(103 days)
BD Nexiva closed IV catheter systems 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 be used for any patient population with consideration given to adequacy of vascular anatomy, procedure 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) when access ports not suitable for use with power injectors are removed.
BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations).
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector 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).
This document is a 510(k) summary for the BD Nexiva™ Closed IV Catheter System. It describes the device, its intended use, a comparison to predicate devices, and a summary of performance testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "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." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and states that the device met the criteria.
| Test Performed | Reported Device Performance |
|---|---|
| MaxZero Retention Rate (BD internal specification) | Met predetermined acceptance criteria |
| MaxZero Removal Torque (BD internal specification) | Met predetermined acceptance criteria |
| Flow Control Plug Retention Rate (BD internal specification) | Met predetermined acceptance criteria |
| Packaging Integrity (ASTM F2096) | Met predetermined acceptance criteria |
| Damage to Device (ISO 11607-1 §6.3.5) | Met predetermined acceptance criteria (testing conducted to ensure packaging system provides adequate protection to the product through the hazards of handling, distribution and storage) |
| Biocompatibility: Cytotoxicity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Sensitization | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Intracutaneous Reactivity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Systemic Toxicity (Acute) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Pyrogenicity (Material-Mediated Rabbit Pyrogen) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Pyrogenicity (LAL) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Subchronic Toxicity (subacute toxicity) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Genotoxicity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Implantation | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Haemocompatibility | Met predetermined acceptance criteria (leveraged from predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual performance tests listed.
The provenance of the data is not explicitly stated as a country of origin or retrospective/prospective. The tests were likely conducted in-house by Becton Dickinson or by a contracted laboratory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This study does not involve clinical data or "ground truth" established by experts in a diagnostic sense. The tests performed are engineering and biocompatibility tests for a medical device. Therefore, this question is not applicable.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring adjudication of expert opinions or diagnostic findings.
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 510(k) submission for a physical medical device (IV catheter system), not an AI/Software as a Medical Device (SaMD).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a 510(k) submission for a physical medical device.
7. The Type of Ground Truth Used
Not applicable as this is a physical medical device and the performance tests are based on engineering and biocompatibility standards, not diagnostic "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The performance tests are for device validation.
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).