(153 days)
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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).