(251 days)
The SUPERCATH Z3V is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks.
The SUPERCATH Z3V (PROPOSED) is an intravascular catheter and is available in following eight models.
- with a check valve
- with a wing
- with a filter adapter
- with a check valve and a wing
- with a check valve and a filter adapter
- with a wing and a filter adapter
- with a check valve, a wing, and a filter adapter
- without a check valve, a wing, or a filter adapter
The SUPERCATH Z3V (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V (PROPOSED) is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks by the safety system. In the safety system, the metallic introducer needle is retracted into the extendable needle casing.
The SUPERCATH Z3V (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely.
Some of the SUPERCATH Z3V (PROPOSED) has a filter adapter. The filter adapter can be removed and the SUPERCATH Z3V (PROPOSED) can be connected to a syringe in place of the filter adapter, under negative pressure and assist visual confirmation of blood access.
The SUPERCATH Z3V (PROPOSED) is available in 14G, 18G, 20G, 22G, and 24G.
The provided text is a 510(k) summary for a medical device (intravascular catheter) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device with specific performance metrics and a clinical study as typically described for such products.
Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable to this document as it describes a non-AI/ML medical device.
I will extract the relevant information available for this type of device (bench testing and a simulated clinical study for a sharps injury prevention feature).
Here's the analysis of the provided text, focusing on the available information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
For non-AI/ML devices like this catheter, performance is typically demonstrated through compliance with established international standards (e.g., ISO) and in-house standards through bench testing. The document lists several bench tests and their outcomes.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Tensile Strength for the Catheter (ISO 10555-1) | Meets acceptable minimum force until breakage. |
| Tensile Strength for the Wing (in-house standard) | Meets acceptable minimum force until breakage. |
| Air and Liquid Leakage for the Hub Attachment (ISO 10555-1) | Impervious to air/liquid infiltration under positive pressure and aspiration. |
| Flow rate (ISO 10555-5) | Meets allowable limits, compliant with ISO standard and comparable to predicate. |
| Leakage at the Check Valve under pressure (in-house standard) | Impervious to liquid infiltration under positive pressure. |
| Leakage (Liquid) from vent fitting (ISO 10555-5) | Impervious to liquid infiltration under positive pressure. |
| Biocompatibility Testing: | |
| Cytotoxicity | No biocompatibility concern raised. |
| Intracutaneous reactivity | No biocompatibility concern raised. |
| Delayed hypersensitivity | No biocompatibility concern raised. |
| Acute Systemic Toxicity | No biocompatibility concern raised. |
| Pyrogen test | No biocompatibility concern raised. |
| LAL test | No biocompatibility concern raised. |
| Leachable test | No biocompatibility concern raised. |
| Sharps Injury Prevention Feature (Simulated Clinical Study): | Statistically significant safety feature confirmed for sharp needle injury prevention. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document states "All SUPERCATH Z3V (PROPOSED) samples were compliant..." but does not specify the sample size for each bench test.
- Simulated Clinical Study (Sharps Injury Prevention Feature): The document mentions a "Simulated Clinical Use of Study" was performed to confirm a statistically significant safety feature. However, no specific sample size or data provenance (country of origin, retrospective/prospective) is provided for this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. For a medical device like an intravascular catheter, "ground truth" established by experts in the context of clinical interpretation (e.g., reading images) is not relevant. The performance is assessed via engineering tests and biological safety tests.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No. An MRMC study is relevant for diagnostic imaging devices where multiple readers interpret cases. This document describes an intravascular catheter, not an AI/ML diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device, so there is no "algorithm only" performance to evaluate. The device is a physical, mechanical product.
7. The Type of Ground Truth Used
- For Bench Testing: The "ground truth" is typically defined by the ISO standards or in-house engineering specifications that dictate acceptable performance limits (e.g., minimum tensile strength, maximum leakage).
- For Biocompatibility Testing: The "ground truth" reflects the absence of adverse biological reactions as assessed by standard biological safety tests (e.g., cytotoxicity, irritation).
- For Sharps Injury Prevention Feature: The "ground truth" would be the quantifiable reduction in simulated needlesticks compared to a control or a defined safety threshold. The study confirmed a "statistically significant safety feature."
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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).