(142 days)
The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.
The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.
The catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the introducer needle is withdrawn following blood vessel puncture. The introducer needle is retracted into the telescope casing to prevent needle stick injury.
This document is a 510(k) Premarket Notification for the Supercath Z3V intravascular catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the way one might expect for a novel diagnostic or AI-driven device.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm) are not applicable or not provided in this type of submission. This document highlights a regulatory pathway based on showing similarity to already approved devices, not necessarily a de novo clinical validation study with specific performance metrics.
Here's the information that can be extracted from the provided text, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of intended use and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is sufficiently similar to the predicate devices. There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text.
| Factor | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in comparison) |
|---|---|---|
| Same Intended Use | Must be "Yes" | Yes |
| Polyurethane Catheter | Must be "Yes" | Yes |
| Radiopaque Catheter | Must be "Yes" | Yes |
| Flashback Visualization | Must be "Yes" | Yes |
| Needle stick Injury Prevention Feature | Must be "Yes" | Yes |
| Hemostatic Valve | Can be "Yes" or "No" (technological difference allowed if not raising new safety/effectiveness questions) | Yes |
| EtO Sterilized | Must be "Yes" | Yes |
| Single Sterile Wrapped | Must be "Yes" | Yes |
| Multiple gauge Sizes and Needle Lengths | Must be "Yes" | Yes |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This is not a study that involved a test set of data in the context of diagnostic performance. The substantial equivalence is based on device design, materials, and intended use comparison.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.
4. Adjudication method for the test set
- Not applicable.
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 device is an intravascular catheter, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The Supercath Z3V aims to show it is equivalent.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).