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Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.

The passive safety needle-shielding mechanism of the Introcan Safety® IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used with power injectors with a maximum pressure setting is 325 psi with a luer lock connection only.

This document is a 510(k) summary for the Introcan Safety® IV Catheter from B. Braun Medical Inc. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an existing one, rather than presenting a study of the device's independent performance against predefined acceptance criteria for AI or a detailed clinical study with human readers.

Therefore, the requested information cannot be fully extracted or is not applicable in this context. Here's why and what information can be provided:

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

This document does not refer to "acceptance criteria" in the sense of performance metrics for an AI device (e.g., accuracy, sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the proposed device performs comparably to its predicate device, particularly regarding "power injection capabilities" and "flow rate."

The relevant performance information is for the power injection capabilities and gravity flow rate, presented as a comparison:

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

• Test Set Sample Size: The document refers to "bench testing" but does not specify the sample size (number of catheters tested). It mentions testing for "flowrate and device pressure per ISO 10555-1 Section 4.10 9 AnnexG" and "burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F." The number of units needed to demonstrate equivalence per these standards would be part of the full submission, but not typically detailed in the public 510(k) summary.
• Data Provenance: This is not applicable in the typical sense of AI algorithm evaluation (country of origin, retrospective/prospective). The data comes from bench testing of the physical medical device.

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

This is not applicable. This is a physical medical device (IV catheter), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed via engineering bench tests against industry standards (ISO).

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

This is not applicable. There is no human interpretation of data for ground truth establishment as it's a physical device being tested via engineering methods.

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:

This is not applicable. This is not an AI-powered diagnostic device; it's an IV catheter. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. This is not an algorithm, but a physical medical device. Performance is measured through bench testing of the device itself.

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

The "ground truth" for the device's performance here is defined by standard engineering test methods (ISO 10555-1), which dictate how concepts like "flow rate" and "burst pressure" are measured objectively and quantitatively.

8. The sample size for the training set:

This is not applicable. This is a manufactured physical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary of what the document focuses on:

The document focuses on demonstrating substantial equivalence of the Introcan Safety® IV Catheter to its predicate device (K020785 and K021094). The key "differences" and how they were addressed are:

• Increased Power Injection Pressure: The proposed device is capable of handling a maximum pressure of 325 psi, an increase from the predicate's 300 psi for certain gauges. This extended capability was supported by bench testing (Power Injection test for flowrate and device pressure per ISO 10555-1).
• Combined Indications for Use: The new 510(k) combines indications for use across the product family, which doesn't alter the device's fundamental performance but rather its labeling and marketing scope.
• e-IFU: The Instructions for Use were revised to align with other Introcan products and to utilize an electronic format.

The conclusion states that "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate device." This indicates that the bench testing results met the necessary criteria to show comparable safety and effectiveness, allowing for the 510(k) clearance despite the slight change in power injection capability.

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Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

B. Braun Medical's Introcan Safety IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions.

This document is a 510(k) summary for the Introcan® Safety™ IV Catheter and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/CAD/imaging device.

The provided text describes a medical device (an IV catheter) and its regulatory clearance process, focusing on substantial equivalence to predicate devices rather than a performance study with defined acceptance criteria and statistical analysis to demonstrate novel efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is missing:

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

This information is not provided in the document. The document focuses on regulatory clearance based on substantial equivalence for a medical device (intravenous catheter), not an AI/CAD/imaging device with specific performance metrics like sensitivity, specificity, or F1-score.

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

This information is not provided. The document states "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for the Introcan® Safety™ IV Catheter." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

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 information is not provided. As this is a physical medical device (IV catheter), the concept of "ground truth" and "experts" for establishing it in the context of an AI/CAD/imaging device's performance study does not directly apply here. The "functional testing" mentioned would typically involve engineering and biocompatibility tests, not expert interpretation of outputs.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not described for this device.

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

This information is not applicable/provided. An MRMC study is relevant for AI/CAD systems that assist human readers (e.g., radiologists). This document describes an IV catheter, which is a physical medical device, not an AI system.

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

This information is not applicable/provided. This document describes an IV catheter, which is a physical medical device, not an algorithm.

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

This information is not provided. For physical devices like an IV catheter, "ground truth" would relate to meeting engineering specifications, biocompatibility, and functional requirements (e.g., flow rate, pressure resistance, needle stick prevention efficacy). The document refers to "functional testing" but does not detail the specific ground truth metrics or how they were established.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for AI/machine learning models. This document describes a physical medical device.

