(147 days)
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle cover. A MaxZero™ needle-free connector with protective cover is provided in the package. 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). These devices are available with 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).
This document (K231239) is a 510(k) Premarket Notification for the BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access. This submission aims to demonstrate substantial equivalence to a predicate device.
The provided text describes the regulatory aspects, technical characteristics, and the summary of performance testing for the device. However, it does not contain information regarding studies that establish a ground truth through expert consensus, MRMC studies, or training set details typically found in AI/ML device submissions. This is because the device in question is an IV catheter system, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system. Therefore, the concepts of "ground truth for the test set," "number of experts," "adjudication method," "effect size of human readers improving with AI," "standalone algorithm performance," and "training set details" are not applicable in this context.
The acceptance criteria here pertain to engineering and biological performance standards for medical devices, rather than accuracy metrics for AI/ML models.
Here's a breakdown of the available information relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for this physical medical device:
Acceptance Criteria and Reported Device Performance
The device manufacturer conducted various performance tests to ensure the Nexiva™ Closed IV Catheter System with NearPort™ IV Access meets predetermined design requirements and demonstrates substantial equivalence to its predicate device (BD Nexiva™ Closed IV Catheter System, K183399).
The document states that the subject devices met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence. While specific numerical outcomes of these tests are not provided in this 510(k) summary, the overall statement of meeting acceptance criteria serves as the "reported device performance."
Table of Acceptance Criteria (based on stated tests and standards):
| Performance Test Category | Specific Tests/Standards | Acceptance Criteria (Implied: Device meets all predetermined criteria as per standards) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | Demonstrates biological safety for body contact (circulating blood, limited to prolonged duration). | Achieved. |
| Sterilization | ISO 10993-7 (Residuals), ISO 11135-1 (Validation) | Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ and safe residual levels. | Achieved. |
| Packaging | ASTM D4169 | Maintains integrity and sterility of the device until use. | Achieved. |
| Catheter Performance (ISO 10555-1 and ISO 10555-5) | Peak Tensile Force | Meets required tensile strength. | Achieved. |
| Liquid Leakage | No unacceptable liquid leakage. | Achieved. | |
| Air Leakage | No unacceptable air leakage. | Achieved. | |
| Gravity Flow Rate | Achieves specified flow rates. | Achieved. | |
| Power Injection Flow Rate | Achieves specified flow rates under power injection conditions (up to 300 psi for 24-18 GA). | Achieved. | |
| Needle Safety | ISO 23908 | Demonstrates effective needle tip protection. | Achieved. |
| Luer Connections | ISO 594-1 and ISO 594-2 | Ensures secure and leak-free Luer connections. | Achieved. |
| BD Internal Studies | Catheter tubing open flow pressure | Meets internal performance specifications. | Achieved. |
| Catheter tubing rupture pressure | Withstands specified pressure without rupture. | Achieved. | |
| System burst | Withstands specified pressure without bursting. | Achieved. | |
| Catheter adapter separation force | Meets required separation force. | Achieved. | |
| Extension tubing detachment force | Meets required detachment force. | Achieved. | |
| Wing bending force | Withstands specified bending force. | Achieved. | |
| Needle cover removal force | Meets specified removal force. | Achieved. | |
| Needle cover retention | Meets specified retention. | Achieved. | |
| Flow control plug retention rate | Meets specified retention rate. | Achieved. | |
| MR Compatibility | ASTM F2182-19, FDA Guidance for MR Environment Medical Devices (May 2021) | Demonstrates safety in MR environment. | Achieved. |
| Microbial Ingress | Intravascular Administration Sets Premarket Notification Submissions [510(k)] Guidance (July 2008) | Prevents unacceptable microbial ingress. | Achieved. |
| Usability | Applying Human Factors and Usability Engineering to Medical Devices Guidance (February 2016) | Demonstrated safe and effective use by intended users. | Achieved. |
Study Details (as applicable to a physical medical device)
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Sample sizes used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes (e.g., number of units tested) for each performance test. It refers to "performance tests completed on the subject devices."
- Data Provenance: The studies were conducted by Becton Dickinson Infusion Therapy Systems Inc., based in Sandy, Utah, USA. The data is from internal performance verification testing ("BD Internal Studies") and compliance testing to international (ISO, ASTM) and national (FDA guidance) standards. The studies would be considered prospective as they were conducted specifically for this submission to demonstrate compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device (IV catheter), not an AI/ML diagnostic. "Ground truth" in this context refers to engineering specifications and performance standards established by organizations like ISO, ASTM, and FDA. The "experts" involved would be engineers, scientists, and regulatory affairs professionals ensuring the device meets these pre-defined physical and functional requirements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in subjective interpretation tasks (e.g., radiology image review) to establish consensus ground truth. For objective physical performance tests (e.g., tensile strength, flow rate), the results are quantitative and do not require expert adjudication in this manner. Compliance is determined by meeting numerical or descriptive criteria within established standards.
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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:
- No, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic devices where human readers interpret medical images. This document is for a physical IV catheter; AI assistance for human readers is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI algorithm. Its performance is tested as a standalone physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and quality standards, including:
- International Standards (ISO 10993, ISO 10555, ISO 23908, ISO 594, ISO 11135, ISO 14971)
- ASTM Standards (ASTM D4169, ASTM F2182)
- FDA Guidance Documents (e.g., for Usability, Microbial Ingress, MR Compatibility)
- Internal design requirements and specifications, which are based on the above standards and common medical device engineering principles.
- "Ground truth" is not based on expert consensus for subjective interpretation or pathology/outcomes data in the way it would be for a diagnostic tool.
- The "ground truth" for this device's performance is established by engineering and quality standards, including:
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The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a non-AI/ML device, ground truth establishment for it is irrelevant.
§ 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).