(32 days)
ACUVANCE PLUS Safety IV Catheter: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a selfblunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
Intravascular catheters are single use devices which provide access to veins or arteries.
The provided text describes a 510(k) Pre-Market Notification for IV catheters and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies with specific acceptance criteria as one might find for more complex software or AI-driven medical devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, I can extract the information available and indicate what is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to current material for the catheter tube | "Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material." |
| Indication for Use: Access to vein or artery | Remains the same as predicate devices; "A properly placed I.V. catheter provides access to a vein or artery." |
| Indication for Use: Single use | Remains the same as predicate devices; "The I.V. Catheter System is designed for single use." |
| Needlestick protection feature (ACUVANCE PLUS) | "risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically" |
| Minimize inadvertent needlesticks (PROTECTIV PLUS) | "a needle guard can be locked over the introducer needle" |
| Compatibility with power injectors (14-22G for ACUVANCE PLUS, 16G-24G for PROTECTIV PLUS and OPTIVA) | "may be used with power injectors up to 300 psi." |
| Any patient population consideration for size, solution, duration of therapy | Remains the same as predicate devices. |
| All other technological characteristics remain the same as predicate devices | "All other technological characteristics of the new device remain the same as those of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench testing and biocompatibility data" but does not detail the number of devices or tests performed.
- Data Provenance: Not specified. The nature of "bench testing" suggests laboratory/in-vitro testing, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This document is a 510(k) summary for a physical medical device, not a study involving expert-established ground truth for diagnostic accuracy (e.g., in imaging or pathology). The performance data cited is for material equivalence based on bench and biocompatibility tests.
4. Adjudication method for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials or studies where human expert disagreement needs resolution, particularly in diagnostic contexts. This is not described in the context of this device's performance data.
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 conventional medical device (IV catheter), not an AI-driven or diagnostic system that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a conventional medical device (IV catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the performance of the predicate device's material and the established standards for "bench testing and biocompatibility." The document implies that the new material's performance was compared directly against these established baselines and standards, rather than requiring expert consensus, pathology, or outcomes data for a diagnostic purpose.
8. The sample size for the training set
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. 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).