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BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ Shielded IV Catheter incorporates BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey, 14 GA (2.1 mm) = Orange).

BD Insyte™ Autoguard™ Shielded IV Catheter facilitates the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the following inside diameter (ID): 24 GA (0.40 mm ID), 22 GA (0.55 mm ID), 20 GA (0.7 mm ID), 18 GA (0.8 mm ID), 16 GA (1.2 mm ID), and 14 GA (1.6 mm ID).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.

The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ BC Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.

The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

This document is a 510(k) clearance letter for three IV catheter devices, indicating that they are substantially equivalent to a previously cleared predicate device (K201075). It describes the changes made (new performance specifications and revised IFU) and provides a summary of performance tests conducted.

However, it does not contain the detailed acceptance criteria and reported device performance information that you specifically asked for in a table, nor does it describe a study that "proves the device meets the acceptance criteria" in the format of a clinical trial or algorithm validation study. The document primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on bench testing and comparisons of technological characteristics, rather than extensive clinical studies or AI algorithm performance validation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it is not present. Similarly, information regarding sample sizes for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, or training set ground truth establishment is not applicable or not provided within this 510(k) clearance document, as it pertains to a physical medical device (IV catheter) and not an AI/ML-driven device.

The study described to demonstrate substantial equivalence consists of bench testing to verify new performance specifications and ensuring compliance with relevant ISO and ASTM standards.

Here's an overview of the information that is available in relation to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in this document. The document states that "the subject device met all predetermined acceptance criteria for the above-listed performance tests," but it does not specify what those acceptance criteria were (e.g., specific thresholds or ranges for frequency response, kink resistance, or blood fill time). It also does not present the numerical results ("reported device performance") of these tests.

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

• Not applicable / Not provided. The document describes bench testing of physical devices, not an AI/ML system or a clinical study with a "test set" of patients or data in the context of AI validation.

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

• Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present for this physical medical device.

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

• Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present for this physical medical 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:

• No. This is not an AI/ML device, so an MRMC study is not relevant.

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

• No. This is not an AI/ML device.

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

• Not applicable / Not provided. For the performance tests listed (Frequency Response, Kink Resistance, Blood Fill Time, Catheter Separation Force), the "ground truth" would be the direct measurements obtained from the physical properties of the devices themselves, compared against pre-defined engineering specifications.

8. The sample size for the training set:

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

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

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

Summary of Performance Tests and Compliance (as described in the document):

The document states that a risk analysis was conducted to assess the impact of modifications. When technological characteristics were identical to the predicate, results from the predicate were applied. For other aspects, the following tests were conducted:

BD Internal Requirements:

• Frequency Response Testing: To support blood pressure monitoring indications.
• Kink Resistance Testing: To support blood pressure monitoring indications.
• Blood Fill Time Testing: To support blood sampling indications.
• Catheter Separation Force: (No specific indication mentioned, but likely related to structural integrity during withdrawal)

Compliance with Standards Testing:

• Luer Testing: According to ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications).
• Packaging Testing: According to ISO 11607-1, ASTM F2096-11 (for gross leaks), and ASTM F88/F88M-15 (for seal strength).
• Biocompatibility: According to ISO 10993-1 (general biological evaluation) and ISO 10993-5 (for in vitro cytotoxicity).

Conclusion: The document explicitly states: "Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices." This indicates that the tests were performed and the results aligned with the internal and regulatory specifications, affirming the device's substantial equivalence.

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BD Insyte™ Autoguard™ Shielded IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may also be used to facilitate the placement of guidewires and other vascular access devices without pre-attached hubs. These for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068kPa).

BD Insyte™ Autoguard™ BC shielded IV catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood pressure, or administer fluids. 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro shielded IV catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood pressure, or administer fluids. 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ shielded IV catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip with button, flash chamber with vent plug, and barrel. The needle and catheter are protected by a needle cover. The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. These devices incorporate BD Autoguard™ push-button shielding technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury. These devices are available with or without wings. The catheter hub and wings are color coded to indicate outside catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey, 14 GA (2.1 mm) = Orange). These devices facilitate the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the listed inside diameter: 24 GA (0.40 mm), 22 GA (0.55 mm), 20 GA (0.7 mm), 18 GA (0.8 mm), 16 GA (1.2 mm), and 14 GA (1.6 mm). The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC shielded IV catheters are over-the-needle, intravascular (IV) catheters with blood control technology. These devices include a radiopaque BD Vialon™ catheter, needle, grip with button, flash chamber with vent plug, and barrel. The needle and catheter are protected by a needle cover. The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction. The blood control technology limits blood exposure to the device user. The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. These devices incorporate BD Autoguard™ push-button shielding technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grev). The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro shielded IV catheters are over-the-needle, intravascular (IV) catheters with blood control technology. These devices include a radiopaque BD Vialon™ catheter, needle, grip with button, flash chamber with vent plug, and barrel. The needle and catheter are protected by a needle cover. The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction. The blood control technology limits blood exposure to the device user. The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. These devices incorporate BD Autoguard™ push-button shielding technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

This is a 510(k) summary for three IV catheter devices, which are physical medical devices, not AI/ML-driven software devices. Therefore, the questions related to AI/ML specific acceptance criteria, study types, ground truth, sample sizes for training/test sets, expert qualifications, and adjudication methods are not applicable.

The document describes the acceptance criteria and supporting studies for these traditional medical devices primarily through a comparison to predicate devices and adherence to established international standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table of technological characteristics, rather than a direct table of acceptance criteria and performance against those criteria in a quantitative sense. However, it implicitly states that the subject devices meet the performance of equivalent predicate devices and relevant standards.

