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The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

The BD Intima II™ and Intima II PLUS™ Closed IV Catheter Systems are closed system IV catheters designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing (4.0 IN), and a Luer connector. The 24G and 26G products are also provided with 2.8 IN extension tubing. The system incorporates an integrated extension set which is available in multiple configurations: 1) Y connection (dual port) with a PRN adapter or needleless connector (MaxZero) and end cap; 2) Y connection (dual port) with two PRN adapters or two needleless connectors (MaxZero); 3) Y connection (dual port) with one PRN adapter and one needleless connector (MaxZero); and 4) Straight connection (single port) with a PRN adapter or needleless connector (MaxZero). The Luer connectors are color-coded to indicate catheter gauge size.

This is a 510(k) premarket notification for a medical device (intravascular catheter), not an AI/ML device. Therefore, the requested information categories concerning AI/ML device performance (such as sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this document.

However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets them for the BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

The acceptance criteria are implicitly derived from the types of tests conducted, which are standard for intravascular catheters and needleless connectors. The "reported device performance" is a general statement of compliance rather than specific numerical results.

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

The document does not specify the exact sample sizes used for each test. It generally refers to "performance tests" being completed.
The data provenance is internal to Becton Dickinson, as indicated by "BD internal" next to several tests. The studies are prospective in the sense that they are conducted to verify design changes for market approval. The country of origin is not explicitly stated for the test execution, but the submitter is based in Sandy, Utah, USA.

The studies relate to the subject devices (BD Intima II™ Closed IV Catheter System and BD Intima II PLUS™ Closed IV Catheter System with new configurations and modifications) in comparison to predicate devices.

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

This question is not applicable as the device is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests are objective, measurable physical properties and performance characteristics defined by engineering specifications and international standards (e.g., ISO, ASTM, USP).

4. Adjudication method for the test set

Not applicable in the context of this device type. Performance is measured against predefined engineering and regulatory specifications, not subject to human adjudication for accuracy or diagnosis.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth used for these performance tests is based on:

• Established engineering specifications and design requirements for the device's physical and functional performance.
• International standards such as ISO 10555-1, ISO 10555-5, ASTM F2182-19.
• Pharmacopeial standards such as USP for particulate matter testing.
• Biocompatibility standards guidance from ISO 10993-1:2009 and FDA guidance.

These are objective, measurable outcomes rather than expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of AI/ML.

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The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy.

The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter. The closed system is designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque VialonTM material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp), extension tubing and Luer connector. It incorporates an integrated extension set which is available in two configurations: Y Connection (dual port) and Straight Connection (single port). The Luer connector is color-coded to indicate catheter gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain the sterility during its specified shelf life of 3 years.

This document describes the BD Intima II™ Closed IV Catheter System and compares it to a predicate device, also named BD Intima II™ Closed IV Catheter System (K100775). The key takeaway is that the new device is a modified version of the predicate device, specifically regarding some adhesives, lubricants, and the addition of a new pinch clamp option. Because this document focuses on establishing substantial equivalence to another device and the described modifications are minor, the "study" referred to is a series of design verification tests, not a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document states "Same Methodology as Predicate" for most tests, implying the acceptance criteria would be to perform equivalently to the predicate device, or meet established internal specifications derived from the predicate's performance.

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

The document does not specify exact sample sizes for each test. It refers to "design verification tests" without providing details on the number of units tested. The data provenance is internal design verification data from Becton Dickinson Infusion Therapy Systems Inc. (USA), for modifications made to an existing device. It is retrospective in the sense that it's comparing a new version to an existing design.

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

This is not applicable. The "ground truth" for a medical device such as an IV catheter is typically established through established engineering principles, international standards (like ISO 10993 for biocompatibility), and internal quality control specifications. These are objective measures, not subjective interpretations by experts in the same way clinical diagnoses would be.

4. Adjudication method for the test set

Not applicable. The tests are objective and quantitative (e.g., Pass for biocompatibility, pull force tests). There's no subjective interpretation requiring adjudication.

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 an IV catheter, a physical medical device, not an AI-powered diagnostic or decision support system that would involve human readers.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The ground truth used for these tests is based on:

• Engineering specifications and performance characteristics of the predicate device.
• International standards (e.g., ISO 10993 for biocompatibility).
• Internal quality control and design requirements for medical devices.
• Objective physical and chemical properties.

8. The sample size for the training set

Not applicable. This device does not use an AI model or machine learning, therefore there is no "training set."

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

Not applicable, as there is no training set.

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The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.

The Intima II IV Catheter consists of a Vialon® material catheter, a notched needle to enhance flashback visualization, septum, extension tubing and either a straight or Y Luer connector. A needle-accessed PRN is attached to the Luer connector. An end cap is attached to the second Luer connector on the Y design. Blood is contained within the device. A slide clamp is provided on the extension tube. A notched needle resides within the catheter until it is withdrawn through the septum after the catheter has been threaded into the vein. The needle unit includes a paddle that is held during the insertion process. This device does not include a needle-shielding mechanism.

The provided 510(k) summary for the BD Intima II™ IV Catheter (K100775) describes non-clinical tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting with defined performance metrics for AI.

Therefore, the requested information elements related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to this document. This submission focuses on traditional medical device testing for safety and effectiveness.

However, I can extract information regarding the non-clinical test results which serve as the "acceptance criteria" and "reported device performance" in the context of this traditional device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BD Intima II™ IV Catheter are based on compliance with various ISO standards and in-house protocols. The reported device performance is indicated by "Passed" for each test.

Study Details (Relevant to this Traditional Device Submission)

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

   • The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of catheters tested for bond strength). It refers to "in-house protocol" for some tests and specifies compliance with ISO standards, which typically outline sample size requirements, but the specifics are not detailed in this summary.
   • All data provenance is in vitro or in vivo animal testing (for biocompatibility components like implantation, sensitization), conducted by the submitting company (Becton Dickinson Infusion Therapy Systems Inc.) or their contracted labs. This is not human clinical data.

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

   • Not applicable in the context of this non-clinical submission. "Ground truth" in this context is defined by objective measurements against established international standards (ISO) and internal protocols. Expert opinion is not used to establish truth for these performance metrics.

3. Adjudication method for the test set:

   • Not applicable. Results are typically based on quantitative measurements and pass/fail criteria defined by the test methods and standards, not human adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a non-clinical submission for a physical medical device, not an AI software.

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

   • Not applicable. This is not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by objective measurements against the specified requirements and methodologies of international standards (ISO) and validated in-house protocols. For biocompatibility, this includes biological responses observed in in vitro or in vivo models according to the relevant ISO 10993 parts.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm.

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

   • Not applicable. This is not an AI algorithm.

Conclusion:

The BD Intima II™ IV Catheter's substantial equivalence was demonstrated through non-clinical testing against established physical, chemical, and biological performance standards (primarily ISO standards) and validated in-house protocols. All enumerated tests "Passed" or were "Determined substantially equivalent," indicating that the device meets the defined acceptance criteria for safety and effectiveness in a non-clinical context. No clinical studies or AI-related evaluations were conducted or are relevant to this 510(k) submission.

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