(141 days)
The VantageCath™ is a short-term intravascular catheter which allows health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy.
The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated.
The VantageCath™ is a short-term intravascular catheter that includes a needle-shielding feature. After threading the catheter into the vein, the sharps safety feature is activated and the needle is retracted into the cylindrical needle shield. The catheter hub and needle assembly components are automatically separated.
It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by providing a sharps safety feature, thus minimizing the opportunity for accidental needle sticks.
It is supplied sterile for single use only.
The provided document is a 510(k) premarket notification for the VantageCath™ intravascular catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (biocompatibility, mechanical performance, etc.). It is not a clinical study report for an AI/ML medical device, and therefore does not contain information about acceptance criteria for an algorithm, study design to prove performance, ground truth, or expert review panels typically associated with such devices.
Based on the provided text, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes nonclinical testing related to biocompatibility and device function, but it does not specify quantitative acceptance criteria or performance metrics in the way an AI/ML device submission would (e.g., sensitivity, specificity, AUC).
Instead, the closest equivalent is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility standards (e.g., ISO 10993-1, FDA G95-1) | "All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part- 10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by Edwards Lifesciences LLC Quality Laboratory. The studies indicate that the VantageCath™ is biocompatible and safe for its intended use." |
| Functionality (e.g., needle shielding mechanism operates) | "The VantageCath™ is an intravascular catheter that allows the health care practitioner to sample blood and administer fluids or medication intravenously...The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated." |
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. The "test set" in this context would refer to the samples used for biocompatibility and mechanical testing (e.g., material samples for cytotoxicity, irritation, sensitization; multiple units of the device for functional testing). The document does not specify the number of samples used for these nonclinical tests or their provenance.
- This document is not about an AI/ML device that uses patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" as understood in AI/ML validation (e.g., expert consensus on image findings, pathology reports) is not a concept relevant to the nonclinical testing described here. Biocompatibility and functional tests rely on predefined methods and measurable endpoints, interpreted by laboratory personnel and engineers, rather than expert diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human reviewers establishing ground truth for AI/ML performance studies. This is not pertinent to the nonclinical testing described.
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:
- No. This is not an AI/ML device, and an MRMC study was not conducted. The device (VantageCath™) is a physical intravascular catheter with a mechanical needle-shielding feature.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no algorithm. The device is a physical catheter.
7. The type of ground truth used:
- Not applicable. As noted above, "ground truth" in the AI/ML context is not relevant. The "ground truth" for the nonclinical tests would be the established scientific and regulatory standards for biocompatibility (e.g., absence of cytotoxicity, irritation) and engineering specifications for device function.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so 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).