Here's a summary derived from the "Performance" rows in the comparison tables:

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

The document states that "Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices." It does not specify sample sizes for these tests, nor does it explicitly mention data provenance (e.g., country of origin). Since these are physical devices, the testing would typically involve laboratory bench testing, animal testing (if applicable, not specified here), and potentially human clinical trials (not described in this summary, implying equivalence was sufficient).

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

Not applicable. This is not an AI/ML device where expert ground truth is established for a dataset. The "ground truth" for these physical devices is determined by adherence to established engineering, materials, and biological safety standards (e.g., ISO standards) and performance specifications.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process is described for evaluating the performance of these physical devices against a dataset. Device performance is assessed via objective measurements against predefined standards and specifications.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This document pertains to physical intravascular catheters.

6. Standalone Performance Study (Algorithm Only):

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

7. Type of Ground Truth Used:

The "ground truth" for the device's performance relies on:

• Compliance with International Standards: ISO 10555, ISO 594, ISO 23908, ISO 11070 for performance, and ISO 10993 and ISO 11135/11607 for biocompatibility, sterilization, and packaging.
• Engineering Specifications: Meeting pre-defined physical and functional requirements for parameters like pressure limits, dimensions, and material properties.
• Substantial Equivalence to Predicate Devices: Demonstrating that the new devices are as safe and effective as previously cleared devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable.

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The BD Insyte TM Autoguard™ BC catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids.

The purpose of the premarket notification is to introduce a new intravascular catheter. the BD Insyle™ Autoquard™ BC Shielded IV Catheter. This new catheter is identical to the BD Insyle™ Autoguard device (K013800) with the addition of a septum and actuator (blood control features) integrated into the catheter hub.

The BD Insyte Autoquard BC catheter's, catheter hub has a built in blood control septurn. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made.

BD Insyte ™ Autoguard™ BC device is an over-the-needle, peripheral intravascular catheter that incorporates a spring-activated needle-shielding technology. Each catheter needle-shielding component inciudes a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber, and a needle.

The catheter component that is advanced into the vasculature is a BD Vialon™ polyurethane material. The catheter hub accommodates a luer slip or luer lock connection. It is available either with a straight or a winged catheter hub.

The BD Insyte Autoguard BC catheter needle-shielding technology provided the clinician with a user-activated button, the clinician pushes it to initiate the needle's retraction into the needle-shielding barrel. Once the button has been pushed and the needle retracted, the user cannot override the shielding mechanism to re-expose the needle tip.

The BD Insvte Autoquard BC catheter's needle incorporates BD Instaflash™ Needle Technology: this feature allows the clinician to visualize flashback through a notch in the side of the needle indicating that there is confirmation of vessel entry. This is available on the 20, 22, 24 gauge catheters only.

The BD Insyte Autoguard BC catheter is available in 16GA, 18GA, 20GA, 22GA, and 24GA sizes.

Here's a breakdown of the acceptance criteria and study information for the BD Insyte Autoguard BC IV Catheter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K110443) is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance data in a quantitative table.

While the document states that "Verification and validation activities were designed and performed to demonstrate that the BD Insyte Autoguard BC catheter met predetermined product specifications," and "Bench testing were performed to ensure the safety and effectiveness of the BD Insyte Autoquard BC catheter, to verify conformity to the standards listed in this application and demonstrate substantial equivalence to the predicates devices used in this application," the specific numerical acceptance criteria and reported device performance metrics are NOT explicitly detailed in the provided text.

The document primarily states that "No new issues of safety and effectiveness were raised with the testing performed, so therefore, the BD Insyte Autoguard BC is substantially equivalent." and "Test results and technological characteristics of like gauge size catheters were shown to be equivalent between the subject device and the predicates."

Therefore, a table with specific numerical acceptance criteria and reported performance cannot be generated from the given text.

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

• Sample Size for Test Set: The document mentions a "prospective, randomized, unblinded healthy volunteer (subjects) clinical study." However, it does not specify the sample size (number of subjects/catheters) used in this clinical study.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Prospective. The study is explicitly described as "A prospective, randomized, unblinded healthy volunteer (subjects) clinical study."

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

• The document describes a clinical study focused on "the clinician's perception of blood exposure" and "the frequency of blood leakage observed from the IV Catheter hub."
• The document does NOT specify the number of experts, or their qualifications (e.g., radiologist with X years of experience), used to establish ground truth. The observations appear to have been made by the clinicians performing the insertions, but no specific qualification or independent expert review process is detailed for determining "ground truth."

4. Adjudication Method for the Test Set

• Not specified. The document does not describe any adjudication method (e.g., 2+1, 3+1) for the observations made during the clinical study.

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

• No, an MRMC comparative effectiveness study was NOT done. The clinical study described is focused on the performance of the new device (BD Insyte Autoguard BC) in healthy volunteers, evaluating its blood control features and clinician perception. It does not compare human readers' performance with and without AI assistance, as it is a medical device (catheter) and not an AI or imaging diagnostic tool.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a physical medical catheter, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the direct observations made during the clinical study related to the device's function.
• Type of Ground Truth: The "ground truth" was based on direct clinical observation and clinician perception during actual IV catheter insertions by healthy volunteers. Specifically:
  • Overall clinical acceptability.
  • Clinician's perception of blood exposure.
  • Frequency of blood leakage observed from the IV Catheter hub.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This device is a physical medical catheter, not an AI or machine learning model that would require a "training set" in the conventional sense. The "training" for such devices involves design, engineering, and manufacturing processes, not data-driven model training.

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

• Not applicable. As mentioned above, a "training set" for AI/ML is not relevant for this type of medical device.

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