provided text. The questions about sample sizes for test and training sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the non-AI device described in this 510(k) summary.

The only relevant information that can be extracted from the document regarding "acceptance criteria" and "study" is for the physical device:

Acceptance Criteria and Study for the Tamper Evident Cap (Non-AI Device)

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

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

• Sample Size: Not explicitly stated in the document, but standard medical device testing involves a sufficient number of samples to ensure statistical significance for the specific tests (e.g., multiple samples for each biocompatibility test, mechanical tests as per ISO standards).
• Data Provenance: The tests were conducted as part of the Design Control process, presumably by the manufacturer (International Medical Industries, Inc.) or contracted labs. The document does not specify country of origin for the data or if it was retrospective/prospective, but implies prospective testing for regulatory submission.

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 as this is a physical device being tested against established international standards (ISO, ASTM, USP). "Ground truth" in this context refers to the defined parameters and passing criteria of these standards, not expert interpretations of images or clinical outcomes.

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

• Not applicable. Testing is against objective, predefined criteria in established international standards.

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-powered diagnostic or assistive tool for human readers.

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):

• The ground truth is based on the objective passing criteria defined by the relevant international standards (ISO 80369-7, ISO 80369-20, various ISO 10993 standards for biocompatibility, ASTM, USP) for mechanical performance and material safety.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device.

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The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.

The provided document describes the NRFit® Caps, Male and Female Neuraxial Tip Caps, and its substantial equivalence to a predicate device. It specifies performance testing but does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document is purely about the 510(k) premarket notification for a physical medical device (caps for neuraxial devices) and its comparison to a similar predicate device. The performance data presented are for non-clinical, physical tests of the device (e.g., leakage, stress cracking, axial separation), not for AI/ML performance metrics.

Therefore, I cannot provide the requested information regarding AI/ML device performance, as the provided text does not pertain to an AI/ML powered medical device.

If you have a document describing an AI/ML medical device and its performance studies, please provide that.

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The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Additive Port Cap" (APC) device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details performance testing for engineering characteristics rather than clinical performance or AI/human reader studies. Therefore, many of the requested points related to AI, human readers, and ground truth for clinical outcomes will not be present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that was conducted, and states that "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria and the exact reported performance values are not explicitly provided in detail within this summary. Instead, it lists the types of tests performed.

Here's a table based on the information available, indicating where details are missing:

Information Not Found / Not Applicable Given the Device Type:

The device, an "Additive Port Cap," is a physical medical device (plastic cap) designed for tamper evidence and visual indication. It is not an AI/software device or diagnostic imaging device. Therefore, many of the requested points related to AI/ML study design are not applicable to this submission.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It merely states that "Performance testing to demonstrate tamper evidence was conducted" and lists various tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are engineering and benchtop tests of a physical product.

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

• Not applicable. This is a physical device. "Ground truth" in the sense of expert medical interpretation for a diagnostic AI is not relevant here. The "ground truth" for the performance tests would be the measurement results from the engineering tests themselves (e.g., force required to open, presence of leakage).

4. Adjudication Method for the Test Set

• Not applicable. There's no clinical "test set" requiring adjudication by multiple experts. The tests are physical measurements and observations against engineering specifications.

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

• No. This type of study is typically done for diagnostic imaging devices or AI-assisted solutions to compare human performance with and without AI. It is not relevant for a physical device like an IV port cap.

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

• Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: The ground truth for this device's performance would be derived from the mechanical properties, dimensional tolerances, and functional performance (e.g., ability to indicate tamper, withstand certain forces, prevent leakage) as defined by its design and intended use. This is established via physical testing.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not applicable. There is no AI/ML device or training set.

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The Tamper Evident Cap with Male Luer Lock is indicated for use as a cap for female Luer ports on medical devices such as manifolds, stopcocks or set.

The Tamper Evident Cap with Male Luer Lock (MTEC) is a sterile, single use device which will be used to cover female Luer ports on medical devices and provide evidence of access. MTEC is provided in two packaging configurations; a 10-up tray and single unit blisters. Both configurations are offered in multiple colors and all the components used in the manufacture of MTEC are comprised of polystyrene and polypropylene resin.

Here's a breakdown of the acceptance criteria and study information based on the provided text, while noting limitations in detail for device performance and several other categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for the test set used for any of the bench tests (e.g., ISO 80369-7:2016, tamper evident feature testing).
The data provenance is from non-clinical bench testing performed by International Medical Industries, Inc. (the manufacturer). The country of origin for the data is not explicitly stated but implies testing was done internally by the manufacturer. The data is prospective in the sense that it was generated specifically for this submission.

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

This information is not applicable as the studies are non-clinical bench tests comparing device performance to established international standards and internal specifications, not studies involving human interpretation or ground truth establishment by experts in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical bench tests against objective criteria, not studies requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (tamper evident cap) and relies on non-clinical bench testing for substantial equivalence, not clinical effectiveness studies with human readers.

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

This question is not applicable as the device is a physical medical component, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench tests is established by:

• International Standards: e.g., ISO 80369-7:2016, ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008.
• Internal Specifications: For the tamper-evident design feature.
• FDA Recognized Guidance Documents: For biocompatibility testing (e.g., ISO 10993-1 and specific FDA guidance for intravascular administration sets).

These are objective, quantitative criteria rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical component, not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the device is a physical medical component, not an AI/ML algorithm.

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Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.

Tamper Evident Cap For use with ENFit® Syringes is a sterile, single use disposable device for use as a closure cap with evidence of access for Enteral Syringes with ENFit™ Connectors. Removal of the cap is achieved by removing a restrictive sleeve covering the ENFit™ Lock Cap. A damaged or missing restrictive sleeve indicates potential tampering. A non-sterile version of the device is also offered.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Tamper Evident Cap For use with ENFit® Syringes) and focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the document lists various performance bench tests that were conducted (Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load, etc., as per AAMI/ISO 80369-3, and additional internal specifications like Visual Indication of Tamper Evidence). However, it does not provide specific acceptance criteria values or the reported performance data in a tabular format as requested. It only states that the device "meets the bench testing requirements" and "passed all biocompatibility tests."

Therefore, I cannot populate the requested table or provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information.

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