(43 days)
The BD Noxiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to mo be Norte - binonice of administer fluids. The BD Nextra Diffusics catheters are suitable for use with power injectors when a direct connection is made. The maximum flow rate and maximum power injector pressure setting for each catheter size are listed in the table below:
| | Max Flow Rate
(ml/sec) | Max Injector Setting
(psi) |
|-----------------|---------------------------|-------------------------------|
| 24 GA x 0.75 IN | 3.0 | 325 |
| 22 GA x 1.00 IN | 6.5 | 325 |
| 20 GA x 1.00 IN | 10.0 | 325 |
| 20 GA x 1.25 IN | 10.0 | 325 |
| 18 GA x 1.25 IN | 15.0 | 325 |
The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and Luer adapter are color-coded.
Here's a breakdown of the acceptance criteria and study information for the BD Nexiva™ Diffusics™ Closed IV Catheter System, based on the provided text:
Important Note: The provided text is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some of the requested information (like specific sample sizes for training/test sets, data provenance for clinical studies, number/qualifications of experts for ground truth, and MRMC study details) is not present in this type of regulatory document. The responses below reflect what can be extracted from the given text.
Acceptance Criteria and Reported Device Performance
The core of the study described here is to demonstrate that the modified BD Nexiva™ Diffusics™ Closed IV Catheter System meets predetermined requirements, particularly in relation to its maximum flow rate specifications. The provided document doesn't list specific acceptance criteria as distinct quantitative metrics beyond the specified flow rates and pressure.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Mechanical Performance (Maximum Flow Rate for Power Injection): | |
| 24 GA x 0.75 IN Catheter: Max Flow Rate (ml/sec) | 3.0 ml/sec |
| 22 GA x 1.00 IN Catheter: Max Flow Rate (ml/sec) | 6.5 ml/sec |
| 20 GA x 1.00 IN Catheter: Max Flow Rate (ml/sec) | 10.0 ml/sec |
| 20 GA x 1.25 IN Catheter: Max Flow Rate (ml/sec) | 10.0 ml/sec |
| 18 GA x 1.25 IN Catheter: Max Flow Rate (ml/sec) | 15.0 ml/sec |
| Mechanical Performance (Maximum Injector Pressure Setting): | |
| All Catheter Sizes: Max Injector Setting (psi) | 325 psi |
| General Safety and Performance: | Met all predetermined acceptance criteria |
| Compliance with 21 CFR 820.30 (Design Controls) | Compliant |
| Compliant with ISO 14971:2009 (Risk Management) | Compliant |
| Compliant with various ISO and ANSI/AAMI standards (listed in the text) | Compliant |
| No new questions regarding safety or effectiveness (vs. predicate device) | Demonstrated; substantially equivalent to predicate device |
Study Information
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample sizes used for the "design verification and validation" testing.
- Data Provenance: Not specified. As a 510(k) submission, the data is typically generated internally by the manufacturer through laboratory and engineering tests, rather than a multi-center clinical trial with patient data. It is implied to be prospective testing carried out for regulatory submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. The "testing" primarily involves engineering and performance verification against established standards and internal protocols, not interpretation by medical experts.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No adjudication method is mentioned as the testing is performance-based and objective against specified metrics.
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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. This is a medical device clearance for an IV catheter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effectiveness are not relevant or described.
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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 algorithmic or AI 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 specifications, recognized national and international standards (e.g., ISO, ANSI/AAMI), and internal protocols. For example, the maximum flow rates are determined through physical testing in a laboratory setting, not through expert consensus or clinical outcomes data in the context of this 510(k) summary.
-
The sample size for the training set:
- Not applicable/Not specified. This is a traditional medical device, and the concept of a "training set" in the context of machine learning or AI is not relevant here. Device design and validation follow a different paradigm (design controls, risk analysis, verification/validation testing).
-
How the ground truth for the training set was established:
- Not applicable. (See point 7).
§ 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).