(89 days)
A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.
The Via Valve™ Safety I.V. Catheter provides access to a vein or artery. The ViaValve™ Safety I. V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain oven after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve™ Safety.I.V. Catheter is threaded into the vessel to help reduce the risk of accidental rieedlesticks.
The provided text describes the ViaValve™ Safety I.V. Catheter, an intravascular catheter designed to reduce blood exposure during placement and prevent accidental needlesticks.
Here's an analysis of the acceptance criteria and supporting studies based on the provided information, organized according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Similar Performance to Predicates | Equivalence to predicate devices based on applicable standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features". | Confirmed through bench testing and ISO standard compliance testing. |
| Blood Exposure Reduction | Valve inside the catheter hub designed to reduce blood exposure during initial catheter placement. | "Equivalent to the blood control feature of the predicate BD Insyte" Autoguard " BC catheter." |
| Accidental Needlestick Prevention | Needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. | "Employs the same technology as the Smiths Medical predicate ProtectIV® Plus Catheter" and confirmed in "simulated clinical use studies" that the needle was shielded after use. |
| Safe and Effective Use | Device can be used safely and effectively. | Confirmed through "simulated clinical use studies" and "Human Factors Engineering (HFE) and Usability testing," which concluded the device was "adequately safe and effective for its intended users, uses and use environments." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for any specific "test set" in terms of how many devices were tested or how many participants were involved in the usability studies.
- Bench Testing & ISO Standard Compliance Testing: No sample size or specific data provenance (e.g., country of origin) is mentioned. This testing is inherently retrospective in nature, as it evaluates the manufactured product.
- Simulated Clinical Use Studies: No specific sample size is provided. The nature of "simulated clinical use" implies prospective data collection in a controlled environment, likely within the manufacturing country (USA, given the company information).
- Human Factors Engineering (HFE) and Usability Testing: No specific sample size is provided. This is typically prospective data collection involving human participants. The provenance is not explicitly stated but would likely be within the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of "experts" to establish ground truth in the context of the device's technical or clinical performance. The evaluation relies on:
- Bench testing: Against established ISO standards and FDA guidance.
- Simulated clinical use: To confirm operational aspects like needle shielding.
- Human Factors/Usability testing: To assess user interaction for safety and effectiveness.
Therefore, there is no information provided about a specific number of experts or their qualifications for establishing a "ground truth" as it might be understood in an AI/diagnostic context (e.g., radiologists interpreting images).
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned. This type of method is typically used in studies involving expert interpretation of data (like medical images) where there might be inter-reader variability, which is not the primary focus of the described device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not reported. The information describes testing to demonstrate substantial equivalence to predicate devices and confirm safety and effectiveness, not to compare the performance of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the described medical device. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in its function as a physical catheter, evaluated through bench and simulated clinical tests.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Compliance with validated standards: ISO standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features."
- Engineering specifications and design intent: For features like blood control and needle-stick prevention, confirmed through testing.
- Usability metrics: Derived from Human Factors and Usability testing to ensure the device is "adequately safe and effective for its intended users, uses and use environments."
There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for the device's fundamental function.
8. The Sample Size for the Training Set
This question is not applicable. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this physical 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).