(240 days)
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:
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Power Injection Capability (22-18 GA devices): Suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). | For all subject devices: 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). (Stated as "Same" in Substantial Equivalence column compared to predicates) |
| Flashback Chamber / Technology: Presence and functionality of flashback chamber. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates) They incorporate BD Instaflash™ technology to assist with flashback visualization. |
| Safety Design (Needlestick Safety Mechanism): Device incorporates a safety mechanism to reduce the risk of accidental needlestick injury. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). They 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. For BD Insyte™ Autoguard™ Shielded IV Catheter, it's noted: "The subject and predicate BD Insyte™ Autoguard™ Safety IV Catheter active needlestick safety mechanisms are identical." |
| Radiopaque: Catheter is radiopaque. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). Catheter tubing is polyurethane with radiopaque barium sulfate. |
| Guidewire Passage (for BD Insyte™ Autoguard™ Shielded IV Catheter): Must allow passage of appropriate size guide wire or catheter. | For BD Insyte™ Autoguard™ Shielded IV Catheter: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). "Catheter ID dimensions allow passage of vascular access devices, including a standard appropriately sized guidewire or catheter through the lumen of the subject/predicate devices." |
| Blood Control Mechanism (for BC and BC Pro Shielded IV Catheters): Presence and functionality of a blood control septum to stop blood flow until Luer connection. | For BD Insyte™ Autoguard™ BC Shielded IV Catheter & BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). 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. |
| Material Biocompatibility: Compliance with ISO 10993 series for biological evaluation. | Bio-compatibility evaluation conducted in accordance with ISO 10993-1, 3, 4, 5, 6, 10, 11, 12, and FDA guidance. Conclusion: Evaluation results support the biocompatibility of the subject devices. |
| Sterilization & Packaging: Compliance with relevant ISO standards for sterilization and packaging validation. | Validation conducted in accordance with ISO 11135-1 (Ethylene oxide sterilization), ISO 11607-1, 11607-2 (Packaging), and ISO 10993-7 (Ethylene oxide sterilization residuals). Conclusion: The devices meet these standards. |
| General Requirements for Intravascular Catheters: Compliance with ISO 10555-1 and ISO 10555-5. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Conical Fittings (Luer): Compliance with ISO 594-1 and ISO 594-2. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Sharps Injury Protection: Compliance with ISO 23908. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Intravascular Introducer, Dilators, and Guidewires (for BD Insyte™ Autoguard™ Shielded IV Catheter): Compliance with ISO 11070 for facilitation of guidewires and other vascular access devices. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
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.
§ 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).