(30 days)
BD Cathena Safety 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 catheters 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 catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These 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. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey). These devices are not made with natural rubber latex.
This document describes a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter, demonstrating its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or comparative effectiveness against human readers, as it is a physical medical device. The acceptance criteria and "study" described refer to various design verification tests and compliance with recognized standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests and standards compliance that serve as the acceptance criteria. The reported device performance is that it met all predetermined acceptance criteria.
| Acceptance Criteria (Performance Tests) | Reported Device Performance |
|---|---|
| Package maintains integrity | Met all predetermined acceptance criteria |
| Needle cover does not fall off | Met all predetermined acceptance criteria |
| Force to remove needle cover | Met all predetermined acceptance criteria |
| Incremental force to decouple shielded needle from catheter adapter during safety activation | Met all predetermined acceptance criteria |
| System penetration force | Met all predetermined acceptance criteria |
| Needle to needle hub pull force | Met all predetermined acceptance criteria |
| Time to visualize flashback in flash chamber | Met all predetermined acceptance criteria |
| Catheter average drag force | Met all predetermined acceptance criteria |
| Force to break adhesion between catheter unit and needle (initial adhesion) | Met all predetermined acceptance criteria |
| Force to remove needle from catheter unit (average system drag) | Met all predetermined acceptance criteria |
| Force to prematurely decouple tip-shield from adapter | Met all predetermined acceptance criteria |
| Needle is not re-exposed upon application of compressive force | Met all predetermined acceptance criteria |
| Tensile force to defeat safety system | Met all predetermined acceptance criteria |
| No air leakage from device in a connected state at low pressure less than 30 psi | Met all predetermined acceptance criteria |
| Device burst pressure | Met all predetermined acceptance criteria |
| Catheter separation force | Met all predetermined acceptance criteria |
| Blood escape time | Met all predetermined acceptance criteria |
| Force to connect Luer to catheter adapter | Met all predetermined acceptance criteria |
| Time to visualize flashback in catheter adapter | Met all predetermined acceptance criteria |
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| Gauging (ISO 594-1) | Met all predetermined acceptance criteria |
| Liquid leakage (ISO 594-1,-2, ISO 10555-1) | Met all predetermined acceptance criteria |
| Air leakage (ISO 594-1,-2) | Met all predetermined acceptance criteria |
| Separation force (ISO 594-1.-2) | Met all predetermined acceptance criteria |
| Stress cracking (ISO 594-2) | Met all predetermined acceptance criteria |
| Unscrewing torque (ISO 594-2) | Met all predetermined acceptance criteria |
| Ease of assembly (ISO 594-2) | Met all predetermined acceptance criteria |
| Resistance to overriding (ISO 594-2) | Met all predetermined acceptance criteria |
| Radio detectability (ISO 10555-1) | Met all predetermined acceptance criteria |
| Surface (ISO 10555-1. -5) | Met all predetermined acceptance criteria |
| Corrosion resistance (ISO 10555-1) | Met all predetermined acceptance criteria |
| Peak tensile force (ISO 10555-1) | Met all predetermined acceptance criteria |
| Flow rate (ISO 10555-1) | Met all predetermined acceptance criteria |
| Power injection (ISO 10555-1) | Met all predetermined acceptance criteria |
| Distal tip (ISO 105551-1) | Met all predetermined acceptance criteria |
| Needle point (ISO 10555-5) | Met all predetermined acceptance criteria |
| Strength of union between needle hub and needle tube (ISO 10555-5) | Met all predetermined acceptance criteria |
| Vent fitting (ISO 10555-1) | Met all predetermined acceptance criteria |
| Activation of the sharps injury protection feature (ISO 23908) | Met all predetermined acceptance criteria |
| Security of safe mode protection (ISO 23908) | Met all predetermined acceptance criteria |
| Biocompatibility (ISO 10993-1:2009) | Met all predetermined acceptance criteria |
| Simulated clinical use testing (FDA Guidance, IEC 62366-1:2015) | Met all predetermined acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each of the performance or standards tests. It generically states "Performance tests completed on the subject device were those tests required to support a determination of substantial equivalence to the predicate devices. Design verification tests were performed based on the risk analysis." It also does not specify the origin of any data (e.g., country of origin, retrospective/prospective), as these are laboratory and simulated use tests rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study involving human interpretation of medical images or data requiring expert ground truth in that sense. The "ground truth" for these tests would be derived from physical measurements and adherence to engineering specifications and international standards.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective physical or material property measurements, and standards compliance. There is no mention of adjudication among multiple evaluators.
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 a physical medical device (intravenous catheter and safety mechanism), not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the tests mentioned are:
- Engineering Specifications: The design specifications for the device, including dimensions, forces, pressures, and other physical properties.
- International Standards: Adherence to recognized international standards such as ISO 594, ISO 10555, ISO 23908, and ISO 10993 for various aspects like gauging, leakage, mechanical strength, sharps injury protection, and biocompatibility.
- Risk Analysis Outcomes: The design verification tests were performed based on a risk analysis, meaning acceptance criteria were likely set to mitigate identified risks.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of physical medical device design verification described here. The development of the device involves engineering design, prototyping, and iterative testing, not machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).