(51 days)
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's 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 performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device
This document is a 510(k) summary for the BD Nexiva Diffusics Closed IV Catheter System (K173354). It describes a modification to an existing device (predicate device K170283), specifically a change in the extension tubing polyurethane material formulation and manufacturer. The submission aims to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria (Implicit from "met all predetermined acceptance criteria") | Reported Device Performance |
|---|---|---|---|
| Performance Testing | No Leak after Repeated Bending Cycles | No leaks after specified bending cycles. | Met predetermined acceptance criteria. |
| Extension Set Pull Force | Withstand specified pull force without failure. | Met predetermined acceptance criteria. | |
| Extension Tube Yield / Rupture Pressure | Withstand specified pressure without yield or rupture. | Met predetermined acceptance criteria. | |
| Pinch Clamp Vacuum Occlusion | Achieve specified occlusion under vacuum conditions. | Met predetermined acceptance criteria. | |
| Pinch Clamp Engagement Force | Engage with specified force. | Met predetermined acceptance criteria. | |
| Biocompatibility Testing (per ISO 10993-1:2009) | Cytotoxicity | Non-cytotoxic. | Met predetermined acceptance criteria. |
| Sensitization | Non-sensitizing. | Met predetermined acceptance criteria. | |
| Intracutaneous Reactivity | Non-reactive intracutaneously. | Met predetermined acceptance criteria. | |
| Systemic Toxicity (Acute) | Non-systemically toxic in acute exposure. | Met predetermined acceptance criteria. | |
| Material-Mediated Pyrogenicity | Non-pyrogenic. | Met predetermined acceptance criteria. | |
| Subchronic Toxicity (subacute toxicity) | Non-toxic in subchronic exposure. | Met predetermined acceptance criteria. | |
| Haemocompatibility | Compatible with blood. | Met predetermined acceptance criteria. | |
| Material/Physical Properties | Particulate Analysis (surface and fluid path) | Meet clinically relevant limits per USP . | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each test. It broadly mentions "Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices." It also states, "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device."
- Sample size: Not explicitly stated. The tests are industrial-standard tests for medical device components.
- Data provenance: Not explicitly stated, though it implicitly refers to "design verification" and "risk analysis" conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc. The testing results are presented as having met internal, pre-determined criteria. Given the nature of a 510(k) submission for a material change, the testing would be prospective for the modified component.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and submission. The tests are physical, chemical, and biological performance tests for a medical device, not clinical studies requiring expert interpretation of outcomes. The "ground truth" is defined by the technical specifications and standards (e.g., ISO 10993-1, USP ) that the device must meet.
4. Adjudication Method for the Test Set
This information is not applicable. The nature of the tests (e.g., measuring pull force, pressure, or biological response) does not involve adjudication by human readers or experts in the sense of clinical image interpretation or diagnostics. The results are objective measurements compared against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a Class II medical device (intravascular catheter) involving a material change. MRMC studies are typically associated with diagnostic imaging devices where human interpretation is a key component of the clinical workflow.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is derived from engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility, USP for particulate analysis), and internal design requirements developed by BD according to 21 CFR 820.30 Design Controls. These objective criteria define what constitutes acceptable performance for the device and its material components.
8. The Sample Size for the Training Set
This information is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this 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).