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

This information is not applicable/provided. As above, this concept applies to AI/ML model development, not the regulatory submission for a physical IV catheter.

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The Introcan® Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

The Introcan Safety IV Catheter consists of an over-the-needle catheter with a safety clip feature. Upon removal of the needle from the catheter, the safety clip is automatically secured over the needle tip as it exits the catheter hub. The Introcan Safety IV Catheter is available in sizes ranging from 14 Gauge through 24 Gauge.

The provided text is a 510(k) summary for the Introcan® Safety™ IV Catheter from 2002. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that quantitatively proves the device meets those criteria with performance metrics, sample sizes, or details about ground truth establishment.

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It states: "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805." It also mentions a new indication for use as an introducer catheter, which is similar to a previously cleared device (K013304).

Without a dedicated performance study described within the provided text, it's impossible to create the requested table or answer most of the detailed questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Therefore,Based on the provided 510(k) summary, the following information can be extracted:

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

The provided 510(k) summary does not present specific quantitative acceptance criteria or detailed device performance metrics derived from a study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on materials, construction, design, and safety features.

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

This information is not provided in the given document. The submission focuses on substantial equivalence rather than reporting on a new performance study with a distinct test set.

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 information is not provided in the given document. The concept of "ground truth" and expert consensus is not applicable here as no specific diagnostic or performance study is detailed.

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

This information is not provided in the given document. No performance study with adjudication is described.

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

An MRMC study is not mentioned in the provided document. This device is an IV catheter, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

This information is not applicable as the device is a medical instrument (IV catheter), not a standalone algorithm.

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

This information is not applicable as there is no mention of a performance study requiring ground truth establishment in the provided document.

8. The sample size for the training set

This information is not applicable as the device is an IV catheter and not an AI/machine learning system that requires a "training set."

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

This information is not applicable for the reasons stated above.

Summary of what the document does provide regarding acceptance:

The primary "acceptance criteria" appear to be based on the device's design, materials, construction, and safety features being substantially equivalent to the predicate devices. The document states:

• "The Introcan Safety IV Catheter includes the same materials, construction, design, and safety clip feature as the Introcan Safety IV Catheter previously cleared under the B. Braun Medical Inc. Premarket Notification, K982805."
• Its new indication for use as an introducer catheter is "the same indication previously cleared for Becton Dickinson Infusion Therapy Systems Inc.'s Premarket Notification, BD Introsyte™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, K013304."

Therefore, the "study" proving the device meets acceptance criteria is effectively the comparison against predicate devices to demonstrate substantial equivalence, rather than a clinical or performance study with quantified metrics. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination by the FDA serves as the regulatory "acceptance."

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passive anti-needle stick device to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components

The Introcan Safety I.V. Catheter which is a passive antineedle stick device. The device is to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

Based on the provided text, the device in question is the Introcan Safety I.V. Catheter, which is a passive anti-needle stick device. The document is a 510(k) summary indicating its substantial equivalence to a previously cleared device, the "Microcath"™ Intravenous Catheter Placement Unit and Catheter (K801941).

Here's the analysis of acceptance criteria and the study based on the provided text:

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 a sample size for any specific test set or clinical study. The testing described appears to be manufacturing quality control and component testing rather than a clinical trial or performance study against pre-defined acceptance criteria with clinical endpoints.

The data provenance is implied to be internal testing by B. Braun Medical, Inc., rather than external clinical data or country-specific data. It's retrospective in the sense that it refers to internal testing of finished products, not a prospective clinical trial.

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

This information is not provided in the document. The "ground truth" for the internal quality control tests would be the established product design specifications and testing procedures, not expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study is more common for diagnostic imaging devices or software. The device here is an I.V. catheter.

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

The device is a physical medical device (an I.V. catheter), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The described testing (physical, visual) is standalone performance for the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the described testing appears to be:

• Established engineering/design specifications: For physical testing.
• ISO Standard 10993 requirements: For biocompatibility.
• cGMP (Current Good Manufacturing Practices) for quality control: For manufacturing and release procedures.

There is no mention of pathology, outcomes data, or expert consensus as a ground truth for this specific device's performance. The comparison is to a predicate device for "substantial equivalence" based on materials, form, and intended use, implying that its safety and effectiveness are derived from its similarity to an already approved device.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a physical I.V. catheter, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this physical device.

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