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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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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 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

• Separation Force
• Unscrewing torque
• Ease of assembly
• Stress cracking
• Liquid leakage test
• Resistance to overriding |
  | Shelf Life Evaluation | Design verification of the shelf life was conducted and implied to meet criteria. The document states "All test results meet the acceptance criteria." |
  | Sterilization Product Adoption (AAMI TIR 28:2009/(R)2013) | Implied to meet criteria: "All test results meet the acceptance criteria." |
  | Packaging (ISO 11607-1:2006) | Implied to meet criteria: "All test results meet the acceptance criteria." |
  | Sterility (ISO 11135:2014) | Implied to meet criteria: "All test results meet the acceptance criteria." |
  | Residuals (ISO 10993-7:2008) | Implied to meet criteria: "All test results meet the acceptance criteria." |
  | Biocompatibility (ISO 10993-1, relevant FDA Guidance) | Biocompatibility testing was conducted according to the cited guidance and standards for an External Communicating Device, Blood Path, Indirect Contact, Limited Duration, and implied to meet criteria: "All test results meet the acceptance criteria." |
  | Tamper Evident Design Feature | The MTEC device's tamper evident design feature was tested and successfully passed all internal specifications. |

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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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:

• 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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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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